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

Phase 3

Completed

• Conditions: Defecatory Disorders After Left Colonic or Rectal Resection

• Registration Number: NCT01326052
• Lead Sponsor: University of Roma La Sapienza

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-01
• Primary Completion: 2010-01
• Study First Submitted: 2011-03-25
• Study First Submitted QC: 2011-03-28
• Study First Posted: 2011-03-30
• Study Completion: 2011-12
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-12
• Last Update Posted: 2012-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change from preoperative time in anorectal function	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

Name	Time	Method
Incontinence	6 and 12 months	We evaluate with a questionnaire (Continence scale), anorectal manometry and eventually with endoanal ultrasonography the precence of incontinence
Postoperative complication	1 month	We evaluate the presence of postoperative complication such as anastomotic leakage, anastomotic stricture, pneumonia etc.
Constipation	6 and 12 months	We evaluate with a questionnaire (Constipation scoring system) the presence of postoperative constipation
Quality of life	6 and 12 months	We evaluate with SF-36 questionnaire the postoperative quality of life

Trial Locations

Locations (1)

Azienda Ospedaliera Sant'Andrea; 🇮🇹 Rome, Italy