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Background Surgical interventions are complex, with multiple components that require consideration in trial reporting. This review examines the reporting of details of surgical interventions in randomized clinical trials ( RCTs) within the context of explanatory and pragmatic study designs. Methods Systematic searches identified RCTs of surgical interventions published in 2010 and 2011. Included studies were categorized as predominantly explanatory or pragmatic. The extent of intervention details in the reports were compared with the CONSORT statement for reporting trials of non-pharmacological treatments ( CONSORT-NPT). CONSORT-NPT recommends reporting the descriptions of surgical interventions, whether they were standardized and adhered to (items 4a, 4b and 4c). Reporting of the context of intervention delivery (items 3 and 15) and operator expertise (item 15) were assessed. Results Of 4541 abstracts and 131 full-text articles, 80 were included (of which 39 were classified as predominantly pragmatic), reporting 160 interventions. Descriptions of 129 interventions (80·6 per cent) were provided. Standardization was mentioned for 47 (29·4 per cent) of the 160 interventions, and 22 articles (28 per cent) reported measurement of adherence to at least one aspect of the intervention. Seventy-one papers (89 per cent) provided some information about context. For one-third of interventions (55, 34·4 per cent), some data were provided regarding the expertise of personnel involved. Reporting standards were similar in trials classified as pragmatic or explanatory. Conclusion The lack of detail in trial reports about surgical interventions creates difficulties in understanding which operations were actually evaluated. Methods for designing and reporting surgical interventions in RCTs, contributing to the quality of the overall study design, are required. This should allow better implementation of trial results into practice. [ABSTRACT FROM AUTHOR]

Background: Since 1977, restorative proctocolectomy with ileoanal anastomosis (IAA) has evolved into the surgical treatment of choice for most patients with intractable ulcerative colitis. Construction of an ileal pouch reservoir is now standard, usually in the form of a J pouch (IPAA). The aim of this report is to review selection criteria for, and functional outcomes, follow-up and management of complications of IPAA after 30 years of widespread clinical application. Methods and results: Literature published in English on the clinical indications, surgical technique, morbidity, complications and outcome following IAA and IPAA was sourced by electronic search, performed independently by two reviewers who selected potentially relevant papers based on title and abstract. Additional articles were identified by cross-referencing from papers retrieved in the initial search. Conclusion: The functional results of IPAA are good. Pouchitis, irritable pouch syndrome and cuffitis are specific long-term complications but rarely result in failure. Pouch salvage is possible in selected patients with poor functional outcomes. One-stage operations are increasingly performed. [ABSTRACT FROM AUTHOR]

Presents correspondence on results of randomized controlled trials of methods of groin hernia repair. Comparison of mesh versus non-mesh methods; Comparison of laparoscopic versus open methods; Complication rate; Safety parameters; Complications.

Background Recruitment into surgical RCTs can be threatened if new interventions available outside the trial compete with those being evaluated. Adapting the trial to include the new intervention may overcome this issue, yet this is not often done in surgery. This paper describes the challenges, rationale and methods for adapting an RCT to include a new intervention. Methods The By-Band study was designed in the UK in 2009-2010 to compare the effectiveness of laparoscopic adjustable gastric band and Roux-en- Y gastric bypass for severe obesity. It contained a pilot phase to establish whether recruitment was possible, and the grant proposal specified that an adaptation to include sleeve gastrectomy would be considered if practice changed and recruitment was successful. Information on changing obesity surgery practice, updated evidence and expert opinion about trial design were used to inform the adaptation. Results The pilot phase recruited over 13 months in 2013-2014 and randomized 80 patients (79 anticipated). During this time, major changes in obesity practice in the UK were observed, with gastric band reducing from 32·6 to 15·8 per cent and sleeve gastrectomy increasing from 9·0 to 28·1 per cent. The evidence base had not changed markedly. The British Obesity and Metabolic Surgery Society and study oversight committees supported an adaptation to include sleeve gastrectomy, and a proposal to do so was approved by the funder. Conclusion Adaptation of a two-group surgical RCT can allow evaluation of a third procedure and maintain relevance of the RCT to practice. It also optimizes the use of existing trial infrastructure to answer an additional important research question. Registration number: ISRCTN00786323 (/). [ABSTRACT FROM AUTHOR]

Background Anastomotic leak ( AL) represents a dreaded complication following colorectal surgery, with a prevalence of 1-19 per cent. There remains a lack of consensus regarding factors that may predispose to AL and the relative risks associated with them. The objective was to perform a systematic review of the literature, focusing on the role of preoperative, intraoperative and postoperative factors in the development of colorectal ALs. Methods A systematic review was performed to identify adjustable and non-adjustable preoperative, intraoperative and postoperative factors in the pathogenesis of AL. Additionally, a severity grading system was proposed to guide treatment. Results Of 1707 papers screened, 451 fulfilled the criteria for inclusion in the review. Significant preoperative risk factors were: male sex, American Society of Anesthesiologists fitness grade above II, renal disease, co-morbidity and history of radiotherapy. Tumour-related factors were: distal site, size larger than 3 cm, advanced stage, emergency surgery and metastatic disease. Adjustable risk factors were: smoking, obesity, poor nutrition, alcohol excess, immunosuppressants and bevacizumab. Intraoperative risk factors were: blood loss/transfusion and duration of surgery more than 4 h. Stomas lessen the consequences but not the prevalence of AL. In the postoperative period, CT is the most commonly used imaging tool, with or without rectal contrast, and a C-reactive protein level exceeding 150 mg/l on day 3-5 is the most sensitive biochemical marker. A five-level classification system for AL severity and appropriate management is presented. Conclusion Specific risk factors and their potential correction or indications for stoma were identified. An AL severity score is proposed to aid clinical decision-making. [ABSTRACT FROM AUTHOR]

Copyright of British Journal of Surgery is the property of Oxford University Press / USA and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Background: Thoracic epidural anaesthesia (TEA) is used widely in colorectal surgery. However, there is increasing concern that epidurals are associated with postoperative hypotension, mediating a potential reduction in splanchnic flow. The aim was to review the literature on the effects of TEA on splanchnic blood flow. Methods: PubMed and Cochrane databases were searched. Search terms used were: English language, 'thoracic epidural splanchnic flow', 'thoracic epidural gut blood flow', 'thoracic epidural intestinal blood flow' and 'thoracic epidural colonic blood flow'. Abstracts were reviewed by two independent researchers and irrelevant studies excluded. The full text of the remaining articles was then retrieved. Results: Twenty-two abstracts were reviewed and three excluded. Nineteen papers were reviewed in full and seven irrelevant articles excluded. Five human studies investigated the effects of TEA on splanchnic flow. Two studies measured splanchnic flow directly and found an epidural-mediated fall in flow, unresponsive to intravenous fluids and requiring vasopressors or inotropes to restore baseline flow. The remaining three studies had inconsistent findings and haemodynamic stability was maintained. The seven animal studies identified were heterogeneous in both methodology and findings. Three suggested a protective role for thoracic epidurals in septic shock and pancreatitis. Conclusion: These findings are inconsistent; however, the two studies that investigated the effects of vasoconstrictors on splanchnic blood flow directly both found a significant epidural-mediated reduction in splanchnic blood flow that was unresponsive to fluid therapy. Copyright © 2012 British Journal of Surgery Society Ltd. Published by John Wiley & Sons, Ltd. [ABSTRACT FROM AUTHOR]

Background: Stapled haemorrhoidopexy is a well recognized alternative to haemorrhoidectomy, and is associated with reduced pain and earlier return to normal activity. This paper reports all published cases of life-threatening sepsis following stapled haemorrhoidopexy, identifies causative factors and makes recommendations. Methods: A systematic review of the literature was performed by searching the major electronic databases. All relevant references were reviewed for possible inclusion. All references of the relevant articles were screened for any further articles that were not identified in the initial search. Results: From 2000 to the present, 29 articles reporting complications in 40 patients were identified. Thirty-five patients underwent laparotomy with faecal diversion and a further patient was treated by low anterior resection. A specific complication was rectal perforation with peritonitis. Factors that led to life-threatening sepsis were identified in 30 patients. Despite surgical treatment and resuscitation, there were four deaths. Conclusion: Severe sepsis can complicate stapled haemorrhoidopexy. Rectal perforation and peritonitis are a particular risk of this technique and the associated mortality rate is high. Copyright © 2012 British Journal of Surgery Society Ltd. Published by John Wiley & Sons, Ltd. [ABSTRACT FROM AUTHOR]

Background: Pilonidal disease is a common and usually minor disease. Although wide excisional surgery has been common practice, there are more simple alternatives. This review focused on the aetiology and management of pilonidal disease. Methods: A comprehensive review of the literature on pilonidal disease was undertaken. MEDLINE searches for all articles listing pilonidal disease (1980-2010) were performed to determine the aetiology and results of surgical and non-surgical treatments. Single papers describing new techniques or minor modifications of established techniques were excluded. Further articles were traced through reference lists. Results: Patients with minimal symptoms and those having drainage of a single acute abscess can be treated expectantly. Non-surgical treatments may be of value but their long-term results are unknown. There is no rational basis or need for wide excision of the abscess and sinus. Simple removal of midline skin pits, the primary cause of pilonidal disease, with lateral drainage of the abscess and sinus is effective in most instances. Hirsute patients with extensive primary disease and deep natal clefts, or with recurrent disease and unhealed midline wounds, may also require flattening of the natal cleft with off-midline skin closure. These more conservative procedures are usually done as a day case, require minimal care in the community and are associated with a rapid return to work. They also avoid the occasional debilitating complications of surgical treatment. Conclusion: Simple day-case surgery to eradicate midline skin pits without wide excision of the abscesses and sinus is rational, safe and effective for patients with pilonidal sinus disease. Copyright © 2010 British Journal of Surgery Society Ltd. Published by John Wiley & Sons, Ltd. [ABSTRACT FROM AUTHOR]

Background: This study aims to establish the risk of developing a metachronous contralateral inguinal hernia (MCIH) following open repair of a unilateral inguinal hernia in children. Methods: A systematic review was performed using a defined search strategy. Studies in which children undergoing open repair of a unilateral inguinal hernia without contralateral exploration and who were followed up for MCIH development were included. Results: Of 5937 titles and abstracts screened, 154 full-text articles were identified for review; 49 papers were analysed with data on 22 846 children. The incidence of MCIH was 7.2 per cent overall, 6.9 per cent in boys and 7.3 per cent in girls (P = 0.381). Children with a left-sided inguinal hernia had a significantly higher risk of developing a MCIH than those with a right-sided hernia (10.2 versus 6.3 per cent respectively; P < 0.001). Conclusion: Overall, in both boys and girls, 14 contralateral explorations are required to prevent one metachronous hernia. The risk of developing a MCIH appears unchanged in early childhood, with a slight reduction after 12 years of age. Children with a left-sided hernia have the greatest risk of developing a contralateral hernia, but ten explorations are still required to prevent one metachronous hernia. Most MCIHs occur in the first 5 years after unilateral inguinal hernia repair. [ABSTRACT FROM AUTHOR]

Background: This systematic review examined the use of immunomodulators and the risk of postoperative complications after abdominal surgery in patients with inflammatory bowel disease. Methods: Electronic databases (PubMed, Embase, Ingenta, Zetoc and Ovid) were searched and the reference lists in all articles identified were hand-searched for further relevant papers. Studies were included if they evaluated postoperative complications and defined exposure to individual immunomodulators. Results: All 11 studies that met the inclusion criteria were observational studies; two were reported only in abstract form. Five studies reported risks associated with azathioprine, five reported risks associated with cyclosporin and three reported risks associated with infliximab. None showed an increased risk of either total or infectious complications associated with immunomodulator use. However, subgroup analysis in one study, published as an abstract, suggested increased rates of anastomotic complications and reoperation associated with azathioprine. Conclusion: Available evidence does not suggest an increased rate of postoperative complications associated with immunomodulator use. [ABSTRACT FROM AUTHOR]

Presents the abstracts of several papers on endocrine surgery presented to the 2003 Annual Meeting of the British Association of Endocrine Surgeons. "Cancellations For Thyroid Surgery: Unacceptable to Everyone," by R. Hughes, P.M. Mackey, A. Asderakis and D.M. Scott-Coombes; "Does Thyroidectomy Exacerbate or Relieve Globus Pharyngeus?," by D. Mather, S.L. Atkin and R.J.A. England; "Osteoprotegerin is a Survival Factor for Thyroid Cancer Cells In Vitro," by J.L. Scoffiled, B.J. Harrison and C.L. Eaton.

Background: The impact of method of anastomosis and minimally invasive surgical technique on surgical and clinical outcomes after right hemicolectomy is uncertain. The aim of the MIRCAST study was to compare intracorporeal and extracorporeal anastomosis (ICA and ECA respectively), each using either a laparoscopic approach or robot-assisted surgery during right hemicolectomies for benign or malignant tumours. Methods: This was an international, multicentre, prospective, observational, monitored, non-randomized, parallel, four-cohort study (laparoscopic ECA; laparoscopic ICA; robot-assisted ECA; robot-assisted ICA). High-volume surgeons (at least 30 minimally invasive right colectomy procedures/year) from 59 hospitals across 12 European countries treated patients over a 3-year interval The primary composite endpoint was 30-day success, defined by two measures of efficacy--absence of surgical wound infection and of any major complication within the first 30 days after surgery. Secondary outcomes were: overall complications, conversion rate, duration of operation, and number of lymph nodes harvested. Propensity score analysis was used for comparison of ICA with ECA, and robot-assisted surgery with laparoscopy. Results: Some 1320 patients were included in an intention-to-treat analysis (laparoscopic ECA, 555; laparoscopic ICA, 356; robotassisted ECA, 88; robot-assisted ICA, 321). No differences in the co-primary endpoint at 30 days after surgery were observed between cohorts (7.2 and 7.6 per cent in ECA and ICA groups respectively; 7.8 and 6.6 per cent in laparoscopic and robot-assisted groups). Lower overall complication rates were observed after ICA, specifically less ileus, and nausea and vomiting after robotassisted procedures. Conclusion: No difference in the composite outcome of surgical wound infections and severe postoperative complications was found between intracorporeal versus extracorporeal anastomosis or laparoscopy versus robot-assisted surgery. [ABSTRACT FROM AUTHOR]

Background: Mastectomy rates in breast cancer are higher in older patients. The aim was to compare postoperative complication rates after breast-conserving surgery (BCS) to mastectomy in women aged 70–79 and older than 80 years versus those aged 50–69 years, and to evaluate survival effects. Methods: This population-based cohort included women aged 50 years and older with invasive breast cancer T1–3 N0–3 M0 operated on in Sweden 2008–2017. Major surgical and medical 30-day postoperative complications were assessed in adjusted logistic regression models. Overall survival was assessed in Cox models adjusted for clinical confounders, socio-economics, and comorbidity. Results: Of 34 139 women, 8372 (24.5 per cent) were aged 70–79 years, 3928 (11.5 per cent) were 80 years of age or older, and 21 839 (64.0 per cent) were aged 50–69 years. Major surgical postoperative complications did not differ between age groups receiving equivalent surgery (BCS: 2.1 per cent and 2.0 per cent versus 2.1 per cent (P=0.90); mastectomy: 4.6 per cent and 5.1 per cent versus 4.6 per cent (P=0.49)). Major medical postoperative complications were higher in women aged >70 years than in women aged 50–69 years (BCS: 1.0 per cent and 2.3 per cent versus 0.4 per cent (P< 0.001); mastectomy: 3.1 per cent and 6.2 per cent versus 1.1 per cent (P<0.001)), which persisted after adjustments. In women treated by mastectomy, major medical and surgical postoperative complications were associated with worse overall survival in all but the middle age group. Conclusion: Mastectomy has higher medical and surgical postoperative complication rates than BCS. Major medical postoperative complications increase significantly with age. Major postoperative complications are associated with worse survival after mastectomy, which should be used with caution in older women. [ABSTRACT FROM AUTHOR]

In their recent paper, Spinelli and Pellino talked about emergency surgery during the COVID-19 pandemic[1]. A 65-4 per cent decrease in emergency surgery activity was observed; the mean number of patients who underwent emergency surgery daily in each hospital decreased from 2-6 during the control period to 0-9 during pandemic period ( I P i < 0-001). Considering these results, those regions where the COVID-19 pandemic is now developing should assume that emergency surgery activity will decrease to one-third of normal. [Extracted from the article]

Comment on: Performance of a modified three-level classification in stratifying open liver resection procedures in terms of complexity and postoperative morbidity Kawaguchi I et al i . recently described a three-level classification for stratifying complexity of open liver surgery[1] based on their previously published classification of laparoscopic liver operations[2]. But caudate resection and segmentectomy (Sg) 2/3 resection values are present in the utility method and these fall into the posterosuperior and anterolateral segment groups according to Kawaguchi I et al i .'s original paper[2]. [Extracted from the article]

Background Postoperative delirium ( POD) is common after surgery. As age is a known risk factor, the increased ageing of the population undergoing surgery emphasizes the importance of the subject. Knowledge of other potential risk factors in older patients with surgical gastrointestinal diseases is lacking. The aim here was to collate and synthesize the published literature on risk factors for delirium in this group. Methods Five databases were searched ( MEDLINE, Web of Science, Embase, CINAHL® and PSYCinfo®) between January 1987 and November 2014. The Newcastle-Ottawa Scale was used to rate study quality. Pooled odds ratios or mean differences for individual risk factors were estimated using the Mantel-Haenszel and inverse-variance methods. Results Eleven studies met the inclusion criteria; they provided a total of 1427 patients (318 with delirium and 1109 without), and predominantly included patients undergoing elective colorectal surgery. The incidence of POD ranged from 8·2 to 54·4 per cent. A total of 95 risk factors were investigated, illustrating wide heterogeneity in study design. Seven statistically significant risk factors were identified in pooled analysis: old age, American Society of Anesthesiologists ( ASA) physical status grade at least III, body mass index, lower serum level of albumin, intraoperative hypotension, perioperative blood transfusion and history of alcohol excess. Patients with POD had a significantly increased duration of hospital stay and a higher mortality rate compared with those without delirium. Conclusion Delirium is common in older patients undergoing gastrointestinal surgery. Several risk factors were consistently associated with POD. [ABSTRACT FROM AUTHOR]

Background: Prepectoral breast reconstruction (PPBR) has recently been introduced to reduce postoperative pain and improve cosmetic outcomes in women having implant-based procedures. High-quality evidence to support the practice of PPBR, however, is lacking. Pre-BRA is an IDEAL stage 2a/2b study that aimed to establish the safety, effectiveness, and stability of PPBR before definitive evaluation in an RCT. The short-term safety endpoints at 3 months after surgery are reported here. Methods: Consecutive patients electing to undergo immediate PPBR at participating UK centres between July 2019 and December 2020 were invited to participate. Demographic, operative, oncology, and complication data were collected. The primary outcome was implant loss at 3 months. Other outcomes of interest included readmission, reoperation, and infection. Results: Some 347women underwent 424 immediate implant-based reconstructions at 40 centres. Mostwere single-stage direct-to-implant (357, 84.2 per cent) biologicalmesh-assisted (341, 80.4 per cent) procedures. Conversion to subpectoral reconstruction was necessary in four patients (0.9 per cent) owing to poor skin-flap quality. Of the 343 women who underwent PPBR, 144 (42.0 per cent) experienced at least one postoperative complication. Implant loss occurred in 28 women (8.2 per cent), 67 (19.5 per cent) experienced an infection, 60 (17.5 per cent) were readmitted for a complication, and 55 (16.0 per cent) required reoperation within 3 months of reconstruction. Conclusion: Complication rates following PPBR are high and implant loss is comparable to that associated with subpectoral mesh-assisted implant-based techniques. These findings support the need for a well-designed RCT comparing prepectoral and subpectoral reconstruction to establish best practice for implant-based breast reconstruction. [ABSTRACT FROM AUTHOR]

The author discusses a study which explores the short-term benefits of laparoscopic subtotal colectomy in patients with inflammatory bowel disease (IBD). The author believes that the study's findings are important in determining the role of laparoscopic approach in acute and subacute conditions. The author mentions the lack of randomized trials and clear definitions of complications as the paper's major limitation.

The article presents abstracts on papers presented at the 100th Annual Congress of the Swiss Society of Surgery held in Berne, Switzerland from June 12-14, 2013 on topics including laparoscopic sleeve gastrectomy, complications linked with Roux-en-Y gastric bypass, and intra-operative infiltration.

Background: Injectable bulking agents have been used with varying success for the treatment of faecal incontinence. This systematic review aimed to investigate the various injectable agents and techniques used for the treatment of faecal incontinence, and to assess their safety and efficacy. Methods: Thirty-nine publications were identified and studied. The following variables were pooled for univariable analysis: type, location, route of bulking agents, and the use of ultrasound guidance, antibiotics, laxatives and anaesthetics. Predictors of the development of complications and successful outcomes were identified by multivariable logistic regression analysis. Results: A total of 1070 patients were included in the analysis. On multivariable analysis, the only significant predictor of the development of complications was the route of injection of bulking agents (odds ratio 3·40, 95 per cent confidence interval 1·62 to 7·12; P = 0·001). Two variables were significant predictors of a successful short-term outcome: the use of either PTQ® (OR 5·93, 2·21 to 16·12; P = 0·001) or Coaptite® (OR 10·74, 1·73 to 65·31; P = 0·001) was associated with a greater likelihood of success. Conversely, the use of local anaesthetic was associated with a lower likelihood of success (OR 0·18, 0·05 to 0·59; P = 0·005). Failure to use laxatives in the postoperative period resulted in a poorer medium- to longer-term outcome (OR 0·13, 0·06 to 0·25; P = 0·001). Conclusion: This systematic review has identified variations in the practice of injection of bulking agents that appear to influence the likelihood of complications and affect the outcomes after treatment. Copyright © 2011 British Journal of Surgery Society Ltd. Published by John Wiley & Sons, Ltd. [ABSTRACT FROM AUTHOR]

The article presents a systematic review and meta-analysis of steatosis, which is considered a risk factor in major hepatic resection. Mortality rates and risk probabilities for complication were estimated for patients with steatosis. It was found out that patients with steatosis had an increased risk of postoperative complications, and even of death. An estimate of the effect of steatosis on patient outcome after a major hepatic surgery is also provided.

We congratulate Saunders and colleagues[1] on their large, single-centre study demonstrating that major postoperative complications, but not anastomotic leaks, impact on long-term survival. As such, a subgroup analysis assessing long-term outcomes depending on the operation performed (oesophagectomy I versus i gastrectomy) or the severity and location of the anastomotic leak should be performed. [Extracted from the article]

The article discusses the results of endoscopic management of post-traumatic bile leaks in patients with complex hepatic injuries. The bile leak is based on the persistent drainage of bile through a surgical wound or via an abdominal drain after surgery. A biliary sphincterotomy and temporary internal stenting represent a safe and effective strategy for the management of bile leaks following blunt and penetrating hepatic trauma. Damage control techniques is applied to patients with penetrating hepatic trauma.

Background The aim of this study was to determine whether the routine use of an antibiotic-bonded gelatin-coated Dacron graft could reduce the incidence of prosthetic graft infection. Extra-anatomic grafts were chosen for study as they have the highest risk of graft infection. This paper reports early results up to 1 month after surgery. Methods This multicentre study involved 14 vascular units in the UK. A total of 257 patients underwent extra-anatomic bypass. Patients were randomized to rifampicin bonding (1 mg/ml rifampicin soak for 15 min before graft insertion) or a control group. Routine three-dose antibiotic prophylaxis was administered to patients in both groups. Results There were 178 men and 79 women of median age 69 (range 43–92) years. Rifampicin-bonded (n=123) and control (n=134) groups were well matched for clinical details, risk factors and operative techniques. No side-effects were noted from rifampicin bonding. Only one patient (in the control group) developed a graft infection and this proved fatal. There were no significant differences between bonded and unbonded grafts in terms of perioperative mortality rate (9 and 5 per cent respectively), median hospital stay (10 days for both groups), total infective complications (15 and 21 per cent respectively) or need for postoperative antibiotics (13 and 18 per cent respectively). Conclusion Early results from this study have not identified any significant advantage in the routine use of rifampicin bonding, but the rate of graft infection was very low (0·4 per cent). Gelatin coating alone may provide protection against infection. Definitive recommendations about the role of antibiotic bonding cannot be made until longer follow-up becomes available. [ABSTRACT FROM AUTHOR]

Copyright of British Journal of Surgery is the property of Oxford University Press / USA and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Copyright of British Journal of Surgery is the property of Oxford University Press / USA and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

The article offers information related to surgical complications and associated pain in intra-abdominal adhesions, the collective term for internal scar formation as a response to intraperitoneal injury. A study is presented exploring the role of surgical division of adhesions to alleviate symptoms.

Copyright of British Journal of Surgery is the property of Oxford University Press / USA and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Background: Postoperative complications have a great impact on the postoperative course and oncological outcomes following major cancer surgery. Among them, infective complications play an important role. The aim of this study was to evaluate whether postoperative infective complications influence long‐term survival after liver resection for hepatocellular carcinoma (HCC). Methods: Patients who underwent resection with curative intent for HCC between July 2003 and June 2016 were identified from a multicentre database (8 institutions) and analysed retrospectively. Independent risk factors for postoperative infective complications were identified. After excluding patients who died 90 days or less after surgery, overall survival (OS) and recurrence‐free survival (RFS) were compared between patients with and without postoperative infective complications within 30 days after resection. Results: Among 2442 patients identified, 332 (13·6 per cent) had postoperative infective complications. Age over 60 years, diabetes mellitus, obesity, cirrhosis, intraoperative blood transfusion, duration of surgery exceeding 180 min and major hepatectomy were identified as independent risk factors for postoperative infective complications. Univariable analysis revealed that median OS and RFS were poorer among patients with postoperative infective complications than among patients without (54·3 versus 86·8 months, and 22·6 versus 43·2 months, respectively; both P < 0·001). After adjustment for other prognostic factors, multivariable Cox regression analyses identified postoperative infective complications as independently associated with decreased OS (hazard ratio (HR) 1·20, 95 per cent c.i. 1·02 to 1·41; P = 0·027) and RFS (HR 1·19, 1·03 to 1·37; P = 0·021). Conclusion: Postoperative infective complications decreased long‐term OS and RFS in patients treated with liver resection for HCC. [ABSTRACT FROM AUTHOR]

Background: The aim was to investigate whether preoperative weight loss results in improved clinical outcomes in surgical patients with clinically significant obesity. Methods: This was a systematic review and aggregate data meta‐analysis of RCTs and cohort studies. PubMed, MEDLINE, Embase and CINAHL Plus databases were searched from inception to February 2018. Eligibility criteria were: studies assessing the effect of weight loss interventions (low‐energy diets with or without an exercise component) on clinical outcomes in patients undergoing any surgical procedure. Data on 30‐day or all‐cause in‐hospital mortality were extracted and synthesized in meta‐analyses. Postoperative thromboembolic complications, duration of surgery, infection and duration of hospital stay were also assessed. Results: A total of 6060 patients in four RCTs and 12 cohort studies, all from European and North American centres, were identified. Most were in the field of bariatric surgery and all had some methodological limitations. The pooled effect estimate suggested that preoperative weight loss programmes were effective, leading to significant weight reduction compared with controls: mean difference –7·42 (95 per cent c.i. –10·09 to –4·74) kg (P < 0·001). Preoperative weight loss interventions were not associated with a reduction in perioperative mortality (odds ratio 1·41, 95 per cent c.i. 0·24 to 8·40; I2 = 0 per cent, P = 0·66) but the event rate was low. The weight loss groups had shorter hospital stay (by 27 per cent). No differences were found for morbidity. Conclusion: This limited preoperative weight loss has advantages but may not alter the postoperative morbidity or mortality risk. Possible, but how much is enough? [ABSTRACT FROM AUTHOR]

Background: The Clavien–Dindo classification is perhaps the most widely used approach for reporting postoperative complications in clinical trials. This system classifies complication severity by the treatment provided. However, it is unclear whether the Clavien–Dindo system can be used internationally in studies across differing healthcare systems in high‐ (HICs) and low‐ and middle‐income countries (LMICs). Methods: This was a secondary analysis of the International Surgical Outcomes Study (ISOS), a prospective observational cohort study of elective surgery in adults. Data collection occurred over a 7‐day period. Severity of complications was graded using Clavien–Dindo and the simpler ISOS grading (mild, moderate or severe, based on guided investigator judgement). Severity grading was compared using the intraclass correlation coefficient (ICC). Data are presented as frequencies and ICC values (with 95 per cent c.i.). The analysis was stratified by income status of the country, comparing HICs with LMICs. Results: A total of 44 814 patients were recruited from 474 hospitals in 27 countries (19 HICs and 8 LMICs). Some 7508 patients (16·8 per cent) experienced at least one postoperative complication, equivalent to 11 664 complications in total. Using the ISOS classification, 5504 of 11 664 complications (47·2 per cent) were graded as mild, 4244 (36·4 per cent) as moderate and 1916 (16·4 per cent) as severe. Using Clavien–Dindo, 6781 of 11 664 complications (58·1 per cent) were graded as I or II, 1740 (14·9 per cent) as III, 2408 (20·6 per cent) as IV and 735 (6·3 per cent) as V. Agreement between classification systems was poor overall (ICC 0·41, 95 per cent c.i. 0·20 to 0·55), and in LMICs (ICC 0·23, 0·05 to 0·38) and HICs (ICC 0·46, 0·25 to 0·59). Conclusion: Caution is recommended when using a treatment approach to grade complications in global surgery studies, as this may introduce bias unintentionally. The Clavien–Dindo classification is perhaps the most widely used approach to reporting postoperative complications in clinical trials. However, it is unclear whether it can be used internationally in studies across differing healthcare systems in high‐ (HIC) and low‐ to middle‐income (LMIC) countries. The results of this study suggest that caution is needed when using treatment approach to grade complications in global surgery studies, as this may unintentionally introduce bias. The challenge of standard measures [ABSTRACT FROM AUTHOR]

Background: To allocate healthcare resources optimally, complication‐related quality initiatives should target complications that have the greatest overall impact on outcomes after surgery. The aim of this study was to identify the most clinically relevant complications after oesophagectomy for cancer in a nationwide cohort study. Methods: Consecutive patients who underwent oesophagectomy for cancer between January 2011 and December 2016 were identified from the Dutch Upper Gastrointestinal Cancer Audit. The adjusted population attributable fraction (PAF) was used to estimate the impact of specific postoperative complications on the clinical outcomes postoperative mortality, reoperation, prolonged hospital stay and readmission to hospital in the study population. The PAF represents the percentage reduction in the frequency of a given outcome (such as death) that would occur in a theoretical scenario where a specific complication (for example anastomotic leakage) was able to be prevented completely in the study population. Results: Some 4096 patients were analysed. Pulmonary complications and anastomotic leakage had the greatest overall impact on postoperative mortality (risk‐adjusted PAF 44·1 and 30·4 per cent respectively), prolonged hospital stay (risk‐adjusted PAF 31·4 and 30·9 per cent) and readmission to hospital (risk‐adjusted PAF 7·3 and 14·7 per cent). Anastomotic leakage had the greatest impact on reoperation (risk‐adjusted PAF 47·1 per cent). In contrast, the impact of other complications on these outcomes was relatively small. Conclusion: Reducing the incidence of pulmonary complications and anastomotic leakage may have the greatest clinical impact on outcomes after oesophagectomy. Pulmonary and anastomotic complications matter most [ABSTRACT FROM AUTHOR]

Background: Internal herniation, a serious complication after bariatric surgery, is challenging to diagnose. The aim of this study was to determine the accuracy of abdominal CT in diagnosing internal herniation. Methods: The study included consecutive patients who had undergone laparoscopic gastric bypass surgery between 1 January 2011 and 1 January 2015 at a bariatric centre of excellence. To select patients suspected of having internal herniation, reports of abdominal CT and reoperations up to 1 January 2017 were screened. CT was presumed negative for internal herniation if no follow‐up CT or reoperation was performed within 90 days after the initial CT, or no internal herniation was found during reoperation. The accuracy of abdominal CT in diagnosing internal herniation was calculated using two‐way contingency tables. Results: A total of 1475 patients were included (84·7 per cent women, mean age 46·5 years, median initial BMI 41·8 kg/m2). CT and/or reoperation was performed in 192 patients (13·0 per cent) in whom internal herniation was suspected. Internal herniation was proven laparoscopically in 37 of these patients. The incidence of internal herniation was 2·5 per cent. An analysis by complaint included a total of 265 episodes, for which 247 CT scans were undertaken. CT was not used to investigate 18 episodes, but internal herniation was encountered in one‐third of these during reoperation. Combining the follow‐up and intraoperative findings, the accuracy of CT for internal herniation had a sensitivity of 83·8 (95 per cent c.i. 67·3 to 93·2) per cent, a specificity of 87·1 (81·7 to 91·2) per cent, a positive predictive value of 53·4 (40·0 to 66·5) per cent and a negative predictive value of 96·8 (92·9 to 98·7) per cent. Conclusion: Abdominal CT is an important tool in diagnosing internal herniation, with a high specificity and a high negative predictive value. Important tool for correct diagnosis [ABSTRACT FROM AUTHOR]

Background: The objective of this study was to investigate the potential benefit of local haemostatic agents for the prevention of postoperative bleeding after thyroidectomy. Methods: A systematic literature search was performed, and RCTs involving adult patients who underwent thyroid surgery using either active (AHA) or passive (PHA) haemostatic agents were included in the review. The main outcome was the rate of cervical haematoma that required reoperation. A Bayesian random‐effects model was used for network meta‐analysis with minimally informative prior distributions. Results: Thirteen RCTs were included. The rate of cervical haematoma requiring reoperation ranged from 0 to 9·1 per cent, and was not reduced by haemostatic agents: AHA versus control (odds ratio (OR) 1·53, 95 per cent credibility interval 0·21 to 10·77); PHA versus control (OR 2·74, 0·41 to 16·62) and AHA versus PHA (OR 1·77, 0·12 to 25·06). No difference was observed in the time required for drain removal, duration of hospital stay, and the rate of postoperative hypocalcaemia or recurrent nerve palsy. AHA led to a significantly lower total postoperative blood loss and reduced operating time in comparison with both the control and PHA groups. Conclusion: The general use of local haemostatic agents has not been shown to reduce the rate of clinically relevant bleeding. Little value [ABSTRACT FROM AUTHOR]

Background: Improving patients' oral hygiene is an option for preventing postoperative pneumonia that may be caused by aspiration of oral and pharyngeal secretions. Whether preoperative oral care by a dentist can decrease postoperative complications remains controversial. A retrospective cohort study was undertaken to assess the association between preoperative oral care and postoperative complications among patients who underwent major cancer surgery. Methods: The nationwide administrative claims database in Japan was analysed. Patients were identified who underwent resection of head and neck, oesophageal, gastric, colorectal, lung or liver cancer between May 2012 and December 2015. The primary outcomes were postoperative pneumonia and all‐cause mortality within 30 days of surgery. Patient background was adjusted for with inverse probability of treatment weighting using propensity scoring. Results: Of 509 179 patients studied, 81 632 (16·0 per cent) received preoperative oral care from a dentist. A total of 15 724 patients (3·09 per cent) had postoperative pneumonia and 1734 (0·34 per cent) died within 30 days of surgery. After adjustment for potential confounding factors, preoperative oral care by a dentist was significantly associated with a decrease in postoperative pneumonia (3·28 versus 3·76 per cent; risk difference − 0·48 (95 per cent c.i. −0·64 to−0·32) per cent) and all‐cause mortality within 30 days of surgery (0·30 versus 0·42 per cent; risk difference − 0·12 (−0·17 to −0·07) per cent). Conclusion: Preoperative oral care by a dentist significantly reduced postoperative complications in patients who underwent cancer surgery. Preoperative dental care reduces postoperative pneumonia [ABSTRACT FROM AUTHOR]

Background: Surgical‐site infection (SSI) is associated with significant healthcare costs. To reduce the high rate of SSI among patients undergoing colorectal surgery at a cancer centre, a comprehensive care bundle was implemented and its efficacy tested. Methods: A pragmatic study involving three phases (baseline, implementation and sustainability) was conducted on patients treated consecutively between 2013 and 2016. The intervention included 13 components related to: bowel preparation; oral and intravenous antibiotic selection and administration; skin preparation, disinfection and hygiene; maintenance of normothermia during surgery; and use of clean instruments for closure. SSI risk was evaluated by means of a preoperative calculator, and effectiveness was assessed using interrupted time‐series regression. Results: In a population with a mean BMI of 30 kg/m2, diabetes mellitus in 17·5 per cent, and smoking history in 49·3 per cent, SSI rates declined from 11·0 to 4·1 per cent following implementation of the intervention bundle (P = 0·001). The greatest reductions in SSI rates occurred in patients at intermediate or high risk of SSI: from 10·3 to 4·7 per cent (P = 0·006) and from 19 to 2 per cent (P < 0·001) respectively. Wound care modifications were very different in the implementation phase (43·2 versus 24·9 per cent baseline), including use of an overlying surface vacuum dressing (17·2 from 1·4 per cent baseline) or leaving wounds partially open (13·2 from 6·7 per cent baseline). As a result, the biggest difference was in wound‐related rather than organ‐space SSI. The median length of hospital stay decreased from 7 (i.q.r. 5–10) to 6 (5–9) days (P = 0·002). The greatest reduction in hospital stay was seen in patients at high risk of SSI: from 8 to 6 days (P < 0·001). SSI rates remained low (4·5 per cent) in the sustainability phase. Conclusion: Meaningful reductions in SSI can be achieved by implementing a multidisciplinary care bundle at a hospital‐wide level. Protocol‐driven programme works [ABSTRACT FROM AUTHOR]

SummaryBackground: Despite advances in diagnosis, surgery, antimicrobial therapy and intensive care support, the mortality rate associated with severe secondary peritonitis remains unacceptably high. This article presents various surgical treatment strategies for severe secondary peritonitis, emphasizing the role of open management of the abdomen and planned relaparotomies. Methods: Material was identified from previous review articles, references cited in original papers and a Medline search of the literature. Results and conclusion: Surgical treatment of severe secondary peritonitis is highly demanding and very complex. The combination of improved surgical techniques, antimicrobial therapy and intensive care support has improved the outcome of such peritonitis following perforation or anastomotic disruption of the digestive tract, or infected necrotizing pancreatitis. However, aggressive surgical treatment strategies, such as open management of the abdomen and planned relaparotomies, may have reached their limits. [ABSTRACT FROM AUTHOR]

Background: A large number of scoring systems for assessing a patient’s risk of complications or death has been developed over recent years. This is a review of those that are of relevance to general surgeons. Methods: A Medline literature search was performed to identify all articles concerning ‘severity of illness’, ‘morbidity’, ‘mortality’ and ‘postoperative complications’ in the field of surgery from 1966 to 1997. Further searches were performed to find papers about specific identified scoring systems, and relevant articles from the reference lists of these were also sought. Results and conclusion: The advantages of an accurate assessment of a patient’s risk include, on an individual level, the opportunity to give a more accurate prognosis and choose the most appropriate treatment. If the risk of an adverse outcome is known for a group of patients, the actual outcome can be compared with the predicted outcome, and comparison can be made between groups in different surgical units for the purposes of audit or research. The Physiological and Operative Severity Score for enUmeration of Mortality and morbidity (POSSUM) is the most appropriate of the currently available scores for general surgical practice. [ABSTRACT FROM AUTHOR]

Background: This was an 8-year follow-up of an RCT comparing ultrasound-guided foam sclerotherapy (UGFS) with high ligation and surgical stripping (HL/S) of the great saphenous vein (GSV). Methods: Patients were randomized to UGFS or HL/S of the GSV. The primary outcome was the recurrence of symptomatic GSV reflux. Secondary outcomes were patterns of reflux according to recurrent varices after surgery, Clinical Etiologic Anatomic Pathophysiologic (CEAP) classification, Venous Clinical Severity Score (VCSS) and EuroQol Five Dimensions (EQ-5D™) quality-of-life scores. Results: Of 430 patients originally randomized (230 UGFS, 200 HL/S), 227 (52.8 per cent; 123 UGFS, 103 HL/S) were available for analysis after 8 years. The proportion of patients free from symptomatic GSV reflux at 8 years was lower after UGFS than HL/S (55.1 versus 72.1 per cent; P = 0.024). The rate of absence of GSV reflux, irrespective of venous symptoms, at 8 years was 33.1 and 49.7 per cent respectively (P = 0.009). More saphenofemoral junction (SFJ) failure (65.8 versus 41.7 per cent; P = 0.001) and recurrent reflux in the above-knee GSV (72.5 versus 20.4 per cent; P = 0.001) was evident in the UGFS group. The VCSS was worse than preoperative scores in both groups after 8 years; CEAP classification and EQ-5D® scores were similar in the two groups. Conclusion: Surgical stripping had a technically better outcome in terms of recurrence of GSV and SFJ reflux than UGFS in the long term. Long-term follow-up suggests significant clinical progression of venous disease measured by VCSS in both groups, but less after surgery. [ABSTRACT FROM AUTHOR]

Background: Pelvic exenteration for locally recurrent rectal cancer (LRRC) is associated with variable outcomes, with the majority of data from single-centre series. This study analysed data from an international collaboration to determine robust parameters that could inform clinical decision-making. Methods: Anonymized data on patients who had pelvic exenteration for LRRC between 2004 and 2014 were accrued from 27 specialist centres. The primary endpoint was survival. The impact of resection margin, bone resection, node status and use of neoadjuvant therapy (before exenteration) was assessed. Results: Of 1184 patients, 614 (51.9 per cent) had neoadjuvant therapy. A clear resection margin (R0 resection) was achieved in 55.4 per cent of operations. Twenty-one patients (1.8 per cent) died within 30 days and 380 (32.1 per cent) experienced a major complication. Median overall survival was 36 months following R0 resection, 27 months after R1 resection and 16months following R2 resection (P <0.001). Patients who received neoadjuvant therapy had more postoperative complications (unadjusted odds ratio (OR) 1.53), readmissions (unadjusted OR 2.33) and radiological reinterventions (unadjusted OR 2.12). Three-year survival rates were 48.1 per cent, 33.9 per cent and 15 per cent respectively. Bone resection (when required) was associated with a longer median survival (36 versus 29 months; P <0.001). Node-positive patients had a shorter median overall survival than those with node-negative disease (22 versus 29 months respectively). Multivariable analysis identified margin status and bone resection as significant determinants of long-term survival. Conclusion: Negative margins and bone resection (where needed) were identified as the most important factors influencing overall survival.Neoadjuvant therapy before pelvic exenteration did not affect survival, but was associated with higher rates of readmission, complications and radiological reintervention. [ABSTRACT FROM AUTHOR]

Background: Choledochal malformations comprise various congenital cystic dilatations of the extrahepatic and/or intrahepatic biliary tree. Choledochal malformation is generally considered a premalignant condition, but reliable data on the risk of malignancy and optimal surgical treatment are lacking. The objective of this systematic review was to assess the prevalence of malignancy in patients with choledochal malformation and to differentiate between subtypes. In addition, the risk of malignancy following cystic drainage versus complete cyst excision was assessed. Methods: A systematic review of PubMed and Embase databases was performed in accordance with the PRISMA statement. A meta‐analysis of the risk of malignancy following cystic drainage versus complete cyst excision was undertaken in line with MOOSE guidelines. Prevalence of malignancy was defined as the rate of biliary cancer before resection, and malignant transformation as new‐onset biliary cancer after surgery. Results: Eighteen observational studies were included, reporting a total of 2904 patients with a median age of 36 years. Of these, 312 in total developed a malignancy (10·7 per cent); the prevalence of malignancy was 7·3 per cent and the rate of malignant transformation was 3·4 per cent. Patients with types I and IV choledochal malformation had an increased risk of malignancy (P = 0·016). Patients who underwent cystic drainage had an increased risk of developing biliary malignancy compared with those who had complete cyst excision, with an odds ratio of 3·97 (95 per cent c.i. 2·40 to 6·55). Conclusion: The risk of developing malignancy among patients with choledochal malformation was almost 11 per cent. The malignancy risk following cystic drainage surgery was four times higher than that after complete cyst excision. Complete surgical resection is recommended in patients with choledochal malformation. [ABSTRACT FROM AUTHOR]

Background: Surgeons in the operating theatre deal constantly with high‐demand tasks that require simultaneous processing of a large amount of information. In certain situations, high cognitive load occurs, which may impact negatively on a surgeon's performance. This systematic review aims to provide a comprehensive understanding of the different methods used to assess surgeons' cognitive load, and a critique of the reliability and validity of current assessment metrics. Methods: A search strategy encompassing MEDLINE, Embase, Web of Science, PsycINFO, ACM Digital Library, IEEE Xplore, PROSPERO and the Cochrane database was developed to identify peer‐reviewed articles published from inception to November 2016. Quality was assessed by using the Medical Education Research Study Quality Instrument (MERSQI). A summary table was created to describe study design, setting, specialty, participants, cognitive load measures and MERSQI score. Results: Of 391 articles retrieved, 84 met the inclusion criteria, totalling 2053 unique participants. Most studies were carried out in a simulated setting (59 studies, 70 per cent). Sixty studies (71 per cent) used self‐reporting methods, of which the NASA Task Load Index (NASA‐TLX) was the most commonly applied tool (44 studies, 52 per cent). Heart rate variability analysis was the most used real‐time method (11 studies, 13 per cent). Conclusion: Self‐report instruments are valuable when the aim is to assess the overall cognitive load in different surgical procedures and assess learning curves within competence‐based surgical education. When the aim is to assess cognitive load related to specific operative stages, real‐time tools should be used, as they allow capture of cognitive load fluctuation. A combination of both subjective and objective methods might provide optimal measurement of surgeons' cognition. [ABSTRACT FROM AUTHOR]

Background: Studies comparing the anastomotic leak rate in patients with an intrathoracic versus a cervical anastomosis after oesophagectomy are equivocal. The aim of this study was to compare clinical outcome after oesophagectomy in patients with an intrathoracic or cervical anastomosis, and to identify predictors of anastomotic leakage in a nationwide audit. Methods: Between January 2011 and December 2015, all consecutive patients who underwent oesophagectomy for cancer were identified from the Dutch Upper Gastrointestinal Cancer Audit. For the comparison between an intrathoracic and cervical anastomosis, propensity score matching was used to adjust for potential confounders. Multivariable logistic regression modelling with backward stepwise selection was used to determine independent predictors of anastomotic leakage. Results: Some 3348 patients were included. After propensity score matching, 654 patients were included in both the cervical and intrathoracic anastomosis groups. An intrathoracic anastomosis was associated with a lower leak rate than a cervical anastomosis (17·0 versus 21·9 per cent; P = 0·025). The percentage of patients with recurrent nerve paresis was also lower (0·6 versus 7·0 per cent; P < 0·001) and an intrathoracic anastomosis was associated with a shorter median hospital stay (12 versus 14 days; P = 0·001). Multivariable analysis revealed that ASA fitness grade III or higher, chronic obstructive pulmonary disease, cardiac arrhythmia, diabetes mellitus and proximal oesophageal tumours were independent predictors of anastomotic leakage. Conclusion: An intrathoracic oesophagogastric anastomosis was associated with a lower anastomotic leak rate, lower rate of recurrent nerve paresis and a shorter hospital stay. Risk factors for anastomotic leak were co‐morbidities and proximal tumours. [ABSTRACT FROM AUTHOR]

Background: A temporary ileostomy may reduce symptoms from anastomotic leakage after rectal cancer resection. Earlier results of the EASY trial showed that early closure of the temporary ileostomy was associated with significantly fewer postoperative complications. The aim of the present study was to compare health‐related quality of life (HRQOL) following early versus late closure of a temporary ileostomy. Methods: Early closure of a temporary ileostomy (at 8–13 days) was compared with late closure (at more than 12 weeks) in a multicentre RCT (EASY) that included patients who underwent rectal resection for cancer. Inclusion of participants was made after index surgery. Exclusion criteria were signs of anastomotic leakage, diabetes mellitus, steroid treatment, and signs of postoperative complications at clinical evaluation 1–4 days after rectal resection. HRQOL was evaluated at 3, 6 and 12 months after resection using the European Organisation for Research and Treatment of Cancer (EORTC) questionnaires QLQ‐C30 and QLQ‐CR29 and Short Form 36 (SF‐36®). Results: There were 112 patients available for analysis. Response rates of the questionnaires were 82–95 per cent, except for EORTC QLQ‐C30 at 12 months, to which only 54–55 per cent of the patients responded owing to an error in questionnaire distribution. There were no clinically significant differences in any questionnaire scores between the groups at 3, 6 or 12 months. Conclusion: Although the randomized study found that early closure of the temporary ileostomy was associated with significantly fewer complications, this clinical advantage had no effect on the patients' HRQOL. Registration number: NCT01287637 ( https://www.clinicaltrials.gov). [ABSTRACT FROM AUTHOR]

Background: The aim was to carry out phase 4 international field‐testing of the European Organisation for Research and Treatment of Cancer (EORTC) breast reconstruction (BRECON) module. The primary objective was finalization of its scale structure. Secondary objectives were evaluation of its reliability, validity, responsiveness, acceptability and interpretability in patients with breast cancer undergoing mastectomy and reconstruction. Methods: The EORTC module development guidelines were followed. Patients were recruited from 28 centres in seven countries. A prospective cohort completed the QLQ‐BRECON15 before mastectomy and the QLQ‐BRECON24 at 4–8 months after reconstruction. The cross‐sectional cohort completed the QLQ‐BRECON24 at 1–5 years after reconstruction, and repeated this 2–8 weeks later (test–retest reliability). All participants completed debriefing questionnaires. Results: A total of 438 patients were recruited, 234 in the prospective cohort and 204 in the cross‐sectional cohort. A total of 414 reconstructions were immediate, with a comparable number of implants (176) and donor‐site flaps (166). Control groups comprised patients who underwent two‐stage implant procedures (72, 75 per cent) or delayed reconstruction (24, 25 per cent). Psychometric scale validity was supported by moderate to high item‐own scale and item‐total correlations (over 0·5). Questionnaire validity was confirmed by good scale‐to‐sample targeting, and computable scale scores exceeding 50 per cent, except nipple cosmesis (over 40 per cent). In known‐group comparisons, QLQ‐BRECON24 scales and items differentiated between patient groups defined by clinical criteria, such as type and timing of reconstruction, postmastectomy radiotherapy and surgical complications, with moderate effect sizes. Prospectively, sexuality and surgical side‐effects scales showed significant responsiveness over time (P < 0·001). Scale reliability was supported by high Cronbach's α coefficients (over 0·7) and test–retest (intraclass correlation more than 0·8). One item (finding a well fitting bra) was excluded based on high floor/ceiling effects, poor test–retest and weak correlations in factor analysis (below 0·3), thus generating the QLQ‐BRECON23 questionnaire. Conclusion: The QLQ‐BRECON23 is an internationally validated tool to be used alongside the EORTC QLQ‐C30 (cancer) and QLQ‐BR23 (breast cancer) questionnaires for evaluating quality of life and satisfaction after breast reconstruction. [ABSTRACT FROM AUTHOR]