MInimal inVasive versus open AbdominoThoracic Esophagectomy

Conditions

C15.5

Felix Nickel, Alexander Studier‐Fischer, David Hausmann, Rosa Klotz, Sophia Lara Vogel-Adigozalov et al. (28 authors)

BMJ Open2022-10-0113 citations

10.1136/bmjopen-2022-064286

Minimally Invasive Versus open AbdominoThoracic Esophagectomy for esophageal carcinoma (MIVATE) - study protocol for a randomized controlled trial DRKS00016773.

Nickel F, Probst P, Studier-Fischer A, Nienhüser H, Pauly J, Kowalewski KF, Weiterer S, Knebel P, Diener MK, Weigand MA, Büchler MW, Schmidt T, Müller-Stich BP.

2021-01-1112 citations

10.1186/s13063-020-04966-z

Interventions

Group 1: Laparotomy + Thoracotomy with circular stapler anastomosis Group 2: Laparoscopy + Thoracoscopy with linear stapler anastomosis

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Malignoma of the distal esophagus Resection in curative intent with planned intrathoracic anastomosis Informed consent

Exclusion criteria

Exclusion criteria: Resection margin above V. azygos Emergency procedure (e.g. bleeding, perforation) Suspected infiltration of adjacent organs

Design outcomes

Primary

Measure	Time frame
Comprehensive Complication Index (CCI) 30d postoperative	—

Secondary

Measure	Time frame
Blood loss, duration of the procedure, length of ICU stay, compliance with the Fast-Track SOP, rate of anastomotic leakage, pneumonia, frequency of complete histopathological resections (R0), number of resected lymph nodes, length of hospital stay, CCI 90d postoperative, Quality of life (measured by SF-36 at 3, 12, 36 & 60 months postoperative), survival	—

Countries

Germany

Contacts

Public ContactFelix Nickel

Chirurgische Universitätsklinik

Felix.Nickel@med.uni-heidelberg.de06221-56-8641

Outcome results

None listed