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Feasibility of a 4-Week Intensive Postoperative Multimodal Rehabilitation Program in Complicated Patients After Proximal Pancreatectomy: A Prospective Single-Cohort Study

NCT07768384 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-08-17

No results posted yet for this study

Summary

The REACT study is a prospective, single-center, single-cohort study designed to evaluate the feasibility of a 4-week intensive multimodal postoperative rehabilitation program in patients who develop severe complications after proximal pancreatic resection (pancreatoduodenectomy or total pancreatectomy).

Postoperative complications after pancreatic surgery may result in substantial physiological and metabolic stress, leading to loss of muscle mass, malnutrition, reduced functional capacity, and delayed recovery. Although prehabilitation programs have been proposed to improve patients' functional capacity before surgery, evidence regarding structured multimodal rehabilitation after pancreatic surgery is currently lacking.

Adult patients undergoing elective proximal pancreatic resection who develop a severe postoperative complication (Comprehensive Complication Index \>21) will be eligible for the study. Participants will undergo a 4-week multimodal rehabilitation program starting after hospital discharge and including individualized exercise training, nutritional therapy, and anxiety-reducing techniques. The program may be delivered either in a supervised hospital-based setting or through a home-based program according to patient preference and availability.

The primary objective is to assess the feasibility of the rehabilitation program in terms of recruitment, adherence, completion of outcome assessments, completeness of data, and safety. Secondary objectives include evaluating postoperative functional recovery using PROMIS-29 Physical and Mental Health Summary Scores, the 6-minute walk test, and the Duke Activity Status Index. In patients with malignancy who are candidates for adjuvant treatment, return to intended oncologic treatment will also be evaluated.

A total of 40 patients will be enrolled and followed for up to 90 days after surgery.

Conditions

Interventions

BEHAVIORAL

Multimodal Postoperative Rehabilitation Program

Participants will undergo a 4-week multimodal postoperative rehabilitation program starting during the first week after hospital discharge. The program includes individualized exercise training, nutritional therapy, and anxiety-reducing techniques. Exercise includes moderate-intensity endurance, resistance, and breathing exercises tailored to the patient's clinical condition and may be delivered in a hospital-based or home-based setting. Nutritional therapy consists of an individualized dietary plan, with a recommended protein intake of 1.5-2.0 g/kg of ideal body weight and whey protein supplementation if needed. Participants will also receive instruction in relaxation techniques, including imagery, visualization, and deep-breathing exercises. The program is delivered by qualified physiotherapists, nutritionists, and psychology-trained personnel.

Sponsors & Collaborators

  • IRCCS San Raffaele

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-30
Primary Completion
2027-03-31
Completion
2028-03-31

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Entities

Diseases

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 NCT07768384 on ClinicalTrials.gov