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

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ClinicalTrials.gov Identifier: NCT01326052
Recruitment Status : Completed
First Posted : March 30, 2011
Last Update Posted : June 13, 2012
Sponsor:
Information provided by (Responsible Party):
Francesco Saverio Mari, University of Roma La Sapienza

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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 or disease Intervention/treatment Phase
Defecatory Disorders After Left Colonic or Rectal Resection Procedure: Inferior Mesenteric Artery Preservation Procedure: Inferior Mesenteric Artery Ligation Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Effect of Inferior Mesenteric Artery Preservation Performing Left Hemicolectomy for Diverticulosis in the Anorectal Function
Study Start Date : January 2004
Actual Primary Completion Date : January 2010
Actual Study Completion Date : December 2011

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Arms and Interventions
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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 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


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Constipation [ Time Frame: 6 and 12 months ]
    We evaluate with a questionnaire (Constipation scoring system) the presence of postoperative constipation

  2. 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

  3. Quality of life [ Time Frame: 6 and 12 months ]
    We evaluate with SF-36 questionnaire the postoperative quality of life

  4. Postoperative complication [ Time Frame: 1 month ]
    We evaluate the presence of postoperative complication such as anastomotic leakage, anastomotic stricture, pneumonia etc.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01326052


Locations
Italy
Azienda Ospedaliera Sant'Andrea
Rome, Italy, 00188
Sponsors and Collaborators
University of Roma La Sapienza
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
First Posted: March 30, 2011    Key Record Dates
Last Update Posted: June 13, 2012
Last Verified: June 2012

Additional relevant MeSH terms:
Diverticulum
Pathological Conditions, Anatomical