Dataset Information

Cauterisation versus fibrin glue for conjunctival autografting in primary pterygium surgery (CAGE CUP): study protocol of a randomised controlled trial.

ABSTRACT: INTRODUCTION:Pterygium is a non-cancerous growth of the conjunctival tissue over the cornea that may lead to visual impairment in advanced stages, restriction of ocular motility, chronic inflammation and cosmetic concerns. Surgical removal is the treatment of choice, but recurrence of pterygium is a frequent problem. It has been previously shown that fibrin glue may result in less recurrence and may take less time than sutures for fixing the conjunctival graft in place during pterygium surgery. However, fibrin glue is a biological material and it carries the risk of transmitting infectious agents from pooled and single-donor blood donors and anaphylaxis in susceptible individuals. Cauterisation is another surgical option, and it would be advantageous to know whether cauterisation may be superior surgical option compared with fibrin glue. This protocol describes the rationale and design of the randomised controlled trial (RCT) in which we will compare cauterisation versus fibrin glue for conjunctival autografting in primary pterygium surgery. METHODS AND ANALYSES:This will be a parallel group RCT comparing cauterisation versus fibrin glue for conjunctival autografting in primary pterygium surgery. Computer-generated randomisation will be used, and allocation concealment will be conducted using sequentially numbered opaque sealed envelopes. Surgeons will not be blinded to the procedures, but participants, other investigators and outcome assessors will be blinded. Adult participants with primary pterygium operated in a tertiary hospital in Split, Croatia, will be included. Primary outcome will be recurrence of pterygium, defined as any regrowth of tissue from the area of excision across the limbus onto the cornea after 180 days. ETHICS AND DISSEMINATION:The trial was approved by the ethics review board of the University Hospital Split (500-03/17-01/68). Results will be disseminated at conferences and through peer-reviewed publications. TRIAL REGISTRATION NUMBER:NCT03321201; Pre-results.

SUBMITTER: Lesin M

PROVIDER: S-EPMC6020953 | biostudies-literature | 2018 Jun

REPOSITORIES: biostudies-literature

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Cauterisation versus fibrin glue for conjunctival autografting in primary pterygium surgery (CAGE CUP): study protocol of a randomised controlled trial.

Lešin Mladen M Paradžik Martina M Marin Lovrić Josipa J Olujić Ivana I Ljubić Žana Ž Vučinović Ana A Bućan Kajo K Puljak Livia L

BMJ open 20180627 6

<h4>Introduction</h4>Pterygium is a non-cancerous growth of the conjunctival tissue over the cornea that may lead to visual impairment in advanced stages, restriction of ocular motility, chronic inflammation and cosmetic concerns. Surgical removal is the treatment of choice, but recurrence of pterygium is a frequent problem. It has been previously shown that fibrin glue may result in less recurrence and may take less time than sutures for fixing the conjunctival graft in place during pterygium s ...[more]

PMID: 29950464

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Project description:To compare clinical parameters and the tear levels of inflammatory cytokines between pterygium surgery using sutures or fibrin glue.Fifty-six patients with primary pterygium were divided into the suture group and the glue group, in which the autograft was secured with 10-0 Vicryl sutures and fibrin glue, respectively. A questionnaire, slit-lamp examination, Schirmer test, and visual acuity test were performed in all participants. Real-time quantitative PCR (q-PCR) was used to analyze the expression of genes in pterygium and healthy conjunctival tissues. Based on the qPCR results and literature reports, five inflammatory cytokines, including hepatocyte growth factor (HGF), fibroblast growth factor 2 (FGF2), transforming growth factor-?1 (TGF-?1), matrix metalloproteinase 2 (MMP2), and tumor necrosis factor-? (TNF-?), were selected, and their protein levels were measured with enzyme-linked immunosorbent assay (ELISA) in patient tears before surgery as well as at postoperative day 1, 7, and 30.There are 28 patients in either the suture or the glue group. The average duration of surgery was 20.17 ± 3.23 min for the glue group and 32.42 ± 4.47 min for the suture group (p = 0.000). Visual acuity in both groups was improved (p = 0.002) after the surgical procedures. There were more symptoms in the suture group than in the glue group at postoperative day 7 (p = 0.002). Postoperative symptoms disappeared in both groups at 1 month after surgery. Recurrence was observed in one case in the glue group and in two cases in the suture group at the 6 month postoperative follow-up (p = 0.714). In comparison to the preoperative levels (4.33 ± 0.43 ng/ml for the suture group; 4.20 ± 0.26 ng/ml for the glue group), the levels of TNF-? in tears increased in the suture group (5.02 ± 0.49 ng/ml, p = 0.016) and decreased in the glue group (3.84 ± 0.35 ng/ml, p = 0.052) on postoperative day 1. The glue treatment induced higher HGF production (4.78 ± 1.25 ng/ml) than the suture treatment (3.04 ± 1.18 ng/ml) at postoperative day 1 (p = 0.020). Higher levels of TGF-?1 in the glue group were detected at postoperative day 1 (3.71 ± 0.18 ng/ml) and postoperative day 30 (4.50 ± 0.51 ng/ml), compared to those in the suture group, respectively (2.74 ± 0.21 ng/ml, p = 0.000 for day 1; 3.36 ± 0.96 ng/ml, p = 0.017 for postoperative day 30).Fibrin glue is effective and safe for attaching conjunctival autografts with an easy surgical procedure, shortened operating time, and less postoperative discomfort. In the early postoperative period, the protein expression of inflammatory cytokines implicates that fibrin glue may induce accelerated healing and subdued inflammation on the ocular surface compared to sutures.

Dataset Information

Cauterisation versus fibrin glue for conjunctival autografting in primary pterygium surgery (CAGE CUP): study protocol of a randomised controlled trial.

Publications

Cauterisation versus fibrin glue for conjunctival autografting in primary pterygium surgery (CAGE CUP): study protocol of a randomised controlled trial.

Similar Datasets

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