Drainless Robot-assisted Minimally Invasive Esophagectomy

Studien-Informationen Einschlusskriterien Studien-Rationale Studien-Arme Geprüfte Regime

Rekrutierend

NCT-Nummer:
NCT05553795

Studienbeginn:
April 2023

Letztes Update:
28.04.2023

Wirkstoff:
-

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Technische Universität Dresden

Collaborator:
German Cancer Research Center

Studienleiter

Johanna Kirchberg, Dr. med.
Principal Investigator
Department of Gastrointestinal-, Thoracic and Vascular Surgery University Hospital Carl Gustav Carus

Kontakt

Korn, Dr. rer. nat.
Kontakt:
Phone: +493514584098
E-Mail: studienzentrum-vtg@uniklinikum-dresden.de» Kontaktdaten anzeigen

Studienlocations
(1 von 1)

Department of Gastrointestinal-, Thoracic and Vascular Surgery University Hospital Carl Gustav Carus Technische Universität Dresden
01307 Dresden
(Sachsen)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Johanna Kirchberg, Dr. med.» Ansprechpartner anzeigen

Studien-Informationen

Brief Summary:

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.

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

1. Postoperative pain (Time Frame - Day 2 after surgery):
Postoperative pain according to a numeric rating scale

Secondary outcome:

1. Mean postoperative pain (Time Frame - Day 4 after surgery):
Postoperative pain according to a numeric rating scale

2. Additional analgesic drug use (Time Frame - Day 4 after surgery):
opioids [mg], non-opioids [mg]

3. Postoperative mobilization (Time Frame - Day 7 after surgery):
steps per day as measured with an activity tracker

4. Postoperative morbidity (Time Frame - Through hospital stay, an average of 14 days):
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

5. Postoperative mortality (Time Frame - Through hospital stay, an average of 14 days):
The postoperative mortality of all patients is assessed between operation date and date of death of any cause during hospital stay

6. Daily postoperative pain (Time Frame - Day 7 after surgery):
Postoperative pain according to a numeric rating scale measured daily from postoperative day 1-7

Studien-Arme

Experimental: A - Early removal of chest drain
Other: B - Control

Geprüfte Regime

Early removal of chest drain:
Chest drains are removed 3 hours after the end of surgery in absence of contraindications in arm A.
Chest drain:
The chest drains in arm B are removed during the further postoperative course according to standard algorithm.

Quelle: ClinicalTrials.gov

Sie können folgenden Inhalt einem Kollegen empfehlen:

"Drainless Robot-assisted Minimally Invasive Esophagectomy"

Bitte tragen Sie auch die Absenderdaten vollständig ein, damit Sie der Empfänger erkennen kann.

Die mit (*) gekennzeichneten Angaben müssen eingetragen werden!