Clinical trial NCT06762652: ImpRovEd Care After eSophageCtomy Using an Algorithm for postoperativE Complications - RESCUE Trial
Official title: ImpRovEd Care After eSophageCtomy Using an Algorithm for postoperativE Complications - RESCUE Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Diagnosis and Treatment of Complications After Esophagectomy
Keywords: diagnosis
treatment
complications
esophagectomy
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: Catharina Ziekenhuis Eindhoven
name: Erasmus Medical Center
name: University Medical Center Groningen
name: Hospital Group Twente (ZGT)
name: Antoni van Leeuwenhoek Hospital
name: Leiden University Medical Center
name: Elisabeth-TweeSteden Ziekenhuis
name: medical center leeuwarden
name: Zuyderland Medical Centre
name: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
name: Reinier de Graaf Groep
name: Gelre Hospitals
name: UMC Utrecht
First posted: 2025-01-07
Enrollment: 1050
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: CROSSOVER
Intervention model description: Stepped-wedge cluster-randomized superiority trial.
Primary purpose: OTHER

Brief 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.


Eligibility criteria: Inclusion Criteria:

In order to be eligible to participate in this study, a subject must meet all of the following criteria:

1. Age ≥ 18 years
2. Histologically proven esophageal or gastro-esophageal junction carcinoma (cT1-4aN0-3M0)
3. Scheduled to undergo curatively-intended esophagectomy with gastric tube reconstruction. All techniques (i.e. minimally invasive, robotic, hybrid, open) and approaches (i.e. transthoracic, transcervical, transhiatal) of esophagectomy are suitable for inclusion.
4. Ability to provide written informed consent

Exclusion Criteria:

A potential subject who meets any of the following criteria will be excluded from participation in this study:

1. Emergency resection
2. Patients who underwent (additional) total gastrectomy
3. Patients who underwent reconstruction using colonic or jejunal interposition
4. Patients in whom no anastomosis is created during resection
5. Secondary malignancy which determines prognosis

Primary outcomes:
measure: Severe complications
timeFrame: 90 days
Secondary outcomes:
measure: General quality of life
timeFrame: 6 weeks, and 3, 6, and 12 months after esophagectomy
measure: Time to functional recovery
timeFrame: 90 days after esophagectomy
measure: Comprehensive Complications index
timeFrame: 90 days after esophagectomy
measure: Failure to rescue
timeFrame: 90 days after esophagectomy
measure: Length of hospital (intensive care unit) stay
timeFrame: 90 days after esophagectomy
measure: Succes of algorithm implementation
timeFrame: 90 days after esophagectomy
measure: Economic evaluation
timeFrame: 3,6 and 12 months after esophagectomy
measure: Productivity losses
timeFrame: 3,6 and 12 months after esophagectomy
measure: Budget Impact Analysis
timeFrame: 3,6 and 12 months after esophagectomy
measure: Cancer-specific quality of life
timeFrame: 6 weeks, and 3, 6, and 12 months after esophagectomy
measure: Esophageal cancer-specific quality of life
timeFrame: 6 weeks, and 3, 6, and 12 months after esophagectomy
Other outcomes:
Locations:
Study officials:
References: