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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorIRCCS San Raffaele

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Multimodal Postoperative Rehabilitation Program

Treatment groups

40 Participants
are divided into 1 treatment group

Locations

This trial has no locations

Sponsors and collaborators