Endometriosis Rectovaginal Septum Clinical Trial
Official title:
Laparoscopic Surgery for Severe Recto-vaginal Endometriosis: A Prospective Cohort Study
NCT number | NCT02471443 |
Other study ID # | 15DEV0009 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | May 2004 |
Est. completion date | January 2040 |
To determine the quality of life following the radical excision of recto-vaginal endometriosis.
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. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Royal Surrey County Hospital NHS Trust | Guildford | Surrey |
Lead Sponsor | Collaborator |
---|---|
Royal Surrey County Hospital |
United Kingdom,
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 |
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