Effect of intermittent postoperative drain irrigation on time to functional recovery (TFR) following pancreatoduodenectomy (PD): The MARTINI Trial – A Randomized Controlled Trial.
Organizational Data
- DRKS-ID:
- DRKS00025073
- Recruitment Status:
- Recruiting ongoing
- Date of registration in DRKS:
- 2021-06-15
- Last update in DRKS:
- 2023-01-27
- Registration type:
- Prospective
Acronym/abbreviation of the study
MARTINI
URL of the study
No Entry
Brief summary in lay language
Regardless of improvements in surgical technique and perioperative management, complications after pancreatic surgery are relevant issues in abdominal surgery. The occurrence of pancreatic fistula is of central importance for the time to functional recovery (TFR) of the patients. Complications following pancreatic fistula are various and associated with a higher postoperative morbidity and mortality. In pancreatic surgery a surgical drain is placed adapted to the risk of the occurrence of pancreatic fistula at the end of the surgical operation. It is used postoperatively to evacuate intra-abdominal fluids. Super infected intraabdominal fluids are routinely evacuated and irrigated via the intraoperatively placed drains with saline solution. The usage of a surgical drain with preventive intermittent irrigation and the evacuation of potentially harmful fluids could decrease TFR in patients undergoing elective pancreatoduodenectomy. Furthermore the complications of pancreatic fistula and the overall morbidity of these patients could decrease and therefore quality of life could be improved. Aim of this trial is to determine whether the TFR can be reduced by usage of a surgical drain with preventive intermittent irrigation compared to the standard of care. Therefore in one group a surgical drain will be placed without using it for concomitant irrigation, while the other group will receive intermittent postoperative irrigation.
Brief summary in scientific language
Postoperative pancreatic fistula has been and is still the defining complication and challenge since the beginning of pancreatic surgery. Its occurrence is the largest contributor to major morbidity and mortality and may lead to a variety of additional complications and prolonged recovery. The placement of a surgical drain is standard operating procedure in pancreatic head resection. As well as using the drain for irrigation in case of suspected or proven intra-abdominal infection. The usage of a surgical drain with intermittent irrigation after pancreatoduodenectomy could decrease time to functional recovery (TFR) and reduce complications. In this prospective superiority study with an experimental parallel group design and equal allocation, two randomized controlled arms are used to determine whether TFR can be reduced by usage of a surgical drain compared to the standard of care with drain placement but without concomitant active intermittent irrigation. While the primary endpoint is TFR, the effect of active drain usage on the development of a clinically relevant postoperative pancreatic fistula, postoperative complications and associated costs, a set of general and surgical variables as well as patient reported outcomes will be analysed to evaluate efficacy of both methods.
Health condition or problem studied
- Free text:
- Patients scheduled for elective pancreatoduodenectomy
- ICD10:
- C25.0 - Head of pancreas
- ICD10:
- D37.70
- ICD10:
- D37.6 - Liver, gallbladder and bile ducts
- ICD10:
- K86.1 - Other chronic pancreatitis
- ICD10:
- K86.2 - Cyst of pancreas
- ICD10:
- K86.3 - Pseudocyst of pancreas
- ICD10:
- C24.0 - Extrahepatic bile duct
- ICD10:
- C24.1 - Ampulla of Vater
- ICD10:
- D13.2 - Duodenum
- ICD10:
- D13.6 - Pancreas
- ICD10:
- D13.7 - Endocrine pancreas
- ICD10:
- C17.0 - Duodenum
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 1:
- Control group - Pancreatoduodenectomy according to the standard of care (drain will only be used for drainage and will not be used for irrigation)
- Arm 2:
- Experimental group - Pancreatoduodenectomy according to the standard of care and intervention via intermittent postoperative drain irrigation
Endpoints
- Primary outcome:
- Time to functional recovery (TFR) Time to functional recovery [days]. Functional recovery is assumed when all of the following conditions are fulfilled at the same time: 1. Adequate pain control with oral analgesia only (no need of intravenous (i.v.) or epidural analgesia and Numeric Rating Scale (NRS) ≤3); 2. Tolerance of solid food (oral intake of solid food is resumed and continued for at least 24 hours without vomiting); 3. Absence of intravenous fluids administration; 4. Independent mobility or mobility at the preoperative level [Postoperative Mobility Scale (PMS)]; 5. No signs of active abdominal infection [in case of suspected or confirmed abdominal infection this item is fulfilled when the patient has no fever (<38.5°C) and serum C-reactive protein concentration is decreasing and below 150mg/L]. The evaluation of time to functional recovery will start on POD 2 and will be assessed daily until discharge. It will be assessed whether or not if patients reach TFR until POD 90 or not. TFR will be counted as 90 days in case of death before reaching TFR.
- Secondary outcome:
- • Drain management and fluid contamination • Clinically relevant postoperative pancreatic fistulas (CR-POPF) • Delayed gastric emptying (DGE) (ISGPS definition) • Postpancreatectomy hemorrhage (PPH) • Health-related quality of life • Perioperative morbidity and mortality according to Clavien-Dindo classification at 90 days (±7 days) respectively comprehensive complication index (CCI) with focus on overall rate of Clavien-Dindo grade III or higher
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 Chirurgische Klinik Mannheim
Recruitment period and number of participants
- Planned study start date:
- 2021-09-20
- Actual study start date:
- 2021-09-20
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- No Entry
- Target Sample Size:
- 100
- Final Sample Size:
- No Entry
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- no maximum age
- Additional Inclusion Criteria:
- • Age equal to or greater than 18 years • elective open or minimally invasive pancreatoduodenectomy • Ability to understand the character and individual consequences of the clinical trial • Written informed consent
Exclusion Criteria
• Significant cardiac or respiratory failure (ASA >3) • Impaired mental state or incompetence of understanding the German language (no fluent German language speaker) • Expected lack of compliance • Participation in another study with interference of primary outcome
Addresses
Primary Sponsor
- Address:
- Universitätsmedizin Mannheim - Chirurgische KlinikTheodor-Kutzer- Ufer 1-368167 MannheimGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Universität Heidelberg, Medizinische Fakultät Mannheim, Chirurgische KlinikProf. Dr. med. Nuh N. RahbariTheodor-Kutzer-Ufer 1-368167 MannheimGermany
- Telephone:
- +49621-383-2225
- Fax:
- -
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.umm.de/chirurgische-klinik/
Contact for Public Queries
- Address:
- Universität Heidelberg, Medizinische Fakultät Mannheim, Chirurgische KlinikProf. Dr. med. Nuh N. RahbariTheodor-Kutzer-Ufer 1-368167 MannheimGermany
- Telephone:
- +49621-383-2225
- Fax:
- -
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.umm.de/chirurgische-klinik/
Principal Investigator
- Address:
- Universität Heidelberg, Medizinische Fakultät Mannheim, Chirurgische KlinikProf. Dr. med. Nuh N. RahbariTheodor-Kutzer-Ufer 1-368167 MannheimGermany
- Telephone:
- +49621-383-2225
- Fax:
- -
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.umm.de/chirurgische-klinik/
Other contact for public queries
- Address:
- Universität Heidelberg, Medizinische Fakultät Mannheim, Chirurgische KlinikPD Dr. med. Patrick TéouleTheodor-Kutzer-Ufer 1-368167 MannheimGermany
- Telephone:
- +49621383-2225
- Fax:
- -
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Sources of Monetary or Material Support
Institutional budget, no external funding (budget of sponsor/PI)
- Address:
- Universitätsmedizin Mannheim - Chirurgische KlinikTheodor-Kutzer- Ufer 1-368167 MannheimGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Ethics Committee
Address Ethics Committee
- Address:
- Medizinische Ethik-Kommission II Medizinischen Fakultät Mannheim, Forschungsgebäude, Haus 42 - Ebene 3Theodor-Kutzer-Ufer 1-368167 MannheimGermany
- Telephone:
- +49-621-38371770
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2021-04-27
- Ethics committee number:
- 2021-565
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2021-06-07
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT 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
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- 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