Plain English Summary
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 2021
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr Bergthor Björnsson
bergthor.bjornsson@liu.se
Trial website
Contact information
Type
Scientific
Primary contact
Dr Bergthor Björnsson
ORCID ID
Contact details
Linköping University Hospital
Linköping
58185
Sweden
+46 (0)703766890
bergthor.bjornsson@liu.se
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
DrainRemovalStudy1.1
Study information
Scientific title
Post-operative drainage after pancreaticoduodenectomy: a randomized controlled trial of early drain removal vs late drain removal
Acronym
Study hypothesis
Early drain removal after pancreatoduodenectomy shortens hospital stay.
Ethics approval
Regional Ethical Review Board, Linköping, Sweden, 16/10/2017, ref: Dnr 2017/310-31
Study design
Prospective randomized study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
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
Phase
Drug names
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 trial start date
01/04/2017
Overall trial end date
31/12/2021
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Patients planned for pancreatoduodenectomy with high risk for anastomosis leakage
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
280
Participant exclusion criteria
Low risk for anastomosis leakage
Recruitment start date
01/09/2018
Recruitment end date
31/08/2021
Locations
Countries of recruitment
Norway, Sweden
Trial participating centre
Linköping University Hospital
Linköping
58185
Sweden
Trial participating centre
Skånes University Hospital
Lund
22242
Sweden
Trial participating centre
Sahlgrenska University Hospital
Gothenburg
41345
Sweden
Trial participating centre
Oslo University Hospital
Oslo
0372
Norway
Funders
Funder type
Other
Funder name
Investigator initiated and funded
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
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 statement
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.
Intention to publish date
31/12/2022
Participant level data
To be made available at a later date
Basic results (scientific)
Publication list