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NCT Number: NCT03918369

Study of the Intracorporeal Versus Extracorporeal Anastomosis in 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

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Key information

Conditions

Colon Cancer Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitario Parc Tauli de Sabadell

Sabadell, Barcelona, 08208, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Laparoscopic right hemicolectomy with intracorporeal anastomosis.

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

Laparoscopic right hemicolectomy with extracorporeal anastomosis.

Procedure

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

Primary outcomes

  1. Percentage of anastomotic leak (AL)

    Time frame: 30 days

    Percentage of anastomic leak (defined in accordance with Peel et al.).

  2. Rate of global morbidity

    Time frame: 30 days

    Dindo-Clavien Classification

  3. Rate of Surgical site infection

    Time frame: 30 days

    SSI in accordance with the Center for Disease Control (CDC) National Nosocomial Infection Monitoring System

  4. Rate of Re-interventions

    Time frame: 30 days

    Percentage of re-interventions due to surgical complications

Sponsors and collaborators

Lead sponsor

Corporacion Parc Tauli

Other

Collaborators

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

Registry information

Official study title

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

Acronym: HEMI-D-TREND

Important dates

Study start
2019
Primary completion
2022
Study completion
2023
First posted
Apr 17, 2019
Registry last updated
Feb 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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