Effectiveness of ovarian suspension in preventing post-operative ovarian adhesions in women with pelvic endometriosis
| ISRCTN | ISRCTN24242218 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN24242218 |
| Secondary identifying numbers | N0263139724 |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 01/09/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Not provided at time of registration
Contact information
Dr William Hoo
Scientific
Scientific
Clinic 3
Gynaecology Diagnostic Ultrasound Unit
Elizabeth Garrett Anderson Wing
University College London Hospital
235 Euston Road
London
NW1 2BU
United Kingdom
| Phone | +44 (0)20 7380 9411 |
|---|
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details below to request a patient information sheet |
| Scientific title | Effectiveness of ovarian suspension in preventing post-operative ovarian adhesions in women with pelvic endometriosis: a randomised controlled trial |
| Study hypothesis | Added 03/11/2010: Suspending the ovaries to the anterior abdominal wall (ovarian suspension) after laparoscopic surgery for severe pelvic endometriosis for 36 to 48 hours will reduce the incidence of post-operative ovarian adhesion. No information provided at time of registration. Please note that as of 03/11/2010 this record has been extensively updated, with further revisions and clarifications to the record on 12/11/2010. Due to issues with recruitment the trial, originally planned for 19/11/2003 to 01/11/2008, was stopped and underwent protocol and ethics amendments. Details of these amendments can be found in the relevant field with one of the above update dates. |
| Ethics approval(s) | The Medical Ethical Committees of the University College Hospital, London approved amendments to the protocol on 08/04/2009 and 29/04/2010, ref: 03/0279 |
| Condition | Endometriosis; Laparoscopic surgery |
| Intervention | Current information as of 12/11/2010: Ovarian suspension following laparoscopic excision of severe pelvic endometriosis: Patients will be randomised at the time of surgery to have either their left or right ovary suspended. The other ovary will be allowed to fall back into the pelvis, therefore acting as a control within the same patient. Ovarian suspension will be for at least 36 hours. An extra 12 hours is allowed for practical reasons in situations where sutures may needs to be removed in the middle of the night. There will be no comparision between variations in the duration of suspension. Initial information at time of registration: 1. Ovary suspension 2. Non ovary suspension |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Current information as of 03/11/2010: Presence of ovarian adhesions as assessed by pelvic ultrasound scan, 3 months post-operatively. Initial information at time of registration: The grade of peri-ovarian adhesion with and without ovarian suspension. |
| Secondary outcome measures | Current information as of 03/11/2010: Presence, intensity and site of postoperative pain Initial information at time of registration: Difference in pain between the two sides of the abdomen in the first three post-operative days. |
| Overall study start date | 01/10/2008 |
| Overall study end date | 01/06/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | Added 03/11/2010: 50 patients (at time of registration: 20 patients) |
| Participant inclusion criteria | Added 03/11/2010: 1. Age 19 or older 2. Internal scan not contraindicated 3. Severe pelvic endometriosis involving rectovaginal space and/or both ovaries 4. Fertility preserving surgery Information not provided at time of registration |
| Participant exclusion criteria | Added 03/11/2010: 1. Mild or moderate endometriosis 2. Incomplete resection of pelvic endometriosis (cyst drainage pre-IVF treatment or planned two-stage operations) 3. Patients undergoing radical surgery for endometriosis including oophrectomies or hysterectomies 4. Complications requiring ileostomies or open surgery Information not provided at time of registration |
| Recruitment start date | 01/10/2008 |
| Recruitment end date | 01/06/2011 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Clinic 3
London
NW1 2BU
United Kingdom
NW1 2BU
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.dh.gov.uk/Home/fs/en |
|---|
Funders
Funder type
Hospital/treatment centre
University College London Hospitals NHS Trust (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 11/05/2011 | Yes | No | |
| Results article | results | 01/04/2014 | Yes | No |
