The Assessment of the Use of Anti-Adhesion Agents to Prevent Pelvic Postoperative Adhesions (NCT04063085) | Clinical Trial Compass
CompletedNot Applicable
The Assessment of the Use of Anti-Adhesion Agents to Prevent Pelvic Postoperative Adhesions
Taiwan188 participantsStarted 2018-04-25
Plain-language summary
The aim of this study is to assess the safety and effectiveness of PROTAHERE Absorbable Adhesion Barrier to prevent pelvic postoperative adhesions.
Who can participate
Age range20 Years – 65 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
What they're measuring
1
The incidence of postoperative adhesion at 3 months