Study of the Intracorporeal Versus Extracorporeal Anastomosis in Right Hemicolectomy: HEMI-D-TREND-study

Summary

INTRODUCTION: Colorectal cancer is the second most frequent cancer in the Western world. Roughly a third of colorectal tumors are located in the right colon, and right hemicolectomy surgery is the treatment of choice in non-disseminated right colon cancer and other benign pathologies. Despite the introduction of laparoscopy and multimodal fast-track perioperative management programs in recent years, postoperative complication rates remain high. The most serious complication is anastomotic leak (AL), which is associated with increased mortality, longer hospital stay, and reduced quality of life due to the presence of ostomies. For a long time, the importance of ileo-colic AL was underestimated. However, the ANACO study, conducted in 52 hospitals in our environment, reported a rate of AL of 8.4% with a range of 0 to 35%. This wide range is due to the differences in the surgical procedures and anastomoses used (the surgical approach may be open or laparoscopic, and the anastomosis may be manual or mechanical, with all its variations).

The results of intracorporeal laparoscopic anastomosis in the literature vary widely and, are discordant, although those reported so far estimate a DA less than 2%. But the latest publications report low rates of morbidity and of surgical space infection (SSI). The main problem with this technique is that it requires a learning curve somewhat greater than the others and its results depend on the skill of the surgeon and his casuistry. For all these reasons, it is necessary to carry out comparative studies that favor the use of this technique as gold standard.

The multicentre, controlled and randomized controlled studies have the disadvantage that randomization in centers not used with one of the techniques does include a learning curve bias. Besides the fact that in a center there is a belief that one of the techniques is superior to the other, it is not ethical to randomize the techniques. This situation has encouraged us to perform a non-randomized TREND-study design (Transparent Reporting of Evaluations with Non-randomized Designs-TREND).

Main objective:

To assess if laparoscopic right hemicolectomy, with anastomosis, obtains better results than laparoscopic with extracorporeal anastomosis and open surgery in terms of global morbidity, surgical space infection, anastomotic leak, re-interventions and hospital stay, in the first 30 postoperative days.

Secondary objectives:

To analyze the rate of anastomotic leak (AL) and organ-cavitary infections in each hospital.

* Compare the results obtained with those published in the literature.
* Try to identify the risk factors associated with AL.
* Analyze the comorbidities associated with the type of incision made for the extraction of the surgical piece, in intra and extracorporeal anastomosis

Conditions

• Colon Cancer

Interventions

PROCEDURE

Laparoscopic right hemicolectomy with intracorporeal anastomosis.

Intracorporeal anastomosis group The laparoscopic right hemicolectomy with intracorporeal mechanical side-to-side isoperistaltic anastomosis. In this procedure, intracorporeal division of the mesoileum and transverse colon is performed, as shown in the animation. The ileum and transverse colon are divided with the Endopath® Echelon Flex ™ 60 stapler. The specimen is inserted in a plastic bag. Side-to-side isoperistaltic mechanical anastomosis is performed using the same endostapler. A running suture is performed of the mechanical suture orifice, with another reinforcing suture with Monocryl ™ (poliglecaprone 25) or with STRATAFIX ™ Spiral Knotless barbed suture. The specimen is extracted through a Pfannestiel minilaparotomy (3.5-4 cm) Wound Protector

PROCEDURE

Laparoscopic right hemicolectomy with extracorporeal anastomosis.

Laparoscopic right hemicolectomy with extracorporeal anastomosis with the technical features of each center

Sponsors & Collaborators

• Mireia Pascua-Solé

  collaborator UNKNOWN

• Laura Mora-Lopez

  collaborator UNKNOWN

• Anna Pallisera-Lloveras

  collaborator UNKNOWN

• Sheila Serra-Pla

  collaborator UNKNOWN

• Ricard Sales

  collaborator UNKNOWN

• Beatriz Espina

  collaborator UNKNOWN

• Luis Romangolo

  collaborator UNKNOWN

• Anna Serracant

  collaborator UNKNOWN

• Cristina Ruiz

  collaborator UNKNOWN

• Mº José Mañas Gomez

  collaborator UNKNOWN

• Angels Montserrat-Marti

  collaborator UNKNOWN

• Mireia Merichal

  collaborator UNKNOWN

• Carlos Cerdán-Santacruz

  collaborator UNKNOWN

• Antonio Sanchez

  collaborator UNKNOWN

• Helena Vallverdú

  collaborator UNKNOWN

• Corporacion Parc Tauli

  lead OTHER

Principal Investigators

• Xavier Serra-Aracil, MD, PhD · Corporacio Parc Tauli. Parc Tauli University Hospital

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-03-07

Primary Completion

2022-07-31

Completion

2023-09-01

Countries

• Spain

Study Locations