Total or a posterior partial fundoplication in the treatment of gastroesophageal reflux disease (GERD)
| ISRCTN | ISRCTN59614486 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN59614486 |
| Protocol serial number | N/A |
| Sponsor | Sahlgrenska University Hospital (Sweden) |
| Funder | Sahlgrenska University Hospital (Sweden) - Department of Surgery |
- Submission date
- 15/03/2010
- Registration date
- 10/03/2011
- Last edited
- 04/07/2011
- 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
Dr Cecilia Engström
Scientific
Scientific
Per Dubb gatan
Göteborg
413045
Sweden
| Phone | +46 (0)31 342 10 00 |
|---|---|
| cecilia.engstrom@surgery.gu.se |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Total or a posterior partial fundoplication in the treatment of gastroesophageal reflux disease (GERD): results of a randomised trial after two decades of follow up |
| Study objectives | Differences in side effect and reflux control between open fundoplication total or partial, after 18 years of follow up of a earlier randomised controlled trial (RCT). |
| Ethics approval(s) | Not provided at time of registration - please note that this is the follow-up of an RCT. |
| Health condition(s) or problem(s) studied | Gastroesophageal reflux disease (GERD) |
| Intervention | Surgery for GERD, total nissen or partial fundoplication. Please note that this is the follow-up for a RCT performed 20 years ago; the mean follow up has now reached 18 years. During these years 26% had died and 16% were unable to trace for follow up. Symptom outcomes were assessed by the use of validated self-reporting questionnaires. |
| Intervention type | Other |
| Primary outcome measure(s) |
1. Reflux control after 18 years |
| Key secondary outcome measure(s) |
Number of recurrences and reoperations |
| Completion date | 01/01/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 75 Years |
| Sex | All |
| Target sample size at registration | 137 |
| Key inclusion criteria | 1. Aged from 18 to 75 years, either sex 2. Established gastroesophageal reflux referred for surgical treatment in the beginning of 1990 |
| Key exclusion criteria | 1. Pregnant 2. No possibility of compliance in the study protocol 3. Addict 4. Unable to understand the circumstances or the RCT information |
| Date of first enrolment | 01/01/1990 |
| Date of final enrolment | 01/01/2008 |
Locations
Countries of recruitment
- Sweden
Study participating centre
Per Dubb gatan
Göteborg
413045
Sweden
413045
Sweden
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 | 01/05/2011 | Yes | No |
