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Laparoscopic Surgery for Severe Recto-vaginal Endometriosis

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02471443
Enrollment
1000
Registered
2015-06-15
Start date
2004-05-31
Completion date
2040-01-31
Last updated
2019-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endometriosis Rectovaginal Septum

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.

Interventions

PROCEDURESurgery for severe endometriosis

Consecutive patients undergoing excisional surgery for severe endometriosis with bowel involvement

Sponsors

Royal Surrey County Hospital NHS Foundation Trust
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
Yes

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.

Design outcomes

Primary

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

Secondary

MeasureTime frame
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
Bowel symptoms were measured using GIQLI.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.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
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
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

Countries

United Kingdom

Contacts

Primary ContactAndrew Kent, TD MD FRCOG
kenta@doctors.org.uk

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026