Endometriosis Rectovaginal SeptumNCT02471443

Laparoscopic Surgery for Severe Recto-vaginal Endometriosis

An observational study of Endometriosis Rectovaginal Septum, run by Royal Surrey County Hospital NHS Foundation Trust at 1 site in United Kingdom.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

To determine the quality of life following the radical excision of recto-vaginal endometriosis. Read more about this study

Who is it for?: Any age, women onlyHealthy volunteers can take part
Conditions the study is for: Endometriosis Rectovaginal Septum
What is being tested?: Surgery for severe endometriosis
Type of treatment: Surgery or procedure
How many people: 1,000 participants
Where: 1 siteUnited Kingdom
Study dates: May 2004to Jan 2040
Phase: Observational

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
Women only
Healthy volunteers accepted
Child, Adult, Older adult

Study population: Consecutive patients who underwent surgery for endometriosis with bowel involvement.

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Andrew Kent, TD MD FRCOG contact

kenta@doctors.org.uk

United Kingdom1 site, 1 recruiting

Royal Surrey County Hospital NHS Trust
Guildford, Surrey, GU2 7XX
Andrew Kent, TD MD FRCOG, kenta@doctors.org.uk
Recruiting

Other trials in United Kingdom

About this study

Official title: Laparoscopic Surgery for Severe Recto-vaginal Endometriosis: A Prospective Cohort Study

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

Read the detailed description

Patients undergoing surgery for severe endometriosis with bowel involvement were asked to complete pre-operative and post operative questionnaires at 2, 6 and 12 months, then 5, 10, 15, 20 and 25 years post operatively.

Quality of life measured using the EHP-30 and EQ-5D questionnaires. Bowel symptoms were measured using GIQLI. Dysmenorrhoea, dyspareunia, dyschezia and chronic pain were measured using a visual analogue scale.

Conditions: Endometriosis Rectovaginal Septum
Being tested: Surgery for severe endometriosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Surgery for severe endometriosisProcedure or surgery
Consecutive patients undergoing excisional surgery for severe endometriosis with bowel involvement

Study groups in NCT02471443
Study group	Role	What they receive
Surgery for severe endometriosis		Consecutive patients undergoing excisional surgery for severe endometriosis with bowel involvement Receives: Procedure: Surgery for severe endometriosis

What is being measured

The primary outcome is the main question the study is designed to answer.

Quality of life measured using the Endometriosis Health Profile 30 (EHP-30) and EuroQol-5 dimension (EQ-5D) questionnaires.
Recruitment is continuous
Measured: 1 year post operative
Bowel symptoms measured using the Gastro-intestinal Quality of Life Index (GIQLI).
Recruitment is continuous
Measured: 1 year post operative
Dysmenorrhoea measured using a visual analogue scale (VAS).
Recruitment is continuous
Measured: 1 year post operative
Dyspareunia measured using a visual analogue scale (VAS).
Recruitment is continuous
Measured: 1 year post operative
Dyschezia measured using a visual analogue scale (VAS).
Recruitment is continuous
Measured: 1 year post operative
Chronic pain measured using a visual analogue scale (VAS).
Recruitment is continuous
Measured: 1 year post operative

Secondary outcomes (6)

Quality of life measured using the EHP-30 and EQ-5D questionnaires.
Measured: 2 months, 6 months, 5 years, 10 years, 15 years, 20 years, 25 years follow up post operative
Bowel symptoms were measured using GIQLI.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 2 months, 6 months, 5 years, 10 years, 15 years, 20 years, 25 years follow up post operative
Chronic pain measured using a visual analogue scale.
Measured: 2 months, 6 months, 5 years, 10 years, 15 years, 20 years, 25 years follow up post operative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2004Jan 2040

First posted15 Jun 2015 (estimated)
Study startMay 2004
Primary completionJan 2025 (estimated)
Study completionJan 2040 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Endometriosis Rectovaginal SeptumStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 1,000 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02471443
Sponsor's protocol ID: 15DEV0009
Status last verified: Mar 2019
First submitted: 6 Jun 2015
Last updated: 26 Mar 2019
Results posted: No
Data monitoring committee: Yes