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2021-01-01
2023-05-30
2023-05-30
56
NCT05489419
Hospital Clinic of Barcelona
Hospital Clinic of Barcelona
INTERVENTIONAL
Evaluation of Prehabilitation as a Strategy to Minimize Surgical Risk in Pancreatic Surgery: Efficacy and Determining Factors.
Several studies in major abdominal surgery demonstrated that preoperative optimization of surgical patients through prehabilitation is associated with fewer postoperative complications. However, patients' response to preoperative optimization is unpredictable, and there are no studies confirming the real benefit in pancreatic surgery. Aims: To assess the benefits of pre-rehabilitation in pancreatic surgery, and identify those factors associated with an effective optimization. Secondary aims: impact of prehabilitation on nutritional status, sarcopenia, quality of life, inflammation markers, postoperative complications and hospital stay compared to low-risk patients. Design: An objective multimodal assessment will be performed on those patients who are candidates to pancreaticoduodenectomy (PD) to identify patients at high-risk of postoperative complications. These patients will undergo prehabilitation and response will be evaluated. Intervention:Multimodal Prehabilitation will include: 1. Physical and cardiopulmonary training followed by a personalized program according to basal aerobic capacity, patient circumstances and compliance, community-based and remote-controlled with information and communication technology (ICT). 2. Personalized nutrition program adapted to the underlying disease (exocrine insufficiency, cachexia and sarcopenia, diabetes). 3. Treatment of anxiety and depression. Subjects: 56 consecutive patients who are high-risk candidates (anaerobic threshold 11ml/kg/min at CPET) for PD recruited at Hospital Clinic of Barcelona. Postoperative variables will be compared to low-risk patients evaluated during the same study period. Analysis: The main variable will be aerobic capacity (VO2max, AT). Secondary variables (before and after the program) will be nutritional status, sarcopenia, quality of life, inflammation markers and immune response, hospital stay, complications, 90-days mortality and costs.
N/A
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2022-07-04 | N/A | 2022-08-03 |
2022-08-03 | N/A | 2022-08-05 |
2022-08-05 | N/A | 2022-07 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Prevention
Allocation:
Na
Interventional Model:
Single Group
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: Prehabilitation Patients undergo prehabilitation during 3-4 weeks before undergoing pancreatic surgery. | BEHAVIORAL: Multimodal Prehabilitation
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Efficacy of a multimodal prehabilitation | To evaluate the efficacy of a multimodal prehabilitation program in high risk surgical patients undergoing oncological resection of the pancreas in terms of improvement in aerobic capacity (peak oxygen consumption, anaerobic threshold) measured through a CPET. | 4 weeks |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Evaluation of the adherence to the program | Assess the % of sessions that the patient has completed | 30 days |
| Evaluation of sarcopenia after prehabilitation | Sarcopenia analyzed objectively with a CT scan. | 4 weeks |
| Evaluation of the impact on perceived quality of life | Evaluation of the impact of the program in patient quality of life according EuroQol (Qual Life Res. 1999 ;8:303-10) | 4 weeks |
| Evaluation of the impact on the inflammatory response after the intervention | Presence or abscence of Systemic Inflammatory Response Syndrome (SIRS) during the preoperative period. SIRS defined by two of the following criteria: Body temperature over 38 or under 36 degrees Celsius. Heart rate greater than 90 beats/minute Respiratory rate greater than 20 breaths/minute or partial pressure of CO2 less than 32 mmHg Leucocyte count greater than 12000 or less than 4000 /microliters or over 10% immature forms or bands. | 30 days |
| Evaluation of the impact on the incidence of postoperative complications | Incidence of complications | 30 days |
| Evaluation of complications severity | Complications according Clavien-Dindo Classification | 30 days |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Carol González, MD Phone Number: +34638725100 Email: carol.gonzaleza@gmail.com |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
