Intracorporeal Anastomosis in Laparoscopic Left Colectomy. Cohort Comparative Study (RIAL-COLECTOMY)

RESECTION AND INTRACORPOREAL ANASTOMOSIS IN LAPAROSCOPIC LEFT COLECTOMY AS AN ADAPTATION TO THE PANDEMIC CAUSED BY SARS-CoV-2 (COVID19). A COMPARATIVE COHORT STUDY

OBJECTIVE: The aim of the study is to demonstrate that the intracorporeal resection and anastomosis in left-sided colon cancer, sigma and upper rectum, is not inferior to extracoprporeal resection and anastomosis, in terms of anastomotic leakage.

BACKGROUND: Due to the recent events of a pandemic respiratory disease secondary to infection by SARS-CoV-2 virus or coronavirus 19 (COVID19), surgeons have been forced to adapt our surgical procedures in order to minimize exposure to the virus as much as possible.

Based on the recommendations in case of surgery in patients with highly contagious viral diseases, the latest studies suggest minimally invasive accesses to minimize the risk of contagion. One of the proposed measures is the performance of intracorporeal anastomoses. Therefore, given the extensive experience of our center in minimally invasive surgery and studies on the validation of intracorporeal anastomosis techniques in both laparoscopic surgery of the right colon and rectum (TaTME), and the study of advantages that they can provide to the patient, our intention is to apply it to surgery on the left colon, sigma and upper rectum. Our hypothesis is that exteriorization of the colon through an accessory incision increases the risk of tension at the mesocolon level, thus increasing the risk of vascular deficit at the level of the staple area and it may increase the rate of anastomotic leakage. In this sense, studies that validate a standard technique of intracorporeal anastomosis in left colon surgery and that demonstrate its benefit with respect to extracorporeal anastomosis are lacking. We intend to describe a new intracorporeal anastomosis technique (ICA) that is feasible and safe for the patient and that can be applied universally. Once the ICA technique is established, it will allow us to determine its non-inferiority compared to the standard technique performed up to now with extracorporeal anastomosis.

METHODS: All consecutive patients with left-sided, sigma and upper rectum adenocarcinoma will be included into a prospective cohort and treated by laparoscopy with totally intracorporeal resection and anastomosis. They will be compared with a retrospective cohort of consecutive patients of identical characteristics treated by laparoscopy with extracorporeal resection and anastomosis, in the immediate chronological period.

Study Overview

• Status: Recruiting
• Conditions: Colon Cancer
• Intervention / Treatment: Procedure: Extracorporeal left hemicolectomy anastomosis; Procedure: Intracorporeal left hemicolectomy anastomosis

Detailed Description

HYPOTHESIS Resection of the left colon / sigmoid with intracorporeal colorectal TT anastomosis is safe and not inferior to that performed extracorporeally. With the benefits of reduced intraoperative dissection, traction on the mesenteries, reduced vascular compromise of the anastomosis, a smaller incision size and being able to choose its location.

Main Aim:

The objective of this study is to demonstrate that colorectal mechanical end-to-end intracorporeal anastomosis is not inferior to extracorporeal approach in terms of anastomotic dehiscence.

Secondary Aims:

• To demonstrate the reproducibility of the colorectal mechanical end-to-end intracorporeal anastomosis technique in terms of reconversion, anastomotic dehiscence, organo-cavitary infection, and other postoperative complications.
• To determine the benefits that the IC anastomosis technique can bring to patients with obesity.
• To determine the benefits that the IC anastomosis technique can provide in terms of postoperative complications, hospital stay, and size of the accessory incision.
• To determine the benefit of the application of indocyanine green to determine the point of resection and anastomosis.

STUDY DESIGN

Comparative, single-center, controlled non-inferiority cohort study of resection and mechanical end-to-end intracorporeal anastomosis in left colon, sigmoid, and upper rectum surgery (prospective cohort) versus the standard technique of extracorporeal laparoscopic surgery (retrospective cohort).

SUBJECTS OF THE STUDY

In group 1 or control (retrospective cohort): patients diagnosed with adenocarcinoma of the left colon, sigmoid or upper rectum who meet the inclusion criteria Operated on surgically by our unit, collected in our database, by laparoscopic oncological surgery applying the conventional extracorporeal anastomosis technique.

In group 2 or case (prospective cohort): patients diagnosed with adenocarcinoma of the left colon, sigmoid or upper rectum, that meet the inclusion criteria, with an oncological surgical indication with a laparoscopic approach since July 2020, to which the resection and intracoporeal anastomosis technique will be applied.

• Study Type: Observational
• Enrollment (Anticipated): 148

Contacts and Locations

Study Locations

• Spain
  • Barceelona
    • Sabadell, Barceelona, Spain, 08208
      • Recruiting
      • Hospital Universitario Parc Tauli de Sabadel
      • Contact: Xavier Serra-Aracil, MD,PhD; Phone Number: 21490 937 231 010‬; Email: jserraa@tauli.cat

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

In group 1 or control (retrospective cohort): patients diagnosed with adenocarcinoma of the left colon, sigmoid or upper rectum who meet the inclusion criteria Operated on surgically by our unit, collected in our database, by laparoscopic oncological surgery applying the conventional extracorporeal anastomosis technique.

In group 2 or case (prospective cohort): patients diagnosed with adenocarcinoma of the left colon, sigmoid or upper rectum, that meet the inclusion criteria, with an oncological surgical indication with a laparoscopic approach since July 2020, to which the resection and intracoporeal anastomosis technique will be applied.

Description

Inclusion Criteria:

• Left Colonic Adenocarcinoma. Location of the tumor in the left colon, sigma or high rectum (with the anastomosis performed above the peritoneal reflection). Non-metastatic stage. Scheduled oncological surgery with curative intention operated on with laparoscopic surgery with resection technique and intracorporeal anastomosis. Over 18 years

Exclusion Criteria:

• Other tumor locations. Non-adenocarcinoma tumors. Synchronous tumors. T4 tumor stage and stage IV of TNM classification. ASA IV (American Society of Anesthesiologists). Non-optimal nutritional study (preoperative albumin ≤3.4 g / dl). Do not sign informed consent. Pregnant patients. Diagnosis of another type of neoplasm with active disease. Liver cirrhosis, Chronic kidney failure on dialysis treatment, patients with stent bridge to elective surgery.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of anastomotic leak (AL)	Percentage of anastomic leak (defined in accordance with Peel et al.).	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of global morbidity	Dindo-Clavien Classification	30 days
Rate of Surgical site infection	SSI in accordance with the Center for Disease Control (CDC) National	30 days
Rate of Re-interventions	Percentage of re-interventions due to surgical complications	30 days

Collaborators and Investigators

• Sponsor: Corporacion Parc Tauli
• Collaborators: Irene Gómez Torres; Laura Mora López; Anna Pallisera-Lloveras; Sheila Serra-Pla; Albert García Nalda; Anna Serracant-Barrera; Mercedes Muñoz; Oriol Pino-Pérez
• Investigators: Principal Investigator: Xavier Serra-Aracil, MD,PhD, Corporacio Parc Tauli. Parc Tauli University Hospital

Publications and helpful links

General Publications

• Serra-Aracil X, Mora-Lopez L, Casalots A, Pericay C, Guerrero R, Navarro-Soto S. Hybrid NOTES: TEO for transanal total mesorectal excision: intracorporeal resection and anastomosis. Surg Endosc. 2016 Jan;30(1):346-54. doi: 10.1007/s00464-015-4170-5. Epub 2015 Mar 27.
• Akamatsu H, Omori T, Oyama T, Tori M, Ueshima S, Nakahara M, Abe T, Nishida T. Totally laparoscopic sigmoid colectomy: a simple and safe technique for intracorporeal anastomosis. Surg Endosc. 2009 Nov;23(11):2605-9. doi: 10.1007/s00464-009-0406-6. Epub 2009 Mar 6.

Study record dates

Study Major Dates

• Study Start (Actual): June 29, 2020
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): February 28, 2022

Study Registration Dates

• First Submitted: June 30, 2020
• First Submitted That Met QC Criteria: June 30, 2020
• First Posted (Actual): July 7, 2020

Study Record Updates

• Last Update Posted (Actual): November 16, 2021
• Last Update Submitted That Met QC Criteria: November 15, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Left Colon Cancer,; Left hemicolectomy; Laparoscopic left hemicolectomy; Intracorporeal resection and anastomosis
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Colorectal Neoplasms; Colonic Neoplasms
• Other Study ID Numbers: HEMI-E-INTRACORPOREA-2020

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No