- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04063085
The Assessment of the Use of Anti-Adhesion Agents to Prevent Pelvic Postoperative Adhesions
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Taipei, Taiwan
- Taipei Veterans General Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: PROTAHERE group
The PROTAHERE group received intra-pelvic PROTAHERE Absorbable Adhesion Barrier during the scheduled pelvic surgery and be followed for 24 months.
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40 mg/ml (4%) cross-linked hyaluronan
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Active Comparator: Hyalobarrier group
The Hyalobarrier group received intra-pelvic Hyalobarrier Gel during the scheduled pelvic surgery and be followed for 24 months.
|
Laparotomy: 40 mg/ml (4%) cross-linked hyaluronan Endoscopy: 30 mg/ml (3%) cross-linked hyaluronan
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Sham Comparator: 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.
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No anti-adhesion agent applied
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Active Comparator: Seprafilm group
The Seprafilm group received intra-pelvic Seprafilm Adhesion Barrier during the scheduled pelvic surgery and be followed for 24 months.
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a hyaluronate carboxymethylcellulose-based bioresorbable membrane
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Active Comparator: 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.
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an oxidized regenerated cellulose absorbable membrane
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The incidence of postoperative adhesion at 3 months
Time Frame: 3 months post-operation
|
Divide the number of patients with postoperative adhesion at 3 months in each group by the total number of patients enrolled.
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3 months post-operation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The incidence of adverse events in each group from the baseline and during the study period
Time Frame: 14 days, 3, 6, 12, 18, 24 months
|
Divide the number of patients who suffered from adverse events by the number of patients enrolled in each group.
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14 days, 3, 6, 12, 18, 24 months
|
The incidence of each adverse event from the baseline and during the study
Time Frame: 14 days, 3, 6, 12, 18, 24 months
|
Divide the number of each adverse event by the number of total adverse events.
|
14 days, 3, 6, 12, 18, 24 months
|
The severity of adverse events
Time Frame: 14 days, 3, 6, 12, 18, 24 months
|
The severity of adverse events are evaluated by blinded evaluators.
The severity is classified into slight (no requirement for treatment), moderate (required for treatments, hospitalization or hospitalization prolongation) and serious (death, life-threatening, required for intensive care, required 7 days or longer time for recovery, permanent disability or congenital malformation)
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14 days, 3, 6, 12, 18, 24 months
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The change of medication or treatment related to adverse event
Time Frame: 14 days, 3, 6, 12, 18, 24 months
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The change of time or dose of the medication or treatment in each group are evaluated by blinded evaluators.
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14 days, 3, 6, 12, 18, 24 months
|
The proportion of sites with adhesions at 3 months
Time Frame: 3 months post-operation
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Divide the number of sites with adhesions by the total number of sites observed.
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3 months post-operation
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The score of adhesion severity and extent at each sites at 3 months
Time Frame: 3 months post-operation
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Scoring method published by America Fertility Society: The score of filmy adhesions with less than 1/3 enclosure is 1. The score of filmy adhesions with 1/3-2/3 enclosure is 2. The score of filmy adhesions with more than 2/3 enclosure is 4. The score of dense adhesions with less than 1/3 enclosure is 4. The score of dense adhesions with 1/3-2/3 enclosure is 8. The score of dense adhesions with more than 2/3 enclosure is 16. Higher score indicates more severe and extent adhesions, and represents worse outcome. |
3 months post-operation
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The total score of America Fertility Society classifications of adhesions at all sites in each group at 3 months
Time Frame: 3 months post-operation
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Scoring method published by America Fertility Society: The score of filmy adhesions with less than 1/3 enclosure is 1. The score of filmy adhesions with 1/3-2/3 enclosure is 2. The score of filmy adhesions with more than 2/3 enclosure is 4. The score of dense adhesions with less than 1/3 enclosure is 4. The score of dense adhesions with 1/3-2/3 enclosure is 8. The score of dense adhesions with more than 2/3 enclosure is 16. The evaluated sites include anterior and posterior uterus, anterior and posterior cul-de-sac, left and right pelvic sidewall, left and right ovaries, left and right tubes, small bowel, large bowel, omentum, left and right abdominal wall as well as the incision, left and right broad ligament, left and right round ligament of uterus. Sum up all the adhesion scores at all sites in each group. The minimum total score is 0 and the maximum total score is 320. Higher score indicates more severe and extent adhesions, and represents worse outcome. |
3 months post-operation
|
The incidence of postoperative adhesion from the baseline and during the study period
Time Frame: 14 days, 3, 6, 12, 18, 24 months
|
Divide the number of patients with postoperative adhesion from the baseline and during the study in each group by the total number of patients enrolled.
|
14 days, 3, 6, 12, 18, 24 months
|
The change of CA125 value in each group during the study period
Time Frame: 3, 6, 12, 18, 24 months
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CA125 value (U/ml) is considered as one of the indexes of pelvic inflammation.
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3, 6, 12, 18, 24 months
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The change of the results of SF-36 questionnaire in each group from the baseline and during the study period
Time Frame: 14 days, 3, 6, 12, 18, 24 months
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SF-36 questionnaires are filled out by patients to evaluate their health status during the study period.
8 categories of scales are evaluated including physical functioning, role limitations due to physical or emotional problems, energy/fatigue, emotional well beings, social functioning, pain and general health.
For each category, the minimum average score is 0 and the maximum average score is 100.
Higher score indicates better health status, which represents a better outcome.
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14 days, 3, 6, 12, 18, 24 months
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The residual status of anti-adhesion agents at 3 months
Time Frame: 3 months post-operation
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The residual status of anti-adhesion agents at each site is evaluated by blinded evaluators.
No residue is scored to be 0, and with residue is scored to be 1.
Sum up the scores of all sites in each group.
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3 months post-operation
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Visual analog scale (VAS) score for pain change
Time Frame: 14 days, 3, 6, 12, 18, 24 months
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Patients enrolled who had endometriosis or intra-pelvic adhesions would subjectively evaluate their feeling of pain through a 100 mm line labelled at '0' with 'no pain' and '100' with 'worst pain' during the study period.
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14 days, 3, 6, 12, 18, 24 months
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RDCT-TWPH
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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