Use of Chitosan Powder in Loop Electrosurgical Excision Procedure

NCT ID: NCT05661708

Last Updated: 2024-06-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 130 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-15
• Study Completion Date: 2024-05-17

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

Conditions

Vaginal Bleeding; Loop Electrosurgical Excision

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Chitosan

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.

Group Type: EXPERIMENTAL

Chitosan

Intervention Type: DRUG

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

Interventions

Chitosan

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Erzincan Military Hospital

OTHER

Sponsor Role: lead

Responsible Party

Kemal GUNGORDUK

Medical Doctor - Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Kemal Güngördük

Menteşe, Muğla, Turkey (Türkiye)

Mugla Sıtkı Kocman University Education and Research Hospital

Muğla, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

MUGLA-9

Identifier Type: -

Identifier Source: org_study_id