Effects of Inferior Mesenteric Artery Preservation in Laparoscopic Colorectal Resection for Diverticular Disease.

Not Applicable

Completed

• Conditions: Colonic Diverticuar Disease; Defecatory Functions; Fecal Incontinence; Constipation

• Registration Number: NCT06506552
• Lead Sponsor: University of Roma La Sapienza

Brief Summary

This is a prospective randomized study aimed to verifying the short and long-term results of inferior mesenteric artery preservation following colorectal resection for diverticular disease

Detailed Description

This study wants to demonstrate that the preservation of the inferior mesenteric artery allow to improve postoperative defecatory function and improve patient\'s quality of life.

Study Timeline

• Study Start: 2012-01-01
• Primary Completion: 2024-01-15
• Study Completion: 2024-01-20
• Status Verified: 2024-07
• Study First Submitted: 2024-07-11
• Study First Submitted QC: 2024-07-11
• Study First Posted: 2024-07-17
• Last Update Submitted: 2024-07-21
• Last Update Posted: 2024-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• BMI < 35
• ASA I-III
• Hinchey I-III

Exclusion Criteria

• BMI > 35
• ASA IV
• Hinchey IV
• Previous procedures that could have been modified the nervous mesenteric pattern (surgery, radiotherapy or chemotherapy)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Defecatory disorders	6 years from surgery	the presence of defecatory disorders was evaluated (Costipation, Evacuation frequency,evacuation urgency, fragmented evacuation,flatus incontinence, liquid incontinence)

Secondary Outcome Measures

Name	Time	Method
Postoperative surgical complication	1 month from surgery	The incidence of postoperative surgical complications was evaluated
Constipation	6 years from surgery	The incidence and severity of postoperative constipation was evaluated with Cleveland Clinic Constipation Score ( score range from 0 to 30, the higher score defines worse constipation status)
Incontinence	6 years from surgery	The presence of fecal incontinence was evaluated with Cleveland Clinic Incontinence Score( score ranges from 0 to 20, the higher score defines worse symptoms)
Anorectal Muscles function	6 years from surgery	the anorectal muscles function was evaluated with anorectal manometry ( sphincter lenght, maximum squeeze pression, resting anal pressure, squeeze duration, maximum pressure sustained)
Postoperative quality of life	6 years from surgery	The postoperative QOL was evaluated with SF-36 score (Short form-36 score, each item scored from 0 to 100, the higher scores defines a favorable health state)