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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Francesco Saverio Mari, University of Roma La Sapienza

ClinicalTrials.gov Identifier:

NCT01326052

First received: March 25, 2011

Last updated: June 12, 2012

Last verified: June 2012

History of Changes

Purpose

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.

Condition	Intervention	Phase
Defecatory Disorders After Left Colonic or Rectal Resection	Procedure: Inferior Mesenteric Artery Preservation Procedure: Inferior Mesenteric Artery Ligation	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Official Title:	Effect of Inferior Mesenteric Artery Preservation Performing Left Hemicolectomy for Diverticulosis in the Anorectal Function

Further study details as provided by University of Roma La Sapienza:

Primary Outcome Measures:

Change from preoperative time in anorectal function [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
We evaluate the presence of modification in anorectal function respect to the preoperative time. This is assessed with specific questionnnaires and anorectal manometry

Secondary Outcome Measures:

Constipation [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
We evaluate with a questionnaire (Constipation scoring system) the presence of postoperative constipation
Incontinence [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
We evaluate with a questionnaire (Continence scale), anorectal manometry and eventually with endoanal ultrasonography the precence of incontinence
Quality of life [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
We evaluate with SF-36 questionnaire the postoperative quality of life
Postoperative complication [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
We evaluate the presence of postoperative complication such as anastomotic leakage, anastomotic stricture, pneumonia etc.


Enrollment:	150
Study Start Date:	January 2004
Study Completion Date:	December 2011
Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 Name: 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 Name: IMA-L

Eligibility


Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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)

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01326052

Locations


Italy
Azienda Ospedaliera Sant'Andrea
Rome, Italy, 00188

Sponsors and Collaborators

University of Roma La Sapienza

More Information

No publications provided


Responsible Party:	Francesco Saverio Mari, Reserch Fellows, University of Roma La Sapienza
ClinicalTrials.gov Identifier:	NCT01326052 History of Changes
Other Study ID Numbers:	DS-004
Study First Received:	March 25, 2011
Last Updated:	June 12, 2012
Health Authority:	Italy: Ethics Committee

ClinicalTrials.gov processed this record on March 03, 2015

To Top