Randomised controlled trial of laparoscopic adhesiolysis for women with chronic pelvic pain
| ISRCTN | ISRCTN43852269 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN43852269 |
| Secondary identifying numbers | STH14212 |
- Submission date
- 08/09/2005
- Registration date
- 21/12/2005
- Last edited
- 14/03/2014
- 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
Prof Tin-Chiu Li
Scientific
Scientific
Level 4
Jessop Wing
Royal Hallamshire Hospital
Sheffield
S10 2SF
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | |
| Study objectives | Adhesiolysis leads to the improvement of pain and quality of life. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Adhesions and chronic pelvic pain |
| Intervention | Operative laparoscopy or diagnostic laparoscopy. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | 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 study start date | 01/01/2006 |
| Completion date | 01/01/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 200 |
| Key inclusion criteria | 1. Age over 18 years 2. Chronic pelvic pain over 6 months duration |
| Key exclusion criteria | 1. Pregnancy 2. Malignancy 3. Acute pathology that neeeds immediate treatment 4. On CNS stimulant/medications for psychiatric illness |
| Date of first enrolment | 01/01/2006 |
| Date of final enrolment | 01/01/2008 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Level 4
Sheffield
S10 2SF
United Kingdom
S10 2SF
United Kingdom
Sponsor information
Sheffield Hospitals Charitable Trust (UK)
Charity
Charity
5 Old Fulwood Road
Sheffield
S10 3TG
United Kingdom
Funders
Funder type
Charity
Sheffield Hospitals Charitable Trust
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Abstract results | results (meeting abstract) | 01/06/2013 | No | No | |
| Results article | results | 04/03/2014 | Yes | No |
