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

NCT05489419 | Unknown

• 1 other identifier: HCB/2020/0477
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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. 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. 2.Personalized nutrition program adapted to the underlying disease (exocrine insufficiency, cachexia and sarcopenia, diabetes).
3. 3.Treatment of anxiety and depression.

Conditions

Pancreatic Neoplasms; Anesthesia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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

Study Arms (1)

Prehabilitation

EXPERIMENTAL

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

Behavioral: Multimodal Prehabilitation

Interventions

Multimodal Prehabilitation BEHAVIORAL

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

Prehabilitation

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Clinic of Barcelona: lead

Study Sites (1)

Hospital Clinic de Barcelona

Barcelona, 08036, Spain

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Central Study Contacts

Carol González, MD

CONTACT

+34638725100; carol.gonzaleza@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2022
• First Posted: August 5, 2022
• Study Start: January 1, 2021
• Primary Completion: May 30, 2023
• Study Completion: May 30, 2023
• Last Updated: August 5, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)