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

Organizational Data

DRKS-ID:
DRKS00013763
Recruitment Status:
Recruiting ongoing
Date of registration in DRKS:
2018-03-06
Last update in DRKS:
2018-06-06
Registration type:
Prospective

Acronym/abbreviation of the study

PANDRA II

URL of the study

No Entry

Brief summary in lay language

The placement of prophylactic intraabdominal drains has been common practice in abdominal surgery. The rationale for inserting drains following surgery was that the drains were thought to evacuate fluids that may accumulate after surgery. However, up to now there is no evidence that the use of drains might reduce the risk for bearing complications after surgery and might be beneficial for patients after abdominal surgery. The aim of the present study was to evaluate the outcome after open or closed pancreatic left resection according to the presence or absence of prophylactic abdominal cavity drainage. Specific outcome endpoints were postoperative complications.

Brief summary in scientific language

Nowadays it is a common practice to place prophylactic intraabdominal drains at the end of an abdominal surgery. The rationale for inserting drains following surgery was that the drains were thought to evacuate fluids that may accumulate after surgery. However, up to now there is no evidence that the use of drains might reduce the risk for bearing complications after surgery and might be beneficial for patients after abdominal surgery. The aim of the present study was to evaluate the outcome after open or closed pancreatic left resection according to the presence or absence of prophylactic abdominal cavity drainage. Specific outcome endpoints were postoperative complications.

Health condition or problem studied

ICD10:
D37.70
ICD10:
C25 - Malignant neoplasm of pancreas
Healthy volunteers:
No Entry

Interventions, Observational Groups

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

Endpoints

Primary outcome:
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 outcome:
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)

Study Design

Purpose:
Treatment
Allocation:
Randomized controlled study
Control:
  • Active control (effective treatment of control group)
Phase:
N/A
Study type:
Interventional
Mechanism of allocation concealment:
No Entry
Blinding:
No
Assignment:
Parallel
Sequence generation:
No Entry
Who is blinded:
No Entry

Recruitment

Recruitment Status:
Recruiting ongoing
Reason if recruiting stopped or withdrawn:
No Entry

Recruitment Locations

Recruitment countries:
  • Germany
Number of study centers:
Monocenter study
Recruitment location(s):
  • University medical center Klinik für Allgemein-, Viszeral- und Transplantationschirurgie Heidelberg, Im Neuenheimer Feld 110

Recruitment period and number of participants

Planned study start date:
2018-03-19
Actual study start date:
2018-04-09
Planned study completion date:
No Entry
Actual Study Completion Date:
No Entry
Target Sample Size:
252
Final Sample Size:
No Entry

Inclusion Criteria

Sex:
All
Minimum Age:
18 Years
Maximum Age:
no maximum age
Additional 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

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

Addresses

Primary Sponsor

Universitätsklinikum Heidelberg
Im Neuenheimer Feld 672
69120 Heidelberg
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
http://www.klinikum.uni-heidelberg.de
Investigator Sponsored/Initiated Trial (IST/IIT):
Yes

Contact for Scientific Queries

Klinik für Allgemein-, Viszeral- und TransplantationschirurgieUniversitätsklinikum Heidelberg
Prof. Dr. med. Thilo Hackert
Im Neuenheimer Feld 110
69120 Heidelberg
Germany
Telephone:
06221/566250
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Contact for Public Queries

Klinisches Studienzentrum (KSC)Klinik für Allgemein-, Viszeral- und Transplantationschirurgie Universitätsklinikum Heidelberg
Ärztliche Leitung: PD Dr. Phillip Knebel
Im Neuenheimer Feld 110
69120 Heidelberg
Germany
Telephone:
00496221566110
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Principal Investigator

Klinik für Allgemein-, Viszeral- und TransplantationschirurgieUniversitätsklinikum Heidelberg
Prof. Dr. med. Thilo Hackert
Im Neuenheimer Feld 110
69120 Heidelberg
Germany
Telephone:
06221/566250
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Sources of Monetary or Material Support

Institutional budget, no external funding (budget of sponsor/PI)

Universitätsklinikum Heidelberg
Im Neuenheimer Feld 672
69120 Heidelberg
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
http://www.klinikum.uni-heidelberg.de

Ethics Committee

Address Ethics Committee

Ethikkommission der Medizinischen Fakultät Heidelberg
Alte Glockengießerei 11/1
69115 Heidelberg
Germany
Telephone:
+49-6221-338220
Fax:
+49-6221-3382222
Contact per E-Mail
URL:
No Entry

Vote of leading Ethics Committee

Date of ethics committee application:
2017-12-05
Ethics committee number:
S-675/2017
Vote of the Ethics Committee:
Approved
Date of the vote:
2018-01-04

Further identification numbers

Other primary registry ID:
No Entry
EudraCT Number:
No Entry
Other secondary IDs:
No Entry
UTN (Universal Trial Number):
U1111-1207-3031
EUDAMED Number:
No Entry

IPD - Individual Participant Data

Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
No Entry
IPD Sharing Plan:
No Entry

Study protocol and other study documents

Study protocols:
Studienprotokoll
Studienprotokoll Version 2.2. vom 27.05.2018
Study abstract:
No Entry
Other study documents:
Einwilligungserklärung Version 2.2. vom 27.05.2018
Informationsschrift Version 2.2. vom 27.05.2018
Background literature:
No Entry
Related DRKS studies:
No Entry

Publication of study results

Planned publication:
No Entry
Publikationen/Studienergebnisse:
No Entry
Date of first publication of study results:
No Entry
DRKS entry published for the first time with results:
No Entry

Basic reporting

Basic Reporting / Results tables:
No Entry
Brief summary of results:
No Entry