Early or late drain removal after pancreatic surgery
| ISRCTN | ISRCTN26484363 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN26484363 |
| Secondary identifying numbers | DrainRemovalStudy1.1 |
- Submission date
- 10/04/2018
- Registration date
- 11/05/2018
- Last edited
- 08/06/2023
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Surgery
Plain English summary of protocol
Background and study aims
Abdominal drains are sometimes placed during surgery in order to minimize the risk from bowel contents or other dangerous fluids collecting in the abdomen. This practice has been reduced in many branches of surgery during the last decades as the benefit of this treatment is questionable and the risk associated with having drains (plastic tubes) inside the abdomen is inevitable. When it comes to pancreatic surgery the risk from leakage of pancreatic juice into the abdominal cavity is high and the routine use of drains is therefore the standard of care. The drains are usually left in place for a minimum of 3 days after surgery and then removed if no signs of leakage are found. There are results available from earlier research indicating that drains can safely be removed as early as one day after surgery if no leakage is present. The aim of this study is to find out whether early drain removal after pancreatic surgery shortens hospital stay.
Who can participate?
Patients undergoing removal of the pancreatic head and associated tissue (Whipple operation) and with normal concentration of drain amylase (pancreatic enzyme) the day after surgery
What does the study involve?
Participants are randomly allocated to undergo either early drain removal (one day after surgery) or conventional drain removal (at earliest three days after surgery). Their treatment is otherwise according to hospital standards and the follow up (within the study) is 90 days. Length of hospital stay is measured at discharge.
What are the possible benefits and risks of participating?
The possible benefits of participating are that early drain removal may shorten hospital stay and reduce the risk of drain-associated complications. The main risk is that the normal drain amylase on the day after surgery may not completely exclude leakage and therefore longer drain treatment could be of value.
Where is the study run from?
1. Linköping University Hospital (Sweden)
2. Skånes University Hospital (Sweden)
3. Sahlgrenska University Hospital (Sweden)
4. Oslo University Hospital (Norway)
When is the study starting and how long is it expected to run for?
April 2017 to December 2025
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr Bergthor Björnsson
bergthor.bjornsson@liu.se
Contact information
Scientific
Linköping University Hospital
Linköping
58185
Sweden
| Phone | +46 (0)703766890 |
|---|---|
| bergthor.bjornsson@liu.se |
Study information
| Study design | Prospective randomized study |
|---|---|
| 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 to request a patient information sheet |
| Scientific title | Post-operative drainage after pancreaticoduodenectomy: a randomized controlled trial of early drain removal vs late drain removal |
| Study objectives | Early drain removal after pancreatoduodenectomy shortens hospital stay. |
| Ethics approval(s) | Regional Ethical Review Board, Linköping, Sweden, 16/10/2017, ref: Dnr 2017/310-31 |
| Health condition(s) or problem(s) studied | Pancreatic disease treated with pancreatoduodenectomy |
| Intervention | The randomisation will be by online websolution after the results of drain amylase POD 1 are known and within the inclusion limits of the study. There are two treatment arms: 1. Early drain removal (POD 1) 2. Conventional drain removal earliest on POD 3 when no pancreatic fistula exist according to the definition of POPF (postoperative pancreatic fistula) The treatment will otherwise be according to hospital standards and the follow up (within the study) is 90 days. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Hospital stay, measured at discharge |
| Secondary outcome measures | 1. Overall morbidity rate classified as Clavien-Dindo ≥3a within 90 days 2. Mortality rate (in-hospital, 30 and 90 days) 3. Overall morbidity rate as classified by Clavien-Dindo within 90 days 4. Fistula rate according to ISGPF (grade B and C fistulas) within 90 days 5. Intraabdominal abscess rate within 90 days 6. Wound infection rate within 90 days 7. Delayed gastric emptying according to ISGPF within 90 days 8. Postpancreatectomy bleeding according to ISGPF within 90 days 9. Need of interventional radiology within 90 days 10. Need for reoperation within 90 days 11. Readmission rate within 90 days |
| Overall study start date | 01/04/2017 |
| Completion date | 31/12/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 280 |
| Key inclusion criteria | Patients planned for pancreatoduodenectomy with high risk for anastomosis leakage |
| Key exclusion criteria | Low risk for anastomosis leakage |
| Date of first enrolment | 01/09/2018 |
| Date of final enrolment | 31/08/2025 |
Locations
Countries of recruitment
- Norway
- Sweden
Study participating centres
58185
Sweden
22242
Sweden
41345
Sweden
0372
Norway
Sponsor information
Hospital/treatment centre
Garnisonvägen
Linköping
58185
Sweden
"ROR" |
https://ror.org/0326gsy75 |
|---|
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 31/12/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | The results of the primary endpoint will be published in a high-impact peer reviewed journal within 1 year after inclusion of the last patient. Further analysis of secondary endpoints will be done thereafter. |
| IPD sharing plan | The data sharing plans for the current study are unknown and will be made available at a later date. Additional documents (such as study protocol, statistical analysis plan) will not be made available online at this time. |
Editorial Notes
08/06/2023: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/08/2021 to 31/08/2025.
2. The overall end date was changed from 31/12/2021 to 31/12/2025.
3. The intention to publish date was changed from 31/12/2022 to 31/12/2026.
4. The plain English summary was updated to reflect these changes.
