Feasibility of a 4-Week Intensive Postoperative Multimodal Rehabilitation Program in Complicated Patients After Proximal Pancreatectomy: A Prospective Single-Cohort Study
- Pancreatic Diseases
At a glance
- Phase
- Phase not stated
- Study type
- Interventional
- Sponsor
- IRCCS San Raffaele
- Enrolment target
- 40
- Started
- 25 September 2026
- Main results due
- 31 March 2027
- Study sites
- 1
- Registry updated
- 29 September 2026
Can you take part?
- Aged 18 years and over.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility criteria
* Inclusion Criteria: * 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. * Exclusion Criteria: * 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.
What this study is about
In the sponsor’s own words, from the registry.
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.
Study sites(1)
Ospedale San Raffaele
Milan, Italy
Recruiting
Showing 1 of 1 sites. 1 of the 1 site on this study is recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT07768384. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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