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

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

Sponsors

Lead Sponsor: Hospital Clinic of Barcelona

Source Hospital Clinic of Barcelona
Brief 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.

Overall Status Recruiting
Start Date 2021-01-01
Completion Date 2023-05-30
Primary Completion Date 2023-05-30
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Efficacy of a multimodal prehabilitation 4 weeks
Secondary Outcome
Measure Time Frame
Evaluation of the adherence to the program 30 days
Evaluation of sarcopenia after prehabilitation 4 weeks
Evaluation of the impact on perceived quality of life 4 weeks
Evaluation of the impact on the inflammatory response after the intervention 30 days
Evaluation of the impact on the incidence of postoperative complications 30 days
Evaluation of complications severity 30 days
Enrollment 56
Condition
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

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

Overall Contact

Last Name: Carol González, MD

Phone: +34638725100

Email: [email protected]

Location
Facility: Status: Contact: Hospital Clinic de Barcelona Carol González, MD +34638725100 [email protected]
Location Countries

Spain

Verification Date

2022-07-01

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: Prehabilitation

Type: Experimental

Description: Patients undergo prehabilitation during 3-4 weeks before undergoing pancreatic surgery.

Patient Data No
Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Prevention

Masking: None (Open Label)

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