Royal Surrey County Hospital NHS Trust
Guildford, Surrey, GU2 7XX, United Kingdom
Location status: Recruiting
Recruiting
NCT Number: NCT02471443
Laparoscopic Surgery for Severe Recto-vaginal Endometriosis
To determine the quality of life following the radical excision of recto-vaginal endometriosis.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Sex eligibility
Female
Study type
Observational
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Surgery for severe endometriosis
ProcedureConsecutive patients undergoing excisional surgery for severe endometriosis with bowel involvement
Primary outcomes
-
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
Recruitment is continuous
-
Bowel symptoms measured using the Gastro-intestinal Quality of Life Index (GIQLI).
Time frame: 1 year post operative
Recruitment is continuous
-
Dysmenorrhoea measured using a visual analogue scale (VAS).
Time frame: 1 year post operative
Recruitment is continuous
-
Dyspareunia measured using a visual analogue scale (VAS).
Time frame: 1 year post operative
Recruitment is continuous
-
Dyschezia measured using a visual analogue scale (VAS).
Time frame: 1 year post operative
Recruitment is continuous
-
Chronic pain measured using a visual analogue scale (VAS).
Time frame: 1 year post operative
Recruitment is continuous
Secondary outcomes
-
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
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Royal Surrey County Hospital NHS Foundation Trust
Other
Registry information
Official study title
Laparoscopic Surgery for Severe Recto-vaginal Endometriosis: A Prospective Cohort Study
Important dates
- Study start
- 2004
- Primary completion
- 2025
- Study completion
- 2040
- First posted
- Jun 15, 2015
- Registry last updated
- Mar 26, 2019
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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