Use of Chitosan Powder in Loop Electrosurgical Excision Procedure

Study Overview
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Brief Summary
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Early treatment of cervical intraepithelial neoplasia (CIN) II-III gives rise to a decrease in the incidence of invasive cervical cancer. Though there is no obvious consensus from randomized studies as to the optimal management of CIN II-III, loop electrosurgical excision procedure (LEEP) is the most extensively used method because of its technical ease, inexpensive, steep learning curve, and low rate of complications. In spite of these benefits, current literature suggests that some patients experience some complications such as postoperative vaginal bleeding, abnormal vaginal discharge, abdominal pain, and infection. These adversely affect the recovery period, increase patient anxiety, readmission to the hospital for further treatment and encumber patients' daily life. Postoperative vaginal bleeding (PVB) is one of the most common and unpleasant of these complications. Its incidence has been reported to vary between 2% to 78%. Many different types of treatments have been applied to avert or diminish PVC such as the use of vasopressin, tranexamic acid, Monsel's solution, and local hemostats (e.g., TachoSil or Tisseel), but these attempts have failed to show precise benefits over routine clinical approaches. Chitosan is a biodegradable, natural polyaminosaccharide with a nontoxic, non-allergenic, positively-charged polysaccharide derived from the deacetylation of chitin. Due to its molecular characteristics, chitosan has been used for improved hemostasis. Furthermore, chitosan has an antimicrobial and wound-healing effect. The current literature concerning the influence of using chitosan after the LEEP is limited to only one trial. The authors of that study reported that using chitosan after the LEEP can reduce vaginal bleeding and enhancing wound healing. However, that study has some limitations. Therefore, investigators designed this randomized trial to assess the effect of local chitosan implementation on postoperative vaginal bleeding and wound healing in LEEP

Official Title
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Use of Chitosan Powder in Loop Electrosurgical Excision Procedure to Reduce Postoperative Complications: A Randomized Controlled Trial

Conditions
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Vaginal Bleeding, Loop Electrosurgical Excision

Intervention / Treatment
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* Drug: Chitosan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: women were aged > 21 years old women were not pregnant women who were undergoing LEEP. Exclusion Criteria: Women with pelvic infection Women with abnormal vaginal bleeding Women with coagulopathy Women with chronic pain syndromes Women with psychiatric disorders Women with the previous hysterectomy with removal of the cervix, Women with a history of cervical cancer Women who could not complete follow-up calls

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>LEEP was performed in an outpatient setting by a single resident physician (KG). A full blood count was taken (hematocrit 1). The procedure was designed according to colposcopic findings such as the type of transformation zone and position of the lesion. After positioning of the patient, 50 mg of lidocaine spray (5 pumps, 10 mg in each pump) was applied to the ectocervix, then 2 mL bupivacaine hydrochloride was injected submucosally using a 27-gauge needle tip at the 3, 6, 9, and 12 o'clock locations in the ectocervix. LEEP was performed as described in a previous trial. After the hemostasis that obtained using the ball electrode at a 40-W coagulation setting, the remaining cervical tissue was washed with 20 ccs of sterile saline to ensure no active bleeding from the cervical wound. An empty spray pump was used because we cannot find any identical powder for the placebo | |
| Experimental: Chitosan<br>LEEP was performed in an outpatient setting by a single resident physician (KG). A full blood count was taken (hematocrit 1). The procedure was designed according to colposcopic findings such as the type of transformation zone and position of the lesion. After positioning of the patient, 50 mg of lidocaine spray (5 pumps, 10 mg in each pump) was applied to the ectocervix, then 2 mL bupivacaine hydrochloride was injected submucosally using a 27-gauge needle tip at the 3, 6, 9, and 12 o'clock locations in the ectocervix. LEEP was performed as described in a previous trial. After the hemostasis that obtained using the ball electrode at a 40-W coagulation setting, the remaining cervical tissue was washed with 20 ccs of sterile saline to ensure no active bleeding from the cervical wound. The application of 3 or 4 pumps of chitosan powder was carried out into the wound bed by spray pump which was prepared by a nurse. | Drug: Chitosan<br>* Chitosan is a biodegradable, natural polyaminosaccharide with a nontoxic, non-allergenic, positively-charged polysaccharide derived from the deacetylation of chitin. Due to its molecular characteristics, chitosan has been used for improved hemostasis. Furthermore, chitosan has an antimicrobial and wound-healing effect<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| median early postoperative blood loss | early postoperative blood loss using the difference in hematocrit values after LEEP and 24 h after the procedure according to the following formula: estimated blood loss = estimated blood volume × (hematocrit 1 - hematocrit 2) / hematocrit 1, where the estimated blood volume in milliliters = body weight in kilograms × 85 | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound healing score | wound healing score was evaluated according to scale (min: 0, max:4) | 6 weeks |