Clinical trial · Interventional

Genito Urinary Function With High or Low Inferior Mesenteric Artery Ligation in Laparoscopic Anterior Rectal Resection

Sexual Urinary Function in Patients Undergoing Laparoscopic Low Anterior Resection With Total Mesorectal Excision With High Or Low Ligation of the Inferior Mesenteric Artery With Preservation of Left Colic Artery Multicentre Randomized Trial

NCT02153801CI-TRIAL-00026748completedN/AClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

The aim of this study is to compare the incidence of genito-urinary function depression and anastomotic leak in Laparoscopic Anterior Rectal Resection (LAR) with Total Mesorectal Excision with Ligation if the Inferior Mesenteric Artery at the origin or preserving the Left Colic Artery by a prospective randomized trial.

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Genito Urinary Function Evaluation	—	UNRESOLVED	—

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
During the surgical procedure of Laparoscopic Low Anterior Resection with Total mesorectal Excision .	Procedure	—	UNRESOLVED

Design

Arms and outcomes

Arms (2)

type
ACTIVE_COMPARATOR
label
Low Inferior Mesenterci Artery Ligation
description
The opening of the peritoneum proceeds cephalad towards the duodenojejunal angle of Treitz, and the mesenteric root is incised 1 cm below the inferior margin of the pancreas. The aortomesenteric window is opened wide and the inferior mesenteric vessels are exposed. The inferior mesenteric artery (IMA) is ligated and divided at 2 cm from its origin. The inferior mesenteric vein is ligated and divided below the pancreatic margin.
interventionNames
1. Procedure: During the surgical procedure of Laparoscopic Low Anterior Resection with Total mesorectal Excision .
type
OTHER
label
High Inferior Mesenterci Artery Ligation
description
For Low Ligation The opening of peritoneum proceeds upward and then laterally towards the sigmoid colon. Left colic artery is identified and preserved while low ligation of the inferior mesenteric artery (superior hemorrhoidal artery) is performed. Lymphadenectomy is carried on medially along the inferior mesenteric artery until 2 cm from the aorta. For both groups dissection is then carried on windowing Toldt and Gerota fascias till the parietocolic gutter.
interventionNames

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

Inclusion Criteria:

* middle or low rectal cancer (from 0 to 12 cm from the anal verge), American Society Anesthesiologist (ASA) I II III, Body Mass index (BMI) lower than 30.

Exclusion Criteria:

* prior surgery on the abdominal aorta,
* conversion to laparotomy,
* intraoperative decision for colostomy.

References

Publications (4)

DERIVEDMari GM, Crippa J, Achilli P, Montroni I, Ugolini G, Taffurelli G, Cocozza E, Borroni G, Valenti F, Roscio F, Ferrari G, Origi M, Zuliani W, Pugliese R, Costanzi ATM, Fingherut A, Maggioni D. High Versus Low Ligation of the Inferior Mesenteric Artery During Rectal Resection for Cancer: Oncological Outcomes After Three Years of Follow-Up From the HIGHLOW Trial. Ann Surg Open. 2020 Oct 19;1(2):e017. doi: 10.1097/AS9.0000000000000017. eCollection 2020 Dec. PMID 37637440
DERIVEDMari G, Santambrogio G, Crippa J, Cirocchi R, Origi M, Achilli P, Ferrari G, Megna S, Desio M, Cocozza E, Maggioni D, Montroni I, Spinelli A, Zuliani W, Costanzi A, Crestale S, Petri R, Bicelli N, Pedrazzani C, Boccolini A, Taffurelli G, Fingerhut A; AIMS Academy Clinical Research Network. 5 year oncological outcomes of the HIGHLOW randomized clinical trial. Eur J Surg Oncol. 2023 Mar;49(3):641-646. doi: 10.1016/j.ejso.2022.10.017. Epub 2022 Oct 28. PMID 36335077
DERIVEDMari GM, Crippa J, Cocozza E, Berselli M, Livraghi L, Carzaniga P, Valenti F, Roscio F, Ferrari G, Mazzola M, Magistro C, Origi M, Forgione A, Zuliani W, Scandroglio I, Pugliese R, Costanzi ATM, Maggioni D. Low Ligation of Inferior Mesenteric Artery in Laparoscopic Anterior Resection for Rectal Cancer Reduces Genitourinary Dysfunction: Results From a Randomized Controlled Trial (HIGHLOW Trial). Ann Surg. 2019 Jun;269(6):1018-1024. doi: 10.1097/SLA.0000000000002947. PMID 31082897
DERIVEDMari G, Maggioni D, Costanzi A, Miranda A, Rigamonti L, Crippa J, Magistro C, Di Lernia S, Forgione A, Carnevali P, Nichelatti M, Carzaniga P, Valenti F, Rovagnati M, Berselli M, Cocozza E, Livraghi L, Origi M, Scandroglio I, Roscio F, De Luca A, Ferrari G, Pugliese R. "High or low Inferior Mesenteric Artery ligation in Laparoscopic low Anterior Resection: study protocol for a randomized controlled trial" (HIGHLOW trial). Trials. 2015 Jan 27;16:21. doi: 10.1186/s13063-014-0537-5. PMID 25623323

Registry

Dates and enrollment

Start: Sep 1, 2014
Primary completion: Dec 1, 2015
Completion: Mar 1, 2017
First posted: Jun 3, 2014
Last update posted: Apr 4, 2017
Enrollment: 212 (actual)
Lead sponsor: Niguarda Hospital OTHER
Keywords: High Ligation, Low ligation, Genito-urinary function, laparoscopy, rectal cancer, aterior resection, Total mesorectal Excision, anastomotic leak.

Data updated 22 days agoSource updated Apr 4, 2017source: clinicaltrials

Locations

Locations by country (1)

Country	Sites	Recruiting
Italy	1	0

Trial listing is informational. Eligibility is decided by the study team; contact information is on ClinicalTrials.gov.