Laparoscopic Surgery for Severe Recto-vaginal Endometriosis

Endometriosis Rectovaginal Septum Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02471443
• Other study ID #: 15DEV0009
• Status: Recruiting
• Start date: May 2004
• Est. completion date: January 2040

Study information

• Verified date: March 2019
• Source: Royal Surrey County Hospital
• Contact: Andrew Kent, TD MD FRCOG
• Email: kenta[@]doctors.org.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: January 2040
• Est. primary completion date: January 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Endometriosis
• Endometriosis Rectovaginal Septum

Intervention

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

Locations

Country	Name	City	State
United Kingdom	Royal Surrey County Hospital NHS Trust	Guildford	Surrey

Sponsors (1)

Lead Sponsor	Collaborator
Royal Surrey County Hospital

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life measured using the Endometriosis Health Profile 30 (EHP-30) and EuroQol-5 dimension (EQ-5D) questionnaires.	Recruitment is continuous	1 year post operative
Primary	Bowel symptoms measured using the Gastro-intestinal Quality of Life Index (GIQLI).	Recruitment is continuous	1 year post operative
Primary	Dysmenorrhoea measured using a visual analogue scale (VAS).	Recruitment is continuous	1 year post operative
Primary	Dyspareunia measured using a visual analogue scale (VAS).	Recruitment is continuous	1 year post operative
Primary	Dyschezia measured using a visual analogue scale (VAS).	Recruitment is continuous	1 year post operative
Primary	Chronic pain measured using a visual analogue scale (VAS).	Recruitment is continuous	1 year post operative
Secondary	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
Secondary	Bowel symptoms were measured using GIQLI.		2 months, 6 months, 5 years, 10 years, 15 years, 20 years, 25 years follow up post operative
Secondary	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
Secondary	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
Secondary	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
Secondary	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