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The paradigm of emergency laparotomy with sigmoid resection and protective stoma has been challenged for perforated diverticular disease (PDD) with free extraluminal air. Early clinical stabilization could lead to interval laparoscopic resection without stoma within 2 weeks from perforation. Patients admitted for acute diverticulitis underwent abdominal computed tomography (CT) scan. When free air was seen, endoluminal enema was administred. All patients underwent assessement of clinical stability. In unstable patients, upfront emergency surgery was performed. Stable patients underwent a conservative management consisting in fasting, central line intravenous fluids, antibiotic therapy, pain management, O

BACKGROUND The current treatment of symptomatic diverticular disease is left colectomy/sigmoidectomy with low ligation of the inferior mesenteric artery versus the inferior mesenteric artery preservation. Up to now, there is no strong evidence in favor of one of the 2 strategies. The aim of this study is to compare the bowel-specific quality of life and functional outcomes between these 2. METHODS Between June 2015 and February 2019, patients were randomly assigned to inferior mesenteric artery low ligation or inferior mesenteric artery preservation during elective laparoscopic sigmoidectomy for diverticular disease. Gastrointestinal, genitourinary functions and surgical outcomes were compared postoperatively between groups. RESULTS One-hundred sixty-eight patients were randomized providing 2 homogenous groups. Gastrointestinal and genitourinary functions were not significantly different between groups after 1 and 6 months postoperative. In both groups, the function was restored to the preoperative level 6 months after surgery. There was no statistically significant difference in terms of conversion rate, blood loss, length of surgery, between groups. There was no difference in the overall complication rate and the anastomotic leak rate among groups. CONCLUSIONS Inferior mesenteric artery low ligation or inferior mesenteric artery preservation during elective laparoscopic sigmoidectomy for a diverticular disease can be considered equivalent in affecting the postoperative bowel-related quality of life, genitourinary function, and surgical outcomes.

Magnetic resonance imaging (MRI) is routinely used for preoperative tumor staging and to assess response to therapy in rectal cancer patients. The aim of our study was to evaluate the accuracy of MRI based restaging after neoadjuvant chemoradiotherapy (CRT) in predicting pathologic response. This multicenter cohort study included adult patients with histologically confirmed locally advanced rectal adenocarcinoma treated with neoadjuvant CRT followed by curative intent elective surgery between January 2014 and December 2019 at four academic high-volume institutions. Magnetic resonance tumor regression grade (mrTRG) and pathologic tumor regression grade (pTRG) were reviewed and compared for all the patients. The agreement between radiologist and pathologist was assessed with the weighted k test. Risk factors for poor agreement were investigated using logistic regression. A total of 309 patients were included. Modest agreement was found between mrTRG and pTRG when regression was classified according to standard five-tier systems (k = 0.386). When only two categories were considered for each regression system, (pTRG 0-3 vs pTRG 4; mrTRG 2-5 vs mrTRG 1) an accuracy of 78% (95% confidence interval [CI] 0.73-0.83) was found between radiologic and pathologic assessment with a k value of 0.185. The logistic regression model revealed that "T3 greater than 5 mm extent" was the only variable significantly impacting on disagreement (OR 0.33, 95% CI 0.15-0.68, P = .0034). Modest agreement exists between mrTRG and pTRG. The chances of appropriate assessment of the regression grade after neoadjuvant CRT appear to be higher in case of a T3 tumor with at least 5 mm extension in the mesorectal fat at the pretreatment MRI.

Gerstmann-Sträussler-Scheinker syndrome (GSS) is a rare, infectious syndrome related to a mutation in the prion protein gene. Described here are the challenges posed by surgery for a patient with GSS. A 61-yr-old woman with GSS was admitted to this department and underwent surgery twice for large and small bowel obstruction. This is the first report of two major surgical procedures in a patient with GSS. Experiences with this case and precautions when using a disposable device during endotracheal intubation and a surgical procedure to manage a patient with GSS are described.

The aim of the present study was to compare the incidence of genitourinary (GU) dysfunction after elective laparoscopic low anterior rectal resection and total mesorectal excision (LAR + TME) with high or low ligation (LL) of the inferior mesenteric artery (IMA). Secondary aims included the incidence of anastomotic leakage and oncological outcomes.The criterion standard surgical approach for rectal cancer is LAR + TME. The level of artery ligation remains an issue related to functional outcome, anastomotic leak rate, and oncological adequacy. Retrospective studies failed to provide strong evidence in favor of one particular vascular approach and the specific impact on GU function is poorly understood.Between June 2014 and December 2016, patients who underwent elective laparoscopic LAR + TME in 6 Italian nonacademic hospitals were randomized to high ligation (HL) or LL of IMA after meeting the inclusion criteria. GU function was evaluated using a standardized survey and uroflowmetric examination. The trial was registered under the ClinicalTrials.gov Identifier NCT02153801.A total of 214 patients were randomized to HL (n = 111) or LL (n = 103). GU function was impaired in both groups after surgery. LL group reported better continence and less obstructive urinary symptoms and improved quality of life at 9 months postoperative. Sexual function was better in the LL group compared to HL group at 9 months. Urinated volume, maximum urinary flow, and flow time were significantly (P0.05) in favor of the LL group at 1 and 9 months from surgery. The ultrasound measured post void residual volume and average urinary flow were significantly (P0.05) better in the LL group at 9 months postoperatively. Time of flow worsened in both groups at 9 months compared to baseline. There was no difference in anastomotic leak rate (8.1% HL vs 6.7% LL). There were no differences in terms of blood loss, surgical times, postoperative complications, and initial oncological outcomes between groups.LL of the IMA in LAR + TME results in better GU function preservation without affecting initial oncological outcomes. HL does not seem to increase the anastomotic leak rate.

Background: The Covid-19 pandemic in Northern Italy has slowed down the clinical surgical activity. A system of hub and spoke hospitals was set up to take care of oncological patients with the consequent almost complete abolition of the elective surgical activity for non-oncological pathologies. Methods: We retrospectively analyzed the surgical volumes of 4 different non academic general hospitals in Lombardy belonging to 4 different provinces. The quarter March April May 2019 was compared with the same period of 2020. All different procedures were listed. The cost analysis was performed using the DRG system. Resultas: In the four hospitals involved the surgical procedures reduced from 1903 to 350 with a drop of the 81.6%. Procedures for cancer from 403 to 161 with a drop of 60.1%. Procedures for benign disease from 1310 to 118 with a drop ofthe 91%. Emergencies from 190 to 71 with a drop ofthe 62.600. State refund for the procedures performed from 6.708.023 € to 1.678.154 C with a drop of 75%. Conclusions: Elective surgery was dramatically impaired by the Covid-19 pandemic. Above all procedures for non oncological and non urgent patients were particularly affected. In View of a possible second wave of the pandemic, the surgical planning must select patients not only on onco- logical criteria but rather on clinical ones. An ad hoc hub and spoke hospitals pathway has to be implemented for benign surgical diseases by whoever is facing the Covid pandemic at its spike.

Background: HD systems are routinely used in laparoscopic surgery, 4K ultra HD monitors are mainly available within specialized, high-volume laparoscopic centers. The higher resolution of 4K ultra HD video could upgrade the surgical performance improving intraoperative and post-operative outcomes. Methods: We performed a retrospective comparative analysis of intraoperative parameters and post-operative outcomes in a cohort of patients operated on for elective laparoscopic procedures for colo-rectal cancer during two different time frames: 2017 procedures performed using the Visera Elite full HD technology (® Olympus America, Medical) and the 2018 procedures performed the Visera 4K Ultra HD System (® Olympus America, Medical). Results: There was a statistically significant reduction in operative time in patients operated on with the 4K ultra HD technology compared to HD technology (p < 0.05). Intraoperative blood loss was significantly reduced in patients operated in 2018 (p < 0.05). There were no statistically significant differences in complication rate and postoperative outcomes between the two groups.

Total laparoscopic right hemicolectomy is a procedure that involves an intracorporeal anastomosis. This approach may reduce tissue injury resulting in a significant lower surgical stress response (SSR) compared with the same procedure performed with an extracorporeal anastomosis. The purpose of this study was to compare the SSR level between 2 groups of patients undergoing laparoscopic right hemicolectomy with intracorporeal or extracorporeal anastomosis. From June 2015 to December 2016, 60 patients were enrolled and randomized. Interleukin-6, C-reactive protein, procalcitonin, white blood cell count, cortisol, prolactin, prealbumin, albumin, triglycerides, and transferrin were analyzed preoperatively and at 1, 3, and 5 days postoperatively. Interleukin-6 and C-reactive protein levels were significantly lower in the intracorporeal group on days 1, 3, and 5 postoperatively compared with the extracorporeal group. Gastrointestinal recovery was significantly earlier in the intracorporeal group. The intracorporeal anastomosis in laparoscopic right hemicolectomy reduces SSR, which may play a role in bowel recovery.

Background: The management of rectal cancer is multimodal and involves a multidisciplinary team of cancer specialists with expertise in medical oncology, surgical oncology, radiation oncology and radiology. It is crucial for highly specialized centers to collaborate via networks that aim to maintain uniformity in every aspect of treatment and rigorously gather patients’ data, from the first clinical evaluation to the last follow-up visit. The Advanced International Mini-Invasive Surgery (AIMS) academy clinical research network aims to create a rectal cancer registry. This will prospectively collect the data of patients operated on for non-metastatic rectal cancer in high volume colorectal surgical units through a well design pre-fashioned database for non-metastatic rectal cancer, in order to take all multidisciplinary aspects into consideration. Methods/Design: The protocol describes a multicenter prospective observational cohort study, investigating demographics, frailty, cancer-related features, surgical and radiological parameters, and oncological outcomes among patients with non-metastatic rectal cancer who are candidates for surgery with curative intent. Patients enrolled in the present registry will be followed up for 5 years after surgery. Discussion: Standardization and centralization of data collection for neoplastic diseases is a virtuous process for patient care. The creation of a register will allow the control of the quality of treatments provided and permit prospective and retrospective studies to be carried out on complete and reliable high quality data. Establishing data collection in a prospective and systematic fashion is the only possibility to preserve the enormous resource that each patient represents.

Objective: Older patients with cancer value functional outcomes as much as survival, but surgical studies lack functional recovery (FR) data. The value of a standardized frailty assessment has been confirmed, yet it's infrequently utilized due to time restrictions into everyday practice. The multicenter GOSAFE study was designed to (1) evaluate the trajectory of patients' quality of life (QoL) after cancer surgery (2) assess baseline frailty indicators in unselected patients (3) clarify the most relevant tools in predicting FR and clinical outcomes. This is a report of the study design and baseline patient evaluations. Materials & Methods: GOSAFE prospectively collected a baseline multidimensional evaluation before major elective surgery in patients (≥70 years) from 26 international units. Short−/mid−/long-term surgical outcomes were recorded with QoL and FR data. Results: 1003 patients were enrolled in a 26-month span. Complete baseline data were available for 977(97.4%). Median age was 78 years (range 70–94); 52.8% males. 968(99%) lived at home, 51.6% without caregiver. 54.4% had ≥ 3 medications, 5.9% none. Patients were dependent (ADL < 5) in 7.9% of the cases. Frailty was either detected by G8 ≤ 14(68.4%), fTRST ≥ 2(37.4%), TUG > 20 s (5.2%) or ASAIII-IV (48.8%). Major comorbidities (CACI > 6) were detected in 36%; 20.9% of patients had cognitive impairment according to Mini-Cog. Conclusion: The GOSAFE showed that frailty is frequent in older patients undergoing cancer surgery. QoL and FR, for the first time, are going to be primary outcomes of a real-life observational study. The crucial role of frailty assessment is going to be addressed in the ability to predict postoperative outcomes and to correlate with QoL and FR.

Background: Compliance to adjuvant chemotherapy (AC) for patients undergoing rectal surgery ranges from 43% to 73.6%. Reasons reported for not initiating or completing AC include onset of postoperative complications, drug toxicity, disease progression and/or patient preferences. Little is known regarding the impact of obesity on the compliance to AC in this setting. Methods: This multicenter, retrospective study analyzed compliance to AC and treatment-related morbidity in 511 patients having undergone surgery with curative intent for rectal cancer in six Italian colorectal centers between January 2013 and December 2017. Results: 70 patients were obese (BMI 30 kg/m2). The proportion of open procedures (22.9% vs. 13.4%) and conversions (14.3% vs. 4.8%) was greater in obese compared to non-obese patients (p 0.001). Median hospital stay was one day longer for obese patients (9 days vs. 10 days, p=0.038) while there was no statistically significant difference in the complication rate, whether overall (58.6% in obese vs. 52.3% in non-obese) or with a Clavien-Dindo score 3 (17.1% vs 10.9%). AC was offered to 49/70 (70%) patients in the obese group and 306/441 (69.4%) in the non-obese group (p=0.43). There was no statistically significant difference in AC compliance: 18.4% and 22.9% did not start AC, while 36.7% and 34.6%, started AC but did not complete the scheduled treatment (p=0.79) in the obese and non-obese group, respectively. Overall, 55% of patients who started AC successfully completed their adjuvant treatment. Conclusions: Obesity did not impact compliance to AC for locally advanced rectal cancer: compliance was poor in obese and non-obese patients with no statistically significant difference between the two groups. Major complication rate was not statistically significantly affected by increased BMI.

The one-anastomosis laparoscopic gastric bypass (OAGB) has been proven to provide good weight loss, comorbidity improvement, and quality of life with follow-up longer than five years. Although capable of improving many obesity-related diseases, OAGB is associated with post-operative medical complications mainly related to the induced malabsorption. A 52-year-old man affected by nephrotic syndrome due to a focal segmental glomerulosclerosis underwent OAGB uneventfully. At three months post-surgery, the patient had lost 40kg, reaching a BMI of 32. The patient was admitted to the nephrology unit for acute kidney injury with only mild improvement in renal function (SCr 9 mg/dl); proteinuria was still elevated (4g/24h), with microhaematuria. A renal biopsy was performed: oxalate deposits were demonstrated inside tubules, associated with acute and chronic tubular and interstitial damage and glomerulosclerosis (21/33 glomeruli). Urinary oxalate levels were found to be elevated (72mg/24h, range 13-40), providing the diagnosis of acute kidney injury due to hyperoxaluria, potentially associated to OAGB. No recovery in renal function was observed and the patient remained dialysis dependent. Early and rapid excessive weight loss in patients affected by chronic kidney insufficiency could be associated with the worsening of renal function. Increased calcium oxalate levels associated with OAGB-related malabsorption could be a key factor in kidney injury.

to evaluated pain perception and return to normal daily activities in two groups of patients undergoing elective totally laparoscopic colonic surgery according to two different analgesic protocols within Fast Track programs. we compared two groups of patients prospectively evaluated in terms of post-operative painperception and short term outcomes undergoing totally laparoscopic elective colonic surgery among fasttrack programs. 46 patients (43 completed the study) (Group 1) received analgesia with spinal injection 30 min before surgery of Morphine 0,2 – 0,3 mg , morphine PCA post operatively, Paracetamol 1 gr if needed every 8 h. 43 patients (40 completed the study) (Group 2) received analgesia with Paracetamol 1 gr every 6 h , ketorolac every 12 h, Lidocaine wound infiltration. Patients in G2 passed flatus and stool significantly before those in G1 (p

The arterial ligation during elective laparoscopic sigmoidectomy for diverticular disease can affect genito-urinary function injuring the superior hypogastric plexus, and can weaken the distal colonic stump arterial perfusion. Ligation of the inferior mesenteric artery distal to the left colic artery or the complete preservation of the inferior mesenteric artery can therefore be compared in terms of preservation of the descending sympathetic fibres running along the aorta to the rectum resulting in a different post operative genito urinary function. From January 2015 to March 2016, 66 patients underwent elective laparoscopic sigmoidectomy for diverticular disease among two enrolling hospitals. In one centre 35 patients underwent laparoscopic sigmoidectomy with the ligation of the inferior mesenteric artery distal to the left colic artery (low ligation). In the other centre 31 patient were operated on the same procedure with complete inferior mesenteric artery preservation (IMA preservation). There was no difference in terms of major complication occurred, first passage of stool and length of hospital stay between the two groups. Time of surgery was significantly shorter in LL group compared to IMA preserving group and intra operative blood loss was significantly lower in the LL group. There were no differences in the genito urinary function between the two group pre operatively, at 1 and 9 months post operatively. Genito urinary function did not significantly change across surgery in each groups. The low ligation and the IMA preserving vascular approach are safe end feasible techniques in elective laparoscopic sigmoidectomy for diverticular disease. They both prevent from genito-urinary post-operative disfunction and allow good post operative quality of life. The low ligation approach is related to shorter operative time and slower intra operative blood loss.

Genito-urinary disorders (GUD) for radical rectal cancer surgery range from 10 to 30 %. In this study, primary endpoint is to prospectively assess their incidence in patients undergoing Laparoscopic Total Mesorectal Excision (LTME) without neoadjuvant chemo-radiation (NCR). Secondary endpoint is to detect the potential lesion site evaluating video-recordings of surgery. A study of 35 consecutive patients treated by LTME for extra-peritoneal rectal cancer not subjected to NCR, M:F = 23:12, median age 70, was evaluated preoperatively by Uroflowmetry and US postvoid residual urine measurement (PVR), International Prostatic Symptoms Score (IPSS), and International Consultation on Incontinence Modular Questionnaire (ICIQ) at 1 and 9 months post-operatively. Evaluation of sexual function was carried out by International Index of Erectile Function (IIEF) in males. Data were analyzed performing Fisher and paired samples t tests. Surgical videos of patients affected by GUD were reviewed to identify lesion sites. Urinary function:IPSS average score: baseline 6.03 ± 5.51, 8.93 ± 6.42 (p = .005) at 1 month, and 7.26 ± 5.55 (p = .041) at 9 months. ICIQ baseline 2.67 ± 5.42, 4.27 ± 6.19 (p = NS) at 1 month, and 3.63 ± 5.23 (p = NS) at 9 months. Maximum urine flow rate baseline 15.95 ± 4.78 ml/s, 14.23 ± 5.27 after 1 month (p = .041), and 15.22 ± 4.01 after 9 months (p = NS). Mean urine flow rate baseline 9.15 ± 2.96 ml/s, 7.99 ± 4.12 ml/s at 1 month (p = .044), and 8.54 ± 4.19 ml/s at 9 months (p = NS). PVR baseline 59.62 ± 54.49, 64.59 ± 58.71 (p = NS) at 1 month, and 68.82 ± 77.72 (p = NS) at 9 months. Sexual function: IIEF baseline 19.38 ± 6.25, 14.06 ± 8.65 at 1 month (p = .011), and 15.4 ± 8.41 at 9 months, (p = NS). Video review of patients with disorders showed potential damage at the site of ligation of IMA (high hypogastric plexus) in 1 case, lateral and posterior mesorectum dissection (hypogastric nerves) in 2 cases, anterior dissection of the Denonvilliers fascia from seminal vesicles in 2 cases. GUD at 1 month from LTME for rectal cancer are significant but improve at 9 months. Surgical video review of patients with GUD provides an important tool for detection of lesion sites.

The value of fast-track (FT) multimodal recovery programs in improving hospitalization of surgical patients has been widely proved. The application of FT protocols to laparoscopic colorectal surgery seems to maximize the effects of the minimally invasive approach. The objectives of this randomized-controlled trial are to compare the short-term outcomes (bowel function, return to oral nutrition, day of discharge, fatigue, time to resume normal activities, functional capabilities, and readmission rate) of patients undergoing elective laparoscopic high anterior resection (HAR) following either a FT or a standard program. The prospective randomized-controlled trial included 52 consecutive patients undergoing elective laparoscopic HAR. Group 1 was treated with a FT rehabilitation program, and group 2 was treated with a standard care (SC) program. Patients were interviewed 14 and 30 days postoperatively. One patient in each group was excluded from the study. Mean hospital stay, time of first bowel movement, and bowel function resumption were significantly shorter in the FT group (P

Bleeding from the stapled line is a rare but potentially lethal complication that requires a proper and immediate management. Treatment for stapled anastomotic hemorrhage may be operative or conservative. We report three cases of anastomotic stapled line bleeding after colorectal surgery successfully treated endos-copically. Laparoscopic High Anterior Resection with a trans anal anastomosis according to Knight-Griffen with circular a stapler was performed for adenocarcinoma, rectal endometriosis and diverticular disease. All three patients had major rectal bleeding within 24 hours from surgery. 1 patients had endoscopy before the end of the surgical procedure. Endoscopic wash out with removal of the clots and infiltration of the bleeding sites along the stapled line with Adrenaline 1 : 10000 (2 ml) was performed achieving a good hemostasis. Early endoscopy is a safe and efficient treatment in colorectal anastomotic bleeding.

A laparoscopic approach represents an effective alternative to open surgery in patients undergoing peritoneal dialysis (PD). In these patients, conventional thinking provides for removal of the peritoneal catheter during left colon resections because of higher risk of patient contamination and peritonitis. The present paper describes 3 cases of laparoscopic left hemicolectomy for colon cancer performed in PD patients without complications and without peritoneal catheter removal, leading to subsequent early PD resumption. Three normotype PD patients affected by early-stage sigmoid colon adenocarcinoma (T1-T2, M0, N0) underwent integrated surgical and nephrological management to reduce peritoneum stress, infective risk and postoperative complications. The day before surgery, patients were shifted to isovolumetric hemodialysis through tunneled central venous catheter. All patients underwent laparoscopic left hemicolectomy without Tenckhoff catheter removal. The postoperative period was uneventful, with concomitant antibiotic prophylaxis until the fifth day after surgery. Flushing of the PD catheter was performed twice a week postoperatively. Peritoneal dialysis was recovered 4 weeks after surgery in 2 cases with a well-maintained dialytic adequacy. One patient did not proceed to PD due to improvement of renal function after surgery. In selected PD patients, a minimally invasive surgical approach combined with careful nephrological management may represent a valid and safe strategy to treat early-stage colon cancer, avoiding PD drop-out.

BACKGROUND Enhanced Recovery After Surgery (ERAS) program applied to colorectal laparoscopic surgery is well known to reduce hospitalization improving short-terms outcomes. Its goal is to minimize the surgical stress response in order to maintain the physiological homeostasis altered by surgery. However, there is little knowledge about the involved dynamics in the reduction of the surgical stress that these programs allow. The primary aim of this study was to compare the level of immune and nutritional serum investigators across surgery in patients undergoing elective colorectal laparoscopic surgery within an ERAS protocol or according to a standard care program. MATERIALS AND METHODS One hundred forty patients undergoing major colorectal laparoscopic surgery were enrolled and randomized in 2 groups (70 per arm).Cortisol, C-reactive protein (CRP), white blood cell count, prolactin, interleukin (IL)-6 levels were collected preoperatively, 1, 3, and 5 days after surgery. Transferrin, prealbumin, albumin, and triglyceride level were collected preoperatively, 1 and 5 days after surgery. Short-term outcomes were also prospectively assessed. RESULTS IL-6 levels were lower in the ERAS group on 1, 3, and 5 days postoperatively (P

Laparoscopic anterior rectal resection with total mesorectal excision is related to sexual and urinary disorders. Anastomotic leak and neo-adjuvant radiation therapy are effective factors in worsening pelvic function. We report a series of 50 elderly (age 70) patients who underwent laparoscopic total mesorectal excision inquired about pre and post-operative genito-urinary function. Patients were interviewed preoperatively, 1 and 9 months post-operatively with validated questionnaires about sexual and urinary function and quality of life. They also underwent urofluximetric test with ultrasound measurement of the bladder remnant volume. The geriatric assessment was performed with the BARTHEL index. Urinary and sexual function slightly worsened after surgery although not significantly. Mean Gastrointestinal Quality of Life Indicator score decreased significantly from pre operative levels at 1 month from surgery. BARTHEL index did not change significantly across surgery. Maximum urinary flow, mean urinary flow, bladder residual volume worsened after surgery although not significantly. Laparoscopic anterior rectal resection with total mesorectal excision affects the genito-urinary status of elderly patients. Incidence of severe dysfunctions is similar to normal aged population.

Background The position of arterial ligation during laparoscopic anterior rectal resection with total mesorectal excision can affect genito-urinary function, bowel function, oncological outcomes, and the incidence of anastomotic leakage. Ligation to the inferior mesenteric artery at the origin or preservation of the left colic artery are both widely performed in rectal surgery. The aim of this study is to compare the incidence of genito-urinary dysfunction, anastomotic leak and oncological outcomes in laparoscopic anterior rectal resection with total mesorectal excision with high or low ligation of the inferior mesenteric artery in a controlled randomized trial. Methods/design The HIGHLOW study is a multicenter randomized controlled trial in which patients are randomly assigned to high or low inferior mesenteric artery ligation during laparoscopic anterior rectal resection with total mesorectal excision for rectal cancer. Inclusion criteria are middle or low rectal cancer (0 to 12 cm from the anal verge), an American Society of Anesthesiologists score of I, II, or III, and a body mass index lower than 30. The primary end-point measure is the incidence of post-operative genito-urinary dysfunction. The secondary end-point measure is the incidence of anastomotic leakage in the two groups. A total of 200 patients (100 per arm) will reliably have 84.45 power in estimating a 20% difference in the incidence of genito-urinary dysfunctions. With a group size of 100 patients per arm it is possible to find a significant difference (α = 0.05, β = 0.1555). Allowing for an estimated dropout rate of 5%, the required sample size is 212 patients. Discussion The HIGHLOW trial is a randomized multicenter controlled trial that will provide evidence on the merits of the level of arterial ligation during laparoscopic anterior rectal resection with total mesorectal excision in terms of better preserved post-operative genito-urinary function. Trial registration ClinicalTrials.gov Identifier: NCT02153801 Protocol Registration Receipt 29/5/2014. Electronic supplementary material The online version of this article (doi:10.1186/s13063-014-0537-5) contains supplementary material, which is available to authorized users.

ERAS program applied to colorectal laparoscopic surgery is well known to reduce hospitalization improving short terms outcomes and minimizing the Surgical Stress Response. However its effectiveness in elderly population is yet to be demonstrated. The primary aim of this study is to compare the level of immune and nutritional serum indexes across surgery in patients aged over 70 years old undergoing elective colorectal laparoscopic surgery within an ERAS protocol or according to a Standard program. 83 patients undergoing colorectal laparoscopic surgery were enrolled and randomized in two groups (ERAS Group 40, Standard Group 43) within a larger randomized trial on a general population. Surgical stress parameters were collected preoperatively, 1, 3 and 5 days after surgery. Nutritional parameters were collected preoperatively, 1 and 5 days after surgery. Short Term Outcomes were also prospectively assessed. IL-6 levels were lower in the EG on 1, 3, and 5 days post-operatively (p 0.05). IL-6 levels in the Enhanced group returned to pre operative level 3 days after surgery. C-reactive protein level was lower in the Enhanced group on day 1, 3, and 5 (p 0.05). There was no difference in Cortisol and Prolactin levels between groups. Prealbumin serum level was higher on day 5 (p 0.05) compared to standard group. Postoperative outcomes in terms of normal bowel function and length of hospital stay were significantly improved in the ERAS group. Colorectal laparoscopic surgery within an ERAS prototcol in elderly patients affects Surgical Stress Response, decreasing IL-6 and CRP levels postoperatively and improving Prealbumin post operative synthesis.