Laparoscopic Surgery for Severe Recto-vaginal Endometriosis

Recruiting

• Conditions: Endometriosis Rectovaginal Septum
• Interventions: Procedure: Surgery for severe endometriosis

• Registration Number: NCT02471443
• Lead Sponsor: Royal Surrey County Hospital NHS Foundation Trust

Brief Summary

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.

Study Timeline

• Study Start: 2004-05
• Study First Submitted: 2015-06-06
• Study First Submitted QC: 2015-06-10
• Study First Posted: 2015-06-15
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-25
• Last Update Posted: 2019-03-26
• Primary Completion: 2025-01
• Study Completion: 2040-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 1000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Surgery for severe endometriosis	Surgery for severe endometriosis	Consecutive patients undergoing excisional surgery for severe endometriosis with bowel involvement

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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
Bowel symptoms were measured using GIQLI.	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
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
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
Chronic pain measured using a visual analogue scale.	2 months, 6 months, 5 years, 10 years, 15 years, 20 years, 25 years follow up post operative

Trial Locations

Locations (1)

Royal Surrey County Hospital NHS Trust; 🇬🇧 Guildford, Surrey, United Kingdom