Laparoscopic gastrojejunostomy versus self expanding metal stent for malignant gastric outlet obstruction: a prospective randomised trial
| ISRCTN | ISRCTN03084082 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN03084082 |
| Protocol serial number | N0547102224 |
| Sponsor | Department of Health (UK) |
| Funder | East Norfolk and Waveney Research Consortium - Norfolk and Norwich University Hospital/Norwich PCT (UK) |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 17/07/2008
- 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
Mr Michael PN Lewis
Scientific
Scientific
Consultant Surgeon
General Surgery
Norfolk and Norwich Hospital
Brunswick Road
Norwich
NR1 3SR
United Kingdom
| Phone | +44 (0)1603 287583 |
|---|---|
| karen.turner@nnuh.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Prospective randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | 1. To investigate whether self expanding metal stents are comparable to laparoscopic gastrojejunostomy in treating malignant gastric outlet obstruction 2. To evaluate the cost effectiveness of both treatments 3. To examine the effects of both treatments on quality of life |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Surgery: Gastrojejunostomy |
| Intervention | Laparoscopic gastrojejunostomy versus self expanding metal stent for malignant gastric outlet obstruction |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 10/07/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 60 |
| Key inclusion criteria | 20 per year |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 10/07/2001 |
| Date of final enrolment | 10/07/2004 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Consultant Surgeon
Norwich
NR1 3SR
United Kingdom
NR1 3SR
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | 01/02/2006 | Yes | No |
