Efficacy of a chitosan tampon in the loop electrosurgical excision procedure: A prospective randomized controlled study

Abstract

It has been reported that chitosan has a hemostatic effect and an antibiotic activity. This study aimed to evaluate the efficacy and feasibility of using a chitosan tampon (Hemoblock-Tampon) in preventing hemorrhage and enhancing wound healing after the loop electrosurgical excision procedure (LEEP).This single-blind, prospective, randomized study included 62 consecutive patients who underwent LEEP for cervical intraepithelial neoplasia. A chitosan tampon (31 patients; treatment group), or a general tampon (31 patients; control group) was applied to the uterine cervix immediately after LEEP. One patient in the treatment group declined to participate in this study. Thus, 30 patients in the treatment group and 31 patients in the control group completed this study. For objective analysis of hemorrhage in the postoperative 2 weeks, the amounts of bleeding were checked daily with a pictorial blood assessment chart. We evaluated vaginal discharge, abdominal pain, and impairment in daily living during the postoperative 2 weeks using 5 visual analogue scale questionnaires.The bleeding count was significantly lower in the treatment group than in the control group (21.37 ± 16.86 vs. 40.52 ± 16.55, p = 0.0014). The sum of the scores of the 5 questionnaires was significantly lower in the treatment group than in the control group (6.53 ± 2.84 vs. 8.59 ± 2.88, p = 0.0079). The incidence of vaginal discharge was significantly lower in the treatment group than in the control group (20.0% vs. 48.4%, p = 0.0207). According to logistic regression, only the use of chitosan tampon reduced the risk of moderate to severe vaginal bleeding 2 weeks after surgery (Odd ratio, 0.213; 95% confidence interval, 0.06-0.76; p = 0.0172). Complete healing of the uterine cervix occurred in 86.7% of patients in the treatment group and in 61.3% of patients in the control group at 4 weeks after surgery (p = 0.0255).The use of chitosan tampons can reduce hemorrhage, vaginal discharge, abdominal pain, and impairment of daily living after LEEP. Moreover, chitosan tampon may help enhance wound healing.

Innovative Diagnostic and Therapeutic Interventions in Cervical Dysplasia: A Systematic Review of Controlled Trials

“…Using the remaining 37 citations, cross reference searching identified two further appropriate citations. Thus, in summary, 39 citations reporting on diagnostic and therapeutic interventions in women with cervical dysplasia within a controlled trial setting were included in this review [ 13 , 14 , 15 , 16 , 17 , 18 , 19 , 20 , 21 , 22 , 23 , 24 , 25 , 26 , 27 , 28 , 29 , 30 , 31 , 32 , 33 , 34 , 35 , 36 , 37 , 38 , 39 , 40 , 41 , 42 , 43 , 44 , 45 , 46 , 47 , 48 , 49 , 50 , 51 ]. Among them, we found 5 PCTs [ 13 , 14 , 15 , 16 , 17 ] and 28 RCTs [ 18 , 19 , 20 , 21 , 22 , 23 , 24 , 25 , 26 , …”

“…The clinical characteristics of individual studies reporting on therapeutic procedures in women with cervical dysplasia are shown in Table 2 . We identified 20 RCTs with 3355 participants [ 26 , 27 , 28 , 29 , 30 , 31 , 32 , 33 , 34 , 35 , 36 , 37 , 38 , 39 , 40 , 41 , 42 , 43 , 44 , 45 ] and one PCT with 297 participants [ 17 ]. in total, 4 RCTs found that alternative electrosurgical techniques such as Straight Wire Excision of the Transformation Zone (SWETZ), Contour-Loop Excision of the Transformation Zone (C-LETZ), and True Cone Biopsy Electrode Excision (TCBEE) were comparable to the standard LEEP/LLETZ procedure with minimal differences regarding specimen fragmentation and endocervical resection margin status [ 26 , 27 , 28 , 31 ].…”

“…LEEP performed under direct colposcopic vision led to smaller cone sizes without compromising margin status [ 33 ], but video colposcopy did not have this benefit [ 44 ]. Spray coagulation was better than forced coagulation for intra-operative bleeding control [ 29 ] and a chitosan tampon effectively reduced post-operative bleeding episodes [ 37 ]. Patients preferred LEEP under local anesthesia over general anesthesia [ 38 ].…”

“…Therefore, evidence-based diagnostic and therapeutic interventions for LSIL/HSIL are an important worldwide medical need. In order to clarify what progress has been made in this field during the last decade, we systematically searched the literature between 2012 and 2021 and identified 39 high-quality controlled trials, RCTs, and PCTs, reporting on diagnostic and therapeutic interventions in women with cervical dysplasia [ 13 , 14 , 15 , 16 , 17 , 18 , 19 , 20 , 21 , 22 , 23 , 24 , 25 , 26 , 27 , 28 , 29 , 30 , 31 , 32 , 33 , 34 , 35 , 36 , 37 , 38 , 39 , 40 , 41 , 42 , 43 , 44 , 45 , 46 , 47 , 48 , 49 , 50 , 51 ]. Among them, we found 5 PCTs [ 13 , 14 , 15 , 16 , 17 ] and 28 RCTs [ 18 , 19 , 20 , 21 , 22 , 23 , 24 , ...…”

Flaws In Medicine Must Be Corrected: An Open Report to National Governments amid the COVID-19 Catastrophe

“…They have been the gold-standard of clinical trials for decades [19]" This statement could be correct before it was challenged. I searched from Nature articles containing randomized controlled trials and found several scientific reports [24][25][26][27][28][29]. The articles adhered to the goldstandard of clinical trials in all aspects from experimental designs, data collection, statistical analysis, to conclusion.…”