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Trials
Published in: Trials 1/2015

Open Access 01-12-2015 | Study protocol

“High or low Inferior Mesenteric Artery ligation in Laparoscopic low Anterior Resection: study protocol for a randomized controlled trial” (HIGHLOW trial)

Authors: Giulio Mari, Dario Maggioni, Andrea Costanzi, Angelo Miranda, Luca Rigamonti, Jacopo Crippa, Carmelo Magistro, Stefano Di Lernia, Antonello Forgione, Pietro Carnevali, Michele Nichelatti, Pierluigi Carzaniga, Francesco Valenti, Marco Rovagnati, Mattia Berselli, Eugenio Cocozza, Lorenzo Livraghi, Matteo Origi, Ildo Scandroglio, Francesco Roscio, Antonio De Luca, Giovanni Ferrari, Raffaele Pugliese

Published in: Trials | Issue 1/2015

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Abstract

Background

The position of arterial ligation during laparoscopic anterior rectal resection with total mesorectal excision can affect genito-urinary function, bowel function, oncological outcomes, and the incidence of anastomotic leakage. Ligation to the inferior mesenteric artery at the origin or preservation of the left colic artery are both widely performed in rectal surgery. The aim of this study is to compare the incidence of genito-urinary dysfunction, anastomotic leak and oncological outcomes in laparoscopic anterior rectal resection with total mesorectal excision with high or low ligation of the inferior mesenteric artery in a controlled randomized trial.

Methods/design

The HIGHLOW study is a multicenter randomized controlled trial in which patients are randomly assigned to high or low inferior mesenteric artery ligation during laparoscopic anterior rectal resection with total mesorectal excision for rectal cancer. Inclusion criteria are middle or low rectal cancer (0 to 12 cm from the anal verge), an American Society of Anesthesiologists score of I, II, or III, and a body mass index lower than 30. The primary end-point measure is the incidence of post-operative genito-urinary dysfunction. The secondary end-point measure is the incidence of anastomotic leakage in the two groups. A total of 200 patients (100 per arm) will reliably have 84.45 power in estimating a 20% difference in the incidence of genito-urinary dysfunctions. With a group size of 100 patients per arm it is possible to find a significant difference (α = 0.05, β = 0.1555). Allowing for an estimated dropout rate of 5%, the required sample size is 212 patients.

Discussion

The HIGHLOW trial is a randomized multicenter controlled trial that will provide evidence on the merits of the level of arterial ligation during laparoscopic anterior rectal resection with total mesorectal excision in terms of better preserved post-operative genito-urinary function.

Trial registration

ClinicalTrials.gov Identifier: NCT02153801
Protocol Registration Receipt 29/5/2014.
Appendix
Available only for authorised users
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Metadata
Title
“High or low Inferior Mesenteric Artery ligation in Laparoscopic low Anterior Resection: study protocol for a randomized controlled trial” (HIGHLOW trial)
Authors
Giulio Mari
Dario Maggioni
Andrea Costanzi
Angelo Miranda
Luca Rigamonti
Jacopo Crippa
Carmelo Magistro
Stefano Di Lernia
Antonello Forgione
Pietro Carnevali
Michele Nichelatti
Pierluigi Carzaniga
Francesco Valenti
Marco Rovagnati
Mattia Berselli
Eugenio Cocozza
Lorenzo Livraghi
Matteo Origi
Ildo Scandroglio
Francesco Roscio
Antonio De Luca
Giovanni Ferrari
Raffaele Pugliese
Publication date
01-12-2015
Publisher
BioMed Central
Published in
Trials / Issue 1/2015
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-014-0537-5

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