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

Inferior Mesenteric Artery Preservation in Laparoscopic Colorectal Resection for Diverticular Disease; Short and Long Term Effects in Defecatory Function

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

Study Overview

• Status: Completed
• Conditions: Constipation; Fecal Incontinence; Colonic Diverticuar Disease; Defecatory Functions
• Intervention / Treatment: Procedure: IMA preserving; Procedure: IMA sectioning

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 Type: Interventional
• Enrollment (Actual): 300
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Inferior mesenteric artery preservation; Performing colorectal resection for diverticular disease the IMA was preserved ligating the sigmoids arteries close to colonic wall.	Procedure: IMA preserving; Performing left hemicolectomy, sigmoidectomy or rectal resection the IMA was preserved ligating the sigmoids arteries close to the colonic wall
Active Comparator: Inferior mesenteric ligation; Performing colorectal resection the IMA was sectioned just below the origin of left colic artery.	Procedure: IMA sectioning; Performing left emicolectomy, sigmoidectomy or rectal resection the IMA is sectioned after the origin of left colic artery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Defecatory disorders	the presence of defecatory disorders was evaluated (Costipation, Evacuation frequency,evacuation urgency, fragmented evacuation,flatus incontinence, liquid incontinence)	6 months from surgery
Defecatory disorders	the presence of defecatory disorders was evaluated (Costipation, Evacuation frequency,evacuation urgency, fragmented evacuation,flatus incontinence, liquid incontinence)	12 months from surgery
Defecatory disorders	the presence of defecatory disorders was evaluated (Costipation, Evacuation frequency,evacuation urgency, fragmented evacuation,flatus incontinence, liquid incontinence)	6 years from surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Constipation	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)	6 months from surgery
Constipation	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)	12 months from surgery
Constipation	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)	6 years from surgery
Incontinence	The presence of fecal incontinence was evaluated with Cleveland Clinic Incontinence Score( score range from 0 to 20, the higher score defines worse symptoms)	6 months from surgery
Incontinence	The presence of fecal incontinence was evaluated with Cleveland Clinic Incontinence Score( score range from 0 to 20, the higher score defines worse symptoms)	12 months from surgery
Incontinence	The presence of fecal incontinence was evaluated with Cleveland Clinic Incontinence Score( score ranges from 0 to 20, the higher score defines worse symptoms)	6 years from surgery
Anorectal Muscles function	The anorectal muscles function was evaluated with anorectal manometry( sphincter lenght, maximum squeeze pression, resting anal pressure, squeeze duration, maximum pressure sustained)	6 months from surgery
Anorectal Muscles function	the anorectal muscles function was evaluated with anorectal manometry ( sphincter lenght, maximum squeeze pression, resting anal pressure, squeeze duration, maximum pressure sustained)	6 years from surgery
Postoperative quality of life	the postoperative QOL(quality of life) was evaluated with EORTC-30 tests( European organization for research and treatment of cancer, scores range from 0 to 100; a higher score represents a higher ("better") level of functioning, or a higher ("worse") level of symptoms)	6 months from surgery
Postoperative quality of life	the postoperative QOL was evaluated with EORTC-30 tests( European organization for research and treatment of cancer,scores range from 0 to 100; a higher score represents a higher "better" level of functioning, or a higher "worse" level of symptoms	12 months from surgery
Postoperative quality of life	The postoperative QOL was evaluated with EORTC-30 tests( European organization for research and treatment of cancer,scores range from 0 to 100; a higher score represents a higher "better" level of functioning, or a higher "worse" level of symptoms)	6 years from surgery
Postoperative quality of life	The postoperative QOL was evaluated with EORTC-29 tests (European organization for research and treatment of cancer each question goes from 1 to 4 , the higher score defines worse symptoms)	12 months from surgery
Postoperative quality of life	The postoperative QOL was evaluated with EORTC-29 tests (European organization for research and treatment of cancer each question goes from 1 to 4 , the higher score defines worse symptoms)	6 years from surgery
Postoperative quality of life	The postoperative QOL was evaluated with EORTC-29 tests (European organization for research and treatment of cancer each question goes from 1 to 4 , the higher score defines worse symptoms)	6 months from surgery
Postoperative quality of life	The postoperative QOL(quality of life) 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)	6 months from surgery
Postoperative quality of life	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)	12 months from surgery
Postoperative quality of life	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)	6 years from surgery
Postoperative surgical complication	The incidence of postoperative surgical complications was evaluated	1 month from surgery

Collaborators and Investigators

• Sponsor: University of Roma La Sapienza

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2012
• Primary Completion (Actual): January 15, 2024
• Study Completion (Actual): January 20, 2024

Study Registration Dates

• First Submitted: July 11, 2024
• First Submitted That Met QC Criteria: July 11, 2024
• First Posted (Actual): July 17, 2024

Study Record Updates

• Last Update Posted (Actual): July 23, 2024
• Last Update Submitted That Met QC Criteria: July 21, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: constipation; fecal incontinence; diverticular disease; anterior resection syndrome; defecatory function; fragmented evacuation
• Additional Relevant MeSH Terms: Digestive System Diseases; Signs and Symptoms, Digestive; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Pathological Conditions, Anatomical; Rectal Diseases; Constipation; Fecal Incontinence; Diverticulum; Diverticular Diseases
• Other Study ID Numbers: DS-056

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No