NCT02024776

Effectiveness of Prehabilitation Program for High-risk Patients Underwent Abdominal Surgery

Completed NA Last updated 17 April 2019

What this trial tests

NA trial testing Prehabilitation in Abdominal Surgical Patient in 141 participants. Completed in 30 January 2017.

Timeline

1 February 2014

Primary endpoint
30 August 2016

30 January 2017

Quick facts

Lead sponsor	Hospital Clinic of Barcelona
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	141
Start date	1 February 2014
Primary completion	30 August 2016
Estimated completion	30 January 2017
Sites	1 location across Spain

Drugs / interventions tested

• Prehabilitation

Conditions studied

• Abdominal Surgical Patient — all drugs for Abdominal Surgical Patient →
• High-risk Patient — all drugs for High-risk Patient →

Sponsor

Hospital Clinic of Barcelona

Who can join

18 and older, any sex, with Abdominal Surgical Patient or High-risk Patient. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Despite recent advances, morbidity and mortality associated to major abdominal surgery is significant. A poor physical condition and functional status reduces the ability of a person to cope, mentally and physically, with hospitalization and surgery and may compromise functional recovery, potentially leading to postoperative complications and death. Prehabilitation aims to enhance functional capacity preoperatively for better toleration of surgery and to facilitate recovery and eventually the prognosis of the surgical patient. Whereas the benefits of cardiopulmonary fitness programs are well established, the accessibility, sustainability of effects, and impact on the surgical outcome of these programs are unsolved issues. Wellness programs based on integrated care services supported by Information and Communication Technology (ICT) can overcome such limitations. The investigators hypothesized that a prehabilitation program, inducing beneficial effects on exercise capacity, may improve the surgical outcome in high-risk patients. Moreover, ICT support may contribute to increase the adherence and sustainability of this intervention.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Post-discharge impact and cost-consequence analysis of prehabilitation in high-risk patients undergoing major abdominal surgery: secondary results from a randomised controlled trial.
   Barberan-Garcia A, Ubre M, Pascual-Argente N, Risco R, et al · · 2019 · cited 81× · PMID 31248644 · DOI 10.1016/j.bja.2019.05.032