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Not yet recruiting NCT06762652

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

No phase Interventional Diagnosis and Treatment of Complications After Esophagectomy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Wash-in period, Algorithm-based care.
Who it may be relevant to
Registry conditions: Diagnosis and Treatment of Complications After Esophagectomy. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

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 s

Primary outcome measures

  • Severe complications [Time frame: 90 days]
Secondary outcome measures (11)
  • General quality of life [Time frame: 6 weeks, and 3, 6, and 12 months after esophagectomy]
  • Time to functional recovery [Time frame: 90 days after esophagectomy]
  • Comprehensive Complications index [Time frame: 90 days after esophagectomy]
  • Failure to rescue [Time frame: 90 days after esophagectomy]
  • Length of hospital (intensive care unit) stay [Time frame: 90 days after esophagectomy]
  • Succes of algorithm implementation [Time frame: 90 days after esophagectomy]
  • Economic evaluation [Time frame: 3,6 and 12 months after esophagectomy]
  • Productivity losses [Time frame: 3,6 and 12 months after esophagectomy]
  • Budget Impact Analysis [Time frame: 3,6 and 12 months after esophagectomy]
  • Cancer-specific quality of life [Time frame: 6 weeks, and 3, 6, and 12 months after esophagectomy]
  • Esophageal cancer-specific quality of life [Time frame: 6 weeks, and 3, 6, and 12 months after esophagectomy]

Eligibility criteria

Inclusion criteria

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

  • Age ≥ 18 years
  • Histologically proven esophageal or gastro-esophageal junction carcinoma (cT1-4aN0-3M0)
  • 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.
  • 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:

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Crossover
Masking
Open label
Primary purpose
Other

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06762652 · 2024-17562 · 10390032310024

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗