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OpenTrials
Completed

NCT Number: NCT03353935

Functional Outcomes After Nerve Sparing Surgery for Deep Endometriosis

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.

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Key information

Conditions

Endometriosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Urogenital Diseases

Age range

18 year–55 year

Sex eligibility

Female

Study type

Observational

Primary location

Department of Obstetrics and Gynecology Universita' Dell'Insubria

Varese, 21100, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Deep endometriosis
  • Surgical treatment
  • Single surgeon

Exclusion criteria

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

Treatment and study plan

Validated questionnaires

Other

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.

Primary outcomes

  1. Pelvic function

    Time frame: 6-12 months

    Any change in urinary, sexual or fecal function after surgery, compared to pre-operatively

Sponsors and collaborators

Lead sponsor

Università degli Studi dell'Insubria

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Nov 27, 2017
Registry last updated
Nov 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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