Pancreatectomy Clinical Trials

Clinical trials related to Pancreatectomy Procedure

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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Italy
Ospedale San Raffaele
RECRUITING
Milan
Contact Information
Primary
Nicolò pecorelli
pecorelli.nicolo@hsr.it
0226437810
Time Frame
Start Date: 2026-09-25
Estimated Completion Date: 2028-03-31
Participants
Target number of participants: 40
Treatments
Experimental: Multimodal Postoperative Rehabilitation
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
Sponsors
Leads: IRCCS San Raffaele

This content was sourced from clinicaltrials.gov