Functional Outcomes After Nerve Sparing Surgery for Deep Endometriosis

Endometriosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03353935
• Other study ID #: 630
• Status: Completed
• Phase: N/A
• First received: November 21, 2017
• Last updated: November 21, 2017
• Start date: January 2016
• Est. completion date: March 2017

Study information

• Verified date: November 2017
• Source: Università degli Studi dell'Insubria
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Deep endometriosis

• Surgical treatment

• Single surgeon

Exclusion Criteria:

• Lost to follow-up

• unwillingness to answer the interview

Related Conditions & MeSH terms

• Endometriosis

Intervention

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.

Locations

Country	Name	City	State
Italy	Department of Obstetrics and Gynecology Universita' Dell'Insubria	Varese

Sponsors (1)

Lead Sponsor	Collaborator
Università degli Studi dell'Insubria

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pelvic function	Any change in urinary, sexual or fecal function after surgery, compared to pre-operatively	6-12 months