NCT03918369: HEMI-D-TREND

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

Completed NA Last updated 7 February 2024

What this trial tests

NA trial testing Laparoscopic right hemicolectomy with intracorporeal anastomosis. in Colon Cancer in 416 participants. Completed in 1 September 2023.

Timeline

7 March 2019

Primary endpoint
31 July 2022

1 September 2023

Quick facts

Lead sponsor	Corporacion Parc Tauli
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	416
Start date	7 March 2019
Primary completion	31 July 2022
Estimated completion	1 September 2023
Sites	1 location across Spain

Drugs / interventions tested

• Laparoscopic right hemicolectomy with intracorporeal anastomosis.
• Laparoscopic right hemicolectomy with extracorporeal anastomosis.

Conditions studied

• Colon Cancer — all drugs for Colon Cancer →

Sponsor

Corporacion Parc Tauli — full company profile →

Who can join

18 and older, any sex, with Colon Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Intracorporeal vs extracorporeal anastomosis in laparoscopic right colectomy for colon cancer: a prospective multicenter cohort study (the Hemi-D-TREND study).
   Serra-Aracil X, Pascua-Solé M, Sánchez A, Gómez-Díaz CJ, et al · · 2026 · cited 1× · PMID 41326726 · DOI 10.1007/s00464-025-12401-0