Text Size

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

Resource links provided by NLM:

MedlinePlus related topics: Constipation
U.S. FDA Resources

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
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

Additional relevant MeSH terms:
Diverticulum
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on May 21, 2013