Endometriosis Rectovaginal SeptumNCT02471443
Laparoscopic Surgery for Severe Recto-vaginal Endometriosis
An observational study of Endometriosis Rectovaginal Septum, run by Royal Surrey County Hospital NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
To determine the quality of life following the radical excision of recto-vaginal endometriosis. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Endometriosis Rectovaginal Septum
- What is being tested?
- Surgery for severe endometriosis
- Type of treatment
- Surgery or procedure
- How many people
- 1,000 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2004to Jan 2040
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Consecutive patients who underwent surgery for endometriosis with bowel involvement.
Who may be able to join
- All women undergoing planned surgery for severe endometriosis with bowel involvement.
Who cannot join
- Patients who declined to complete questionnaires for whatever reason and/or have their anonymous data analysed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Andrew Kent, TD MD FRCOG contact
United Kingdom1 site, 1 recruiting
- Recruiting
Royal Surrey County Hospital NHS Trust
Guildford, Surrey, GU2 7XX
Andrew Kent, TD MD FRCOG, kenta@doctors.org.uk
About this study
Official title: Laparoscopic Surgery for Severe Recto-vaginal Endometriosis: A Prospective Cohort Study
To determine the quality of life following the radical excision of recto-vaginal endometriosis.
Read the 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.
- Conditions
- Endometriosis Rectovaginal Septum
- Being tested
- Surgery for severe endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgery for severe endometriosisProcedure or surgery
Consecutive patients undergoing excisional surgery for severe endometriosis with bowel involvement
| Study group | Role | What they receive |
|---|---|---|
| Surgery for severe endometriosis | Consecutive patients undergoing excisional surgery for severe endometriosis with bowel involvement Receives: Procedure: Surgery for severe endometriosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life measured using the Endometriosis Health Profile 30 (EHP-30) and EuroQol-5 dimension (EQ-5D) questionnaires.
Recruitment is continuous
Measured: 1 year post operative
Bowel symptoms measured using the Gastro-intestinal Quality of Life Index (GIQLI).
Recruitment is continuous
Measured: 1 year post operative
Dysmenorrhoea measured using a visual analogue scale (VAS).
Recruitment is continuous
Measured: 1 year post operative
Dyspareunia measured using a visual analogue scale (VAS).
Recruitment is continuous
Measured: 1 year post operative
Dyschezia measured using a visual analogue scale (VAS).
Recruitment is continuous
Measured: 1 year post operative
Chronic pain measured using a visual analogue scale (VAS).
Recruitment is continuous
Measured: 1 year post operative
Secondary outcomes (6)
Quality of life measured using the EHP-30 and EQ-5D questionnaires.
Measured: 2 months, 6 months, 5 years, 10 years, 15 years, 20 years, 25 years follow up post operative
Bowel symptoms were measured using GIQLI.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 2 months, 6 months, 5 years, 10 years, 15 years, 20 years, 25 years follow up post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2015 (estimated)
- Study startMay 2004
- Primary completionJan 2025 (estimated)
- Study completionJan 2040 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometriosis Rectovaginal SeptumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Surrey County Hospital NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mr Andrew Kent, Royal Surrey County Hospital NHS Foundation Trust
- Investigators
- Andrew Kent, TD MD FRCOG, Principal investigator, Royal Surrey County Hospital/Nuffield Health Guildford Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02471443
- Sponsor's protocol ID
- 15DEV0009
- Status last verified
- Mar 2019
- First submitted
- 6 Jun 2015
- Last updated
- 26 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Surgery for Severe Recto-vaginal Endometriosis: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT02471443
- Acronym / sponsor ID
- 15DEV0009
- Conditions
- Endometriosis Rectovaginal Septum
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Royal Surrey County Hospital NHS Foundation TrustUniversity, hospital or other
- Study start
- May 2004
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Jan 2040 (estimated)
- First posted
- 15 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgery for severe endometriosis | – | Procedure: Surgery for severe endometriosisConsecutive patients undergoing excisional surgery for severe endometriosis with bowel involvement |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Consecutive patients who underwent surgery for endometriosis with bowel involvement.
Key inclusion criteria (1 listed)
- All women undergoing planned surgery for severe endometriosis with bowel involvement.
Key exclusion criteria (1 listed)
- Patients who declined to complete questionnaires for whatever reason and/or have their anonymous data analysed.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgery for severe endometriosisConsecutive patients undergoing excisional surgery for severe endometriosis with bowel involvement | Procedure or surgery | Surgery for severe endometriosis |
Primary outcome
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
Bowel symptoms measured using the Gastro-intestinal Quality of Life Index (GIQLI).
Time frame: 1 year post operative
Recruitment is continuous
Dysmenorrhoea measured using a visual analogue scale (VAS).
Time frame: 1 year post operative
Recruitment is continuous
Dyspareunia measured using a visual analogue scale (VAS).
Time frame: 1 year post operative
Recruitment is continuous
Dyschezia measured using a visual analogue scale (VAS).
Time frame: 1 year post operative
Recruitment is continuous
Chronic pain measured using a visual analogue scale (VAS).
Time frame: 1 year post operative
Recruitment is continuous
6 secondary outcomes
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
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
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
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2019.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Andrew Kent, TD MD FRCOG contact
Andrew Kent, TD MD FRCOG principal investigator
Royal Surrey County Hospital/Nuffield Health Guildford Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometriosis Rectovaginal Septum, run by Royal Surrey County Hospital NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andrew Kent, TD MD FRCOG (kenta@doctors.org.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2019.