NCT02471443

Brief Summary

To determine the quality of life following the radical excision of recto-vaginal endometriosis.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
166mo left

Started May 2004

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress62%
May 2004Jan 2040

Study Start

First participant enrolled

May 1, 2004

Completed
11.1 years until next milestone

First Submitted

Initial submission to the registry

June 6, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 15, 2015

Completed
9.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
15 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2040

Expected
Last Updated

March 26, 2019

Status Verified

March 1, 2019

Enrollment Period

20.7 years

First QC Date

June 6, 2015

Last Update Submit

March 25, 2019

Conditions

Endometriosis Rectovaginal Septum

Outcome Measures

Primary Outcomes (6)

  • Quality of life measured using the Endometriosis Health Profile 30 (EHP-30) and EuroQol-5 dimension (EQ-5D) questionnaires.

    Recruitment is continuous

    1 year post operative

  • Bowel symptoms measured using the Gastro-intestinal Quality of Life Index (GIQLI).

    Recruitment is continuous

    1 year post operative

  • Dysmenorrhoea measured using a visual analogue scale (VAS).

    Recruitment is continuous

    1 year post operative

  • Dyspareunia measured using a visual analogue scale (VAS).

    Recruitment is continuous

    1 year post operative

  • Dyschezia measured using a visual analogue scale (VAS).

    Recruitment is continuous

    1 year post operative

  • Chronic pain measured using a visual analogue scale (VAS).

    Recruitment is continuous

    1 year post operative

Secondary Outcomes (6)

  • Quality of life measured using the EHP-30 and EQ-5D questionnaires.

    2 months, 6 months, 5 years, 10 years, 15 years, 20 years, 25 years follow up post operative

  • Bowel symptoms were measured using GIQLI.

    2 months, 6 months, 5 years, 10 years, 15 years, 20 years, 25 years follow up post operative

  • Dysmenorrhoea measured using a visual analogue scale.

    2 months, 6 months, 5 years, 10 years, 15 years, 20 years, 25 years follow up post operative

  • Dyspareunia measured using a visual analogue scale.

    2 months, 6 months, 5 years, 10 years, 15 years, 20 years, 25 years follow up post operative

  • Dyschezia measured using a visual analogue scale.

    2 months, 6 months, 5 years, 10 years, 15 years, 20 years, 25 years follow up post operative

  • +1 more secondary outcomes

Study Arms (1)

Surgery for severe endometriosis

Consecutive patients undergoing excisional surgery for severe endometriosis with bowel involvement

Procedure: Surgery for severe endometriosis

Interventions

Surgery for severe endometriosisPROCEDURE

Consecutive patients undergoing excisional surgery for severe endometriosis with bowel involvement

Surgery for severe endometriosis

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Consecutive patients who underwent surgery for endometriosis with bowel involvement.

You may qualify if:

  • All women undergoing planned surgery for severe endometriosis with bowel involvement.

You may not qualify if:

  • Patients who declined to complete questionnaires for whatever reason and/or have their anonymous data analysed.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Surrey County Hospital NHS Trust

Guildford, Surrey, GU2 7XX, United Kingdom

RECRUITING

MeSH Terms

Interventions

Surgical Procedures, Operative

Study Officials

  • Andrew Kent, TD MD FRCOG

    Royal Surrey County Hospital/Nuffield Health Guildford Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrew Kent, TD MD FRCOG

CONTACT

kenta@doctors.org.uk

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant Gynaecologist

Study Record Dates

First Submitted

June 6, 2015

First Posted

June 15, 2015

Study Start

May 1, 2004

Primary Completion

January 1, 2025

Study Completion (Estimated)

January 1, 2040

Last Updated

March 26, 2019

Record last verified: 2019-03

Locations

GB(1)