Condition category
Surgery
Date applied
10/04/2018
Date assigned
11/05/2018
Last edited
10/05/2018
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Not yet recruiting

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 measures

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

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

Sponsor information

Organisation

Region Östergotland

Sponsor details

Garnisonvägen
Linköping
58185
Sweden

Sponsor type

Hospital/treatment centre

Website

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes