Mesenteric Sparing Surgery in Laparoscopic Colorectal Resection for Endometriosis

NCT ID: NCT03565848

Last Updated: 2021-09-30

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-05-01
• Study Completion Date: 2024-05-01

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.

Conditions

Endometriosis; Bowel Endometriosis; Constipation

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Mesenteric vascular and nerve sparing surgery in laparoscopic segmental colorectal resection

Intervention Type: PROCEDURE

Laparoscopic segmental colorectal resection performed by dissecting adherent to the intestinal wall with mesenteric vascularization and innervation entirely preserved.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Patients referred for bowel endometriosis requiring colorectal resection

Exclusion Criteria

• None

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Università degli Studi dell'Insubria

OTHER

Sponsor Role: lead

Responsible Party

Antonio Simone Laganà

Medical Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Simone Garzon, M.D.

Role: PRINCIPAL_INVESTIGATOR

Universita di Verona

Antonio Simone Laganà, M.D.

Role: PRINCIPAL_INVESTIGATOR

Uninsubria

Paola Pomini, M.D.

Role: PRINCIPAL_INVESTIGATOR

Universita di Verona

Massimo Franchi, M.D.

Role: PRINCIPAL_INVESTIGATOR

Universita di Verona

Central Contacts

Antonio Simone Laganà, M.D.

Role: CONTACT

antoniosimone.lagana@asst-settelaghi.it

00393296279579

Simone Garzon

Role: CONTACT

simone.garzon@univr.it

00393470782287

Other Identifiers

IRE-1

Identifier Type: -

Identifier Source: org_study_id