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


Journal

Techniques in coloproctology
ISSN: 1128-045X
Titre abrégé: Tech Coloproctol
Pays: Italy
ID NLM: 9613614

Informations de publication

Date de publication:
Nov 2019
Historique:
received: 04 08 2019
accepted: 10 10 2019
pubmed: 2 11 2019
medline: 2 7 2020
entrez: 1 11 2019
Statut: ppublish

Résumé

Different 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. From 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. Ninety-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. SCPS 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. clinicaltrials.gov (ID: NCT03637933).

Sections du résumé

BACKGROUND BACKGROUND
Different 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.
METHODS METHODS
From 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.
RESULTS RESULTS
Ninety-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.
CONCLUSIONS CONCLUSIONS
SCPS 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 REGISTRATION BACKGROUND
clinicaltrials.gov (ID: NCT03637933).

Identifiants

pubmed: 31667693
doi: 10.1007/s10151-019-02101-y
pii: 10.1007/s10151-019-02101-y
doi:

Substances chimiques

Coloring Agents 0
Suspensions 0
chinese ink 0
Carbon 7440-44-0
Fibrinogen 9001-32-5
C-Reactive Protein 9007-41-4

Banques de données

ClinicalTrials.gov
['NCT03637933']

Types de publication

Comparative Study Journal Article Randomized Controlled Trial

Langues

eng

Sous-ensembles de citation

IM

Pagination

1073-1078

Commentaires et corrections

Type : CommentIn
Type : CommentIn

Références

Gastrointest Endosc. 1991 Jan-Feb;37(1):65-8
pubmed: 1706285
Colorectal Dis. 2009 Jun;11(5):527-30
pubmed: 19175629
Gastrointest Endosc. 1991 Jan-Feb;37(1):68-71
pubmed: 1706286
Gastrointest Endosc. 1975 Aug;22(1):42-3
pubmed: 1205106
Am J Surg Pathol. 1996 Oct;20(10):1266-70
pubmed: 8827034
Am Surg. 1989 Jul;55(7):457-61
pubmed: 2472762
Gastrointest Endosc Clin N Am. 1997 Jul;7(3):525-39
pubmed: 9177151
World J Emerg Surg. 2013 Jan 31;8(1):6
pubmed: 23369320
Surg Endosc. 1994 Sep;8(9):1085-7
pubmed: 7992181
Korean J Gastroenterol. 2014 Jul;64(1):45-8
pubmed: 25073671
Endoscopy. 2001 Aug;33(8):687-91
pubmed: 11490385
Dis Colon Rectum. 2003 Jul;46(7):987
pubmed: 12847379
World J Surg. 2006 Apr;30(4):605-11
pubmed: 16555023
Langenbecks Arch Chir Suppl II Verh Dtsch Ges Chir. 1990;:1009-16
pubmed: 1983476
Endoscopy. 1999 Mar;31(3):271-3
pubmed: 10344435
J Gastrointest Surg. 2004 Jul-Aug;8(5):543-6
pubmed: 15239988
Am J Gastroenterol. 1996 Sep;91(9):1804-8
pubmed: 8792702
Surg Endosc. 2001 Oct;15(10):1202-3
pubmed: 11727100
Gastrointest Endosc. 1997 Feb;45(2):153-6
pubmed: 9041001
Gastrointest Endosc Clin N Am. 1997 Jul;7(3):401-11
pubmed: 9177142
Am J Gastroenterol. 1992 Jan;87(1):79-81
pubmed: 1370188
Colorectal Dis. 2011 Oct;13(10):1184-7
pubmed: 20860715
Gastrointest Endosc. 1991 Jan-Feb;37(1):99-100
pubmed: 1706288
Gastrointest Endosc. 2002 Sep;56(3):339-42
pubmed: 12196769
World J Emerg Surg. 2018 Jun 19;13:24
pubmed: 29946347

Auteurs

M Milone (M)

Department of Clinical Medicine and Surgery, Federico II University of Naples, Via Sergio Pansini, 5, 80131, Naples, Italy.

A Vignali (A)

Department of Gastrointestinal Surgery, San Raffaele Hospital and San Raffaele Vita-Salute University, Via Olgettina 60, 20132, Milan, Italy.

M Manigrasso (M)

Department of Clinical Medicine and Surgery, Federico II University of Naples, Via Sergio Pansini, 5, 80131, Naples, Italy.

N Velotti (N)

Department of Clinical Medicine and Surgery, Federico II University of Naples, Via Sergio Pansini, 5, 80131, Naples, Italy.

G Sarnelli (G)

Department of Clinical Medicine and Surgery, Federico II University of Naples, Via Sergio Pansini, 5, 80131, Naples, Italy.

G Aprea (G)

Department of Clinical Medicine and Surgery, Federico II University of Naples, Via Sergio Pansini, 5, 80131, Naples, Italy.

G De Simone (G)

Department of Clinical Medicine and Surgery, Federico II University of Naples, Via Sergio Pansini, 5, 80131, Naples, Italy.

F Maione (F)

Department of Clinical Medicine and Surgery, Federico II University of Naples, Via Sergio Pansini, 5, 80131, Naples, Italy.

N Gennarelli (N)

Department of Clinical Medicine and Surgery, Federico II University of Naples, Via Sergio Pansini, 5, 80131, Naples, Italy.

U Elmore (U)

Department 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 Palma (GD)

Department of Clinical Medicine and Surgery, Federico II University of Naples, Via Sergio Pansini, 5, 80131, Naples, Italy.

Articles similaires

[Redispensing of expensive oral anticancer medicines: a practical application].

Lisanne N van Merendonk, Kübra Akgöl, Bastiaan Nuijen
1.00
Humans Antineoplastic Agents Administration, Oral Drug Costs Counterfeit Drugs

Smoking Cessation and Incident Cardiovascular Disease.

Jun Hwan Cho, Seung Yong Shin, Hoseob Kim et al.
1.00
Humans Male Smoking Cessation Cardiovascular Diseases Female
Humans United States Aged Cross-Sectional Studies Medicare Part C
1.00
Humans Yoga Low Back Pain Female Male

Classifications MeSH