Placement of Abdominal Drain Versus No Placement of Abdominal Drain After Open or Closed Pancreatic Left Resection

Placement of Abdominal Drain Versus No Placement of Abdominal Drain After Open or Closed Pancreatic Left Resection - PANDRA II

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00013763

Enrollment

252

Registered

2018-03-06

Start date

2018-04-09

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

D37.70 C25

Interventions

Group 1: A closed-suction drain will be placed near the transection margin at the end of an open or closed pancreatic left resection Group 2: A closed-suction drain will not be placed near the transec

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: surgical indication for open or closed distal pancreatectomy, at least 18 years of age, ability of subject to understand character and individual consequences of the clinical trial, written informed consent

Exclusion criteria

Exclusion criteria: The subject has a surgical indication for pancreatic resection with a pancreaticojejunal anastomosis, American Society of Anesthesiologists (ASA) physical status classification = IV, the subject is not willing to consent to randomization, impaired mental state or language problems of the subject, participation in another intervention-trial with interference of intervention and outcome of this study

Design outcomes

Primary

Measure	Time frame
Evaluation of the Comprehensive Complication Index (CCI) by measuring all complications after open or closed pancreatic left resection (time frame: 90 days) by using the Clavin Dindo Classification	—

Secondary

Measure	Time frame
Measuring the rate of: pancreatic fistula according to the definition of the ISGPS 2017, lymphatic fistula according to the definition of the ISGPS 2017, postoperative bleedings according to the definition of the ISGPS 2007 (including arrosion bleeding), reinterventions and reoperations including CT guided placement of drains due to intraabdominal fluid collection, intraabdominal bleeding and/or pancreatic- and lymphatic fistula, delayed gastric emptying according to the definition of the ISGPS 2007, intraabdominal fluid collections and/or, intraabdominal abscess, wound infections, abdominal fasica dehiscences. Measuring the: duration of hospital/ICU stay, rate of readmission after discharge from hospital (up to day 90 after surgery), mortality (time frame: 90 days after surgery)	—

Measure

Time frame

Measuring the rate of: pancreatic fistula according to the definition of the ISGPS 2017, lymphatic fistula according to the definition of the ISGPS 2017, postoperative bleedings according to the definition of the ISGPS 2007 (including arrosion bleeding), reinterventions and reoperations including CT guided placement of drains due to intraabdominal fluid collection, intraabdominal bleeding and/or pancreatic- and lymphatic fistula, delayed gastric emptying according to the definition of the ISGPS 2007, intraabdominal fluid collections and/or, intraabdominal abscess, wound infections, abdominal fasica dehiscences. Measuring the: duration of hospital/ICU stay, rate of readmission after discharge from hospital (up to day 90 after surgery), mortality (time frame: 90 days after surgery)

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Countries

Germany

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 21, 2026