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NOT YET RECRUITING
NCT07768384
NA

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

Sponsor: IRCCS San Raffaele

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2026-09

Completion Date

2028-03-31

Last Updated

2026-08-17

Healthy Volunteers

No

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.