Drainless Robot-assisted Minimally Invasive Esophagectomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-19

Study Completion Date

2024-05-21

Brief Summary

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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.

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Detailed Description

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Conditions

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Esophageal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled multicentric trial

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A - Early removal of chest drain

Group Type EXPERIMENTAL

Early removal of chest drain

Intervention Type PROCEDURE

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

B - Control

Group Type OTHER

Chest drain

Intervention Type PROCEDURE

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

Interventions

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Early removal of chest drain

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

Intervention Type PROCEDURE

Chest drain

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

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No