A multicenter randomized controlled trial to evaluate overall morbidity after total minimally invasive esophagectomy versus hybrid esophagectomy

Not Applicable

Recruiting

• Conditions: C15.9; Oesophagus, unspecified

• Registration Number: DRKS00027927
• Lead Sponsor: Klinik für Allgemeine, Viszeral- und Transplantationschirurgie Universitätsklinikum Tübingen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-07-04
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 152

Inclusion Criteria

1.) Malignant tumor of the thoracic esophagus or the esophagogastric junction considered to be resectable with curative intent via esophagectomy by means of an abdominal and right thoracic approach (Ivor-Lewis procedure) irrespective of neoadjuvant therapy

2.) Suitability of patient for MIN-E and HYBRID-E

3.) Age = 18 years

4.) Ability of subject to understand character and individual consequences of the clinical trial
Written informed consent

Exclusion Criteria

1.) Distant metastases
2.) Tumor localization above the azygos vein
3.) History of supraumbilical laparotomy or right thoracotomy within last three years
4.) American Society of Anesthesiologists (ASA)>3
5.) Hepatic cirrhosis Child B/C
6.) Participation in another interventional trial with interference of intervention and/or outcome of this trial
7.) Expected lack of compliance or language problems
8.) Participation in another intervention-trial with interference of intervention and outcome of this study

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall postoperative morbidity in terms of the comprehensive complication index (CCI) within 30 days after surgery