A prospective randomised comparison of laparoscopic anterior versus posterior partial fundoplication in patients with gastro-oesophageal reflux disease
| ISRCTN | ISRCTN31024562 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN31024562 |
| Secondary identifying numbers | N0059103687 |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 22/08/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr Roger Ackroyd
Scientific
Scientific
STH NHS Trust
General Surgery
K Floor
Royal Hallamshire Hospital
Sheffield
S10 2JF
United Kingdom
| Phone | +44 (0)114 226 1398 |
|---|---|
| roger.ackroyd@sth.nhs.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study objectives | To prospectively compare laparoscopic anterior versus posterior partial fundoplication in patients with gastro-oesophageal reflux disease. |
| Ethics approval(s) | Ethics approval received from the South Sheffield Research Ethics Committee |
| Health condition(s) or problem(s) studied | Gastro-oesophageal reflux disease (GORD) |
| Intervention | Comparison of laparoscopic anterior versus posterior partial fundoplication. |
| Intervention type | Other |
| Primary outcome measure | 1. Dysphagia 2. Reflux control |
| Secondary outcome measures | No secondary outcome measures |
| Overall study start date | 01/10/2001 |
| Completion date | 30/09/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 100 |
| Key inclusion criteria | 100 patients with gastro-oesophageal reflux disease. |
| Key exclusion criteria | 1. Previous anti-reflux surgery 2. Other concomitant disease being operated at the same time, e.g., gallstones 3. Aged less than 18 or greater than 75 years |
| Date of first enrolment | 01/10/2001 |
| Date of final enrolment | 30/09/2003 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
STH NHS Trust
Sheffield
S10 2JF
United Kingdom
S10 2JF
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.doh.gov.uk |
|---|
Funders
Funder type
Government
Sheffield Teaching Hospitals (Central Campus) (UK)
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? |
|---|---|---|---|---|---|
| Results article | results | 01/07/2010 | Yes | No |
