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Evaluation of Prehabilitation as a Strategy to Minimize Surgical Risk in Pancreatic Surgery: Efficacy and Determining Factors.

NCT05489419 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2022-08-05

No results posted yet for this study

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.

Conditions

  • Pancreatic Neoplasms
  • Anesthesia

Interventions

BEHAVIORAL

Multimodal Prehabilitation

Physical and cardiopulmonary training, personalized nutrition and treatment of anxiety and depression.

Sponsors & Collaborators

  • Hospital Clinic of Barcelona

    lead OTHER

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-01
Primary Completion
2023-05-30
Completion
2023-05-30

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05489419 on ClinicalTrials.gov