Mesenteric Sparing Surgery in Laparoscopic Colorectal Resection for Endometriosis (IRE-1)

Analysis of Surgical Outcomes in Women Undergoing Mesenteric Vascular and Nerve Sparing Surgery in Laparoscopic Segmental Colorectal Resection for Deep Infiltrating Endometriosis

Colorectal resection is a standard surgical treatment of bowel deep infiltrating endometriosis (DIE). Nevertheless, concerns about different bowel functional outcomes related to radical surgery versus conservative surgery as shaving technique is a topic leading to much debate. Different surgical approach are used to perform colorectal resection and there is not a standardized technique. For the same concerns, studies have addressed the mesenteric vascular and nerve preservation both in oncological and benign intestinal disease with improved functional outcome. Therefore, the aim of this prospective study is to analyze feasibility and safety of mesenteric vascular and nerve Sparing Surgery in laparoscopic segmental colorectal resection for DIE with short and long term follow up. Women with DIE ,that underwent laparoscopic segmental colorectal resection, will undergo resection performed with inferior mesenteric artery and branching arteries preservation by dissecting adherent to the intestinal wall with mesenteric vascularization and innervation entirely preserved. Personal history, clinical data, surgical data, short and long term surgical complications and long term outcomes will be recorded. Symptoms and bowel function will be evaluated before and after surgery.

Study Overview

• Status: Not yet recruiting
• Conditions: Constipation; Endometriosis; Bowel Endometriosis
• Intervention / Treatment: Procedure: Mesenteric vascular and nerve sparing surgery in laparoscopic segmental colorectal resection

• Study Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

• Study Contact: Name: Antonio Simone Laganà, M.D.; Phone Number: 00393296279579; Email: antoniosimone.lagana@asst-settelaghi.it
• Study Contact Backup: Name: Simone Garzon; Phone Number: 00393470782287; Email: simone.garzon@univr.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Women with deep infiltrating endometriosis underwent laparoscopic surgery treatment with segmental intestinal resection.

Description

Inclusion Criteria:

• Patients referred for bowel endometriosis requiring colorectal resection

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Women underwent colorectal resection for endometriosis; Women referred for colorectal resection for deep infiltrating endometriosis that underwent laparoscopic segmental colorectal resection performed with mesenteric vascular and nerve sparing surgery.	Procedure: Mesenteric vascular and nerve sparing surgery in laparoscopic segmental colorectal resection; Laparoscopic segmental colorectal resection performed by dissecting adherent to the intestinal wall with mesenteric vascularization and innervation entirely preserved.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in endometriosis related dysmenorrhea evaluated by Numeric Rating Scale for Pain	Dysmenorrhea in 0 - 10 range according to the Numeric Rating Scale for Pain	Change from baseline dysmenorrhea at 60 days after surgery and at 1 year after surgery
Change in endometriosis related dyschezia evaluated by Numeric Rating Scale for Pain	Dyschezia in 0 - 10 range according to the Numeric Rating Scale for Pain	Change from baseline dyschezia at 60 days after surgery and at 1 year after surgery
Change in endometriosis related dyspareunia evaluated by Numeric Rating Scale for Pain	Dyspareunia in 0 - 10 range according to the Numeric Rating Scale for Pain.	Change from baseline dyspareunia at 60 days after surgery and at 1 year after surgery
Change in endometriosis related dysuria evaluated by Numeric Rating Scale for Pain	Dysuria in 0 - 10 range according to the Numeric Rating Scale for Pain.	Change from baseline dysuria at 60 days after surgery and at 1 year after surgery
Change in endometriosis related pelvic chronic pain evaluated by Numeric Rating Scale for Pain	Pelvic chronic pain in 0 - 10 range according to the Numeric Rating Scale for Pain.	Change from baseline pelvic chronic pain at 60 days after surgery and at 1 year after surgery
Change in bowel symptoms evaluated by Constipation Assessment Scale	Bowel symptoms in 0 - 16 range according to the Constipation Assessment Scale. Constipation Assessment Scale includes eight items, each of which is self-rated by the patient as 'no problem' (score of 0), 'some problem' (score of 1), or 'severe problem' (score of 2). The item ratings are then summed, so the overall score may range from 0 (no constipation) to 16 (worst possible constipation).	Change from baseline bowel symptoms at 60 days after surgery and at 2 year after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Endometriosis characteristics	rAFS classification	intraoperative
Complication rate	Number of surgical complications (Clavien-Dindo Classification)	Within 6 months after surgery

Collaborators and Investigators

• Sponsor: Università degli Studi dell'Insubria
• Investigators: Principal Investigator: Antonio Simone Laganà, M.D., Uninsubria; Principal Investigator: Paola Pomini, M.D., Universita di Verona

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): May 1, 2022
• Primary Completion (ANTICIPATED): May 1, 2023
• Study Completion (ANTICIPATED): May 1, 2024

Study Registration Dates

• First Submitted: May 30, 2018
• First Submitted That Met QC Criteria: June 11, 2018
• First Posted (ACTUAL): June 21, 2018

Study Record Updates

• Last Update Posted (ACTUAL): September 30, 2021
• Last Update Submitted That Met QC Criteria: September 28, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Constipation; Laparoscopy; Deep infiltrating endometriosis; Colorectal resection
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Endometriosis; Constipation
• Other Study ID Numbers: IRE-1

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