Functional Outcomes After Nerve Sparing Surgery for Deep Endometriosis

Completed

• Conditions: Endometriosis
• Interventions: Other: Validated questionnaires

• Registration Number: NCT03353935
• Lead Sponsor: Università degli Studi dell'Insubria

Brief Summary

Patients who underwent surgery for deep endometriosis were submitted to procedures aiming at sparing the pelvic autonomic nervous system. They were observed prospectively followed and interviewed in order to evaluate functional outcomes after surgery.

Detailed Description

Surgical tretament for deep endometriosis can produce lesions at the level of the pelvic autonomic system.

Before surgery and 3-12 months after the nerve-sparing surgical procedures, patients were assessed for urinary, sexual and fecal function, in order to evaluate whether sparing of the nerves during the intervention had a beneficial impact on post-operative pelvic function.

Study Timeline

• Study Start: 2016-01
• Primary Completion: 2017-03
• Study Completion: 2017-03
• Status Verified: 2017-11
• Study First Submitted: 2017-11-21
• Study First Submitted QC: 2017-11-21
• Last Update Submitted: 2017-11-21
• Study First Posted: 2017-11-27
• Last Update Posted: 2017-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 36

Inclusion Criteria

• Deep endometriosis
• Surgical treatment
• Single surgeon

Exclusion Criteria

• Lost to follow-up
• unwillingness to answer the interview

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
NERVE SPARING	Validated questionnaires	Patients who underwent surgery for deep endometriosis were submitted to surgical procedures aiming at sparing the pelvic ortho- and parasympathetic nerves. The subjects were then followed with interviews using validated questionnaires, to assess the possible changes in post-operative urinary sexual and fecal function.

Primary Outcome Measures

Name	Time	Method
Pelvic function	6-12 months	Any change in urinary, sexual or fecal function after surgery, compared to pre-operatively

Trial Locations

Locations (1)

Department of Obstetrics and Gynecology Universita' Dell'Insubria; 🇮🇹 Varese, Italy