Laparoscopic Surgery for Severe Recto-vaginal Endometriosis

NCT ID: NCT02471443

Last Updated: 2019-03-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-05-31

Study Completion Date

2040-01-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Endometriosis Rectovaginal Septum

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Surgery for severe endometriosis

Consecutive patients undergoing excisional surgery for severe endometriosis with bowel involvement

Surgery for severe endometriosis

Intervention Type PROCEDURE

Consecutive patients undergoing excisional surgery for severe endometriosis with bowel involvement

Interventions

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Surgery for severe endometriosis

Consecutive patients undergoing excisional surgery for severe endometriosis with bowel involvement

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Royal Surrey County Hospital NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Mr Andrew Kent

Consultant Gynaecologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andrew Kent, TD MD FRCOG

Role: PRINCIPAL_INVESTIGATOR

Royal Surrey County Hospital/Nuffield Health Guildford Hospital

Locations

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Royal Surrey County Hospital NHS Trust

Guildford, Surrey, United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Andrew Kent, TD MD FRCOG

Role: CONTACT

Facility Contacts

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Andrew Kent, TD MD FRCOG

Role: primary

Other Identifiers

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15DEV0009

Identifier Type: -

Identifier Source: org_study_id

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