Evidence map›Paper›PMID 36899404›Full record

ArticleTrials2023

Overall morbidity after total minimally invasive keyhole oesophagectomy versus hybrid oesophagectomy (the MICkey trial): study protocol for a multicentre randomized controlled trial.

Rosa Klotz, Markus K Diener, Thomas Schmidt, Thilo Hackert, Sandra Graf, Hans F Fuchs, Peter Grimminger, Jan-Hendrick Egberts, Ines Gockel, Pieter C van der Sluis and 4 more

Abstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Article
  2. Article
  3. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors.

Rosa KlotzDepartment of General, Visceral and Transplantation Surgery, University Hospital Heidelberg, Im Neuenheimer Feld 420, 69120, Heidelberg, Germany.
Markus K DienerDepartment of Surgery, Medical Center University Hospital Freiburg, Hugstetter Straße 55, 79106, Freiburg, Germany.
Thomas SchmidtDepartment of General, Visceral, Tumor and Transplantation Surgery, University Hospital Cologne, Kerpener Str. 65, 50923, Cologne, Germany.
Thilo HackertDepartment of General, Visceral and Transplantation Surgery, University Hospital Heidelberg, Im Neuenheimer Feld 420, 69120, Heidelberg, Germany.
Sandra GrafDepartment of General and Visceral Surgery and Clinical Trial Centre Department of Surgery (ulmCARES), University Hospital Ulm, Albert-Einstein-Allee 23, 89081, Ulm, Germany.
Hans F FuchsDepartment of General, Visceral, Tumor and Transplantation Surgery, University Hospital Cologne, Kerpener Str. 65, 50923, Cologne, Germany.
Peter GrimmingerDepartment of General, Visceral and Transplantation Surgery, Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Langenbeckstraße 1, 55131, Mainz, Germany.
Jan-Hendrick EgbertsDepartment of Surgery, Israelitisches Krankenhaus Hamburg, Orchideenstieg 14, 22297, Hamburg, Germany.
Ines GockelClinic and Polyclinic for Visceral, Transplant, Thoracic and Vascular Surgery, University Hospital Leipzig, Liebigstraße 20, 04103, Leipzig, Germany.
Pieter C van der SluisErasmus Medical Centre, Dr. Molewaterplein 40, 3015 GD, Rotterdam, The Netherlands.
Colette Doerr-HarimDepartment of General and Visceral Surgery and Clinical Trial Centre Department of Surgery (ulmCARES), University Hospital Ulm, Albert-Einstein-Allee 23, 89081, Ulm, Germany.
Christina KloseInstitute of Medical Biometry (IMBI), University of Heidelberg, Im Neuenheimer Feld 130.3, 69120, Heidelberg, Germany.
Manuel FeißtInstitute of Medical Biometry (IMBI), University of Heidelberg, Im Neuenheimer Feld 130.3, 69120, Heidelberg, Germany.
Andre L MihaljevicDepartment of General and Visceral Surgery and Clinical Trial Centre Department of Surgery (ulmCARES), University Hospital Ulm, Albert-Einstein-Allee 23, 89081, Ulm, Germany. andre.mihaljevic@uni-ulm.de.ORCID http://orcid.org/0000-0003-1902-657X

Funding

Bundesministerium für Bildung und Forschung 01KG2028
6 · The paper itself

Abstract

backgroundOesophageal cancer (EC) is the sixth leading cause of cancer death worldwide. Oesophageal resection is the only curative treatment option for EC which is frequently performed via an abdominal and right thoracic approach (Ivor-Lewis operation). This 2-cavity operation is associated with a high risk of major complications. To reduce postoperative morbidity, several minimally invasive techniques have been developed that can be broadly classified into either hybrid oesophagectomy (HYBRID-E) via laparoscopic/robotic abdominal and open thoracic surgery or total minimally invasive oesophagectomy (MIN-E). Both, HYBIRD-E and MIN-E, compare favourable to open oesophagectomy. However, there is still an evidence gap comparing HYBRID-E with MIN-E with regard to postoperative morbidity.

methodsThe MICkey trial is a multicentre randomized controlled superiority trial with two parallel study groups. A total of 152 patients with oesophageal cancer scheduled for elective oesophagectomy will be randomly assigned 1:1 to the control group (HYBRID-E) or to the intervention group (MIN-E). The primary endpoint will be overall postoperative morbidity assessed via the comprehensive complication index (CCI) within 30 days after surgery. Specific perioperative parameters, as well as patient-reported and oncological outcomes, will be analysed as secondary outcomes. DISCUSSION: The MICkey trial will address the yet unanswered question whether the total minimally invasive oesophagectomy (MIN-E) is superior to the HYBRID-E procedure regarding overall postoperative morbidity.

trial registrationDRKS00027927 U1111-1277-0214. Registered on 4th July 2022.

Indexed as

Esophageal NeoplasmsLaparoscopyEquivalence Trials as TopicEsophagectomyHumansMinimally Invasive Surgical ProceduresMorbidityMulticenter Studies as TopicPostoperative ComplicationsRandomized Controlled Trials as TopicTreatment OutcomeCancer of the oesophagogastric junctionOesophageal neoplasmsOesophagectomyPatient-reported outcome measuresPostoperative complicationsRandomized controlled trial

Identifiers

PMID36899404
PMCPMC9999550

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.