Early or late drain removal after pancreatic surgery

Post-operative drainage after pancreaticoduodenectomy: a randomized controlled trial of early drain removal vs late drain removal

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN26484363

Enrollment

280

Registered

2018-05-11

Start date

2018-09-01

Completion date

Unknown

Last updated

2023-06-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic disease treated with pancreatoduodenectomy Surgery

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients planned for pancreatoduodenectomy with high risk for anastomosis leakage

Exclusion criteria

Exclusion criteria: Low risk for anastomosis leakage

Design outcomes

Primary

Measure	Time frame
Hospital stay, measured at discharge	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Norway, Sweden

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026