Mesenteric Sparing Surgery in Laparoscopic Colorectal Resection for Endometriosis

• Conditions: Constipation; Bowel Endometriosis; Endometriosis
• Interventions: Procedure: Mesenteric vascular and nerve sparing surgery in laparoscopic segmental colorectal resection

• Registration Number: NCT03565848
• Lead Sponsor: Università degli Studi dell'Insubria

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-05-30
• Study First Submitted QC: 2018-06-11
• Study First Posted: 2018-06-21
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-28
• Last Update Posted: 2021-09-30
• Study Start: 2022-05-01
• Primary Completion: 2023-05-01
• Study Completion: 2024-05-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

• Patients referred for bowel endometriosis requiring colorectal resection

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Women underwent colorectal resection for endometriosis	Mesenteric vascular and nerve sparing surgery in laparoscopic segmental colorectal resection	Women referred for colorectal resection for deep infiltrating endometriosis that underwent laparoscopic segmental colorectal resection performed with mesenteric vascular and nerve sparing surgery.

Primary Outcome Measures

Name	Time	Method
Change in endometriosis related dyschezia evaluated by Numeric Rating Scale for Pain	Change from baseline dyschezia at 60 days after surgery and at 1 year after surgery	Dyschezia in 0 - 10 range according to the Numeric Rating Scale for Pain
Change in endometriosis related dysuria evaluated by Numeric Rating Scale for Pain	Change from baseline dysuria at 60 days after surgery and at 1 year after surgery	Dysuria in 0 - 10 range according to the Numeric Rating Scale for Pain.
Change in bowel symptoms evaluated by Constipation Assessment Scale	Change from baseline bowel symptoms at 60 days after surgery and at 2 year after surgery	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 in endometriosis related dysmenorrhea evaluated by Numeric Rating Scale for Pain	Change from baseline dysmenorrhea at 60 days after surgery and at 1 year after surgery	Dysmenorrhea in 0 - 10 range according to the Numeric Rating Scale for Pain
Change in endometriosis related dyspareunia evaluated by Numeric Rating Scale for Pain	Change from baseline dyspareunia at 60 days after surgery and at 1 year after surgery	Dyspareunia in 0 - 10 range according to the Numeric Rating Scale for Pain.
Change in endometriosis related pelvic chronic pain evaluated by Numeric Rating Scale for Pain	Change from baseline pelvic chronic pain at 60 days after surgery and at 1 year after surgery	Pelvic chronic pain in 0 - 10 range according to the Numeric Rating Scale for Pain.

Secondary Outcome Measures

Name	Time	Method
Endometriosis characteristics	intraoperative	rAFS classification
Complication rate	Within 6 months after surgery	Number of surgical complications (Clavien-Dindo Classification)