Clinical Trials Directory

Trials / Not Yet Recruiting

Not Yet RecruitingNCT06762652

ImpRovEd Care After eSophageCtomy Using an Algorithm for postoperativE Complications - RESCUE Trial

Status
Not Yet Recruiting
Phase
N/A
Study type
Interventional
Enrollment
1,050 (estimated)
Sponsor
Radboud University Medical Center · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

The objective of the RESCUE-trial is to investigate whether implementation of a consensus-based clinical care algorithm to standardize diagnosis and management of postoperative complications reduces 90-day mortality, ICU (re)admission and surgical interventions after esophagectomy for esophageal cancer.

Conditions

Interventions

TypeNameDescription
OTHERWash-in periodThe goal of the wash-in period between the control and intervention period is to intensively educate and train physicians to use the algorithm as intended during daily postoperative care. The coordinating investigator along with the local principal investigator will be responsible for this training. Training will be performed in a standardized approach in order to guarantee uniformity across centres.
DIAGNOSTIC_TESTAlgorithm-based careDuring the intervention period, (participating) patients will receive algorithm-based care. The RESCUE algorithm is a consensus-based clinical care algorithm developed to standardize postoperative care. The algorithm includes the same modalities as applied in usual care, and does not include novel/experimental modalities, but rather offers a novel, standardized approach to guide the use of common modalities during postoperative care. The daily objective evaluation of patients' condition, vital signs and biochemical parameters is thought to aid early diagnosis of complications after esophagectomy which enables treatment before systemic symptoms become apparent and prevent development of sepsis. Physicians are always allowed to deviate from the RESCUE, but reasons for deviating will be recorded.

Timeline

Start date
2025-06-01
Primary completion
2027-07-01
Completion
2028-07-01
First posted
2025-01-07
Last updated
2025-01-07

Source: ClinicalTrials.gov record NCT06762652. Inclusion in this directory is not an endorsement.