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11 February 2012
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| [ Print-friendly version ] |
| Effectiveness of ovarian suspension in preventing post operative ovarian adhesions in women with pelvic endometriosis |
| ISRCTN | ISRCTN24242218 |
| ClinicalTrials.gov identifier | |
| Public title | Effectiveness of ovarian suspension in preventing post operative ovarian adhesions in women with pelvic endometriosis |
| Scientific title | Effectiveness of ovarian suspension in preventing post operative ovarian adhesions in women with pelvic endometriosis: A randomised controlled trial |
| Acronym | N/A |
| Serial number at source | N0263139724 |
| Study hypothesis |
Added 03/11/10:
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 03/11/10 this record has been extensively updated, with further revisions and clarifications to the record on 12/11/10. Due to issues with recruitment the trial, originally planned for 19/11/03 to 01/11/08, 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. |
| Lay summary | |
| Ethics approval |
Added 12/11/10: The Medical Ethical Committees of the University College Hospital, London approved ammendments to the protocol on the 8th of April 2009 and the 29th of April 2010 (ref: 03/0279).
Details of the original ethics approval were not provided at the time of registration. |
| Study design | Randomised controlled trial |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Endometriosis; Laparoscopic surgery |
| Participants - inclusion criteria |
Added 03/11/10:
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 |
| Participants - exclusion criteria |
Added 03/11/10:
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 |
| Anticipated start date | 01/10/2008 |
| Anticipated end date | 01/06/2011 |
| Status of trial | Completed |
| Patient information material | Not available in web format, please use contact details below to request a patient information sheet |
| Target number of participants | Added 03/11/10: 50 patients (at time of registration: 20 patients) |
| Interventions |
Current information as of 12/11/10:
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 |
| Primary outcome measure(s) |
Current information as of 03/11/10:
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 measure(s) |
Current information as of 03/11/10:
Presence, intensity and site of postoperative pain Initial information at time of registration: Difference in pain between the 2 sides of the abdomen in the first three post-op days. |
| Sources of funding | University College London Hospitals NHS Trust (UK) |
| Trial website | |
| Publications | |
| Contact name | Dr William Hoo |
| Address |
Clinic 3
Gynaecology Diagnostic Ultrasound Unit Elizabeth Garrett Anderson Wing University College London Hospital 235 Euston Road |
| City/town | London |
| Zip/Postcode | NW1 2BU |
| Country | United Kingdom |
| Tel | +44 (0)20 7380 9411 |
| Fax | +44 (0)20 7691 5861 |
| Sponsor | Record Provided by the NHSTCT Register - 2004 Update - Department of Health (UK) |
| Address |
The Department of Health,
Richmond House, 79 Whitehall |
| City/town | London |
| Zip/Postcode | SW1A 2NL |
| Country | United Kingdom |
| Tel | +44 (0)20 7307 2622 |
| dhmail@doh.gsi.org.uk | |
| Sponsor website: | http://www.dh.gov.uk/Home/fs/en |
| Date applied | 30/09/2004 |
| Last edited | 12/11/2010 |
| Date ISRCTN assigned | 30/09/2004 |
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