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

Browse trials for

• Postoperative Complications 1,233

Keywords

• diagnosis
• treatment
• complications
• esophagectomy

Postoperative Complications

1,233 studies on the registry are indexed under Postoperative Complications; 292 are open to participants now.

This study's planned enrollment of 1,050 is above the median of 119 across 689 interventional studies indexed under Postoperative Complications.

Lead sponsor

Radboud University Medical Center is the lead sponsor of 959 studies on the registry; 134 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Study arms

• Active comparator
  Usual Care

  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

• OtherWash-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 testAlgorithm-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.

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).

   Time frame: 90 days

Secondary outcomes

1. General quality of life

   General quality of life, as measured using the validated EuroQol EQ-5D-5L questionnaire. Assessment will be performed at 6 weeks and 3, 6 and 12 months.

   Time frame: 6 weeks, and 3, 6, and 12 months after esophagectomy

2. Time to functional recovery

   Time to functional recovery, defined as when a patient does not need intravenous fluid, has adequate pain control with oral analgesia (Numeric Rating Scale ≤4), restored mobility to an independent level (e.g. walk to the toilet with(out) walking aids and transfer bed/chair) or back to the previous functioning level of mobilization, sufficient caloric intake (minimum of 50% of the required calories), no signs of an active infection (no fever and declining CRP levels).

   Time frame: 90 days after esophagectomy

3. Comprehensive Complications index

   Comprehensive Complications Index, a measure for the severity of all complications together.

   Time frame: 90 days after esophagectomy

4. Failure to rescue

   Failure to rescue, defined as the rate of mortality in patients with a complication within 90-days after esophagectomy.

   Time frame: 90 days after esophagectomy

5. Length of hospital (intensive care unit) stay

   Length of hospital and ICU stay, defined as the amount of days the patient stays in the ICU and in the hospital during 90 days postoperatively.

   Time frame: 90 days after esophagectomy

6. Succes of algorithm implementation

   succes of implementation (i.e. proportion of patients' days in which the algorithm was not followed)

   Time frame: 90 days after esophagectomy

7. Economic evaluation

   Cost-efficacy analysis will be performed from a societal perspective, including both medical and non-medical costs. Economic evaluation will be performed at 12 months follow-up. Medical resource use will be recorded from hospital records, including length of stay, laboratory and diagnostics use and treatment of complications. Medical resource use as well as out-of-pocket expenses will be recorded using iMTA Medical Consumption Questionnaire (iMCQ). \[26\] Resource use will be multiplied by associated unit costs to obtain total costs. Standard cost prices from the 'Dutch Guidelines for Cost Analyses' and www.medicijnkosten.nl will be used. Volumes of care will be multiplied by the cost price of each volume to calculate costs.

   Time frame: 3,6 and 12 months after esophagectomy

8. Productivity losses

   Productivity losses will be measured using the iMTA Productivity Cost Questionnaire (iPCQ).

   Time frame: 3,6 and 12 months after esophagectomy

9. Budget Impact Analysis

   Budget Impact Analysis (BIA) will be performed to assess the financial consequences of implementing the algorithm-based care, wherein the internationally accepted principles of ISPOR for the design, implementation and reporting of the BIA will be used. The third party payer perspective will be adopted to inform a business case for reimbursement companies.

   Time frame: 3,6 and 12 months after esophagectomy

10. Cancer-specific quality of life

    Cancer-specific quality of life, as measured using the validated EIRTC QLQ-C30 questionnaire. Assessment will be performed at 6 weeks and 3, 6 and 12 months.

    Time frame: 6 weeks, and 3, 6, and 12 months after esophagectomy

11. Esophageal cancer-specific quality of life

    Esophageal cancer-specific quality of life, as measured using the validated EORTC QLQ-OG25 questionnaire. Assessment will be performed at 6 weeks and 3, 6 and 12 months.

    Time frame: 6 weeks, and 3, 6, and 12 months after esophagectomy

Individual participant data

Plan to share: Undecided — This concerns a conceptual registration.