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

Defecatory Disorders After Left Colonic or Rectal Resection Clinical Trial

— IPIMAL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01326052
• Other study ID #: DS-004
• Status: Completed
• Phase: Phase 3
• First received: March 25, 2011
• Last updated: June 12, 2012
• Start date: January 2004
• Est. completion date: December 2011

Study information

• Verified date: June 2012
• Source: University of Roma La Sapienza
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: December 2011
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Defecatory Disorders After Left Colonic or Rectal Resection
• Diverticulum

Intervention

Procedure:
• Inferior Mesenteric Artery Preservation
Performing left hemicolectomy the IMA was preserved ligating close to the colonic wall the sigmoids arteries.
• Inferior Mesenteric Artery Ligation
Performing left hemicolectomy the IMA is ligated and sectioned after the origin of left colic artery

Locations

Country	Name	City	State
Italy	Azienda Ospedaliera Sant'Andrea	Rome

Sponsors (1)

Lead Sponsor	Collaborator
University of Roma La Sapienza

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from preoperative time in anorectal function	We evaluate the presence of modification in anorectal function respect to the preoperative time. This is assessed with specific questionnnaires and anorectal manometry	6 and 12 months	No
Secondary	Constipation	We evaluate with a questionnaire (Constipation scoring system) the presence of postoperative constipation	6 and 12 months	No
Secondary	Incontinence	We evaluate with a questionnaire (Continence scale), anorectal manometry and eventually with endoanal ultrasonography the precence of incontinence	6 and 12 months	No
Secondary	Quality of life	We evaluate with SF-36 questionnaire the postoperative quality of life	6 and 12 months	No
Secondary	Postoperative complication	We evaluate the presence of postoperative complication such as anastomotic leakage, anastomotic stricture, pneumonia etc.	1 month	Yes