NCT03353935

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

November 21, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 27, 2017

Completed
Last Updated

November 27, 2017

Status Verified

November 1, 2017

Enrollment Period

1.2 years

First QC Date

November 21, 2017

Last Update Submit

November 21, 2017

Conditions

Endometriosis

Keywords

surgerypelvic function

Outcome Measures

Primary Outcomes (1)

  • Pelvic function

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

    6-12 months

Study Arms (1)

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

Interventions

Validated questionnairesOTHER

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.

NERVE SPARING

Eligibility Criteria

Age18 Years - 55 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • Deep endometriosis
  • Surgical treatment
  • Single surgeon

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Obstetrics and Gynecology Universita' Dell'Insubria

Varese, 21100, Italy

Location

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Stefano Uccella

    Università degli Studi dell'Insubria

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

November 21, 2017

First Posted

November 27, 2017

Study Start

January 1, 2016

Primary Completion

March 1, 2017

Study Completion

March 1, 2017

Last Updated

November 27, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)