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Background: Incisional hernia occurs approximately in 40% of high-risk patients after midline laparotomy. Prophylactic mesh placement has shown promising results, but long-term outcomes are needed. The present study aimed to assess the long-term incisional hernia rates of the previously conducted PRIMA trial with radiological follow-up. Methods: In the PRIMA trial, patients with increased risk of incisional hernia formation (AAA or BMI ≥27 kg/m2) were randomised in a 1:2:2 ratio to primary suture, onlay mesh or sublay mesh closure in three different countries in eleven institutions. Incisional hernia during follow-up was diagnosed by any of: CT, ultrasound and physical examination, or during surgery. Assessors and patients were blinded until 2-year follow-up. Time-to-event analysis according to intention-to-treat principle was performed with the Kaplan–Meier method and Cox proportional hazard models. Trial registration: NCT00761475 (ClinicalTrials.gov). Findings: Between 2009 and 2012, 480 patients were randomized: 107 primary suture, 188 onlay mesh and 185 sublay mesh. Five-year incisional hernia rates were 53.4% (95% CI: 40.4–64.8), 24.7% (95% CI: 12.7–38.8), 29.8% (95% CI: 17.9–42.6), respectively. Compared to primary suture, onlay mesh (HR: 0.390, 95% CI: 0.248–0.614, p < 0.001) and sublay mesh (HR: 0.485, 95% CI: 0.309–0.761, p = 0.002) were associated with a significantly lower risk of incisional hernia development. Interpretation: Prophylactic mesh placement remained effective in reducing incisional hernia occurrence after midline laparotomy in high-risk patients during long-term follow-up. Hernia rates in the primary suture group were higher than previously anticipated. Funding: B. Braun.

Background: The Scandinavian Diverticulitis (SCANDIV) trial and the LOLA arm of the LADIES trial randomized patients with Hinchey III perforated diverticulitis to laparoscopic peritoneal lavage or sigmoid resection. The aim of this analysis was to identify risk factors for treatment failure in patients with Hinchey III perforated diverticulitis. Methods: This was a post hoc analysis of the SCANDIV trial and LOLA arm. Treatment failure was defined as morbidity requiring general anaesthesia (Clavien-Dindo grade IIIb or higher) within 90 days. Age, sex, BMI, ASA fitness grade, smoking status, previous episodes of diverticulitis, previous abdominal surgery, time to surgery, and surgical competence were all tested in univariable and multivariable logistic regression analyses using an interaction variable. Results: The pooled analysis included 222 patients randomized to laparoscopic lavage and primary resection (116 and 106 patients respectively). Univariable analysis found ASA grade to be associated with advanced morbidity in both groups, and the following factors in the laparoscopic lavage group: smoking, corticosteroid use, and BMI. Significant factors for laparoscopic lavage morbidity in multivariable analysis were smoking (OR 7.05, 95 per cent c.i. 2.07 to 23.98; P = 0.002) and corticosteroid use (OR 6.02, 1.54 to 23.51; P = 0.010). Conclusion: Active smoking status and corticosteroid use were risk factors for laparoscopic lavage treatment failure (advanced morbidity) in patients with perforated diverticulitis.

Background: Inguinal hernia belongs to the most common surgical pathology worldwide. Approximately, one third is asymptomatic. The value of watchful waiting (WW) in patients with asymptomatic or mildly symptomatic inguinal hernia has been established in a few randomised controlled trials (RCTs). The aim of this study was to assess long-term outcomes of a RCT comparing WW and elective surgery.Methods: In the original study, men aged ≥50 years with an asymptomatic or mildly symptomatic inguinal hernia were randomly assigned to WW or elective repair. In the present study, the primary outcome was the 12-year crossover rate to surgery, secondary outcomes were time-to-crossover, patient regret, pain, quality of life and incarceration. Dutch Trial Registry: NTR629. Findings: Out of 496 originally analysed patients, 488 (98.4%) were evaluable for chart review (WW: n = 258, surgery: n = 230), and 200 (41.0%) for telephone contact (WW: n = 106, surgery: n = 94) between November 2021 and March 2022 with a median 12 years follow-up (IQR 9–14). After 12 years, the estimated cumulative crossover rate to surgery was 64.2%, which was higher in mildly symptomatic than in asymptomatic patients (71.7% versus 60.4%, HR 1.451, 95% CI: 1.064–1.979). Time-to-crossover was longer in asymptomatic patients (50% after 6.0 years versus 2.0 years, p = 0.019). Patient regret was higher in the WW group (37.7 versus 18.0%, p = 0.002), as well as pain/discomfort (p = 0.031). Quality of life did not differ (p = 0.737). In the WW group, incarceration occurred in 10/255 patients (3.9%). Interpretation: During 12-year follow-up, most WW patients crossed over to surgery, significantly earlier with mildly symptomatic hernia. Considering the relatively low incarceration rate, WW might still be an option in asymptomatic patients with a clear preference and being well-informed about pros and cons.

Purpose: The current operative report often inadequately reflects events occurring during laparoscopic cholecystectomy (LC). The addition of intraoperative video recording to the operative report has already proven to add important information. It was hypothesized that real-time intraoperative voice dictation (RIVD) can provide an equal or more complete overview of the operative procedure compared to the narrative operative report (NR) produced postoperatively. Methods: SONAR is a multicenter prospective observational trial, conducted at four surgical centers in the Netherlands. Elective LCs of patients aged 18 years and older were included. Participating surgeons were requested to dictate the essential steps of LC during surgery. RIVDs and NRs were reviewed according to the stepwise LC guideline of the Dutch Society for Surgery. The cumulative adequacy rates for RIVDs were compared with those of the postoperatively written NR. Results: 79 of 90 cases were eligible for inclusion and available for further analysis. RIVD resulted in a significantly higher adequacy rate compared to NR for the circumferential dissection of the cystic duct and artery (NR 32.5% vs. RIVD 61.0%, P = 0.016). NR had higher adequacy rates in reporting the transection of the cystic duct (NR 100% vs. RIVD 77.9%, P = < 0.001) and the removal of the gallbladder from the liver bed (NR 98.7% vs. RIVD 68.8%, P < 0.001). The total adequacy was not significantly different between the two reporting methods (NR 78.0% vs. RIVD 76.4%, P = 1.00). Conclusion: Overall, the adequacy of RIVD is comparable to the postoperatively written NR in reporting surgical steps in LC. However, the most essential surgical step, the circumferential dissection of the cystic duct and artery, was reported more adequately in RIVD.

Aim: Minimally invasive colorectal surgery reduces surgical trauma with better preservation of abdominal wall integrity, but the extraction site is still at risk of incisional hernia (IH). The aim of this study was to determine pooled incidence of IH for each type of extraction site and to compare rates of IH after midline, nonmidline and Pfannenstiel extraction. Method: A systematic review and meta-analysis was conducted using the PRISMA guidelines. Single-armed and multiple-armed cohort studies and randomized controlled trials regarding minimally invasive colorectal surgery were searched from five databases. Outcomes were pooled and compared with random-effects, inverse-variance models. Risk of bias within the studies was assessed using the Cochrane ROBINS-I and RoB 2 tool. Results: Thirty six studies were included, with a total 11,788 patients. The pooled extraction site IH rate was 16.0% for midline (n = 4081), 9.3% for umbilical (n = 2425), 5.2% for transverse (n = 3213), 9.4% for paramedian (n = 134) and 2.1% for Pfannenstiel (n = 1449). Nonmidline extraction (transverse and paramedian) showed significantly lower odds ratios (ORs) for IH when compared with midline extraction (including umbilical). Pfannenstiel extraction resulted in a significantly lower OR for IH compared with midline [OR 0.12 (0.50–0.30)], transverse [OR 0.25 (0.13–0.50)] and umbilical (OR 0.072 [0.033–0.16]) extraction sites. The risks of surgical site infection, seroma/haematoma or wound dehiscence were not significantly different in any of the analyses. Conclusion: Pfannenstiel extraction is the preferred method in minimally invasive colorectal surgery. In cases where Pfannenstiel extraction is not possible, surgeons should avoid specimen extraction in the midline.

Objective:To assess prevalence of hernia recurrence, surgical site infection (SSI), seroma, serious complications, and mortality after retro-rectus repair.Summary Background Data:Ventral abdominal wall hernia is a common problem, tied to increasing frailty and obesity of patients undergoing surgery. For noncomplex ventral hernia, retro-rectus (Rives-Stoppa) repair is considered the gold standard treatment. Level-1 evidence confirming this presumed superiority is lacking.Methods:Five databases were searched for studies reporting on retro-rectus repair. Single-armed and comparative randomized and non-randomized studies were included. Outcomes were pooled with mixed-effects, inverse variance or random-effects models.Results:Ninety-three studies representing 12,440 patients undergoing retro-rectus repair were included. Pooled hernia recurrence was estimated at 3.2% [95% confidence interval (CI): 2.2%-4.2%, n = 11,049] after minimally 12months and 4.1%, (95%CI: 2.9%-5.5%, n = 3830) after minimally 24-months. Incidences of SSI and seroma were estimated at respectively 5.2% (95%CI: 4.2%-6.4%, n = 4891) and 5.5% (95%CI: 4.4%-6.8%, n = 3650). Retro-rectus repair was associated with lower recurrence rates compared to onlay repair [odds ratios (OR): 0.27, 95%CI: 0.15-0.51, P < 0.001] and equal recurrence rates compared to intraperitoneal onlay mesh (IPOM) repair (OR: 0.92, 95%CI: 0.75-1.12, P = 0.400). Retro-rectus repair was associated with more SSI than IPOM repair (OR: 1.8, 95%CI: 1.03 -3.14, P = 0.038). Minimally invasive retro-rectus repair displayed low rates of recurrence (1.3%, 95%CI: 0.7%-2.3%, n = 849) and SSI (1.5%, 95%CI: 0.8%-2.8%, n = 982), albeit based on non-randomized studies.Conclusions:Retro-rectus (Rives-Stoppa) repair results in excellent outcomes, superior or similar to other techniques for all outcomes except SSI. The latter rarely occurred, yet less frequently after IPOM repair, which is usually performed by laparoscopy.

Background: A successful innovative medical device is not only technically challenging to develop but must also be readily usable to be integrated into health care professionals' daily practice. Through a user-centered design (UCD) approach, usability can be improved. However, this type of approach is not widely implemented from the early stages of medical device development. Objective: The case study presented here shows how UCD may be applied at the very early stage of the design of a disruptive medical device used in a complex hospital environment, while no functional device is available yet. The device under study is a connected sensor system to detect colorectal anastomotic leakage, the most detrimental complication following colorectal surgery, which has a high medical cost. We also aimed to provide usability guidelines for the initial design of other innovative medical devices. Methods: UCD was implemented by actively involving health care professionals and all the industrial partners of the project. The methodology was conducted in 2 European hospitals: Grenoble-Alpes University Hospital (France) and Erasmus Medical Center Rotterdam (the Netherlands). A total of 6 elective colorectal procedures and 5 ward shifts were observed. In total, 4 workshops were conducted with project partners and clinicians. A formative evaluation was performed based on 5 usability tests using nonfunctional prototype systems. The case study was completed within 12 months. Results: Functional specifications were defined for the various components of the medical device: device weight, size, design, device attachment, and display module. These specifications consider the future integration of the medical device into current clinical practice (for use in an operating room and patient follow-up inside the hospital) and interactions between surgeons, nurses, nurse assistants, and patients. By avoiding irrelevant technical development, this approach helps to promote cost-effective desig

Background: This study aimed to compare laparoscopic lavage and sigmoidectomy as treatment for perforated diverticulitis with purulent peritonitis during a 36 month follow-up of the LOLA trial. Methods: Within the LOLA arm of the international, multicentre LADIES trial, patients with perforated diverticulitis with purulent peritonitis were randomised between laparoscopic lavage and sigmoidectomy. Outcomes were collected up to 36 months. The primary outcome of the present study was cumulative morbidity and mortality. Secondary outcomes included reoperations (including stoma reversals), stoma rates, and sigmoidectomy rates in the lavage group. Results: Long-term follow-up was recorded in 77 of the 88 originally included patients, 39 were randomised to sigmoidectomy (51%) and 38 to laparoscopic lavage (49%). After 36 months, overall cumulative morbidity (sigmoidectomy 28/39 (72%) versus lavage 32/38 (84%), p = 0·272) and mortality (sigmoidectomy 7/39 (18%) versus lavage 6/38 (16%), p = 1·000) did not differ. The number of patients who underwent a reoperation was significantly lower for lavage compared to sigmoidectomy (sigmoidectomy 27/39 (69%) versus lavage 17/38 (45%), p = 0·039). After 36 months, patients alive with stoma in situ was lower in the lavage group (proportion calculated from the Kaplan–Meier life table, sigmoidectomy 17% vs lavage 11%, log-rank p = 0·0268). Eventually, 17 of 38 (45%) patients allocated to lavage underwent sigmoidectomy. Conclusion: Long-term outcomes showed that laparoscopic lavage was associated with less patients who underwent reoperations and lower stoma rates in patients alive after 36 months compared to sigmoidectomy. No differences were found in terms of cumulative morbidity or mortality. Patient selection should be improved to reduce risk for short-term complications after which lavage could still be a valuable treatment option. Graphical abstract: [Figure not available: see fulltext.]

Background: Tumor resection is the common approach in patients with colorectal malignancy. Profound insight into inflammatory changes that accompany the normal post-operative stress response will establish reference parameters useful for identification of putative complications. Alterations in circulating monocytes might be indicative as these cells are considered to be the most responsive leukocytes to trauma. Therefore, the aim of this study is to assess the monocyte subset kinetic and phenotypic changes in response to surgery. Methods: Fifty patients undergoing colorectal tumor resection were included in a multicenter prospective cohort study. Blood samples were collected early in the morning prior to surgery and the next days through postoperative day three for flowcytometric analysis. Leukocyte subtypes were identified and expression of activation stage-related markers by monocyte subsets was quantified. Results: Changes in leukocyte subset composition and monocyte subset phenotypes were most prominent at the first day postoperatively, after which these parameters typically returned to normal or near-normal preoperative values. The immunophenotypic alterations after surgery were most notable in classical and intermediate monocytes. These included up-regulation of activation markers CD64 and CD62L, but down-regulation of HLA-DR and CD54. Markers of de-activation, CD163 and CD206, were consistently increasingly expressed. Discussion/conclusion: The current study gives detailed insight into the peripheral blood leukocyte response after colorectal cancer surgery. This form of short-term stress induces a rapid and significant redistribution of immune cells. Immunophenotypic alterations in monocytes as a response to surgery suggest a mixed profile of cellular activation and de-activation.

Aim: Perioperative anxiety and pain are still prevalent among patients undergoing surgery. Inflammatory bowel disease and colorectal cancer patients are known to have higher anxiety rates than the general population. Perioperatively applied music intervention has been proven to be effective in reducing perioperative anxiety and pain, resulting in a decrease of intra-operative sedative use, postoperative opioid requirement and neurohormonal stress response. IMPROVE evaluates the adherence to music intervention in colorectal perioperative standard care during systematic implementation. Method: The Consolidated Framework for Implementation Research (CFIR) was used for implementation in three steps. This study addresses the first step in which barriers and facilitators for implementing perioperative music were identified by surveying patients who underwent colorectal surgery and healthcare professionals involved in perioperative care. Also, perioperative anxiety scores were assessed and data on perioperative pain was collected from the patients’ medical records. Results: Fifty patients and 69 professionals (response rate 68.3%) were surveyed. For patients, all domains of the CFIR were facilitating implementation. The median reported preoperative and postoperative anxiety scores were 4.5 (1.0–7.0) and 3.0 (1.0–5.75) respectively. The median postoperative pain score on the first postoperative day was 2.8 (2.0–3.7). Also, for professionals most domains were facilitating, except for some factors related to work climate and culture among nurses. Conclusions: In this study it was identified that facilitating factors for implementing music in standard perioperative care were more prominent in both patients and healthcare professionals and therefore successful implementation is probable. Also, this study provides a guideline for assessing facilitators and barriers in other settings.

Background: The aim of the present study is to present the three years follow-up a randomised controlled trial that compared Hartmann's Procedure (HP) with sigmoidectomy with primary anastomosis (with or without defunctioning ileostomy) (PA) in a randomised design to determine the optimal treatment strategy for perforated diverticulitis with purulent or fecal peritonitis. Methods: Data were prospectively gathered for the first 12 months after randomization and retrospectively collected up to 36 months. The primary long-term endpoint was stoma free rate 36 months after the index procedure. Secondary outcomes were patients with a stoma at 36 months, percentage of stoma reversals, related reinterventions, parastomal/incisional hernia rates, total in hospital days including all readmissions regardless their relation to the intervention, overall morbidity and mortality. Results: Three years follow-up was completed in 119 of the originally 130 included patients, with 57 (48%) in the PA-group and 62 (52%) patients in the HP-group. 36 months stoma free rate was significantly better for patients undergoing PA compared with HP (PA 92% vs HP 81%, hazard ratio 2.326 [95% CI 1.538–3.517]; log-rank p < 0·0001). Stoma reversal rates did not significantly differ (PA 31/40(78%) versus HP 45/61(74%), p = 0.814). Overall cumulative morbidity (PA 21/57(36%) versus HP 30/62(48%), p = 0.266) and mortality (PA 6/57(11%) versus HP 7/62 (11%), p = 1.000) did not differ between groups. However, more parastomal hernias occurred in the HP-group (HP 10/62(16%) vs PA 1/57(2%), p = 0.009) and the mean total in hospital days after three years follow-up was significantly lower in the PA-group compared to the HP-group (PA 14 days (IQR 9.5–22.5) versus HP 17 days (IQR 12.5–27.5)), p = 0.025). Conclusion: Long-term results showed that in haemodynamically stable, immunocompetent patients primary anastomosis is superior to Hartmann's procedure as treatment for perforated diverticulitis with respec