Evidence map›Paper›PMID 25539692›Full record

ReviewSurgical endoscopy2015

Comprehensive complication index for NOTES procedures: results from a randomized controlled trial and comparison to published NOTES complication data.

Dietmar H Borchert, Matthias Federlein, Verena A Müller, Stefan Wagenpfeil, Robert M Eisele

Abstract readComparative StudyReview
PubMed Publisher
In one paragraph

Review in Surgical endoscopy, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
1.2field-weighted citation impact, top 21% of its field
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

7 citing papers in PubMed, 12 citations in OpenAlex.

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  4. The comprehensive complication index (CCI) is a more sensitive complication index than the conventional Clavien-Dindo classification in radical gastric cancer surgery.Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association · 2018
    Article
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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

5 authors at 3 institutions in 1 country.

Dietmar H BorchertDepartment of General, Visceral, Vascular and Pediatric Surgery, and Institute of Biometry, Epidemiology and Medical Informatics, Saarland University Hospitals, Kirrberger Straße 100, 66421, Homburg, Saarland, Germany. dietmar.borchert@doctors.org.uk.
Matthias FederleinDepartment of General and Visceral Surgery, Sana Hospital Lichtenberg, Sana Hospitals Berlin-Brandenburg, Affiliated Teaching Hospital to the Charité, Fanningerstraße 32, 10365, Berlin, Germany.
Verena A MüllerDepartment of Surgery, Charité University Medicine, Humboldt University of Berlin, 10117, Berlin, Germany.
Stefan WagenpfeilDepartment of General, Visceral, Vascular and Pediatric Surgery, and Institute of Biometry, Epidemiology and Medical Informatics, Saarland University Hospitals, Kirrberger Straße 100, 66421, Homburg, Saarland, Germany.
Robert M EiseleDepartment of General, Visceral, Vascular and Pediatric Surgery, and Institute of Biometry, Epidemiology and Medical Informatics, Saarland University Hospitals, Kirrberger Straße 100, 66421, Homburg, Saarland, Germany.
Saarland University · DEHumboldt-Universität zu Berlin · DESana Klinikum · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveThis investigation uses the comprehensive complication index (CCI) to compare complications after natural orifice transluminal endoscopic surgery (NOTES) procedures.

backgroundNOTES procedures are developed to miniaturize surgical trauma. NOTES publications inconsistently report complications. The CCI improves reporting of complications.

methodsThe CCI is calculated using complication data from a single center, double blind, randomized controlled trial comparing transvaginal [transvaginal cholecystectomy (TVC), N = 41] and conventional laparoscopic cholecystectomy (CLC, N = 51). Complications are assessed using the classification of surgical complications (CSC). Two different scenarios are applied to the CSC for definition of complications with an emphasis on minor complications. CSC data are fed into the free online CCI-calculator. The CCIs from complication data from other NOTES reports are calculated accordingly and compared to our results.

resultsThe CCI allows easy indexing of complications with or without a CSC table. For scenario I, the mean CCI of CLC versus TVC is 3.3 (± 6.3; SD) versus 3.5 (± 6.4; n.s.) and for scenario II it is 7.6 (± 6.4) versus 6.5 (± 7.0; n.s.). The difference of the mean between the two scenarios is highly significant (p < 0.000). The mean CCIs of both groups and scenarios are below the CCI of 8.7 for a grade I CSC complication. Similar calculation of CCIs from other NOTES publications yields mean CCIs below 8.7 for the surgical procedures reported.

conclusionThe CCI results in a single, easily comparable complication index for surgical procedures whereas the CSC yields tabular results. A significant difference in interpretation occurs with variation in definition of complications. Average CCIs below a value of 10 describe low complication rates. Authors need to describe their definition of complications if using the CSC and the CCI. More emphasis should be given to reporting of minor complications. The use of the CCI for NOTES procedures will enable international comparison.

Indexed as

CholecystectomyCholecystectomy, LaparoscopicFemaleHumansNatural Orifice Endoscopic SurgeryRandomized Controlled Trials as TopicVaginaCholecystectomyClinical papers/trials/researchComplicationsPain

Identifiers

PMID25539692
OpenAlexW2053103647

What OpenQuestion holds

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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.