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

Not Applicable

• Conditions: Anesthesia; Pancreatic Neoplasms
• Interventions: Behavioral: Multimodal Prehabilitation

• Registration Number: NCT05489419
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-01
• Status Verified: 2022-07
• Study First Submitted: 2022-07-04
• Study First Submitted QC: 2022-08-03
• Last Update Submitted: 2022-08-03
• Study First Posted: 2022-08-05
• Last Update Posted: 2022-08-05
• Primary Completion: 2023-05-30
• Study Completion: 2023-05-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 56

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Prehabilitation	Multimodal Prehabilitation	Patients undergo prehabilitation during 3-4 weeks before undergoing pancreatic surgery.

Primary Outcome Measures

Name	Time	Method
Efficacy of a multimodal prehabilitation	4 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Evaluation of the adherence to the program	30 days	Assess the % of sessions that the patient has completed
Evaluation of sarcopenia after prehabilitation	4 weeks	Sarcopenia analyzed objectively with a CT scan.
Evaluation of the impact on the incidence of postoperative complications	30 days	Incidence of complications
Evaluation of the impact on perceived quality of life	4 weeks	Evaluation of the impact of the program in patient quality of life according EuroQol (Qual Life Res. 1999 ;8:303-10)
Evaluation of the impact on the inflammatory response after the intervention	30 days	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.
Evaluation of complications severity	30 days	Complications according Clavien-Dindo Classification

Trial Locations

Locations (1)

Hospital Clinic de Barcelona; 🇪🇸 Barcelona, Spain