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RecruitingNCT02471443Updated Mar 26, 2019

Laparoscopic Surgery for Severe Recto-vaginal Endometriosis

An observational study in Endometriosis Rectovaginal Septum, sponsored by Royal Surrey County Hospital NHS Foundation Trust. Recruiting at 1 site in United Kingdom. Open to female participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-03-26.

Sponsored by Royal Surrey County Hospital NHS Foundation Trust · Observational

From the registry’s dates

  • Primary completion was expected by Jan 2025, 1 year 10 months ago, but the record still lists the study as recruiting.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,000
Sex
Female
01

Study summary

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.

02

Conditions studied

  • Endometriosis Rectovaginal Septum

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03

In context

Endometriosis

920 studies on the registry are indexed under Endometriosis; 266 are open to participants now.

This study's planned enrollment of 1,000 is above the median of 135 across 349 observational studies indexed under Endometriosis.

Browse Endometriosis studies →

Lead sponsor

Royal Surrey County Hospital NHS Foundation Trust is the lead sponsor of 35 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Consecutive patients who underwent surgery for endometriosis with bowel involvement.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,000 participants (estimated)
Patient registry
No

Groups and cohorts

  • Surgery for severe endometriosis

    Consecutive patients undergoing excisional surgery for severe endometriosis with bowel involvement

    Procedure: Surgery for severe endometriosis

Interventions

  • ProcedureSurgery for severe endometriosis

    Consecutive patients undergoing excisional surgery for severe endometriosis with bowel involvement

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What researchers measure

Primary outcomes

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

    Recruitment is continuous

    Time frame: 1 year post operative

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

    Recruitment is continuous

    Time frame: 1 year post operative

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

    Recruitment is continuous

    Time frame: 1 year post operative

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

    Recruitment is continuous

    Time frame: 1 year post operative

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

    Recruitment is continuous

    Time frame: 1 year post operative

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

    Recruitment is continuous

    Time frame: 1 year post operative

Secondary outcomes

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

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

  2. Bowel symptoms were measured using GIQLI.

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

  3. Dysmenorrhoea measured using a visual analogue scale.

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

  4. Dyspareunia measured using a visual analogue scale.

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

  5. Dyschezia measured using a visual analogue scale.

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

  6. Chronic pain measured using a visual analogue scale.

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

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Study locations

1 of 1 sites recruiting
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 26, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02471443
Lead sponsor
Royal Surrey County Hospital NHS Foundation Trust
Responsible party
Mr Andrew Kent (Consultant Gynaecologist, Royal Surrey County Hospital NHS Foundation Trust) — Principal investigator
First posted
Jun 15, 2015
Start date
May 2004
Primary completion
Jan 2025 (estimated)
Completion
Jan 2040 (estimated)
Last update
Mar 26, 2019

Study contacts

Andrew Kent, TD MD FRCOG
Contact
kenta@doctors.org.uk
Andrew Kent, TD MD FRCOG
principal investigator · Royal Surrey County Hospital/Nuffield Health Guildford Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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