Suprapubic versus transurethral catheterization for bladder drainage in male rectal cancer surgery (GRECCAR10), a randomized clinical trial.

BACKGROUND: Bladder drainage is systematically used in rectal cancer surgery; however, the optimal type of drainage, transurethral catheterization (TUC) or suprapubic catheterization (SPC), is still controversial. The aim was to compare the rates of urinary tract infection on the fourth postoperative day (POD4) between TUC and SPC, after rectal cancer surgery regardless of the day of removal of the urinary drain. METHODS: This randomized clinical trial in 19 expert colorectal surgery centers in France and Belgium was performed between October 2016 and October 2019 and included 240 men (with normal or subnormal voiding function) undergoing mesorectal excision with low anastomosis for rectal cancer. Patients were followed at postoperative days 4, 30, and 180. RESULTS: In 208 patients (median age 66 years [IQR 58-71]) randomized to TUC (n = 99) or SPC (n = 109), the rate of urinary infection at POD4 was not significantly different whatever the type of drainage (11/99 (11.1%) vs. 8/109 (7.3%), 95% CI, - 4.2% to 11.7%; p = 0.35). There was significantly more pyuria in the TUC group (79/99 (79.0%) vs. (60/109 (60.9%), 95% CI, 5.7-30.0%; p = 0.004). No difference in bacteriuria was observed between the groups. Patients in the TUC group had a shorter duration of catheterization (median 4 [2-5] vs. 4 [3-5] days; p = 0.002). Drainage complications were more frequent in the SPC group at all followup visits. CONCLUSIONS: TUC should be preferred over SPC in male patients undergoing surgery for mid and/or lower rectal cancers, owing to the lower rate of complications and shorter duration of catheterization. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT02922647.

Risk factors for severe morbidity and definitive stoma after elective surgery for sigmoid diverticulitis: a multicenter national cohort study.

BACKGROUND: In the decision to perform elective surgery, it is of great interest to have data about the outcomes of surgery to individualize patients who could safely undergo sigmoid resection. The aim of this study was to provide information on the outcomes of elective sigmoid resection for sigmoid diverticular disease (SDD) at a national level. METHODS: All consecutive patients who had elective surgery for SDD (2010-2021) were included in this retrospective, multicenter, cohort study. Patients were identified from institutional review board-approved databases in French member centers of the French Surgical Association. The endpoints of the study were the early and the long-term postoperative outcomes and an evaluation of the risk factors for 90-day severe postoperative morbidity and a definitive stoma after an elective sigmoidectomy for SDD. RESULTS: In total, 4617 patients were included. The median [IQR] age was 61 [18.0;100] years, the mean ± SD body mass index (BMI) was 26.8 ± 4 kg/m2, and 2310 (50%) were men. The indications for surgery were complicated diverticulitis in 50% and smoldering diverticulitis in 47.4%. The procedures were performed laparoscopically for 88% and with an anastomosis for 83.8%. The severe complication rate on postoperative day 90 was 11.7%, with a risk of anastomotic leakage of 4.7%. The independent risk factors in multivariate analysis were an American Society of Anesthesiologists (ASA) score ≥ 3, an open approach, and perioperative blood transfusion. Age, perioperative blood transfusion, and Hartmann's procedure were the three independent risk factors for a permanent stoma. CONCLUSIONS: This series provides a real-life picture of elective sigmoidectomy for SDD at a national level. TRIAL REGISTRATION: Comité National Information et Liberté (CNIL) (n°920361).

Natural history of anastomotic leakage after elective stoma closure.

INTRODUCTION: Elective stoma closure (ESC) is a common procedure. The main complication of ESC is anastomotic leakage, which can be revealed by peritonitis or an enterocutaneous fistula (ECF). The objective of the present study was to describe the natural history of AL after ESC. PATIENTS AND METHODS: Between January 2015 and March 2020, all patients having undergone AL after loop or double-barreled ESC were included in a retrospective, single-center study. The rate of ECF and peritonitis at presentation, the success rate of a conservative treatment and the factors associated with the success of healing of ECF were evaluated. RESULTS: From January 2015 to March 2020, 619 patients underwent a loop or double-barreled ESC in our department. The AL rate was 6.3% (n=39). The leakage was revealed by an ECF in 72% of cases (n=28). The mean±standard deviation time between the stoma closure and the diagnosis of the AL was 6±4 days. Conservative treatment was successful in 24 (85%) of the 28 patients with ECF, with a mean±SD time to recovery of 6.6±9.4 months. In a univariate analysis, none of the conservative treatments was significantly associated with healing of the ECF. CONCLUSION: AL is not rare and is mainly revealed by an ECF. Although the fistula heals in most cases, both the surgeon and the patient must be aware that the time to recovery is long.

Time from first seen in specialist care to surgery does not influence survival outcome in patients with upfront resected pancreatic adenocarcinoma.

BACKGROUND: This study evaluated the impact of time to surgery (TTS) on overall survival (OS), disease free survival (DFS) and postoperative complication rate in patients with upfront resected pancreatic adenocarcinoma (PA). METHODS: We retrospectively included patients who underwent upfront surgery for PA between January 1, 2004 and December 31, 2014 from four French centers. TTS was defined as the number of days between the date of the first consultation in specialist care and the date of surgery. DFS for a 14-day TTS was the primary endpoint. We also analyzed survival depending on different delay cut-offs (7, 14, 28, 60 and 75 days). RESULTS: A total of 168 patients were included. 59 patients (35%) underwent an upfront surgery within 14 days. Patients in the higher delay group (> 14 days) had significantly more vein resections and endoscopic biliary drainage. Adjusted OS (p = 0.44), DFS (p = 0.99), fistulas (p = 0.41), hemorrhage (p = 0.59) and severe post-operative complications (p = 0.82) were not different according to TTS (> 14 days). Other delay cut-offs had no impact on OS or DFS. DISCUSSION: TTS seems to have no impact on OS, DFS and 90-day postoperative morbidity.

Long-term outcomes of Hartmann's procedure versus primary anastomosis for generalized peritonitis due to perforated diverticulitis: follow-up of a prospective multicenter randomized trial (DIVERTI).

BACKGROUND: Surgical management of Hinchey III and IV diverticulitis involves Hartmann's procedure (HP) or primary resection anastomosis (PRA) with or without fecal diversion. These procedures were evaluated in four randomized controlled trials. Early results from these trials demonstrated similar rates of complications but higher rates of colonic restoration after PRA than HP. Long-term follow-up has not been reported to date. The aim of this study was to analyze long-term outcomes and quality of life (QoL) in patients previously enrolled in a prospective randomized trial comparing HP and PRA for generalized peritonitis due to perforated diverticulitis (DIVERTI trial). STUDY DESIGN: Follow-up data were available for 78 of 102 patients. Demographic data, incisional hernia rate, need for additional surgery related to the primary procedure, and QoL were recorded. RESULTS: The overall survival rate was 76% and did not differ between the two groups. Incisional hernia was reported in 21 (52%) patients in the HP arm and in 11 (29%) patients in the PRA arm (p = 0.035). The HP arm demonstrated significantly lower SF-36 physical and mental component scores. The mean general QoL (EQ-VAS) and mean EQ-5D index scores were better after PRA than after HP, but this difference was not statistically significant. The results of GIQLI, which measures intestine-specific QOL, did not differ between the two groups. CONCLUSIONS: This follow-up study with a median follow-up time of > 9 years among living patients indicates that PRA for perforated diverticulitis is associated with fewer long-term complications and better QoL than HP. PRA significantly reduced the incisional hernia rate and the need for reoperation. Long-term survival was not jeopardized by the PRA approach. Future studies are needed to address the utility of protective stoma.

Laparoscopic versus open resection of intrahepatic cholangiocarcinoma: nationwide analysis.

BACKGROUND: The relevance of laparoscopic resection of intrahepatic cholangiocarcinoma (ICC) remains debated. The aim of this study was to compare laparoscopic (LLR) and open (OLR) liver resection for ICC, with specific focus on textbook outcome and lymph node dissection (LND). METHODS: Patients undergoing LLR or OLR for ICC were included from two French, nationwide hepatopancreatobiliary surveys undertaken between 2000 and 2017. Patients with negative margins, and without transfusion, severe complications, prolonged hospital stay, readmission or death were considered to have a textbook outcome. Patients who achieved both a textbook outcome and LND were deemed to have an adjusted textbook outcome. OLR and LLR were compared after propensity score matching. RESULTS: In total, 548 patients with ICC (127 LLR, 421 OLR) were included. Textbook-outcome and LND completion rates were 22.1 and 48.2 per cent respectively. LLR was independently associated with a decreased rate of LND (odds ratio 0.37, 95 per cent c.i. 0.20 to 0.69). After matching, 109 patients remained in each group. LLR was associated with a decreased rate of transfusion (7.3 versus 21.1 per cent; P = 0.001) and shorter hospital stay (median 7 versus 14 days; P = 0.001), but lower rate of LND (33.9 versus 73.4 per cent; P = 0.001). Patients who underwent LLR had lower rate of adjusted TO completion than patients who had OLR (6.5 versus 17.4 per cent; P = 0.012). CONCLUSION: The laparoscopic approach did not substantially improve quality of care of patients with resectable ICC.

Combined treatment of refractory ascites with an alfapump® plus hernia repair in the same surgical session: A retrospective, multicentre, European pilot study in cirrhotic patients.

INTRODUCTION: The treatment of symptomatic hernia in cirrhotic patients with refractory ascites is critical but challenging. The objective of this study was to assess the feasibility and safety of the implantation of alfapump® combined with concomitant hernia repair in cirrhotic patients with refractory ascites. METHODS: Using data from six European centres, we retrospectively compared patients treated with alfapump® system implantation and concomitant hernia repair [the combined treatment group (CT group, n=12)] or with intermittent paracentesis hernia repair [the standard treatment group (ST group, n=26)]. Some patients of the ST group had hernia repair in an elective setting (STel group) and others in emergency (STem group). The endpoints were requirement of peritoneal drainage, the rate of infectious complications, the in-hospital mortality, the length of stay, paracentesis-free survival. RESULTS: Postoperatively, none of the patients in the CT group and 21 patients (80%) in the ST group underwent peritoneal drainage for the evacuation of ascites fluid (P<0.0001). The overall incidence of infectious complications was not different between groups but there were fewer infections in the CT group than in the STem group (33% vs. 81%; P=0.01). There was no difference for in-hospital mortality. The length of stay was shorter in the CT group (P=0.03). Paracentesis-free survival was significantly better (P=0.0003) in the CT group than in the ST group. CONCLUSION: Implantation of alfapump combined with concomitant hernia repair seems feasible and safe in cirrhotic patients; however, larger and randomized study are required.

Celiac axis stenosis and digestive disease: Diagnosis, consequences and management.

Arterial blood flow to the organs of the upper abdomen is provided by the celiac axis (CA) and the superior mesenteric artery (SMA) that communicate between each other via the gastro-duodenal artery, the anterior and posterior pancreatico-duodenal arcades, the branches of the dorsal pancreatic artery and inconsistently, though a supplementary arcade that connects the CA and the SMA (arcade of Bühler). Celiac axis stenosis may or may not have a hemodynamic impact on the splanchnic circulation. Hemodynamically significant CA stenosis can be asymptomatic, or symptomatic with variables clinical consequences. Management depends on whether the mechanism of stenosis is extrinsic or intrinsic. When upper gastrointestinal interventional radiology or surgery is indicated, stenosis can pose technical difficulties or create severe ischemia requiring good understanding of this entity in the planning of operative steps and adapted management. Management of CA stenosis is therefore multidisciplinary and may involve interventional radiologists, gastrointestinal surgeons, vascular surgeons as well as medical physicians. Even though the prevalence of CA stenosis is relatively low (between 5 and 10%) and irrespective of its etiology, surgeons, radiologists and physicians must be aware of it because it can intervene in the management of upper gastrointestinal disease. It must be sought, and treatment must be adapted to each particular situation to avoid potentially severe complications.

The value of post-operative antibiotic therapy after laparoscopic appendectomy for complicated acute appendicitis: a prospective, randomized, double-blinded, placebo-controlled phase III study (ABAP study).

BACKGROUND: Approximately 30% of appendectomies are for complicated acute appendicitis (CAA). With laparoscopy, the main post-operative complication is deep abscesses (12% of cases of CAA, versus 4% for open surgery). A recent cohort study compared short and long courses of postoperative antibiotic therapy in patients with CAA. There was no significant intergroup difference in the post-operative complication rate (12% of organ/space surgical site infection (SSI)). Moreover, antibiotic therapy is increasingly less indicated for other situations (non-complicated appendicitis, post-operative course of cholecystitis, perianal abscess), calling into question whether post-operative antibiotic therapy is required after laparoscopic appendectomy for CAA. METHODS/DESIGN: This study is a prospective, multicenter, parallel-group, randomized (1:1), double-blinded, placebo-controlled, phase III non-inferiority study with blind evaluation of the primary efficacy criterion. The primary objective is to evaluate the impact of the absence of post-operative antibiotic therapy on the organ/space surgical site infection (SSI) rate in patients presenting with CAA (other than in cases of generalized peritonitis). Patients in the experimental group will receive at least one dose of preoperative and perioperative antibiotic therapy (2 g ceftriaxone by intravenous injection every 24 h up to the operation) and metronidazole (500 mg by intravenous injection every 8 h up to the operation) and, in the post-operative period, a placebo for ceftriaxone (2 g/24 h in one intravenous injection) and a placebo for metronidazole (1500 mg/24 h in three intravenous injections, for 3 days). In the control group, patients will receive at least one dose of preoperative and perioperative antibiotic therapy (2 g ceftriaxone by intravenous injection every 24 h up to the operation) and metronidazole (500 mg by intravenous injection every 8 h up to the operation) and, in the post-operative period, antibiotic therapy (ceftriaxone 2 g/24 h and metronidazole 1500 mg/24 h for 3 days). In the event of allergy to ceftriaxone, it will be replaced by levofloxacin (500 mg/24 h in one intravenous injection, for 3 days). The expected organ space SSI rate is 12% in the population of patients with CAA operated on by laparoscopy. With a non-inferiority margin of 5%, a two-sided alpha risk of 5%, a beta risk of 20%, and a loss-to-follow-up rate of 10%, the calculated sample size is 1476 included patients, i.e., 738 per group. Due to three interim analyses at 10%, 25%, and 50% of the planned sample size, the total sample size increases to 1494 patients (747 per arm). TRIAL REGISTRATION: Ethical authorization by the Comité de Protection des Personnes and the Agence Nationale de Sécurité du Médicament: ID-RCB 2017-00334-59. Registered on ClinicalTrials.gov (NCT03688295) on 28 September 2018.