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

NCT06762652 | Not Yet Recruiting

• 2 other identifiers: 2024-1756210390032310024
• Study Type: interventional
• Target: 1,050
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Diagnosis and Treatment of Complications After Esophagectomy

Keywords

diagnosis; treatment; complications; esophagectomy

Outcome Measures

Primary Outcomes (1)

• Severe complications

  The primary outcome measure is the incidence of severe complications (i.e. Clavien-Dindo ≥ 3b). Severe complications are defined as a composite endpoint with one or more of the following criteria within 90 days after esophagectomy: 1. The complication was treated under general anaesthesia. 2. Postoperative mortality. 3. Escalation of care due to new onset or progressive organ failure (i.e. patients requiring vasopression, dialysis, (re-)intubation, (re)admission to a medium care or intensive care unit).

  90 days

Secondary Outcomes (11)

• General quality of life

  6 weeks, and 3, 6, and 12 months after esophagectomy

• Time to functional recovery

  90 days after esophagectomy

• Comprehensive Complications index

  90 days after esophagectomy

• Failure to rescue

  90 days after esophagectomy

• Length of hospital (intensive care unit) stay

  90 days after esophagectomy

Study Arms (1)

Usual Care

ACTIVE COMPARATOR

During the control period, (participating) patients will receive usual postoperative care. Postoperative care, including diagnosis and management of postoperative complications, will be performed in line with local standards and/or protocols. For diagnosis of complications, physicians may perform laboratory tests such as CRP or leucocyte count, and diagnostic imaging such as CT-scan, X-ray or endoscopy. For treatment of complications, conservative, radiological, endoscopic and surgical treatments are often applied.

Other: Wash-in period; Diagnostic Test: Algorithm-based care

Interventions

Wash-in period OTHER

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.

Usual Care

Algorithm-based care DIAGNOSTIC_TEST

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.

Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• Ability to provide written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Radboud University Medical Center: lead
• Catharina Ziekenhuis Eindhoven: collaborator
• Erasmus Medical Center: collaborator
• University Medical Center Groningen: collaborator
• Hospital Group Twente (ZGT): collaborator
• Antoni van Leeuwenhoek Hospital: collaborator
• Leiden University Medical Center: collaborator
• Elisabeth-TweeSteden Ziekenhuis: collaborator
• medical center leeuwarden: collaborator
• Zuyderland Medical Centre: collaborator
• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): collaborator
• Reinier de Graaf Groep: collaborator
• Gelre Hospitals: collaborator
• UMC Utrecht: collaborator

MeSH Terms

Conditions

Disease

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Jobbe M.G. Lemmens, MD

CONTACT

0652331762; Jobbe.Lemmens@radboudumc.nl

Gijs van Dongen, MD

CONTACT

gijs.vandongen@radboudumc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Stepped-wedge cluster-randomized superiority trial.

Study Record Dates

• First Submitted: December 19, 2024
• First Posted: January 7, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2028
• Last Updated: January 7, 2025

Record last verified: 2024-12