Condition category
Surgery
Date applied
08/09/2005
Date assigned
21/12/2005
Last edited
14/03/2014
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

Prof Tin-Chiu Li

ORCID ID

Contact details

Level 4
Jessop Wing
Royal Hallamshire Hospital
Sheffield
S10 2SF
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

STH14212

Study information

Scientific title

Acronym

Study hypothesis

Adhesiolysis leads to the improvement of pain and quality of life.

Ethics approval

Not provided at time of registration

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 the contact details below to request a patient information sheet

Condition

Adhesions and chronic pelvic pain

Intervention

Operative laparoscopy or diagnostic laparoscopy.

Intervention type

Procedure/Surgery

Phase

Not Applicable

Drug names

Primary outcome measures

1. Pain (visual analogue scale [VAS])
2. Quality of life (SF 36)
3. Medications requirement

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/01/2006

Overall trial end date

01/01/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age over 18 years
2. Chronic pelvic pain over 6 months duration

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

200

Participant exclusion criteria

1. Pregnancy
2. Malignancy
3. Acute pathology that neeeds immediate treatment
4. On CNS stimulant/medications for psychiatric illness

Recruitment start date

01/01/2006

Recruitment end date

01/01/2008

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Level 4
Sheffield
S10 2SF
United Kingdom

Sponsor information

Organisation

Sheffield Hospitals Charitable Trust (UK)

Sponsor details

5 Old Fulwood Road
Sheffield
S10 3TG
United Kingdom

Sponsor type

Charity

Website

Funders

Funder type

Charity

Funder name

Sheffield Hospitals Charitable Trust

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

1. 2013 results (meeting abstract) in: http://humrep.oxfordjournals.org/content/28/suppl_1/i75.full
2. 2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24588989

Publication citations

  1. Results

    Cheong YC, Reading I, Bailey S, Sadek K, Ledger W, Li TC, Should women with chronic pelvic pain have adhesiolysis?, BMC Womens Health, 2014, 14, 1, 36, doi: 10.1186/1472-6874-14-36.

Additional files

Editorial Notes