Clinical trial NCT02471443: Laparoscopic Surgery for Severe Recto-vaginal Endometriosis
Official title: Laparoscopic Surgery for Severe Recto-vaginal Endometriosis: A Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Endometriosis Rectovaginal Septum
Lead sponsor: Royal Surrey County Hospital NHS Foundation Trust
Sponsor class: OTHER
First posted: 2015-06-15
Enrollment: 1000
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive patients who underwent surgery for endometriosis with bowel involvement.

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.

Eligibility 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.

Primary outcomes:
measure: Quality of life measured using the Endometriosis Health Profile 30 (EHP-30) and EuroQol-5 dimension (EQ-5D) questionnaires.
timeFrame: 1 year post operative
measure: Bowel symptoms measured using the Gastro-intestinal Quality of Life Index (GIQLI).
timeFrame: 1 year post operative
measure: Dysmenorrhoea measured using a visual analogue scale (VAS).
timeFrame: 1 year post operative
measure: Dyspareunia measured using a visual analogue scale (VAS).
timeFrame: 1 year post operative
measure: Dyschezia measured using a visual analogue scale (VAS).
timeFrame: 1 year post operative
measure: Chronic pain measured using a visual analogue scale (VAS).
timeFrame: 1 year post operative
Secondary outcomes:
measure: Quality of life measured using the EHP-30 and EQ-5D questionnaires.
timeFrame: 2 months, 6 months, 5 years, 10 years, 15 years, 20 years, 25 years follow up post operative
measure: Bowel symptoms were measured using GIQLI.
timeFrame: 2 months, 6 months, 5 years, 10 years, 15 years, 20 years, 25 years follow up post operative
measure: Dysmenorrhoea measured using a visual analogue scale.
timeFrame: 2 months, 6 months, 5 years, 10 years, 15 years, 20 years, 25 years follow up post operative
measure: Dyspareunia measured using a visual analogue scale.
timeFrame: 2 months, 6 months, 5 years, 10 years, 15 years, 20 years, 25 years follow up post operative
measure: Dyschezia measured using a visual analogue scale.
timeFrame: 2 months, 6 months, 5 years, 10 years, 15 years, 20 years, 25 years follow up post operative
measure: Chronic pain measured using a visual analogue scale.
timeFrame: 2 months, 6 months, 5 years, 10 years, 15 years, 20 years, 25 years follow up post operative
Other outcomes:
Locations:
city: Guildford
country: United Kingdom
facility: Royal Surrey County Hospital NHS Trust
state: Surrey
Study officials:
affiliation: Royal Surrey County Hospital/Nuffield Health Guildford Hospital
name: Andrew Kent, TD MD FRCOG
role: PRINCIPAL_INVESTIGATOR
References: