NCT03918369

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
416

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 7, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 15, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 17, 2019

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2022

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
Last Updated

February 7, 2024

Status Verified

February 1, 2024

Enrollment Period

3.4 years

First QC Date

April 15, 2019

Last Update Submit

February 5, 2024

Conditions

Colon Cancer

Keywords

Right Colon Cancer,Right hemicolectomyLaparoscopic right hemicolectomyIntracorporeal anastomosis

Outcome Measures

Primary Outcomes (4)

  • Percentage of anastomotic leak (AL)

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

    30 days

  • 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 Nosocomial Infection Monitoring System

    30 days

  • Rate of Re-interventions

    Percentage of re-interventions due to surgical complications

    30 days

Study Arms (2)

Laparoscopic Intracorporeal anastomosis

EXPERIMENTAL

Laparoscopic right hemicolectomy with intracorporeal mechanical side-to-side isoperistaltic anastomosis.

Procedure: Laparoscopic right hemicolectomy with intracorporeal anastomosis.

Laparoscopic extracorporeal anastomosis

ACTIVE COMPARATOR

Laparoscopic right hemicolectomy with extracorporeal anastomosis.

Procedure: Laparoscopic right hemicolectomy with extracorporeal anastomosis.

Interventions

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 Intracorporeal anastomosis
Laparoscopic right hemicolectomy with extracorporeal anastomosis.PROCEDURE

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

Laparoscopic extracorporeal anastomosis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario Parc Tauli de Sabadell

Sabadell, Barcelona, 08208, Spain

Location

Related Publications (3)

  • Frasson M, Granero-Castro P, Ramos Rodriguez JL, Flor-Lorente B, Braithwaite M, Marti Martinez E, Alvarez Perez JA, Codina Cazador A, Espi A, Garcia-Granero E; ANACO Study Group. Risk factors for anastomotic leak and postoperative morbidity and mortality after elective right colectomy for cancer: results from a prospective, multicentric study of 1102 patients. Int J Colorectal Dis. 2016 Jan;31(1):105-14. doi: 10.1007/s00384-015-2376-6. Epub 2015 Aug 28.

    PMID: 26315015BACKGROUND

  • Frasson M, Flor-Lorente B, Rodriguez JL, Granero-Castro P, Hervas D, Alvarez Rico MA, Brao MJ, Sanchez Gonzalez JM, Garcia-Granero E; ANACO Study Group. Risk Factors for Anastomotic Leak After Colon Resection for Cancer: Multivariate Analysis and Nomogram From a Multicentric, Prospective, National Study With 3193 Patients. Ann Surg. 2015 Aug;262(2):321-30. doi: 10.1097/SLA.0000000000000973.

    PMID: 25361221BACKGROUND

  • Serra-Aracil X, Pascua-Sole M, Sanchez A, Gomez-Diaz CJ, Ruiz C, Espina B, Sierra JE, Lamas S, Vallverdu H, Corredera C, Veo C, Hoyuela C, Serracant A, Moreno F, Collera-Ormazabal P, Manas MJ, Merichal M, Cayetano-Paniagua L, Caro-Tarrago A; HEMI-D-TREND-study group. Intracorporeal vs extracorporeal anastomosis in laparoscopic right colectomy for colon cancer: a prospective multicenter cohort study (the Hemi-D-TREND study). Surg Endosc. 2025 Dec 1. doi: 10.1007/s00464-025-12401-0. Online ahead of print.

    PMID: 41326726DERIVED

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Study Officials

  • Xavier Serra-Aracil, MD, PhD

    Corporacio Parc Tauli. Parc Tauli University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Colorectal Unit

Study Record Dates

First Submitted

April 15, 2019

First Posted

April 17, 2019

Study Start

March 7, 2019

Primary Completion

July 31, 2022

Study Completion

September 1, 2023

Last Updated

February 7, 2024

Record last verified: 2024-02

Locations

ES(1)