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
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
-
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.