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

NCT07768384 | Recruiting

• 1 other identifier: REACT
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Pancreatic Diseases

Keywords

Pancreatic Surgery; Multimodal Rehabilitation; Functional Recovery; Postoperative Rehabilitation; Postoperative Complications

Outcome Measures

Primary Outcomes (1)

• Feasibility of the multimodal postoperative rehabilitation program

  Feasibility will be assessed according to five predefined criteria: 1. ≥50% of eligible patients agree to participate; 2. ≥80% of enrolled patients adhere to the program; 3. ≥80% complete the post-rehabilitation outcome assessment; 4. missing data among patients completing outcome assessments are \<10%; (5) no serious adverse events related to the rehabilitation program occur. The intervention will be considered feasible only if all five criteria are met.

  At the end of the 4-week rehabilitation program

Secondary Outcomes (4)

• PROMIS-29 Physical Health Summary Score recovery

  At hospital discharge, at the end of the 4-week rehabilitation program, and 90 days after surgery

• PROMIS-29 Mental Health Summary Score recovery

  At hospital discharge, at the end of the 4-week rehabilitation program, and 90 days after surgery

• Six-Minute Walk Test recovery

  At hospital discharge, at the end of the 4-week rehabilitation program, and 90 days after surgery

• Duke Activity Status Index recovery

  At hospital discharge, at the end of the 4-week rehabilitation program, and 90 days after surgery

Study Arms (1)

Multimodal Postoperative Rehabilitation

EXPERIMENTAL

Participants will receive a 4-week intensive multimodal postoperative rehabilitation program starting during the first week after hospital discharge. The program includes individualized exercise training, nutritional therapy, and anxiety-reducing techniques, tailored to each participant's clinical, physical, nutritional, and psychological condition. Exercise training will be delivered either in a supervised hospital-based setting or through a home-based program according to patient preference and availability. All participants will receive the multimodal rehabilitation program in addition to standard care

Behavioral: Multimodal Postoperative Rehabilitation Program

Interventions

Multimodal Postoperative Rehabilitation Program BEHAVIORAL

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.

Multimodal Postoperative Rehabilitation

Eligibility Criteria

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

You may qualify if:

• Age ≥18 years.
• Patients undergoing elective proximal pancreatic resection (pancreatoduodenectomy or total pancreatectomy).
• Patients developing a severe postoperative complication during their hospital stay, defined as a Comprehensive Complication Index (CCI) \>21.

You may not qualify if:

• Metastatic disease.
• Surgical procedures other than pancreatoduodenectomy or total pancreatectomy.
• Inability to speak Italian.
• Cognitive impairment or illiteracy resulting in inability to read and understand the Italian language.
• Medical conditions contraindicating the rehabilitation regimen (exercise and nutritional intervention), including orthopedic or cognitive disabilities and chronic renal failure (dialysis or creatinine \>250 mmol).
• Pregnancy.

Sponsors & Collaborators

• IRCCS San Raffaele: lead

Study Sites (1)

Ospedale San Raffaele

Milan, Italy

RECRUITING

MeSH Terms

Conditions

Pancreatic Diseases; Postoperative Complications

Condition Hierarchy (Ancestors)

Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Nicolò pecorelli

CONTACT

0226437810; pecorelli.nicolo@hsr.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 11, 2026
• First Posted: August 17, 2026
• Study Start: September 25, 2026
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2028
• Last Updated: September 29, 2026

Record last verified: 2026-09

Locations

IT (1)