Functional Outcomes After Nerve Sparing Surgery for Deep Endometriosis

Functional Outcomes of Nerve-sparing Laparoscopic Eradication of Deep Infiltrating Endometriosis: a Prospective Analysis Using Validated Questionnaires

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.

Study Overview

• Status: Completed
• Conditions: Endometriosis
• Intervention / Treatment: Other: Validated questionnaires

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 Type: Observational
• Enrollment (Actual): 36

Contacts and Locations

Study Locations

• Italy
  • Varese, Italy, 21100
    • Department of Obstetrics and Gynecology Universita' Dell'Insubria

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

All patients undergoimg nerve-sparing surgery for deep endometriosis were enrolled if they were operated by a single surgeon with extensive background in minimally-invasive pelvic surgery.

Description

Inclusion Criteria:

• Deep endometriosis
• Surgical treatment
• Single surgeon

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
NERVE SPARING; 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.	Other: Validated questionnaires; Patients were administered pre- and post-operatively the three validated questionnaires ((FSFI, ICIQ-UI short form Italian, NBD score) investigating sexual, urinary, and fecal function, respectively.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pelvic function	Any change in urinary, sexual or fecal function after surgery, compared to pre-operatively	6-12 months

Collaborators and Investigators

• Sponsor: Università degli Studi dell'Insubria
• Investigators: Principal Investigator: Stefano Uccella, Università degli Studi dell'Insubria

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): March 1, 2017
• Study Completion (Actual): March 1, 2017

Study Registration Dates

• First Submitted: November 21, 2017
• First Submitted That Met QC Criteria: November 21, 2017
• First Posted (Actual): November 27, 2017

Study Record Updates

• Last Update Posted (Actual): November 27, 2017
• Last Update Submitted That Met QC Criteria: November 21, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: surgery; pelvic function
• Additional Relevant MeSH Terms: Endometriosis
• Other Study ID Numbers: 630

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No