Implementing a no-drain policy for extraperitoneal colorectal anastomosis in a real-life setting: analysis of outcomes and surgeons' adherence.

AIM: Recent evidence has questioned the usefulness of anastomotic drain (AD) after low anterior resection (LAR). However, the implementation and adoption of a no-drain policy are still poor. This study aims to assess the clinical outcomes of the implementation of a no-drain policy for rectal cancer surgery into a real-life setting and the adherence of the surgeons to such policy. METHOD: A retrospective analysis was conducted on patients who underwent elective minimally invasive LAR between January 2015 and December 2019 at two tertiary referral centers. In 2017, both centers implemented a policy aimed at reducing the use of AD. Patients were retrospectively categorized into two groups: the drain policy (DP) group, comprising patients treated before 2017, and the no-drain policy (NDP) group, consisting of patients treated from 2017 onwards. The endpoints were the rate of anastomotic leak (AL) and of related interventions. RESULTS: Among the 272 patients included, 188 (69.1%) were in the NDP group, and 84 (30.9%) were in the DP group. Baseline characteristics were similar between the two groups. AL rate was 11.2% in the NDP group compared to 10.7% in the DP group (p = 1.000), and the AL grade distribution (grade A, 19.1% (4/21) vs 28.6% (2/9); grade B, 28.6% (6/21) vs 11.1% (1/9); grade C, 52.4% (11/21) vs 66.7% (6/9), p = 0.759) did not significantly differ between the groups. All patients with symptomatic AL and AD underwent surgical treatment for the leak, while those with symptomatic AL in the NPD group were managed with surgery (66.7%), endoscopic (19.0%), or percutaneous (14.3%) interventions. Postoperative outcomes were similar between the groups. Three years after implementing the no-drain policy, AD was utilized in only 16.5% of cases, compared to 76.2% at the study's outset. CONCLUSION: The introduction of a no-drain policy received a good adoption rate and did not affect negatively the surgical outcomes.

Preoperative lateral lymph node features and impact on local recurrence after neoadjuvant chemoradiotherapy and total mesorectal excision for locally advanced rectal cancer: results from a multicentre international cohort study.

AIM: Locally advanced rectal cancer (LARC) is commonly treated with neoadjuvant chemoradiotherapy (nCRT) and total mesorectal excision (TME) to reduce local recurrence (LR) and improve survival. However, LR, particularly associated with lateral lymph node (LLN) involvement, remains a concern. The aim of this study was to investigate preoperative factors associated with LLN involvement and their impact on LR rates in LARC patients undergoing nCRT and curative surgery. METHOD: This multicentre retrospective study, including four academic high-volume institutions, involved 301 consecutive adult LARC patients treated with nCRT and curative surgery between January 2014 and December 2019 who did not undergo lateral lymph node dissection (LLND). Baseline and restaging pelvic MRIs were evaluated for suspicious LLNs based on institutional criteria. Patients were divided into two groups: cLLN+ (positive nodes) and cLLN- (no suspicious nodes). Primary outcome measures were LR and lateral local recurrence (LLR) rates at 3 years. RESULTS: Among the cohort, 15.9% had suspicious LLNs on baseline MRI, and 9.3% had abnormal LLNs on restaging MRI. At 3 years, LR and LLR rates were 4.0% and 1.0%, respectively. Ten out of 12 (83.3%) patients with LR showed no suspicious LLNs at the baseline MRI. Abnormal LLNs on MRI were not independent risk factors for LR, distant recurrence or disease-free survival. CONCLUSION: Abnormal LLNs on baseline and restaging MRI assessment did not impact LR and LLR rates in this cohort of patients with LARC submitted to nCRT and curative TME surgery.

Garlic consumption in relation to colorectal cancer risk and to alterations of blood bacterial DNA.

PURPOSE: Garlic consumption has been inversely associated to intestinal adenoma (IA) and colorectal cancer (CRC) risk, although evidence is not consistent. Gut microbiota has been implied in CRC pathogenesis and is also influenced by garlic consumption. We analyzed whether dietary garlic influence CRC risk and bacterial DNA in blood. METHODS: We conducted a case-control study in Italy involving 100 incident CRC cases, 100 IA and 100 healthy controls matched by center, sex and age. We used a validated food frequency questionnaire to assess dietary habits and garlic consumption. Blood bacterial DNA profile was estimated using qPCR and16S rRNA gene profiling. We derived odds ratios (ORs) and the corresponding 95% confidence intervals (CIs) of IA and CRC according to garlic consumption from multiple conditional logistic regression. We used Mann-Whitney and chi-square tests to evaluate taxa differences in abundance and prevalence. RESULTS: The OR of CRC for medium/high versus low/null garlic consumption was 0.27 (95% CI = 0.11-0.66). Differences in garlic consumption were found for selected blood bacterial taxa. Medium/high garlic consumption was associated to an increase of Corynebacteriales order, Nocardiaceae family and Rhodococcus genus, and to a decrease of Family XI and Finegoldia genus. CONCLUSIONS: The study adds data on the protective effect of dietary garlic on CRC risk. Moreover, it supports evidence of a translocation of bacterial material to bloodstream and corroborates the hypothesis of a diet-microbiota axis as a mechanism behind the role of garlic in CRC prevention.

Standardized right artery first approach during laparoscopic pancreaticoduodenectomy for periampullary neoplasms: technical aspects and perioperative outcomes.

BACKGROUND: The most debated aspects of laparoscopic pancreaticoduodenectomy (LPD) concern the dissection of the pancreas from the surrounding vessels and the achievement of adequate resection margins, especially in patients with pancreatic cancer. METHODS: Data of consecutive patients undergoing LPD with right artery first approach from September 2020 to September 2021 for periampullary neoplasms (pancreatic, ampullary, duodenal, distal common biliary duct) were prospectively collected and retrospectively analyzed. The overall cohort was divided into two groups: patients affected by pancreatic carcinoma (PC) and patients affected by other periampullary neoplasms (OP). Surgical and postoperative outcomes between PC and OP were compared. RESULTS: Thirty-one patients (15 PC and 16 OP) were selected. No difference was found between PC and OP in terms of baseline characteristics. Median resection time and overall surgical time of the entire cohort were 275 min and 530 min, respectively, without difference between the groups (p = 0.599 and 0.052, respectively). Blood loss was similar between the groups, being 350 ml in PC and 325 ml in OP (p = 0.762). One patient (3.2%) was converted to laparotomy. No difference was found between the groups in terms of pathological outcomes. Median number of retrieved lymph nodes was 17. The majority of the patients (83.9%) received an R0 resection (73.3% and 93.7% in PC and OP, respectively; p = 0.172). Postoperative surgical outcomes did not differ between the groups, excepting for overall complication rate that was higher in the OP group (26.7% vs 68.7% in PC and OP, respectively; p = 0.032). CONCLUSION: Standardized right artery first approach during LPD was feasible and did not show worse surgical and postoperative outcomes in patients with pancreatic cancer as compared to those affected by other periampullary neoplasms, except for a higher rate of minor complications.

Mid-term oncological outcomes after complete versus conventional mesocolic excision for right-sided colon cancer: a propensity score matching analysis.

BACKGROUND: The correct extent of mesocolic dissection for right-sided colon cancer (RCC) is still under debate. Complete mesocolic excision (CME) has not gained wide diffusion, mainly due to its technical complexity and unclear oncological superiority. This study aims to evaluate oncological outcomes of CME compared with non-complete mesocolic excision (NCME) during resection for I-III stage RCC. METHOD: Prospectively collected data of patients who underwent surgery between 2010 and 2018 were retrospectively analysed. 1:1 Propensity score matching (PSM) was used to balance baseline characteristics of CME and NCME patients. The primary endpoint of the study was local recurrence-free survival (LRFS). The two groups were also compared in terms of short-term outcomes, distant recurrence-free survival, disease-free survival, and overall survival. RESULTS: Of the 444 patients included in the study, 292 were correctly matched after PSM, 146 in each group. The median follow-up was 45 months (IQR 33-63). Conversion rate, complications, and 90-day mortality were comparable in both groups. The median number of lymph nodes harvested was higher in CME patients (23 vs 19, p = 0.034). 3-year LRFS rates for CME patients was 100% and 95.6% for NCME (log-rank p = 0.028). At 3 years, there were no differences between the groups in terms of overall survival, distant recurrence-free survival, and disease-free survival. CONCLUSION: Our PSM cohort study shows that CME is safe, provides a higher number of lymph nodes harvested, and is associated with better local recurrence-free survival.

Laparoscopic complete mesocolic excision versus conventional resection for right-sided colon cancer: a propensity score matching analysis of short-term outcomes.

BACKGROUND: Complete mesocolic excision (CME) for right-sided colon cancer (RCC) is a demanding operation, especially when performed laparoscopically. The potential impact of CME in increasing postoperative complications is still unclear. The aim of our study was to evaluate the safety and feasibility of laparoscopic CME compared with laparoscopic non-complete mesocolic excision (NCME) during colectomy for RCC. METHODS: Data from a prospectively collected database of patients who underwent laparoscopic right and extended right colectomy at our institution between January 2008 and February 2020 were retrieved and analyzed. Short-term outcomes of patients undergoing CME and NCME were compared. A 1:1 propensity score matching (PSM) was used to balance baseline characteristics between groups. RESULTS: A total of 663 consecutive patients underwent resection of RCC in the study period. Among these, 500 met the inclusion criteria and after PSM a total of 372 patients were correctly matched, 186 in each group. A similar rate of overall postoperative complications was found between the CME and NCME groups (21.5% and 18.3%, p = 0.436). No difference was found in terms of conversion rate, severe complications, reoperations, readmissions, and mortality. The median number of harvested lymph nodes was higher in the CME group (22 versus 19, p = 0.003), with a lower rate of inadequate sampling (7.0% and 15.1%, p = 0.013). CONCLUSION: Laparoscopic CME for RCC is technically feasible and safe. It does not seem to be associated with a higher rate of complications or mortality compared with the "traditional" approach, but it allows better nodal sampling.

Novel biodegradable internal stent as a mitigation strategy in high-risk pancreaticojejunostomy: technical notes and preliminary results.

Clinically relevant postoperative pancreatic fistula (CR-POPF) is the most feared complication after pancreaticoduodenectomy (PD), as it can lead to extremely poor outcomes. We herein report the preliminary results of an anastomotic technique based on the use of a novel internal biodegradable stent (IBS) to mitigate POPF sequelae. Between October 2020 and May 2021, all patients undergoing PD with high-risk pancreatic anastomosis received a pancreato-jejunal (PJ) anastomosis with an Archimedes™ IBS placement. Fifteen patients comprised our study cohort. In 11 cases, a 2-mm Archimedes™ stent was used, and in the remaining four patients, a 2.6-mm stent was used. Overall postoperative complications occurred in eight patients, with four cases being severe. Two patients developed CR-POPF, with one of them dying. In our small preliminary series, PJ anastomosis with an Archimedes™ IBS showed encouraging results in terms of CR-POPF incidence. Further studies are needed to confirm these findings.

Preoperative immunonutrition in frail patients with colorectal cancer: an intervention to improve postoperative outcomes.

PURPOSE: The aim of this study is to evaluate whether preoperative immunonutrition can shorten length of stay and improve postoperative outcomes in frail patients who are candidates for major oncologic colorectal surgery. METHODS: A single center retrospective analysis of a prospectively collected database of frail patients, who underwent surgery with curative intent for colorectal cancer between January 2014 and December 2017, was performed. From March 2016, frail oncological patients undergoing major surgery were recommended to receive preoperative immunonutrition; their postoperative outcomes were compared to those of patients not treated with any preoperative nutritional support. Propensity score matching in a 1:1 ratio was used to balance patient characteristics. RESULTS: Overall, 175 patients were included in the study. Of 74 patients receiving immunonutrition, 65 were matched with the group not treated with immunonutrition (n = 101). Baseline characteristics were comparable after matching. Although differences in postoperative length of stay were nonsignificant (p = 0.38), patients who received immunonutrition showed a shorter gastrointestinal (GI) recovery time (3.00 [2.00-4.00] versus 4.00 [2.00-5.00], p = 0.04), a lower rate of situs site infections complications (0.31 [0.10, 0.94], p = 0.04) and less need of antibiotic treatment (0.19 [0.06, 0.64], p = 0.01). CONCLUSION: Preoperative immunonutrition was found to reduce both postoperative situs site infections and need of antibiotic treatment during the postoperative course. This study encourages the use of preoperative immune-enhancing nutrition as a part of multimodal prehabilitation programs in the management of frail colorectal cancer patients.

Should Laparoscopic Complete Mesocolic Excision Be Offered to Elderly Patients to Treat Right-Sided Colon Cancer?

BACKGROUND: Despite its potential oncologic benefit, complete mesocolic excision (CME) has rarely been offered to elderly patients. The present study evaluated the effect of age on postoperative outcomes among patients undergoing laparoscopic right colectomies with CME for right-sided colon cancer (RCC). METHODS: Data of patients undergoing laparoscopic right colectomies with CME for RCC between 2015 and 2018 were retrospectively analyzed. Selected patients were divided into two groups: the under-80 group and the over-80 group. Surgical, pathological, and oncological outcomes among the groups were compared. RESULTS: A total of 130 patients were selected (95 in the under-80 group and 35 in the over-80 group). No difference was found between the groups in terms of postoperative outcomes, except for median length of stay and adjuvant chemotherapy received, which were in favor of the under-80 group (5 vs. 8 days, p < 0.001 and 26.3% vs. 2.9%, p = 0.003, respectively). No difference between the groups was found regarding overall survival and disease free survival. Using multivariate analysis, only the ASA score > 2 (p = 0.01) was an independent predictor of overall complications. CONCLUSIONS: laparoscopic right colectomy with CME for RCC was safely performed in elderly patients ensuring similar oncological outcomes compared to younger patients.

Single-access transumbilical laparoscopic unroofing of a giant hepatic cyst using reusable instruments.

INTRODUCTION: Single-access laparoscopy has garnered growing interest in recent years in an attempt to improve cosmesis, reduce postoperative pain, and minimize abdominal wall trauma. CASE DESCRIPTION: A female patient suffering from a symptomatic giant biliary cyst of the liver segments 4-7-8 was admitted for transumbilical single-access laparoscopic cyst unroofing. The procedure was performed using a standard 11-mm reusable trocar for a 10-mm, 30 degree-angled, rigid scope and curved reusable instruments inserted transumbilically without trocars. Operative time was 90 minutes, and the final incision length was 14 mm. The use of minimal pain medication permitted discharge on the third postoperative day, and after 25 months, the patient remains asymptomatic with a no visible umbilical scar. CONCLUSIONS: Giant biliary cysts can be removed by single-access laparoscopy. Because of this technique, surgeons work in ergonomic positions, and the cost of the procedure remains similar to that of the multitrocar technique. The incision length and the use of pain medication are kept minimal as well.

Flavonoid Intake in Relation to Colorectal Cancer Risk and Blood Bacterial DNA.

Flavonoids have been inversely associated to colorectal cancer (CRC) and are plausible intermediaries for the relation among gut microbiome, intestinal permeability and CRC. We analyzed the relation of flavonoid intake with CRC and blood bacterial DNA. We conducted a case-control study in Italy involving 100 incident CRC cases and 200 controls. A valid and reproducible food-frequency questionnaire was used to assess dietary habits and to estimate six flavonoid subclass intakes. We applied qPCR and 16S rRNA gene profiling to assess blood bacterial DNA. We used multiple logistic regression to derive odds ratios (ORs) of CRC and Mann-Whitney and chi--square tests to evaluate abundance and prevalence of operational taxonomic units (OTUs) according to flavonoid intakes. Inverse associations with CRC were found for anthocyanidins (OR for the highest versus the lowest tertile = 0.24, 95% confidence interval, CI = 0.11-0.52) and flavanones (OR = 0.18, 95% CI = 0.08-0.42). We found different abundance and prevalence according to anthocyanidin and flavanone intake for OTUs referring to Oligoflexales order, Diplorickettsiaceae family, Staphylococcus, Brevundimonas, Pelomonas and Escherischia-Shigella genera, and Flavobacterium and Legionella species. The study provides evidence to a protective effect of dietary anthocyanidins and flavanones on CRC and suggests an influence of flavonoids on blood bacterial DNA, possibly through intestinal permeability changes.

Single-access transumbilical diagnostic laparoscopy for pancreatic tumor using curved and reusable instruments.

INTRODUCTION: Diagnostic laparoscopy in pancreatic tumors remains controversial. The main argument in favor of this procedure is that it helps prevent a delay of chemotherapy in cases of unresectable tumors or peritoneal/lymph node metastasis. We report a technique of performing this exploration through single-incision laparoscopy. VIDEO: The umbilicus is incised, and a purse-string suture is applied. An 11-mm nondisposable trocar is inserted for a 10-mm, 30° angled scope. Curved and reusable instruments (Karl Storz-Endoskope, Tuttlingen, Germany) are inserted transumbilically. Laparoscopic exploration of the cavity allows the visualization of suspected peritoneal or lymph node metastasis. Peritoneal lavage for cytology is performed. Biopsy is accomplished through the curved shape of the instruments, which establishes the working triangulation inside the abdomen as well as externally. Laparoscopic ultrasonography of the liver and of the pancreas (after opening the lesser sac) is performed after replacement of the 11-mm trocar with a 13-mm trocar and the use of a 5-mm scope. The procedure can be continued either by laparoscopy or by open surgery. At completion, the umbilicus is meticulously closed to avoid complications. RESULTS: Operative time is 45-60 minutes, blood loss is minimal, and the size of the umbilical incision is less than 15 mm. CONCLUSIONS: In case of unresectable tumors or peritoneal metastasis, single-access diagnostic laparoscopy for pancreatic tumors permits the start of chemotherapy after less than 7 days. Curved and reusable instruments allow the achievement of ergonomic conditions as classic laparoscopy, without increasing of conventional laparoscopic cost.

Single-incision transumbilical laparo-endoscopic gastric benign tumor resection.

INTRODUCTION: The authors report resection of a gastric benign tumor through single-incision laparoscopy, guided by peroperative gastroscopy. VIDEO: A 25-year-old man consulted after diagnosis of a 40 × 20 cm(2) endoluminal lesion of the gastric cardia. Preoperative work-up showed a stromal tumor with invasion of the muscular layer. The umbilical scar was incised and, after placement of a purse-string suture, an 11-mm nondisposable trocar was inserted for a 10-mm 30° angled scope. Curved and reusable instruments (Karl Storz-Endoskope, Tuttlingen, Germany) and straight ultrasonic shears (Ethicon Endosurgery, Cincinnati, OH, US) were inserted transumbilically. Peroperative gastroscopy located the lesion on the smaller gastric curvature, 1 cm from the gastroesophageal junction. A stitch was placed in the center of the lesion, and gastroscopic grasper helped in maintaining the limits of resection. Gastrostomy was closed using two converting absorbable running sutures. Because of the curves of the instruments there was no conflict between the instruments' tips inside the abdomen (Fig. 1a), or between the surgeon's hands outside the abdomen (Fig. 1b). Leak test with the gastroscope checked the integrity of the suture. The specimen was retrieved transumbilically in a plastic bag. RESULTS: Operative time was 150 min, and the umbilical incision was less than 15 mm. The patient was discharged after 5 days, and he is doing well 3 months postoperatively. CONCLUSIONS: Laparoscopic gastric resection can be safely performed through a single-access. Peroperative gastroscopy permits the limits of resection to be precisely determine, and use of curved and reusable instruments allows surgeon to achieve ergonomic conditions as in classic laparoscopy, without increasing the laparoscopic cost.

Single-access transumbilical laparoscopic splenectomy using curved reusable instruments.

BACKGROUND: The authors report a single-access transumbilical laparoscopic splenectomy (SATLS) performed with curved reusable instruments. METHODS: A 23-year-old female consulted for steroid-resistant idiopathic thrombocytopenic purpura and clinical evidence of secondary Cushing syndrome. Preoperative workup showed a normal-sized spleen and thrombocytopenia. The umbilicus was incised and a purse-string suture was applied. A reusable 11-mm trocar was inserted for a 10-mm, 30° angled scope. Curved reusable instruments (Karl Storz-Endoskope, Tuttlingen, Germany) were advanced without trocars transumbilically. After opening the splenocolic and gastrosplenic ligaments, the main splenic artery and vein were dissected off at the level of the hilum, clipped with 5-mm clips introduced transumbilically, and sectioned. Posterior splenic attachments were freed at the hilum cranially and caudally. The spleen was finally retrieved transumbilically in a plastic bag. RESULTS: Addition of supplementary trocars or incisions was not necessary. Operative time was 180 min and final umbilical scar 16 mm. The patient was discharged on postoperative day 3, and after 6 months she was doing well. CONCLUSIONS: SATLS was feasible and safe to be performed using curved reusable instruments. The curves of the instruments permitted the surgeon to work in an ergonomic position, without the instruments clashing thanks to the obtained triangulation. Since only reusable instruments were used, the cost of SATLS remained similar to that of standard laparoscopy.

Permanent end-colostomy parastomal hernia prevention using a novel three-dimensional mesh.

PURPOSE: Prophylactic mesh placement has been proposed to reduce the high occurrence of parastomal hernia (PSH) after stoma formation. METHODS: This is an observational study comparing two cohorts of patients: a mesh prophylaxis group (who received mesh prevention since introduction at our Institution) and a no mesh prophylaxis group (retrospectively selected from our historical series). Same exclusion criteria were applied for both groups. The study was conducted at a tertiary referral center for colorectal surgery. 43 patients were operated with mesh prophylaxis between May 2015 and may 2019. 45 patients underwent end-colostomy formation without prophylaxis between April 2011 and April 2015. The primary outcome measure was PSH development at 12-month follow up. RESULTS: Demographic variables and risk factors for PSH were comparable between the two groups. There was no difference between the two cohorts in terms of operative time and main early postoperative outcomes. 37 patients completed the 12-month follow up in each group. PSH occurrence after 12-months was 11% in the mesh prophylaxis group and 54% in the no mesh prophylaxis group (p < 0.0001). There were no differences in long-term complications. 5% of patients who received mesh prophylaxis underwent emergency surgery for bowel occlusion at 7 and 10 months after surgery, with partial or complete mesh removal. At multivariate analysis, mesh prophylaxis was a protective factor for PSH development at 12 months (p < 0.0001). CONCLUSIONS: Prophylactic intraperitoneal mesh placement appears to be effective in preventing PSH.

Blood Bacterial DNA Load and Profiling Differ in Colorectal Cancer Patients Compared to Tumor-Free Controls.

Inflammation and immunity are linked to intestinal adenoma (IA) and colorectal cancer (CRC) development. The gut microbiota is associated with CRC risk. Epithelial barrier dysfunction can occur, possibly leading to increased intestinal permeability in CRC patients. We conducted a case-control study including 100 incident histologically confirmed CRC cases, and 100 IA and 100 healthy subjects, matched to cases by center, sex and age. We performed 16S rRNA gene analysis of blood and applied conditional logistic regression. Further analyses were based on negative binomial distribution normalization and Random Forest algorithm. We found an overrepresentation of blood 16S rRNA gene copies in colon cancer as compared to tumor-free controls. For high levels of gene copies, community diversity was higher in colon cancer cases than controls. Bacterial taxa and operational taxonomic unit abundances were different between groups and were able to predict CRC with an accuracy of 0.70. Our data support the hypothesis of a higher passage of bacteria from gastrointestinal tract to bloodstream in colon cancer. This result can be applied on non-invasive diagnostic tests for colon cancer control.

Endoscopic multiple metal stenting for the treatment of enteral leaks near the biliary orifice: A novel effective rescue procedure.

Between April 2013 and October 2015, 6 patients developed periampullary duodenal or jejunal/biliary leaks after major abdominal surgery. In all patients, percutaneous drainage of the collection or re-operation with primary surgical repair was attempted at first but failed. A fully covered enteral metal stent was placed in all patients to seal the leak. Subsequently, we cannulated the common bile duct and, in some cases, and the main pancreatic duct inserting hydrophilic guidewires through the stent after dilating the stent mesh with a dilatation balloon or breaking the meshes with Argon Plasma Beam. Finally, we inserted a fully covered biliary metal stent to drain the bile into the lumen of the enteral stent. In cases of normal proximal upper gastrointestinal anatomy, a pancreatic plastic stent was also inserted. Oral food intake was initiated when the abdominal drain outflow stopped completely. Stent removal was scheduled four to eight weeks later after a CT scan to confirm the complete healing of the fistula and the absence of any perilesional residual fluid collection. The leak resolved in five patients. One patient died two days after the procedure due to severe, pre-existing, sepsis. The stents were removed endoscopically in four weeks in four patients. In one patient we experienced stent migration causing small bowel obstruction. In this case, the stents were removed surgically. Four patients are still alive today. They are still under follow-up and doing well. Bilio-enteral fully covered metal stenting with or without pancreatic stenting was feasible, safe and effective in treating postoperative enteral leaks near the biliopancreatic orifice in our small series. This minimally invasive procedure can be implemented in selected patients as a rescue procedure to repair these challenging leaks.

"High or low Inferior Mesenteric Artery ligation in Laparoscopic low Anterior Resection: study protocol for a randomized controlled trial" (HIGHLOW trial).

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, ß = 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.