A prospective randomised clinical trial for closure of the pancreatic remnant following distal pancreatectomy
| ISRCTN | ISRCTN78326544 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN78326544 |
| Secondary identifying numbers | 7/2001 |
- Submission date
- 09/07/2008
- Registration date
- 21/07/2008
- Last edited
- 21/07/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Attila Olah
Scientific
Scientific
Petz Aladar Teaching Hospital
Vasvari P. u. 2.
Gyor
9024
Hungary
Study information
| Study design | Prospective randomised single-centre clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study objectives | Pancreatic fistula and intra-abdominal fluid collection are the most common complications of distal pancreatectomy. Our aim is to compare post-operative complication rates of the techniques of the closure of the pancreatic stump such as the simple stapling or the combined method of covering the stapled stump with a seromuscular patch of the jejunum. |
| Ethics approval(s) | Regional Committee of Science and Research Ethics. Date of approval: 20/11/2001 (ref: 76-1-73/A/09) |
| Health condition(s) or problem(s) studied | Pancreatic fistula and/or intra-abdominal fluid collection |
| Intervention | Distal pancreatectomy was performed in both groups. In the control group the pancreatic stump was closed by a stapler. In the intervention group the pancreatic remnant was first closed by a stapler then covered by a seromuscular patch of the jejunum. The total duration of follow-up was 3 months in both groups. |
| Intervention type | Other |
| Primary outcome measure | The rate of post-operative pancreatic fistula and intra-abdominal fluid collection. The 3-month post-operative period was analysed. |
| Secondary outcome measures | 1. The rate of re-interventions, either surgical or radiological 2. Length of hospital stay The 3-month post-operative period was analysed. |
| Overall study start date | 01/01/2002 |
| Completion date | 31/12/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 70 patients |
| Key inclusion criteria | 1. Aged 18 to 80 years, either sex 2. Distal pancreatectomy is indicated because of a benign or malignant tumour of the pancreas, chronic pancreatitis or malignant neoplasm of other organs infiltrating the pancreas, provided the parenchyma of the pancreas is suitable for stapling |
| Key exclusion criteria | 1. Aged under the age of 18 or over the age of 80 years 2. Too thick or wide parenchyma of the pancreas 3. Death in the first 72 hours of the post-operative period |
| Date of first enrolment | 01/01/2002 |
| Date of final enrolment | 31/12/2006 |
Locations
Countries of recruitment
- Hungary
Study participating centre
Petz Aladar Teaching Hospital
Gyor
9024
Hungary
9024
Hungary
Sponsor information
Petz Aladar Teaching Hospital (Hungary)
Hospital/treatment centre
Hospital/treatment centre
PO Box 92
Gyor
9024
Hungary
"ROR" |
https://ror.org/03vqk1b90 |
|---|
Funders
Funder type
Hospital/treatment centre
Petz Aladar Teaching Hospital (Hungary)
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 |
