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Anastomotic Leak

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Cola

Colorectal anastomosis is created with a two-row circular surgical stapler

Colorectal anastomosis is created with a three-row circular surgical stapler

Para-aortic lymph node dissection, inferior mesenteric artery skeletonisation and ligation below left colic artery origin, nerve-preserving total mesorectal excision, rectum division with a linear stapler, sigmoid colon division and circular stapler envil fixation with a purse-string suture, end-to-end colorectal anastomosis creation with a three-row circular stapler, defunctioning colostomy is performed.

Three-row circular stapler

Para-aortic lymph node dissection, inferior mesenteric artery skeletonisation and ligation below left colic artery origin, nerve-preserving total mesorectal excision, rectum division with a linear stapler, sigmoid colon division and circular stapler envil fixation with a purse-string suture, end-to-end colorectal anastomosis creation with a two-row circular stapler, defunctioning colostomy is performed.

Two-row circular stapler

Inna Tulina, MD

Nikita Nekliudov

Nikita Neklyudov, MD

Petr Tsarkov, MD

This trial aims to assess safety and efficacy of three-row circular staplers compared to two-row surgical stapllers in short-term and long-term perspective in patients with rectal cancer undergoing low anterior resection with stapled colorectal anastomosis. All the patients will undergo a low anterior resection. In a half of patients a colorectal anastomosis will be created with a three-row surgical circular stapler. In another half of patients a colorectal anastomosis will be created with a two-row surgical circular stapler.

A low anterior resection for rectal cancer in most cases results in creating a colorectal anastomosis with a surgical circular stapler device. Using a disposable circular stapler with two rows of staples is standard of care nowadays. Colorectal anastomosis dehiscence and subsequent anastomotic leak in postoperative period happens in 5-25% of cases and is a major and life-threatening complication. Thus different improvements to the procedure of creating a colorectal anastomosis are being proposed. One of them is utilizing a three-row instead of a two-row surgical circular stapler.

A three-row surgical stapler has recently been registered and approved for clinical use in Russia. The primary purpose of this study is to find out the rate of colorectal anastomosis leakage when using a three-row circular stapler and to demonstrate that it is at least not bigger than the rate of colorectal anastomosis leakage when using a two-row circular stapler.

THREE-row Circular STAPLER in Low Anterior Resection for Rectal Cancer

Uni-center, Patient-blinded, Randomized, 12 Month, Parallel-group, Non-inferiority Study to Compare Outcomes of Three-row Versus Two-row Circular Staplers for Colorectal Anastomosis Formation After Low Anterior Resection for Rectal Cancer

The rate of colorectal anastomosis dehiscence documented with an X-ray and/or CT scan

The duration of surgical procedure in minutes

The rate of circular stapler inability to create a colorectal anastomosis in a way declared by the manufacturer

The rate of bleeding from the line of stapled anastomosis verified by proctoscopy

The rate of repeat surgeries due to anastomotic leakage

The rate of complications in first 30 days after surgery

The number of days from the first day after operation to discharge

The rate of complications related to defunctioning stoma

Assessed with patient-reported questionnaire SF-36. A total score in each of 8 sections will be calculated and transformed into a 0-100 scale with a score of zero equivalent to maximum disability and a score of 100 equivalent to no disability

Assessed with patient-reported questionnaire EORTC QLQ-C30 with supplementary module EORTC QLQ-CR29. A total score in each of 4 modules (functional scale, global health status, symptom scale, colorectal cancer module) will be calculated and transformed into a 0-100 scale. For Functional scale, Global health status scale and Colorectal cancer module a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. For Symptom scale a score of 100 is equivalent to maximum disability and a score of 0 is equivalent to no disability.

Assessed with patient-reported questionnaire LARS, total score will be calculated (min 0, max 42) for each patient and also each patient will be assigned to either "no LARS" group (total score 0-20), or "minor LARS" group (total score 21-29) or "major LARS" group (total score 30-42)

The rate of adverse events related to circular stapler usage

The rate of serious adverse events related to circular stapler usage

Meril Life Sciences Pvt. Ltd.

I.M. Sechenov First Moscow State Medical University

Russian Society of Colorectal Surgeons

Head of Oncologic Colorectal Surgery Department, Clinic of Colorectal and Minimally Invasive Surgery

Other Dietary Supplements

Inulin

Patients randomized to the intervention group will receive inulin supplementation for 14 days, preceding the surgery. Inulin will be given at a dosage of 10g/day divided in two doses.

Patients randomized to the control group will receive a placebo for 14 days, two times a day.

Inulin is a water soluble non-digestible carbohydrate, and it is available in more than 36,000 species of plants. It is often used as dietary fiber and has obtained the "Generally recognized as safe" status (GRAS) by the Food and Drug Administration (FDA).

Placebo

Carole Richard, MD

Nassima Taleb

Colorectal cancer (CRC) is the third most diagnosed cancer in Canada. The most common surgical procedure in patients with CRC is an intestinal resection followed by a reconnection to rejoin the ends of the remaining bowel. Among the postoperative complications, leaking of this intestinal connection is notably feared, affecting up to 20% of patients. These leaks are characterized by impaired intestinal healing and are associated with severe infections and even death.

Various studies have shown that gut microbiota, the bacteria that live in the digestive tract, plays an essential role in intestinal healing following surgery. These results support the possibility of enhancing intestinal healing through supplements that act as an energy source for gut bacteria. Indeed, animal studies have shown that inulin supplementation, a fiber commonly found in plants, improves intestinal healing following bowel surgery. However, no studies in humans have evaluated its effects on CRC surgery patients.

This study aims to determine feasibility of a randomized controlled trial that assesses the effects of inulin supplementation before elective colorectal surgery.

Based on preliminary data, our working hypotheses are that the gut microbiome plays a fundamental role in postoperative healing and that manipulation of preoperative microbiota using inulin will improve postoperative healing and prevent potential development of anastomotic leaks.

The pilot study aims to evaluate the feasibility of a randomized controlled trial that assesses the effects of inulin supplementation before elective colorectal surgery. The project has two main components, a clinical study, and a translational research. A randomized, multi-center, triple-blind, placebo-controlled clinical trial will be conducted to evaluate the impact of inulin supplementation on the clinical and oncological outcomes of inulin supplementation before elective colorectal oncological surgery. Mucosal, blood and fecal samples of patients with inulin supplementation will be compared with samples of patients without inulin supplementation.

The study objectives are:

1. Determine the tolerance of colorectal cancer patients to inulin supplementation before surgery.
2. Assess the effect of inulin supplementation on colonic healing and the rate of AL.
3. Determine the impact of inulin supplementation on the gut microbiota, the inflammatory markers, and the gut barrier function.
4. Assess the effect of inulin supplementation on CRC local and distant recurrence after surgery.

Identification of study participants

Patients who are about to undergo an oncological colorectal surgery will be recruited in the CHUM. Informed consent will be obtained from the patient before enrollment in the study.

Patients will be randomized to the inulin group (intervention group) or to the placebo group (control group). A stratified randomization will be conducted according to the sex (1- Male, 2-Female), the cancer location (1- Right and transverse colon, 2-Left colon and sigmoid, 3-Rectum) and the cancer grade.

Patients randomized to the intervention group will receive inulin supplementation for two weeks, preceding the surgery. Inulin will be given at a dosage of 10g/day divided in two doses. To foster compliance, the inulin will be provided in a calendar pill organizer. Patients randomized to the control group will receive a placebo for two weeks, twice a day. Placebo pills will be identical in appearance to the inulin pills. A total of 40 patients, 20 in each group, will be included in the pilot study.

Adequate colonic preparation will also be given to all the patients, including oral mechanical bowel preparation, oral antibiotics the day before surgery and intravenous antibiotics before surgical incision.

Collection of stool samples

Feces will be collected according to International Human Microbiome Standards (IHMS) guidelines (SOP 03). Two pre-operative specimens will be collected for each enrolled patient: pre-inulin/placebo supplementation and post-inulin/placebo supplementation.

Blood samples

Standard blood tests will be conducted for the participating patients. Supplementary volume will be collected during the per-operative test, before the surgery and at post-op day 3. Blood will be collected in two tubes to assess complete blood counts and to obtained serum.

Intraoperative mucosal sample

A mucosal biopsy coming from colonic anastomosis consist of a fragment from the transection line at the anastomosis. The specimen will be collected in a sterile tube and snap frozen.

Statistical Design

R, Stata and Prism will be used to perform the statistical analysis. Decision to use non-parametric tests is based on data normality (Shapiro-Wilk test) and homoscedasticity (Bartlett's test) tests. Multiple comparisons will be evaluated statistically by 1-way analysis of variance (ANOVA) or by Kruskal-Wallis test. Statistically significant differences will then be evaluated by two-tailed Student's t or Wilcoxon test. Multiple testing is corrected via False Discovery Rate estimation. For pre-supplementation and post-supplementation samples, a paired Student's t-test or paired Wilcoxon test will be used. For comparison of 2 groups, an unpaired Student's t-test or unpaired Wilcoxon test will be used.

The Effect of Inulin Supplementation on Colorectal Surgery Outcomes

The Effect of Inulin Supplementation on Colonic Healing and Surgical Outcomes Following Colorectal Surgery

The GSRS is a seven-point Likert-type scale with response options ranging from 1 (no discomfort at all) to 7 (very severe discomfort). It includes 15 questions that assess various gastrointestinal symptoms.

The DQLQ is a 9-item questionnaire that uses a seven-point Likert-type scale to assess the impact of gastrointestinal symptoms on quality of life. The response options range from 'never' to 'always'.

All patients presenting with suspicious clinical features, such as worrisome laboratory results, post-operative fever, or abnormal physical examination findings, will undergo radiological examinations to confirm an anastomotic leak.

The white blood cell count will be monitored on post-operative day 3 to check for signs of infection or inflammation.

The CRP will be monitored on post-operative day 3 to check for signs of infection or inflammation.

Changes in fecal calprotectin levels will be monitored to assess colonic inflammation.

MUC2 levels will assess the amount of mucin present in the mucosa, which is important for colonic healing after surgery

Centre hospitalier de l'Université de Montréal (CHUM)

Colonic Diseases

Intraoperatively under direct vision in the lower rectum, the balloon of the catheter will be inflated with 5-10cc of distilled water and it will be secured with a dressing / tape to the buttock connected to a collection bag.

The usual postoperative care approved by the unit will be followed.

Intraoperative transanal decompression tube placement

Ander Timoteo, MD

There is currently no standardization in the use of the transanal decompressive tube during the postoperative after a colorectal surgery. The available evidence is based on studies with methodological differences. Most of the studies exclude patients with a diverting ileostomy, which are those patients who have a higher risk of anastomotic leak, so the real effect of transanal decompressive tube could have been masked. For this reason we believe that to assess the true effect of rectal decompression, patients with diverting stoma should be included.

One of the complications of performing the colorectal anastomosis is the anastomotic leak, which sometimes entails the need for reinterventions and stoma formation (provisional or definitive). In recent decades, the improvement in surgical techniques together with the knowledge of the causes that predispose to the anastomotic failure have allowed to reduced the rates.

The placement of a tube probe through the anus in the postoperative period that decompresses the contents of the interior of the intestine (liquid or air) has been proposed as a factor that could influence the healing between intestines.

In studies carried out in other centers, with the same characteristics as the present one, differences have been shown in the probability of anastomotic leakage, but these results are not conclusive and do not allow us to know the effectiveness of this procedure.

The Impact of Transanal Decompression Tube Placement After Colorectal Anastomosis: A Randomized Trial

The Impact of Transanal Decompression Tube Placement on Anastomotic Dehiscence After Colorectal Anastomosis. A Randomized and Controlled Clinical Trial

Anastomotic leakage (No/Yes), degree of anastomotic leakage (A, B or C), days of anastomotic leak diagnosis after colorectal surgery

Reintervention due to any cause within 30 days after surgery

Rate of medical and surgical complications within 30 days after surgery using the Dindo-Clavien classification, described as:

Grade I = Any deviation from the normal postoperative course. Grade 2 = Requiring pharmacological treatment with drugs other than such allowed for grade I complications.

Grade III = Requiring surgical, endoscopic or radiological intervention, not under (Grade IIIa) or under general anesthesia (Grade IIIb) Grade IV = Life-threatening complication with single organ (Grade IVa) or Multiorgan dysfunction (Grade IVb) Grade V = Death of a patient.

Stoma formation due to anastomotic leak (No/Yes)

Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta

General and digestive surgeon

Diverticulitis

Diverticulitis, Colonic

Diverticulum

Diverticular Diseases

Gastroenteritis

Diverticulosis, Colonic

Methylene Blue

Intraoperative testing of colorectal anastomoses

1. Insert a Foley catheter through the anus into the rectum.
2. Insufflate the Foley balloon with 5 cc of air.
3. fill the pelvic space with 500 CC of warm saline
4. Insufflate air into the rectum up to a pressure of 35 mmH2o as measured by external manometer
5. Remove the saline from the pelvic space.
6. Inject methylene blue in to the rectum up to a pressure of 35 mmH2o measured by external manometer
7. Remove the methylene blue from rectum.

NB the above procedures are standard practice for assessing the quality of colorectal anastomoses during colorectal surgery.

The purpose of the study is to compare these standard methods of evaluation to determinant which method is superior

1. Insert a Foley catheter through the anus into the rectum.
2. Insufflate the Foley balloon with 5 cc of air.
3. Air tight leak test with saline and insufflating air: fill the pelvic space with 500 CC of warm saline
4. Insufflate air into the rectum up to a pressure of 35 mmH2o as measured by external manometer
5. Remove the saline from the pelvic space.
6. Inject diluted dye (methylene blue) in to the rectum up to a pressure of 35 mmH2o measured by external manometer
7. Remove the methylene blue from rectum.

NB the above procedures are standard practice for assessing the quality of colorectal anastomoses during colorectal surgery.

The purpose of the study is to compare these standard methods of evaluation to determinant which method is superior

Intraoperative testing of colorectal anastomoses

After the resection we do the stapled colorectal anastomosis with a standard circular stapler as part of the regular procedure

Stapled colorectal anastomoses

Yaron Rudnicki, MD

Shmuel Avital, MD

A leak from a colorectal anastomosis is a post-operative complication surgeons fear the most, following colonic resection. Over the years, there have been multiple suggestions for intraoperative tests for the integrity of the colorectal anastomosis.

Two of the most common tests that are performed routinely are:

1. Air tight leak test - filling the pelvis with saline and insufflating air trans anal - looking for air bubbles in the saline filled pelvis.
2. Injecting diluted dye (methylene blue) trans anal, and looking for blue dye stains on gauze pads covering the outer side of anastomosis.

The aim of the study is to compare the two methods, and to assess if there is a superior method. A secondary aim is to establish standards to perform the test, mainly to assess the appropriate pressure to apply on the anastomosis.

In this prospective study patients scheduled to undergo colonic resection of their distal part of the colon/ rectum with colorectal anastomosis, will have both testing methods performed sequentially and will be followed post-operative to assess the yield and sensitivity of the testing methods.

Intraoperative Testing of Colorectal Anastomosis - Air or Water (Methylene Blue)?

The presence or absence of a post-operative clinical anastomotic leak

We will compare the occurence of air leak with the occurence of methylene blue leak in each patient

Meir Medical Center

Colonic Neoplasms

Robot-assisted surgery (RAS), allows many types of complex MIS procedures using robotic systems to aid in surgical procedures providing more precision, flexibility and control than is possible with other MIS techniques.

Intracorporeal anastomosis: when the anastomosis is performed inside the abdominal cavity with a laparoscopic or robotic technique. A Pfannenstiel incision will be done exclusively for specimen extraction.

Robot-assisted surgery (RAS), allows many types of complex MIS procedures using robotic systems to aid in surgical procedures providing more precision, flexibility and control than is possible with other MIS techniques.

Extracorporeal anastomosis: when the anastomosis is performed by pulling out the bowel through a laparotomy wherever that laparotomy is performed.

Laparoscopic surgery, also called minimally invasive surgery (MIS), or keyhole surgery, is a surgical technique in which operations are performed far from their location through small incisions (usually 0.5-1.5 cm) elsewhere in the body.

Intracorporeal anastomosis: when the anastomosis is performed inside the abdominal cavity with a laparoscopic or robotic technique. A Pfannenstiel incision will be done exclusively for specimen extraction.

Laparoscopic surgery, also called minimally invasive surgery (MIS), or keyhole surgery, is a surgical technique in which operations are performed far from their location through small incisions (usually 0.5-1.5 cm) elsewhere in the body.

Extracorporeal anastomosis: when the anastomosis is performed by pulling out the bowel through a laparotomy wherever that laparotomy is performed.

Anastomosis is performed by pulling out the bowel through a laparotomy wherever that laparotomy is performed.

Extracorporeal Anastomosis

Anastomosis is performed inside the abdominal cavity with a laparoscopic or robotic technique

Intracorporeal Anastomosis

Procedure is performed using robotic instruments

Robotic Surgery

Procedure is performed using standard laparoscopic instruments

Laparoscopic Surgery

Marcos Gómez Ruiz, MD PhD

Lucía Lavín Alconero, BSc PhD

Arto Turunen

Pälvi Vento

Jyrki Kössi

Tero Rautio

Tarja Pinta

Anne DUBOIS

Philippe ROUANET

Benoit ROMAIN Benoit

Laurent BRESLER

Markus Winny

Thalia Petropoulou

Andrea Coratti

Paolo Pietro Bianchi, MD PhD

Wanda Luisa Petz

Dominico D´Ugo

Antonino Spinelli

Dario RIBERO

Nuno Rama

Antonio Arroyo Sebastián, MD

Antonio Arroyo Sebastián

Nuria Truan Alonso

Marcos Gómez Ruiz, MD

Carmen Cagigas Fernández

Julio José Del Castillo Diego

Joaquin Alonso Martín

Lidia Cristobal Poch

Manuel Gómez Fleitas

Marcos Gómez Ruiz

Eloy Espin

Franco Marinello

Carlos Placer Galán

José María Enriquez Navascues

Pedro Antonio Sanchez Fuentes, MD

Angel Reina Duarte

Francisco Rubio Gil

Manuel Ferrer Marquez

Vicente Simó Fernández

Mauricio García Alonso, MD

Oscar Cano Valderrama

Mauricio García Alonso

Eduardo Rubio Gonzalez

Oscar García Villar

María Labalde Martinez

Jim Kahn

Galo Peralta, MD

Right colectomy (hemicolectomy) involves the removal of the cecum, the ascending colon, the hepatic flexure, the first one-third of the transverse colon, part of the terminal ileum, and the associated regional fat and lymph nodes, and is the accepted treatment for malignant neoplasms of the right colon.

A minimally invasive approach is commonly used for right colectomy, with studies reporting reduced complications, less blood loss, and hospital stay when compared to an open approach.

However, there remains controversy regarding whether robotic assistance is advantageous for this technique and whether an intracorporeal (ICA) or extracorporeal anastomosis (ECA) is best.

MIRCAST is a prospective, observational, international, multi-center, 4-parallel-cohorts study. Sites or surgeons will select a cohort of the study for which they are qualified. Four cohorts will be the subject of study:

1. Robotic Right Colectomy with ICA
2. Robotic Right Colectomy with ECA
3. Laparoscopic Right Colectomy with ICA
4. Laparoscopic Right Colectomy with ECA

All patient assessments will be done according to the sites standard of care. Parameters routinely recorded during right colectomy surgery will be collected prospectively. Enrolled subjects will undergo assessments at the following intervals: pre-operative, operative, discharge, 30 days, 3 months, 1 year and 2 years post-surgery.

MIRCAST study is an observational, prospective, parallel cohorts, international, multi-center to compare robotic assisted and laparoscopic minimally invasive right colectomy, and intracorporeal anastomosis versus extracorporeal anastomosis.

The research is coordinated by Marcos Gómez Ruiz MD PhD from Hospital Universitario Marqués de Valdecilla in Santander, Spain; the sponsorship is performed by Fundacion Instituto de Investigación Marqués de Valdecilla (IDIVAL). The European Society of Coloproctology (ESCP) endorses MIRCAST Study and will run a quality audit/independent monitoring of the study.

The objectives of study are to compare of the peri-operative complications after robotic assisted and laparoscopic minimally invasive right colectomy with intracorporeal anastomosis versus extracorporeal anastomosis.

To Identify potential benefits of robotic assisted procedures for right colon resections.

Minimally Invasive Right Colectomy Anastomosis Study

A Prospective Observational Multi-center 4 Cohort Study Comparing Robotic Assisted and Laparoscopic Invasive Right Colectomy and Intracorporeal Anastomosis Versus Extracorporeal Anastomosis

PCT values on postoperative dates 1, 3 and 5

Time until patient gets out of bed and engages in light activity (such as sitting, standing, or walking)

o Time to start working/activity at patient´s job again

Visual analogue scale (VAS) scores at postoperative days. Scores will range from 0 to 10 (0 no pain and 10 a pain you would rather prefer to die).

(CDC definition \[Health Protection Agency. Surveillance of Surgical Site Infection in England: October 1997-September 2005. London: Health Protection Agency; 2006): Superficial incisional, affecting the skin and subcutaneous tissue. These infections may be indicated by localised (Celsian) signs such as redness, pain, heat or swelling at the site of the incision or by the drainage of pus.

Complications according to Clavien Dindo Classification.

The length of time from either the date of diagnosis or the start of treatment for a disease, such as cancer, that patients diagnosed with the disease are still alive

Length of time after primary treatment for a cancer ends that the patient survives without any signs or symptoms of that cancer.

Rate of cancer that has recurred at or near the same place as the original (primary) tumor

Rate of Cancer that has spread from the original (primary) tumor to distant organs or distant lymph nodes

When anything apart of the anastomosis had to be done through the laparotomy. If the anastomosis is not completely performed in an intracorporeal approach, the case is considered also converted

Operative time from skin to skin in minutes

Complete Mesocolic Excision is defined as complete resection of the mesocolon with its anatomical envelope. Anatomical report should include any defect on CME specimen (Hohenberger W, Weber K., Matzel K., Papadopoulost T., Merkel S. Standardized surgery for colonic cancer: complete mesocolic excision and central ligation - technical notes and outcome. Colorectal Disease 11, 354-365 2008. doi:10.1111/j.1463-1318.2008.01735.x)

Number of harvested Lymph nodes according to the definitive pathological report.

Rate of resection without any affected margins during the surgical procedure.

In hospital stay of the patient from the day that they are admitted before surgery to the day that they are fit to leave the hospital after the procedure.

Incidence of ventral hernia 1 year after the procedure and 2 years after the procedure at the laparotomy site.

Quality of Life Questionnaire (QLQ) of the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 Score 3 months and 1 year after the procedure.

Quality of Life Questionnaire (QLQ) of the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-CR29 Score 3 months and 1 year after the procedure.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
THREE-row Circular STAPLER in Low Anterior Resection for Rectal Cancer	NCT03910699	Anastomotic Lea... Anastomotic Hae... Anastomotic Com... Rectal Neoplasm... Staple Misfire Anastomosis Anastomotic Ste...	Three-row circu... Two-row circula...	18 Years - 85 Years	Russian Society of Colorectal Surgeons
The Effect of Inulin Supplementation on Colorectal Surgery Outcomes	NCT05860322	Anastomotic Com...	Inulin Placebo	18 Years -	Centre hospitalier de l'Université de Montréal (CHUM)
The Impact of Transanal Decompression Tube Placement After Colorectal Anastomosis: A Randomized Trial	NCT04890015	Colorectal Canc... Postoperative C... Anastomotic Lea... Anastomotic Com...	Intraoperative ...	18 Years -	Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
The Effect of Inulin Supplementation on Colorectal Surgery Outcomes	NCT05860322	Anastomotic Com...	Inulin Placebo	18 Years -	Centre hospitalier de l'Université de Montréal (CHUM)
Intraoperative Testing of Colorectal Anastomosis - Air or Water (Methylene Blue)?	NCT03316677	ColoRectal Canc... Colonic Diverti... Anastomotic Lea... Anastomotic Com... Anastomosis	Intraoperative ... Stapled colorec...	18 Years -	Meir Medical Center
Minimally Invasive Right Colectomy Anastomosis Study	NCT03650517	Colorectal Canc... Anastomotic Com... Colectomy	Extracorporeal ... Intracorporeal ... Robotic Surgery Laparoscopic Su...	18 Years -	Instituto de Investigación Marqués de Valdecilla

Spots Global Cancer Trial Database for anastomotic complication