The Assessment of the Use of Anti-Adhesion Agents to Prevent Pelvic Postoperative Adhesions
NCT ID: NCT04063085
Last Updated: 2024-04-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
188 participants
INTERVENTIONAL
2018-04-25
2023-10-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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PROTAHERE group
The PROTAHERE group received intra-pelvic PROTAHERE Absorbable Adhesion Barrier during the scheduled pelvic surgery and be followed for 24 months.
PROTAHERE Absorbable Adhesion Barrier
40 mg/ml (4%) cross-linked hyaluronan
Hyalobarrier group
The Hyalobarrier group received intra-pelvic Hyalobarrier Gel during the scheduled pelvic surgery and be followed for 24 months.
Hyalobarrier Gel
Laparotomy: 40 mg/ml (4%) cross-linked hyaluronan Endoscopy: 30 mg/ml (3%) cross-linked hyaluronan
No treatment group
The no treatment group did not receive any anti-adhesion agent during the scheduled pelvic surgery and be followed for 24 months.
No treatment
No anti-adhesion agent applied
Seprafilm group
The Seprafilm group received intra-pelvic Seprafilm Adhesion Barrier during the scheduled pelvic surgery and be followed for 24 months.
Seprafilm Adhesion Barrier
a hyaluronate carboxymethylcellulose-based bioresorbable membrane
Interceed group
The Interceed group received intra-pelvic Gynecare Interceed (TC7) Absorbale Adhesion Barrier during the scheduled pelvic surgery and be followed for 24 months.
Gynecare Interceed (TC7) Absorbable Adhesion Barrier
an oxidized regenerated cellulose absorbable membrane
Interventions
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PROTAHERE Absorbable Adhesion Barrier
40 mg/ml (4%) cross-linked hyaluronan
Hyalobarrier Gel
Laparotomy: 40 mg/ml (4%) cross-linked hyaluronan Endoscopy: 30 mg/ml (3%) cross-linked hyaluronan
No treatment
No anti-adhesion agent applied
Seprafilm Adhesion Barrier
a hyaluronate carboxymethylcellulose-based bioresorbable membrane
Gynecare Interceed (TC7) Absorbable Adhesion Barrier
an oxidized regenerated cellulose absorbable membrane
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
20 Years
65 Years
FEMALE
Yes
Sponsors
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Taipei Veterans General Hospital, Taiwan
OTHER_GOV
SciVision Biotech Inc.
INDUSTRY
Responsible Party
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Locations
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Taipei Veterans General Hospital
Taipei, , Taiwan
Countries
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Other Identifiers
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RDCT-TWPH
Identifier Type: -
Identifier Source: org_study_id
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