The Assessment of the Use of Anti-Adhesion Agents to Prevent Pelvic Postoperative Adhesions

The Assessment of the Use of Anti-Adhesion Agents to Prevent Pelvic Postoperative Adhesions

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

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.

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.