Mesenteric Sparing Surgery in Laparoscopic Colorectal Resection for Endometriosis

Endometriosis Clinical Trial

— IRE-1  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03565848
• Other study ID #: IRE-1
• Status: Not yet recruiting
• Start date: May 1, 2022
• Est. completion date: May 1, 2024

Study information

• Verified date: September 2021
• Source: Università degli Studi dell'Insubria
• Contact: Antonio Simone Laganà, M.D.
• Phone: 00393296279579
• Email: antoniosimone.lagana[@]asst-settelaghi.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: May 1, 2024
• Est. primary completion date: May 1, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 45 Years

Eligibility

Inclusion Criteria:

• Patients referred for bowel endometriosis requiring colorectal resection

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Bowel Endometriosis
• Constipation
• Endometriosis

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Università degli Studi dell'Insubria

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Endometriosis characteristics	rAFS classification	intraoperative
Secondary	Complication rate	Number of surgical complications (Clavien-Dindo Classification)	Within 6 months after surgery