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.

Study Overview

• Status: Recruiting
• Conditions: Pancreatic Neoplasms; Anesthesia
• Intervention / Treatment: Behavioral: Multimodal Prehabilitation

• Study Type: Interventional
• Enrollment (Anticipated): 56
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Carol González, MD; Phone Number: +34638725100; Email: carol.gonzaleza@gmail.com

Study Locations

• Spain
  • Barcelona, Spain, 08036
    • Recruiting
    • Hospital Clinic de Barcelona
    • Contact: Carol González, MD; Phone Number: +34638725100; Email: carol.gonzaleza@clinic.cat

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Prehabilitation; Patients undergo prehabilitation during 3-4 weeks before undergoing pancreatic surgery.	Behavioral: Multimodal Prehabilitation; Physical and cardiopulmonary training, personalized nutrition and treatment of anxiety and depression.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Hospital Clinic of Barcelona

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Anticipated): May 30, 2023
• Study Completion (Anticipated): May 30, 2023

Study Registration Dates

• First Submitted: July 4, 2022
• First Submitted That Met QC Criteria: August 3, 2022
• First Posted (Actual): August 5, 2022

Study Record Updates

• Last Update Posted (Actual): August 5, 2022
• Last Update Submitted That Met QC Criteria: August 3, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms
• Other Study ID Numbers: HCB/2020/0477

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No