Improvement of Anorectal Function While Preserving of Inferior Mesenteric Artery Performing Left Hemicolectomy for Diverticulosis (IPIMAL)

June 12, 2012 updated by: Francesco Saverio Mari, University of Roma La Sapienza

Effect of Inferior Mesenteric Artery Preservation Performing Left Hemicolectomy for Diverticulosis in the Anorectal Function

The aim of the study is to evaluate the anorectal function after hemicolectomy if we preserve or not the Inferior Mesenteric Artery (IMA). This study wants to demonstrate that IMA preservation could improve patient's quality of life reducing incontinence and/or constipation rate.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Rome, Italy, 00188
        • Azienda Ospedaliera Sant'Andrea

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age from 18 to 80 years
  • BMI<35
  • Presence of symptomatic diverticular disease
  • ASA I-III

Exclusion Criteria:

  • age > 80 years
  • BMI>35
  • ASA IV
  • Hinchey III-IV
  • Past performed procedure that could be modify the nervous pattern (i.e. colorectal surgery, left nephrectomy, hysteroannessectomy)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Inferior Mesenteric Artery Preservation
Performing left hemicolectomy the IMA was preserved ligating close to the colonic wall the sigmoids arteries.
Procedure: Inferior Mesenteric Artery Preservation
Performing left hemicolectomy the IMA was preserved ligating close to the colonic wall the sigmoids arteries.
Other Names:
  • IMA-P
Active Comparator: Inferior Mesenteric Artery Ligation
Performing left hemicolectomy the IMA is ligated and sectioned after the origin of left colic artery
Procedure: Inferior Mesenteric Artery Ligation
Performing left hemicolectomy the IMA is ligated and sectioned after the origin of left colic artery
Other Names:
  • IMA-L

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from preoperative time in anorectal function
Time Frame: 6 and 12 months
We evaluate the presence of modification in anorectal function respect to the preoperative time. This is assessed with specific questionnnaires and anorectal manometry
6 and 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Constipation
Time Frame: 6 and 12 months
We evaluate with a questionnaire (Constipation scoring system) the presence of postoperative constipation
6 and 12 months
Incontinence
Time Frame: 6 and 12 months
We evaluate with a questionnaire (Continence scale), anorectal manometry and eventually with endoanal ultrasonography the precence of incontinence
6 and 12 months
Quality of life
Time Frame: 6 and 12 months
We evaluate with SF-36 questionnaire the postoperative quality of life
6 and 12 months
Postoperative complication
Time Frame: 1 month
We evaluate the presence of postoperative complication such as anastomotic leakage, anastomotic stricture, pneumonia etc.
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Roma La Sapienza

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2004

Primary Completion (Actual)

January 1, 2010

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

March 25, 2011

First Submitted That Met QC Criteria

March 28, 2011

First Posted (Estimate)

March 30, 2011

Study Record Updates

Last Update Posted (Estimate)

June 13, 2012

Last Update Submitted That Met QC Criteria

June 12, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DS-004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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