Condition category
Surgery
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
01/09/2014
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr William Hoo

ORCID ID

Contact details

Clinic 3
Gynaecology Diagnostic Ultrasound Unit
Elizabeth Garrett Anderson Wing
University College London Hospital
235 Euston Road
London
NW1 2BU
United Kingdom
+44 (0)20 7380 9411

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0263139724

Study information

Scientific title

Effectiveness of ovarian suspension in preventing post-operative ovarian adhesions in women with pelvic endometriosis: a randomised controlled trial

Acronym

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

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

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details below to request a patient information sheet

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

01/10/2008

Overall trial end date

01/06/2011

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Female

Target number of participants

Added 03/11/2010: 50 patients (at time of registration: 20 patients)

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

United Kingdom

Trial participating centre

Clinic 3
London
NW1 2BU
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Hospital/treatment centre

Funder name

University College London Hospitals NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2011 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/21569374
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24491296

Publication citations

  1. Protocol

    Hoo WL, Saridogan E, Cutner A, Pandis G, Jurkovic D, Effectiveness of ovarian suspension in preventing post-operative ovarian adhesions in women with pelvic endometriosis: a randomised controlled trial., BMC Womens Health, 2011, 11, 14, doi: 10.1186/1472-6874-11-14.

  2. Results

    Hoo WL, Stavroulis A, Pateman K, Saridogan E, Cutner A, Pandis G, Tong EN, Jurkovic D, Does ovarian suspension following laparoscopic surgery for endometriosis reduce postoperative adhesions? An RCT., Hum. Reprod., 2014, 29, 4, 670-676, doi: 10.1093/humrep/deu007.

Additional files

Editorial Notes