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

History of Changes

Tracking Information
First Received Date ^ICMJE	March 25, 2011
Last Updated Date	June 12, 2012
Start Date ^ICMJE	January 2004
Primary Completion Date	January 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: March 28, 2011)	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
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01326052 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: March 28, 2011)	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.
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Improvement of Anorectal Function While Preserving of Inferior Mesenteric Artery Performing Left Hemicolectomy for Diverticulosis
Official Title ^ICMJE	Effect of Inferior Mesenteric Artery Preservation Performing Left Hemicolectomy for Diverticulosis in the Anorectal Function
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 Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Condition ^ICMJE	Defecatory Disorders After Left Colonic or Rectal Resection
Intervention ^ICMJE	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
Study Arm (s)	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
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	150
Completion Date	December 2011
Primary Completion Date	January 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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)
Gender	Both
Ages	18 Years to 80 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Italy

Administrative Information
NCT Number ^ICMJE	NCT01326052
Other Study ID Numbers ^ICMJE	DS-004
Has Data Monitoring Committee	No
Responsible Party	Francesco Saverio Mari, University of Roma La Sapienza
Study Sponsor ^ICMJE	University of Roma La Sapienza
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	University of Roma La Sapienza
Verification Date	June 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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