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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

March 25, 2011
June 12, 2012
January 2004
January 2010   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01326052 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Improvement of Anorectal Function While Preserving of Inferior Mesenteric Artery Performing Left Hemicolectomy for Diverticulosis
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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Defecatory Disorders After Left Colonic or Rectal Resection
  • 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
  • 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
  • Experimental: Inferior Mesenteric Artery Preservation
    Performing left hemicolectomy the IMA was preserved ligating close to the colonic wall the sigmoids arteries.
    Intervention: Procedure: Inferior Mesenteric Artery Preservation
  • Active Comparator: Inferior Mesenteric Artery Ligation
    Performing left hemicolectomy the IMA is ligated and sectioned after the origin of left colic artery
    Intervention: Procedure: Inferior Mesenteric Artery Ligation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
150
December 2011
January 2010   (final data collection date for primary outcome measure)

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)
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT01326052
DS-004
No
Francesco Saverio Mari, University of Roma La Sapienza
University of Roma La Sapienza
Not Provided
Not Provided
University of Roma La Sapienza
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP