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

February 5, 2024 updated by: Xavier Serra-Aracil, Corporacion Parc Tauli

A Multicenter Controlled Study of the Intracorporeal Mechanical Side-to-side Isoperistaltic Anastomosis Versus Extracorporeal Anastomosis in Laparoscopic Right Hemicolectomy: HEMI-D-TREND-study

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Study Design: TREND-study design (Transparent Reporting of Evaluations with Non-randomized Designs-TREND):

A multicenter prospective, non-randomized, controlled study of the intracorporeal mechanical side-to-side isoperistaltic anastomosis versus extracorporeal anastomosis in laparoscopic right hemicolectomy. TREND-study.

Study procedure

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 Extracorporeal anastomosis group according to the usual technique in each center.

Expected duration of subject participation; what is done and when: Duration of the study two years.

Population

Patients diagnosed with adenocarcinoma of the right colon up to the hepatic angle after complete colonoscopy, biopsy, and chest, abdominal and pelvic CT, and chest radiography, of the participating hospitals.

Recruitment Plan

Centers intracorporeal group: Parc Taulí University Hospital, Spain. Hospital Universitario Joan XXIII de Tarragona, Spain. Hospital de Cancer de Barretos. Brazil

Centers extracorporeal group: Consorcio Hospitalario de Terrassa (Barcelona), Spain. Hospital de Universitario de Vich (Barcelona), Spain. Hospital Universitario Arnau de Vilanova de Lleida, Spain. Hospital Santa Tecla de Tarragona, Spain. Hospital Universitario Sant Joan de Reus (Tarragona), Spain.

Study Type

Interventional

Enrollment (Actual)

416

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Barcelona
      • Sabadell, Barcelona, Spain, 08208
        • Hospital Universitario Parc Tauli de Sabadell

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients diagnosed with right colon neoplasia non-metastatic.
  • Indication of right hemicolectomy and ileo-colic anastomosis.
  • Over 18 years.
  • Scheduled surgery intervened by the team of surgeons of the Coloproctology Unit of each participating hospital.
  • Patients who undergone a perioperative management program corresponding to the usual practice and technique of each hospital.

Exclusion Criteria:

  • Colon neoplasms from other locations.
  • T4 tumor stage and stage IV of the TNM classification.
  • ASA IV (American Society Anesthesiologists).
  • Non-optimal nutritional status (preoperative albumin ≤3.4 g / dl).
  • Do not sign informed consent.
  • Pregnant patients.
  • Liver cirrhosis.
  • Chronic renal insufficiency in dialysis treatment.
  • BMI <18 and> 35 Kg / m

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Laparoscopic Intracorporeal anastomosis
Laparoscopic right hemicolectomy with intracorporeal mechanical side-to-side isoperistaltic anastomosis.
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
Active Comparator: Laparoscopic extracorporeal anastomosis
Laparoscopic right hemicolectomy with extracorporeal anastomosis.
Procedure: Laparoscopic right hemicolectomy with extracorporeal anastomosis.
Laparoscopic right hemicolectomy with extracorporeal anastomosis with the technical features of each center

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of anastomotic leak (AL)
Time Frame: 30 days
Percentage of anastomic leak (defined in accordance with Peel et al.).
30 days
Rate of global morbidity
Time Frame: 30 days
Dindo-Clavien Classification
30 days
Rate of Re-interventions
Time Frame: 30 days
Percentage of re-interventions due to surgical complications
30 days
Rate of Surgical site infection
Time Frame: 30 days
SSI in accordance with the Center for Disease Control (CDC) National Nosocomial Infection Monitoring System
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Corporacion Parc Tauli

Collaborators

Anna Pallisera-Lloveras
Sheila Serra-Pla
Mireia Pascua-Solé
Laura Mora-Lopez
Ricard Sales
Beatriz Espina
Luis Romangolo
Anna Serracant
Cristina Ruiz
Mº José Mañas Gomez
Angels Montserrat-Marti
Mireia Merichal
Carlos Cerdán-Santacruz
Antonio Sanchez
Helena Vallverdú

Investigators

  • Principal Investigator: Xavier Serra-Aracil, MD, PhD, Corporacio Parc Tauli. Parc Tauli University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 7, 2019

Primary Completion (Actual)

July 31, 2022

Study Completion (Actual)

September 1, 2023

Study Registration Dates

First Submitted

April 15, 2019

First Submitted That Met QC Criteria

April 16, 2019

First Posted (Actual)

April 17, 2019

Study Record Updates

Last Update Posted (Actual)

February 7, 2024

Last Update Submitted That Met QC Criteria

February 5, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HEMI-D-TREND-2019

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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