Laparoscopic Surgery for Severe Recto-vaginal Endometriosis

Recruiting

• Conditions: Endometriosis Rectovaginal Septum

• 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

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