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Recruiting NCT02471443

Laparoscopic Surgery for Severe Recto-vaginal Endometriosis

Observational Endometriosis Rectovaginal Septum

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Surgery for severe endometriosis.
Who it may be relevant to
Registry conditions: Endometriosis Rectovaginal Septum. Basic parameters: No limits · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United Kingdom
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

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.

Interventions

  • Procedure Surgery for severe endometriosis
    Consecutive patients undergoing excisional surgery for severe endometriosis with bowel involvement

Primary outcome measures

  • Quality of life measured using the Endometriosis Health Profile 30 (EHP-30) and EuroQol-5 dimension (EQ-5D) questionnaires. [Time frame: 1 year post operative]
  • Bowel symptoms measured using the Gastro-intestinal Quality of Life Index (GIQLI). [Time frame: 1 year post operative]
  • Dysmenorrhoea measured using a visual analogue scale (VAS). [Time frame: 1 year post operative]
  • Dyspareunia measured using a visual analogue scale (VAS). [Time frame: 1 year post operative]
  • Dyschezia measured using a visual analogue scale (VAS). [Time frame: 1 year post operative]
  • Chronic pain measured using a visual analogue scale (VAS). [Time frame: 1 year post operative]
Secondary outcome measures (6)
  • 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]
  • 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]
  • 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]
  • 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]
  • 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]
  • 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]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

United Kingdom · 1 center
  • Royal Surrey County Hospital NHS Trust — Guildford

Identifiers

NCT: NCT02471443 · 15DEV0009

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗