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OpenTrials
Completed

NCT Number: NCT01326052

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

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.

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Key information

Conditions

Defecatory Disorders After Left Colonic or Rectal Resection

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Azienda Ospedaliera Sant'Andrea

Rome, Italy, 00188

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Inferior Mesenteric Artery Preservation

Procedure

Performing left hemicolectomy the IMA was preserved ligating close to the colonic wall the sigmoids arteries.

Other names: IMA-P

Inferior Mesenteric Artery Ligation

Procedure

Performing left hemicolectomy the IMA is ligated and sectioned after the origin of left colic artery

Other names: IMA-L

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Roma La Sapienza

Other

Registry information

Official study title

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

Acronym: IPIMAL

Important dates

Study start
2004
Primary completion
2010
Study completion
2011
First posted
Mar 30, 2011
Registry last updated
Jun 13, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.