Clinical trial NCT05661708: Use of Chitosan Powder in Loop Electrosurgical Excision Procedure
Official title: Use of Chitosan Powder in Loop Electrosurgical Excision Procedure to Reduce Postoperative Complications: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Vaginal Bleeding
Loop Electrosurgical Excision
Lead sponsor: Erzincan Military Hospital
Sponsor class: OTHER
First posted: 2022-12-22
Enrollment: 130
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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


Eligibility criteria: 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

Primary outcomes:
measure: median early postoperative blood loss
timeFrame: 6 hours
Secondary outcomes:
measure: Wound healing score
timeFrame: 1-4 weeks
Other outcomes:
Locations:
city: Menteşe
country: Turkey
facility: Kemal Güngördük
state: Muğla
city: Mugla
country: Turkey
facility: Mugla Sıtkı Kocman University Education and Research Hospital
Study officials:
References: