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Trial Title:
Evaluation of Prehabilitation as a Strategy to Minimize Surgical Risk in Pancreatic Surgery: Efficacy and Determining Factors.
NCT ID:
NCT05489419
Condition:
Pancreatic Neoplasms
Anesthesia
Conditions: Official terms:
Pancreatic Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Unknown status
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Prevention
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Multimodal Prehabilitation
Description:
Physical and cardiopulmonary training, personalized nutrition and treatment of anxiety
and depression.
Arm group label:
Prehabilitation
Summary:
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Adult patients eligible for pancreatic surgery (PD) who are considered high risk
based on the findings of the CPET (anaerobic threshold, AU <11ml/kg/min) (Older P et
al. Crit Care. 2004;8:369-72) and accepted as candidates for said surgery by the
multidisciplinary committee of our Institution.
Exclusion Criteria:
- Non-elective surgery;
- Palliative surgery;
- Unstable respiratory or cardiac disease;
- Locomotor or cognitive limitations that prevent adherence to the program;
- Refusal to participate in the study.
Gender:
All
Minimum age:
N/A
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Hospital Clinic de Barcelona
Address:
City:
Barcelona
Zip:
08036
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Carol González, MD
Phone:
+34638725100
Email:
carol.gonzaleza@clinic.cat
Start date:
January 1, 2021
Completion date:
May 30, 2023
Lead sponsor:
Agency:
Hospital Clinic of Barcelona
Agency class:
Other
Source:
Hospital Clinic of Barcelona
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05489419
