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Erschienen in: International Journal of Colorectal Disease 9/2017

21.06.2017 | Clinical Study Protocol

Isoperistaltic versus antiperistaltic side-to-side anastomosis after right laparoscopic hemicolectomy for cancer (ISOVANTI) trial: study protocol for a randomised clinical trial

verfasst von: N. Ibañez, J. Abrisqueta, J. Luján, Q. Hernández, P. Parrilla

Erschienen in: International Journal of Colorectal Disease | Ausgabe 9/2017

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Abstract

Background

It is believed that loosing ileocecal valve is well tolerated in patients who do not have short bowel syndrome or Crohn disease. From the hypothesis of colonic peristalsis and transit is regulated by that ileocecal valvular mechanism, we try to find out if the creation of a new pseudo-valvular mechanism as antiperistaltic anastomosis could be considered after right hemicolectomy can cause any short- or long-term changes in gastrointestinal habits.

Purpose

The purpose of the study at primary endpoint is to compare early (occurring within 30 days of surgery) and late (occurring during the follow-up) postoperative complications between both groups
The purpose of the study at secondary endpoint is to compare intraoperative and postoperative events between experimental and control groups in terms of operating time, first oral tolerance day, first flatus and faeces, length of hospital stay and orocecal transit; comparing rates of gastrointestinal life quality and comparing mortality rates between both groups.

Methods

The ISOVANTI trial is a randomized controlled single-centre trial comparing isoperistaltic versus antiperistaltic side-to-side anastomosis after right laparoscopic hemicolectomy. It is designed as a parallel group superiority trial.

Conclusions

It is unknown if a pseudo-valvular mechanism as antiperistaltic anastomosis can be considered has short- or long-term consequences in gastrointestinal habit. Considering the impact that ileocolic anastomosis configuration could have on the restitution of bowel transit after right hemicolectomy, we think it is indicated and necessary a randomized trial comparing iso- and antiperistaltic modalities.

Trial registration

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Metadaten
Titel
Isoperistaltic versus antiperistaltic side-to-side anastomosis after right laparoscopic hemicolectomy for cancer (ISOVANTI) trial: study protocol for a randomised clinical trial
verfasst von
N. Ibañez
J. Abrisqueta
J. Luján
Q. Hernández
P. Parrilla
Publikationsdatum
21.06.2017
Verlag
Springer Berlin Heidelberg
Erschienen in
International Journal of Colorectal Disease / Ausgabe 9/2017
Print ISSN: 0179-1958
Elektronische ISSN: 1432-1262
DOI
https://doi.org/10.1007/s00384-017-2840-6

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