Effect of intermittent postoperative drain irrigation on time to functional recovery (TFR) following pancreatoduodenectomy (PD): The MARTINI Trial – A Randomized Controlled Trial.

Effect of intermittent postoperative drain irrigation on time to functional recovery (TFR) following pancreatoduodenectomy (PD): The MARTINI Trial – A Randomized Controlled Trial. - MARTINI

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00025073

Enrollment

100

Registered

2021-06-15

Start date

2021-09-20

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

Patients scheduled for elective pancreatoduodenectomy C25.0 D37.70 D37.6 K86.1 K86.2 K86.3 C24.0 C24.1 D13.2 D13.6 D13.7 C17.0

Interventions

Group 1: Control group - Pancreatoduodenectomy according to the standard of care (drain will only be used for drainage and will not be used for irrigation) Group 2: Experimental group - Pancreatoduode

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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

Measure	Time frame
• 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	—

Measure

Time frame

• 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

—

Countries

Germany

Contacts

Public ContactPatrick;Nuh N. Téoule;Rahbari

Universitätsklinikum Ulm, Allgemein- und Viszeralchirurgie;Universität Heidelberg, Medizinische Fakultät Mannheim, Chirurgische Klinik

patrick.teoule@umm.de;nuh.rahbari@umm.de+49621383-2225;+49621-383-2225

Outcome results

None listed

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