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Laparoscopic Surgery for Severe Recto-vaginal Endometriosis

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ClinicalTrials.gov Identifier: NCT02471443
Recruitment Status : Recruiting
First Posted : June 15, 2015
Last Update Posted : March 26, 2019
Sponsor:
Information provided by (Responsible Party):
Mr Andrew Kent, Royal Surrey County Hospital NHS Foundation Trust

Study Description
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Brief Summary:
To determine the quality of life following the radical excision of recto-vaginal endometriosis.

Condition or disease Intervention/treatment
Endometriosis Rectovaginal Septum Procedure: Surgery for severe 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.

Study Design
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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Laparoscopic Surgery for Severe Recto-vaginal Endometriosis: A Prospective Cohort Study
Study Start Date : May 2004
Estimated Primary Completion Date : January 2025
Estimated Study Completion Date : January 2040

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endometriosis

Groups and Cohorts
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Group/Cohort Intervention/treatment
Surgery for severe endometriosis
Consecutive patients undergoing excisional surgery for severe endometriosis with bowel involvement
 Procedure: Surgery for severe endometriosis
Consecutive patients undergoing excisional surgery for severe endometriosis with bowel involvement


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. Bowel symptoms measured using the Gastro-intestinal Quality of Life Index (GIQLI). [ Time Frame: 1 year post operative ]
    Recruitment is continuous

  3. Dysmenorrhoea measured using a visual analogue scale (VAS). [ Time Frame: 1 year post operative ]
    Recruitment is continuous

  4. Dyspareunia measured using a visual analogue scale (VAS). [ Time Frame: 1 year post operative ]
    Recruitment is continuous

  5. Dyschezia measured using a visual analogue scale (VAS). [ Time Frame: 1 year post operative ]
    Recruitment is continuous

  6. Chronic pain measured using a visual analogue scale (VAS). [ Time Frame: 1 year post operative ]
    Recruitment is continuous


Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. 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 ]
  6. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Consecutive patients who underwent surgery for endometriosis with bowel involvement.
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02471443


Contacts
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Contact: Andrew Kent, TD MD FRCOG kenta@doctors.org.uk

Locations
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United Kingdom
Royal Surrey County Hospital NHS Trust Recruiting
Guildford, Surrey, United Kingdom, GU2 7XX
Contact: Andrew Kent, TD MD FRCOG       kenta@doctors.org.uk   
Sponsors and Collaborators
Royal Surrey County Hospital NHS Foundation Trust
Investigators
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Principal Investigator: Andrew Kent, TD MD FRCOG Royal Surrey County Hospital/Nuffield Health Guildford Hospital
More Information
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Responsible Party: Mr Andrew Kent, Consultant Gynaecologist, Royal Surrey County Hospital NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02471443    
Other Study ID Numbers: 15DEV0009
First Posted: June 15, 2015    Key Record Dates
Last Update Posted: March 26, 2019
Last Verified: March 2019
Additional relevant MeSH terms:
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Endometriosis
Genital Diseases, Female
Female Urogenital Diseases
 Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Genital Diseases