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Functional Outcomes After Nerve Sparing Surgery for Deep Endometriosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03353935
Recruitment Status : Completed
First Posted : November 27, 2017
Last Update Posted : November 27, 2017
Sponsor:
Information provided by (Responsible Party):
Stefano Uccella, Università degli Studi dell'Insubria

Study Description
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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.

Condition or disease Intervention/treatment
Endometriosis 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 Design
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Study Type : Observational
Actual Enrollment : 36 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Functional Outcomes of Nerve-sparing Laparoscopic Eradication of Deep Infiltrating Endometriosis: a Prospective Analysis Using Validated Questionnaires
Actual Study Start Date : January 2016
Actual Primary Completion Date : March 2017
Actual Study Completion Date : March 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endometriosis

Groups and Cohorts
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Pelvic function [ Time Frame: 6-12 months ]
    Any change in urinary, sexual or fecal function after surgery, compared to pre-operatively


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

  • Deep endometriosis
  • Surgical treatment
  • Single surgeon

Exclusion Criteria:

  • Lost to follow-up
  • unwillingness to answer the interview
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03353935


Locations
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Italy
Department of Obstetrics and Gynecology Universita' Dell'Insubria
Varese, Italy, 21100
Sponsors and Collaborators
Università degli Studi dell'Insubria
Investigators
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Principal Investigator: Stefano Uccella Università degli Studi dell'Insubria
More Information
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Responsible Party: Stefano Uccella, Doctor, Università degli Studi dell'Insubria
ClinicalTrials.gov Identifier: NCT03353935    
Other Study ID Numbers: 630
First Posted: November 27, 2017    Key Record Dates
Last Update Posted: November 27, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Stefano Uccella, Università degli Studi dell'Insubria:
surgery
pelvic function
Additional relevant MeSH terms:
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Endometriosis