Drainless Robot-assisted Minimally Invasive Esophagectomy

Technische Universität Dresden49 enrolled

Overview

The aim of this study is the evaluation of two different chest drain management strategies in patients undergoing robot-assisted minimally invasive esophagectomy (RAMIE) for esophageal cancer with regard to perioperative complications until discharge.The primary objective of the study is to investigate whether the intensity of postoperative pain can be significantly reduced by avoiding thoracic drains after RAMIE. We assume that this will influence secondary endpoints such as early recovery and length of hospital stay.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Esophageal Cancer

Interventions

Early removal of chest drainPROCEDURE

Chest drains are removed 3 hours after the end of surgery in absence of contraindications in arm A.

Chest drainPROCEDURE

The chest drains in arm B are removed during the further postoperative course according to standard algorithm.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients scheduled for elective RAMIE for esophageal cancer with intrathoracic esophagogastrostomy (Ivor-Lewis) * American Society of Anesthesiologists (ASA) score ≤ III * Eastern Cooperative of Oncology Group (ECOG) status ≤ II * Patient suitable for both surgical techniques * Ability of subject to understand character and individual consequences of the clinical trial * Written informed consent Exclusion Criteria: * Open esophagectomy (either abdominal or during the thoracic part) * Emergency operations * ASA IV * ECOG \> II * Chronic pain syndromes requiring routine analgesics * Simultaneous lung resection * Presence of contraindications to the use of epidural anesthesia (e.g. coagulopathies, anticoagulation or allergies) * Participation in an interventional trial, which interferes with the outcome * Impaired mental state

Locations (1)

Department of Gastrointestinal-, Thoracic and Vascular Surgery University Hospital Carl Gustav Carus Technische Universität Dresden

Dresden, Saxony, Germany

Outcomes

Primary Outcomes

Postoperative pain

Postoperative pain according to a numeric rating scale

Time frame: Day 2 after surgery

Secondary Outcomes

Mean postoperative pain

Postoperative pain according to a numeric rating scale

Time frame: Day 4 after surgery

Additional analgesic drug use

opioids \[mg\], non-opioids \[mg\]

Time frame: Day 4 after surgery

Postoperative mobilization

steps per day as measured with an activity tracker

Time frame: Day 7 after surgery

Postoperative morbidity

The postoperative morbidity of all patients is assessed with the comprehensive complication index based on Clavien Dindo classification from postoperative day 1 until day of discharge

Time frame: Through hospital stay, an average of 14 days

Postoperative mortality

The postoperative mortality of all patients is assessed between operation date and date of death of any cause during hospital stay

Time frame: Through hospital stay, an average of 14 days

Daily postoperative pain

Postoperative pain according to a numeric rating scale measured daily from postoperative day 1-7

Time frame: Day 7 after surgery

Data from ClinicalTrials.gov

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