Clinical trial NCT04063085: The Assessment of the Use of Anti-Adhesion Agents to Prevent Pelvic Postoperative Adhesions
Official title: The Assessment of the Use of Anti-Adhesion Agents to Prevent Pelvic Postoperative Adhesions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tissue Adhesion
Gynecologic Surgery
Keywords: Hyaluronan
gel
adhesion agent
Lead sponsor: SciVision Biotech Inc.
Sponsor class: INDUSTRY
Collaborators: name: Taipei Veterans General Hospital, Taiwan
First posted: 2019-08-21
Enrollment: 188
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this study is to assess the safety and effectiveness of PROTAHERE Absorbable Adhesion Barrier to prevent pelvic postoperative adhesions.

Detailed description: The study is a random, evaluator-blinded, controlled, single center clinical trial. Recruiting patients who are premenopausal and scheduled for pelvic surgery including myomectomy, pelvic adhenolysis, endometriosis surgery, salpingostomy, dermoid cyst removal, ovarian cystectomy or any pelvic surgery other than total metrectomy. Patients recruited are randomly divided into five groups, PROTAHERE, Hyalobarrier, Seprafilm, Interceed or no treatment when the inclusion criteria are met and the inform consents are obtained. They are followed for 24 months including visits at 14 days, 3, 6, 12, 18, 24 months post-operation for the safety and effectiveness evaluation. The primary endpoints are the incidence of adhesions at 3-month as well as the incidence of any adverse events during the study.

Eligibility criteria: Inclusion Criteria:

* Patients who are premenopausal.
* Patients who are scheduled for pelvic surgery including myomectomy, pelvic adhenolysis, endometriosis surgery, salpingostomy, dermoid cyst removal, ovarian cystectomy or any pelvic surgery other than total metrectomy.
* Patients who are 20 years old or older.
* Patients who are able to understand the objectives, sign the informed consent form, and willing to comply with study procedures.

Exclusion Criteria:

* Patients who are 65 years old or older.
* Presence of uncontrolled diabetes, coagulative disorders, severe urinary system infection, or other severe diseases.
* Presence of malignant tumor or diagnosed with cancer.
* Any physical or psychological illness or symptom which is considered unsuitable to enroll by physicians.
* Patients who are unwilling to comply with study procedures.
* Patients who are known to have hypersensitivity to hyaluronic acid implants.

Primary outcomes:
measure: The incidence of postoperative adhesion at 3 months
timeFrame: 3 months post-operation
Secondary outcomes:
measure: The incidence of adverse events in each group from the baseline and during the study period
timeFrame: 14 days, 3, 6, 12, 18, 24 months
measure: The incidence of each adverse event from the baseline and during the study
timeFrame: 14 days, 3, 6, 12, 18, 24 months
measure: The severity of adverse events
timeFrame: 14 days, 3, 6, 12, 18, 24 months
measure: The change of medication or treatment related to adverse event
timeFrame: 14 days, 3, 6, 12, 18, 24 months
measure: The proportion of sites with adhesions at 3 months
timeFrame: 3 months post-operation
measure: The score of adhesion severity and extent at each sites at 3 months
timeFrame: 3 months post-operation
measure: The total score of America Fertility Society classifications of adhesions at all sites in each group at 3 months
timeFrame: 3 months post-operation
measure: The incidence of postoperative adhesion from the baseline and during the study period
timeFrame: 14 days, 3, 6, 12, 18, 24 months
measure: The change of CA125 value in each group during the study period
timeFrame: 3, 6, 12, 18, 24 months
measure: The change of the results of SF-36 questionnaire in each group from the baseline and during the study period
timeFrame: 14 days, 3, 6, 12, 18, 24 months
measure: The residual status of anti-adhesion agents at 3 months
timeFrame: 3 months post-operation
measure: Visual analog scale (VAS) score for pain change
timeFrame: 14 days, 3, 6, 12, 18, 24 months
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
Study officials:
References: