Evidence map›Paper›PMID 31667693›Full record

Trial reportTechniques in coloproctology2019

Sterile carbon particle suspension vs India ink for endoscopic tattooing of colonic lesions: a randomized controlled trial.

M Milone, A Vignali, M Manigrasso, N Velotti, G Sarnelli, G Aprea, G De Simone, F Maione, N Gennarelli, U Elmore and 1 more

Registry-linked trialAbstract readComparative StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Techniques in coloproctology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03637933 (Safety and Efficacy of Endoscopic Tattooing in Colorectal Surgery. India Ink vs Sterile Carbon Particle Suspension. Randomized Clinical Trial.), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
2.4field-weighted citation impact, top 11% 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.

NCT03637933 nacompletednot on this map

Safety and Efficacy of Endoscopic Tattooing in Colorectal Surgery. India Ink vs Sterile Carbon Particle Suspension. Randomized Clinical Trial.

TypeinterventionalSponsorFederico II UniversityRan2017 to 2018Enrolled50ConditionsSafety and Efficacy of Tattooing SubstanceArmsendoscopic tattooing
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 17 citations in OpenAlex.

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

Corrections and comments

5 · Who and what money

Authors and funding

11 authors at 2 institutions in 1 country.

M MiloneDepartment of Clinical Medicine and Surgery, Federico II University of Naples, Via Sergio Pansini, 5, 80131, Naples, Italy.
A VignaliDepartment of Gastrointestinal Surgery, San Raffaele Hospital and San Raffaele Vita-Salute University, Via Olgettina 60, 20132, Milan, Italy.
M ManigrassoDepartment of Clinical Medicine and Surgery, Federico II University of Naples, Via Sergio Pansini, 5, 80131, Naples, Italy.
N VelottiDepartment of Clinical Medicine and Surgery, Federico II University of Naples, Via Sergio Pansini, 5, 80131, Naples, Italy.
G SarnelliDepartment of Clinical Medicine and Surgery, Federico II University of Naples, Via Sergio Pansini, 5, 80131, Naples, Italy.
G ApreaDepartment of Clinical Medicine and Surgery, Federico II University of Naples, Via Sergio Pansini, 5, 80131, Naples, Italy.
G De SimoneDepartment of Clinical Medicine and Surgery, Federico II University of Naples, Via Sergio Pansini, 5, 80131, Naples, Italy.
F MaioneDepartment of Clinical Medicine and Surgery, Federico II University of Naples, Via Sergio Pansini, 5, 80131, Naples, Italy.
N GennarelliDepartment of Clinical Medicine and Surgery, Federico II University of Naples, Via Sergio Pansini, 5, 80131, Naples, Italy.
U ElmoreDepartment of Gastrointestinal Surgery, San Raffaele Hospital and San Raffaele Vita-Salute University, Via Olgettina 60, 20132, Milan, Italy. elmore.ugo@hsr.it.
G D De PalmaDepartment of Clinical Medicine and Surgery, Federico II University of Naples, Via Sergio Pansini, 5, 80131, Naples, Italy.
University of Naples Federico II · ITVita-Salute San Raffaele University · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundDifferent markers have been used preoperatively to mark colonic lesions, especially India ink. In recent years, another kind of marker has been developed: sterile carbon particle suspension (SCPS). No comparison between these two markers has yet been made. The aim of the present study was to compare the pyrogenic, inflammatory and intraperitoneal effect of these two markers.

methodsFrom September 2015 to December 2018, adult patients who were candidates for elective laparoscopic colon resection were randomized to the SCPS or conventional India ink injection group using computer-based randomization. The primary endpoint of the study was the presence of intraoperative adhesions related to the endoscopic tattoo. Secondary endpoints were differences in white blood cell, C-reactive protein, and fibrinogen levels as well as, abdominal pain and body temperature at baseline (before endoscopic tattooing) and 6 and 24 h after colonoscopy. Finally, the visibility of the tattoo during the minimally invasive intervention was assessed.

resultsNinety-four patients were included in the study, 47 for each arm. There were 45/94 females (47.9%) and 49/94 males (52.1%), with a median age of 67.85 ± 9.22 years. No differences were found between groups in WBC, fibrinogen levels, body temperature or VAS scores, but we documented significantly higher CRP values at 6 and 24 h after endoscopic tattooing with India ink injection. There were significantly fewer adhesions in the SCPS Endoscopic Marker group. All the endoscopic tattoos were clearly visible.

conclusionsSCPS is an effective method for tattooing colonic lesions and has a better safety profile than traditional India ink in terms of post-procedure inflammatory response and intraoperative bowel adhesions. CLINICAL

trial registrationclinicaltrials.gov (ID: NCT03637933).

Indexed as

Abdominal PainAgedBody TemperatureCarbonColonic NeoplasmsColonoscopyColoring AgentsC-Reactive ProteinFemaleFibrinogenHumansInflammationInjectionsLaparoscopyLeukocyte CountMaleCarbonchinese inkColoring AgentsC-Reactive ProteinFibrinogenSuspensionsCancerColonEndoscopyIndia inkSterile carbon particle suspensionTattooing

Identifiers

PMID31667693
OpenAlexW2982444125

What OpenQuestion holds

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Registered trials

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.