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

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

• Diagnosis and Treatment of Complications After Esophagectomy

Interventions

OTHER

Wash-in period

The 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_TEST

Algorithm-based care

During 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.

Sponsors & Collaborators

• Catharina Ziekenhuis Eindhoven

  collaborator OTHER

• Erasmus Medical Center

  collaborator OTHER

• University Medical Center Groningen

  collaborator OTHER

• Hospital Group Twente (ZGT)

  collaborator UNKNOWN

• Antoni van Leeuwenhoek Hospital

  collaborator OTHER

• Leiden University Medical Center

  collaborator OTHER

• Elisabeth-TweeSteden Ziekenhuis

  collaborator OTHER

• medical center leeuwarden

  collaborator UNKNOWN

• Zuyderland Medical Centre

  collaborator OTHER

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

  collaborator OTHER

• Reinier de Graaf Groep

  collaborator OTHER

• Gelre Hospitals

  collaborator OTHER

• UMC Utrecht

  collaborator OTHER

• Radboud University Medical Center

  lead OTHER

Study Design

Allocation

NA

Purpose

OTHER

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-06-01

Primary Completion

2027-07-01

Completion

2028-07-01