Effectiveness of ovarian suspension in preventing post-operative ovarian adhesions in women with pelvic endometriosis

ISRCTN	ISRCTN24242218
DOI	https://doi.org/10.1186/ISRCTN24242218
Protocol serial number	N0263139724
Sponsor	Department of Health
Funder	University College London Hospitals NHS Trust (UK)

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 of protocol

Not provided at time of registration

Contact information

Dr William Hoo
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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Effectiveness of ovarian suspension in preventing post-operative ovarian adhesions in women with pelvic endometriosis: a randomised controlled trial
Study objectives	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
Health condition(s) or problem(s) studied	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(s)	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.
Key secondary outcome measure(s)	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.
Completion date	01/06/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	50
Key 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
Key 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
Date of first enrolment	01/10/2008
Date of final enrolment	01/06/2011

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Clinic 3

London
NW1 2BU
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/04/2014		Yes	No
Protocol article	protocol	11/05/2011		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes