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| Name | Class |
|---|---|
| Taipei Veterans General Hospital, Taiwan | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PROTAHERE group | Experimental | 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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| Hyalobarrier group | Active Comparator | The Hyalobarrier group received intra-pelvic Hyalobarrier Gel during the scheduled pelvic surgery and be followed for 24 months. |
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| No treatment group | Sham Comparator | 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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| Seprafilm group | Active Comparator | The Seprafilm group received intra-pelvic Seprafilm Adhesion Barrier during the scheduled pelvic surgery and be followed for 24 months. |
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| Interceed group | Active Comparator | The Interceed group received intra-pelvic Gynecare Interceed (TC7) Absorbale Adhesion Barrier during the scheduled pelvic surgery and be followed for 24 months. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PROTAHERE Absorbable Adhesion Barrier | Device | 40 mg/ml (4%) cross-linked hyaluronan |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of postoperative adhesion at 3 months | Divide the number of patients with postoperative adhesion at 3 months in each group by the total number of patients enrolled. | 3 months post-operation |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of adverse events in each group from the baseline and during the study period | Divide the number of patients who suffered from adverse events by the number of patients enrolled in each group. | 14 days, 3, 6, 12, 18, 24 months |
| The incidence of each adverse event from the baseline and during the study |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taipei Veterans General Hospital | Taipei | Taiwan |
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| Hyalobarrier Gel |
| Device |
Laparotomy: 40 mg/ml (4%) cross-linked hyaluronan Endoscopy: 30 mg/ml (3%) cross-linked hyaluronan |
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| No treatment | Other | No anti-adhesion agent applied |
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| Seprafilm Adhesion Barrier | Device | a hyaluronate carboxymethylcellulose-based bioresorbable membrane |
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| Gynecare Interceed (TC7) Absorbable Adhesion Barrier | Device | an oxidized regenerated cellulose absorbable membrane |
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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 | 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) | 14 days, 3, 6, 12, 18, 24 months |
| The change of medication or treatment related to adverse event | The change of time or dose of the medication or treatment in each group are evaluated by blinded evaluators. | 14 days, 3, 6, 12, 18, 24 months |
| The proportion of sites with adhesions at 3 months | Divide the number of sites with adhesions by the total number of sites observed. | 3 months post-operation |
| The score of adhesion severity and extent at each sites at 3 months | 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 |
| The total score of America Fertility Society classifications of adhesions at all sites in each group at 3 months | 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 | 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 | CA125 value (U/ml) is considered as one of the indexes of pelvic inflammation. | 3, 6, 12, 18, 24 months |
| The change of the results of SF-36 questionnaire in each group from the baseline and during the study period | 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. | 14 days, 3, 6, 12, 18, 24 months |
| The residual status of anti-adhesion agents at 3 months | 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. | 3 months post-operation |
| Visual analog scale (VAS) score for pain change | 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. | 14 days, 3, 6, 12, 18, 24 months |
| ID | Term |
|---|---|
| D000267 | Tissue Adhesions |
| ID | Term |
|---|---|
| D002921 | Cicatrix |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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