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.

The workplace quality of life of university hospital digestive surgeons: Results of a 2019 nationwide survey.

INTRODUCTION: Burnout syndrome (BOS) affects all professional categories, particularly in the medical sector. Perceived deterioration of working conditions in university hospital centres impacts not only hospital doctors, but also and more generally, university hospital (UH) staff. The goal of this survey was to analyse workplace quality of life among French UH digestive surgeons. METHODS: An online questionnaire was addressed to all members of sub-section 52-02 (digestive and visceral surgery) of the national university council (CNU). It contained isolated questions, as well as the specific Copenhagen Burnout Inventory (CBI) questionnaire, which assesses three fields: personal burnout (PBO), work-related burnout (WBO) and client-related burnout (CBO). RESULTS: While 132 (85%) out of the 156 surgeons responded, only 110 (70%) filled out the CBI questionnaire. Their perceptions of quality of life were poor or very poor (57%), and progressively poorer; this was mainly due to a lack of human, logistical and financial means, and also to conflictual relations with administration. The CBI questionnaire showed high scores for PBO (37%) and WBO (30%), with lower scores for CBO (8%). Depressive syndrome appeared among 26% of respondents. There were no significant differences according to region, gender or age. CONCLUSION: This study objectifies a perceived deterioration of the working conditions of UH digestive surgeons, with elevated rates of BOS and a depressive risk superior to that of the overall population.

Early and late morbidity of local excision after chemoradiotherapy for rectal cancer.

BACKGROUND: Local excision (LE) after chemoradiotherapy is a new option in low rectal cancer, but morbidity has never been compared prospectively with total mesorectal excision (TME). Early and late morbidity were compared in patients treated either by LE or TME after neoadjuvant chemoradiotherapy for rectal cancer. METHOD: This was a post-hoc analysis from a randomized trial. Patients with clinical T2/T3 low rectal cancer with good response to the chemoradiotherapy and having either LE, LE with eventual completion TME, or TME were considered. Early (1 month) and late (2 years) morbidities were compared between the three groups. RESULTS: There were no deaths following surgery in any of the three groups. Early surgical morbidity (20 per cent LE versus 36 per cent TME versus 43 per cent completion TME, P = 0.025) and late surgical morbidity (4 per cent versus 33 per cent versus 57 per cent, P < 0.001) were significantly lower in the LE group than in the TME or the completion TME group. of LE, was associated with the lowest rate of early (10 versus 18 versus 21 per cent, P = 0.217) and late medical morbidities (0 versus 7 versus 7 per cent, P = 0.154), although this did not represent a significant difference between the groups. The severity of overall morbidity was significantly lower at 2 years after LE compared with TME or completion TME (4 versus 28 versus 43 per cent grade 3-5, P < 0.001). CONCLUSION: The rate of surgical complications after neoadjuvant chemoradiotherapy in the LE group was half that of TME group at 1 month and 10 times lower at 2 years. LE is a safe approach for organ preservation and should be considered as an alternative to watch-and-wait in complete clinical responders and to TME in subcomplete responders.

Use of Malone antegrade continence enemas in neurologic bowel dysfunction.

INTRODUCTION: Patients with neurogenic bowel dysfunction (NBD) suffer severe constipation and/or fecal incontinence that are very difficult to treat. Most medication-based and interventional treatments have been unsuccessful. The goal of this study was to assess the medium-term effectiveness of the Malone procedure in all patients with NBD, as an alternative to colostomy. PATIENTS AND METHODS: In this retrospective single-center study, 23 patients who underwent Malone's surgical treatment were analyzed. The main criteria were the usage of antegrade colonic enemas (ACE) after Malone's procedure at the most recent follow-up and comparison of quality of life scores before and after surgery. RESULTS: The post-procedure mortality was zero, but an overall morbidity of 60% was observed, including minor complications (Clavien 1, 2) in 56%. The median follow-up was 33 months. At the most recent follow-up, the utilization rate of the neo-appendicostomy for ACE was 69.6%; 76.9% of the patients using ACE reported improvement in quality of life scores. Secondary colostomy was performed in 21.7% for functional failure of the Malone procedure. CONCLUSION: The Malone procedure is a reliable technique that can be used in the therapeutic strategy for managing NBD patients with incontinence/constipation refractory to usual treatments. It should be considered as a therapeutic step to take before resorting to colostomy.

Perioperative FOLFOX 4 Versus FOLFOX 4 Plus Cetuximab Versus Immediate Surgery for High-Risk Stage II and III Colon Cancers: A Phase II Multicenter Randomized Controlled Trial (PRODIGE 22).

BACKGROUND: Perioperative chemotherapy has proven valuable in several tumors, but not in colon cancer (CC). OBJECTIVE: The aim of this study was to evaluate the efficacy and safety of perioperative chemotherapy in patients with locally advanced nonmetastatic CC. METHODS: This is a French multicenter randomized phase II trial in patients with resectable high-risk T3, T4, and/or N2 CC on baseline computed tomography (CT) scan. Patients were randomized to receive either 6 months of adjuvant FOLFOX after colectomy (control) or perioperative FOLFOX for 4 cycles before surgery and 8 cycles after (FOLFOX peri-op). In RAS wild-type patients, a third arm testing perioperative FOLFOX-cetuximab was added. Tumor Regression Grade (TRG1) of Ryan et al was the primary endpoint. Secondary endpoints were toxicity, perioperative morbidity, and quality of surgery. RESULTS: A total of 120 patients were enrolled. At interim analysis, the FOLFOX-cetuximab arm was stopped (lack of efficacy). The remaining 104 patients (control, n = 52; FOLFOX preop n = 52) represented our intention-to-treat population. In the FOLFOX perioperative group, 96% received the scheduled 4 cycles before surgery. R0 resection and complete mesocolic excision rate were 94% and 93%, respectively. Overall mortality and morbidity rates were similar in both groups. Perioperative FOLFOX chemotherapy did not improve major pathological response rate (TRG1 = 8%) but was associated with a significant pathological regression (TRG1-2 = 44% vs 8%, P < 0.001) and a trend to tumor downstaging as compared to the control group. CT scan criteria were associated with a 33% rate of overstaging in control group. CONCLUSIONS: Perioperative FOLFOX for locally advanced resectable CC is feasible with an acceptable tolerability but is not associated with an increased major pathological response rate as expected. However, perioperative FOLFOX induces pathological regression and downstaging. Better preoperative staging tools are needed to decrease the risk of overtreating patients.

Technique of the transobturator puborectal sling in fecal incontinence.

BACKGROUND: The puborectoplasty in fecal incontinence (FI) has been described through retropubic approach. Here, we describe a puborectal sling placement through transobturator approach with a device used for vaginal vault prolapse and report long-term outcome at 5 years. METHODS: Six women with FI for whom usual treatments (including sacral nerve stimulation) have failed were enrolled in a pilot study. Cleveland Clinic Incontinence Score (CCIS) and FI quality of life (FIQL) were used to evaluate results. RESULTS: The median CCIS was significantly improved at 12 months (18.5 [15-20] vs 7.5 [4-20] in postoperative assessment; p = 0.037). The median FIQL was improved at 12 months (6.05 [5.6-7] vs 10.2 [5.6-12.5]; p = 0.0542). No adverse event was recorded except the distension of the device in one patient. Finally, at 5 years, 3 patients were improved, 1 had recurrence of FI symptoms (at 24 months) and 2 had no change. CONCLUSION: This technique is a minimally invasive surgical treatment and constitutes a new therapeutic option for FI in case of failure of conventional treatment.

Gastric bleeding risk following spleen preserving distal pancreatectomy with excision of the splenic vessels: a long-term follow-up.

BACKGROUND: Spleen-preserving distal pancreatectomy with resection of the splenic vessels (VR-SPDP) is an effective procedure. However, hemodynamic changes in splenogastric circulation may lead to the development of gastric varices (GV) with a risk of gastrointestinal (GI) bleeding. This retrospective study aimed to assess the long-term postoperative clinical follow-up of patients and review the late postoperative abdominal computed tomography (CT) or endoscopic examination. METHODS: From 1988 to 2015, 48 consecutive VR-SPDP for benign or low-grade malignant disease were included. Late postoperative follow-up was undertaken with the use of a prospective database and assessment undertaken by CT and/or endoscopy. RESULTS: The median follow-up was 76 months (range: 12-334 months). Two patients were lost to follow-up. Gastrointestinal hemorrhage occurred in one patient. Endoscopy and abdominal CT showed submucosal GV in five patients. Ten patients had perigastric varices (27%), but none developed clinical complications from their varices. All varices occurred within one year after distal pancreatectomy and remained stable during follow-up. DISCUSSION: Asymptomatic varices frequently occurred in patients who underwent VR-SPDP, but bleeding risk seemed low. Abdominal CT could identify GV and distinguish submucosal varices with a higher risk of gastric bleeding.

[Oncological principles for local control of primary tumor]. / Principes oncologiques du contrôle local de la tumeur primitive.

OBJECTIVE: Review of the databases of carcinogenesis and the principles of local control of the primary tumor in order to decrease the risk of tumor progression and predict metastatic behavior. MATERIALS AND METHODS: Review of the literature using Medline databases based on scientific relevance. Research was centered on the characteristics of solid tumor development, the basics of local control of the primary tumor, latest advance in genomics and the oncological principles applied on prostate cancer surgery. RESULTS: The cornerstone in order to cure a local or locally advanced cancer is to eradicate the primary tumor. This should be done using effective methods that can assure local control, decrease the risk of progression and metastasis. The oncological surgery is the most important step in order to have this tumor control, beside radiotherapy and systemic therapy associated. In localized prostate cancer, surgery remains the gold standard between the multiple therapeutic modalities proposed. CONCLUSION: The local control of solid malignant tumor is primordial in order to change the natural history of the disease and decrease its risk of progression. This is the goal of oncological surgery, and starting from these principles radical prostatectomy was favored.

Prophylactic cholecystectomy during abdominal surgery.

The presence of asymptomatic gallstones is no longer an indication for elective prophylactic cholecystectomy (PC) according to the recommendations of the 1991 French Consensus Conference on cholelithiasis. However, there may be potential benefits of performing prophylactic cholecystectomy during certain abdominal procedures for non-biliary disease; this remains a subject of debate. This debate has become livelier with the recent increase in bariatric surgery. Gastrectomy for cancer, small bowel resection, colonic resection, and splenectomy for hereditary spherocytosis as well as all bariatric surgical interventions can all alter the physiology of gallstone disease raising the question of the value of PC, but the specific morbidity of cholecystectomy must be kept in mind. The purpose of this study was to report epidemiological and pathophysiological data and the results from literature reports in order to assess the value of concomitant prophylactic cholecystectomy during various common surgical situations.

Interferential therapy: a new treatment for slow transit constipation. a pilot study in adults.

AIM: The study aimed to assess, for the first time, the effectiveness of interferential therapy (IFT) in the treatment of slow transit constipation in adults and its impact on the quality of life. METHOD: All consecutive patients with slow transit constipation diagnosed by symptomology and a colonic transit time (CTT) of > 100 h measured with radiopaque markers were included in this prospective study. IFT was performed for 1 h/day over 3 months. Clinical improvement was based on the stool diary and the Knowles-Eccersley-Scott Symptom and Cleveland Clinic Constipation Scores. Quality of life was assessed with the Gastrointestinal Quality of Life Index questionnaire. RESULTS: Eleven patients with a median age of 51 years were included. At the end of the follow-up period, seven (63.6%) had significantly improved after IFT with a median of 0.66 stools per week [interquartile range (IQR) 0.33-0.66] before treatment and 1.66 (IQR 1.33-1.66) after (P = 0.007). The Knowles-Eccersley-Scott Symptom score changed from 30 (IQR 27-33) before treatment to 19 (IQR 17-26) after treatment (P = 0.005) and the Cleveland Clinic Constipation Score from 26 (IQR 25-28) to 17 (IQR 13-24; P = 0.005). The CTT improved from 103 h (IQR 101-113) to 98 h (IQR 94-107; P = 0.02). The Gastrointestinal Quality of Life Index score improved from 60 (IQR 57-63) to 95 (IQR 68-100; P = 0.005). CONCLUSION: IFT is a new non-invasive treatment for slow transit constipation. Further studies to confirm these results with longer follow-up are necessary.

What is the established contribution of laparoscopy in the treatment of rectal cancer?

The results of laparoscopic treatment of rectal cancer have been evaluated in several randomized trials. Still, the validity of this approach remains controversial because of concerns regarding its oncological safety. In this review, oncological results of laparoscopic rectal resection were similar to those of laparotomy, with no observed survival difference. Conversion from laparoscopy to laparotomy seemed to be associated with worse oncological results and an increased post-operative morbidity including nervous sequelae. Intra-operative blood loss was significantly reduced with the laparoscopic approach, but post-operative morbidity was not different. Post-operative pain and length of hospital stay were decreased by the laparoscopic approach, and short-term quality of life was improved. There was no demonstration of significant reduction in late morbidity such as incisional hernia and bowel adhesions.

The effect of abdominal ventral rectopexy on faecal incontinence and constipation in patients with internal intra-anal rectal intussusception.

AIM: Optimal treatment of anal incontinence in a patients with a normal anal sphincter is controversial, as is the role of intra-anal rectal intussusception in anal incontinence. We evaluated the results of abdominal ventral rectopexy on anal continence in such patients. METHOD: Forty consecutive patients with incontinence and intra-anal rectal intussusception without a sphincter defect were treated by abdominal ventral mesh rectopexy without sigmoidectomy. The Cleveland Clinic Incontinence Score (CCIS), patient satisfaction and constipation before and after surgery and recurrence were recorded. RESULTS: The mean CCI scores were 13.2 (=/-4.25) preoperatively and 3 (±3.44) postoperatively (P<0.0001). Patient assessment was reported as 'cured' in 26 (65%), 'improved' in 13 (32.5%) and 'unchanged' in one (2.5%) patient. Constipation was induced in two (5%) patients and was cured in 13 of 20 (65%) patients who were constipated before surgery. One case of recurrent prolapse occurred after a mean follow-up of 38 months. CONCLUSION: Intra-anal rectal intussusception may be associated with anal incontinence. For these patients, abdominal ventral mesh rectopexy appears to be an adequate treatment.

Efficacy of synthetic glue treatment of high crypoglandular fistula-in-ano.

OBJECTIVES: In France, seton drainage followed by fistulotomy is currently the standard treatment for high cryptoglandular fistula-in-ano. Biological or synthetic glues, such as Glubran(®) 2, have been recently proposed for sealing the fistula tract. The purpose of this study is to determine the healing rate with glubran 2 and to assess the functional outcome after cure of fistula-in-ano. PATIENTS AND METHODS: From July 2006 to July 2008, 34 patients (20 males; median age 48.5 years, range 22-55 years) with high cryptoglandular anal fistulas were treated with glubran 2. Patients were seen for physical examination at 1, 3 and 6 months, then interviewed by telephone at 1 and 2 years, and in September 2009. The Fecal incontinence severity index (FISI) score was used to assess continence. RESULTS: The healing rate at 1 month was 67.6% (23 patients); the fistula failed to heal in 11 patients. All 23 patients with a healed fistula remained recurrence-free, with no continence disorders noted, during the median 34-month follow-up period (range 21-43 months). One patient was lost to follow-up after 6 months. CONCLUSION: Glubran 2 provides an effective treatment for high fistula-in-ano, with no change in continence. In future, a randomized comparison of this agent with fibrin glues should be useful.

Benefits of perineal colostomy on perineal morbidity after abdominoperineal resection.

PURPOSE: Abdominoperineal resection has a high rate of postoperative morbidity of the perineal wound. This study aimed to determine the effects of perineal colostomy on perineal morbidity after abdominoperineal resection. METHODS: All patients who underwent an abdominoperineal resection for rectal adenocarcinoma between 1993 and 2007 were studied. Two groups were identified and compared who had undergone either an iliac colostomy or a perineal colostomy. RESULTS: The analysis included 110 patients (iliac colostomy group, n = 41; perineal colostomy group, n = 69). There were fewer instances of pelviperineal morbidity (P = .008) and fewer instances of wound dehiscence (P = .02) in the perineal colostomy group, which resulted in a shorter time to healing (35.3 vs 45.1 d, respectively; P = .04). There was no specific postoperative morbidity in any patient and no difference between the 2 groups regarding long-term perineal morbidity. The benefits from perineal colostomy were statistically significant in patients who received radiation therapy in terms of pelviperineal morbidity (P = .01) and healing time (50.8 vs 35.9 days, respectively; P = .02), whereas no difference was found in patients who had not received radiation therapy. CONCLUSION: Perineal colostomy is a safe and functionally acceptable procedure for perineal reconstruction after abdominoperineal resection for rectal adenocarcinoma. In the present study, there was no additional morbidity related to perineal colostomy, and this procedure was associated with a decrease in perineal morbidity and healing time compared with primary perineal closure, in particular, after radiotherapy treatment.

Randomized controlled trial of pelvic calcium alginate following rectal cancer surgery.

BACKGROUND: The aim of this randomized controlled trial was to assess the possible benefit of using a new haemostatic agent (Hémoionic) in the pelvic cavity in sphincter-saving surgery for rectal cancer. METHODS: Eighty-five patients undergoing elective sphincter-saving rectal resection for cancer were randomized into Hémoionic (41 patients) and control (44) groups. In both groups, a pelvic suction drain was left in place for as long as the daily output exceeded 20 ml. The primary endpoint was volume of fluid collected by the suction drain; secondary endpoints were duration of drainage, and postoperative mortality and morbidity rates. RESULTS: The mean total drainage volume was significantly lower in the Hémoionic group (453 ml versus 758 ml in control group; P = 0.031). There was no significant difference between groups in duration of drainage and morbidity. The mortality rate was four of 41 in the Hémoioni group and one of 44 in the control group (P = 0.192). CONCLUSION: Hémoionic may reduce the drainage volume after sphincter-saving surgery for rectal cancer, but offers no clinical advantage. REGISTRATION NUMBER: ISRCTN79721331 (http://www.isrctn.org).

Sacral nerve stimulation in faecal incontinence: position statement based on a collective experience.

OBJECTIVE: Since the first paper published by Matzel et al., in 1995, on the efficacy of sacral nerve stimulation (SNS) in patients with faecal incontinence, the indications, the contraindications, the stimulation technique and follow up of implanted patients have changed. The aim of this article was to provide a consensus opinion on the management of patients with faecal incontinence treated with SNS. METHOD: Recommendations were based on a critical review of the literature when available and on expert opinions in areas with insufficient evidence. RESULTS: We have reviewed the indications and contraindications, proposed an algorithm for patient management showing the place of SNS. The temporary test technique, the implantation technique, the patient follow up and the approach in case of treatment failure were discussed. CONCLUSION: We hope not only to provide a guide on patient management to clinical practitioners interested in SNS but also to harmonize our practices.

Tritherapy with fluorouracil/leucovorin, irinotecan and oxaliplatin (FOLFIRINOX): a phase II study in colorectal cancer patients with non-resectable liver metastases.

PURPOSE: To assess the rate of R(0) resection of liver metastases achieved after chemotherapy with FOLFIRINOX. PATIENTS AND METHODS: Patients with histologically proven primary colorectal cancer and bidimensionally measurable liver metastasis, not fully resectable based on technical inability to achieve R(0) resection, but potentially resectable after tumor reduction, were given FOLFIRINOX: oxaliplatin 85 mg/m(2), irinotecan 180 mg/m(2), leucovorin 400 mg/m(2), bolus fluorouracil 400 mg/m(2) and fluorouracil 46-h continuous IV infusion 2,400 mg/m(2), every 2 weeks for a maximum of 12 cycles. RESULTS: Thirty-four patients were enrolled. Response rate before surgery was 70.6% (95%CI: 52.5-84.9). Twenty-eight patients (82.4%) underwent hepatic resection and nine achieved R(0) resection [26.5% (95% CI: 12.9-44.4%)]. The rate of clinical complete remission after surgery was 79.4%. Two-year overall survival was 83%. The most frequent grade 3 or 4 toxicities were neutropenia (64.8%), diarrhea (29.4%), fatigue (23.5%), abdominal cramps (14.7%), neuropathy and nausea (11.8% each), and AST/ALT elevation (14.7/11.8%). Only one patient experienced febrile neutropenia, four patients withdrew due to toxicity and no toxic death was observed. CONCLUSION: FOLFIRINOX, with an acceptable toxicity profile, shows a high response rate in liver metastases from colorectal cancer. The rate of hepatic resection in patients initially not resectable, is attractive and warrants further assessment of this regimen in randomized studies compared to standard regimens.