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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
188
40 mg/ml (4%) cross-linked hyaluronan
Laparotomy: 40 mg/ml (4%) cross-linked hyaluronan Endoscopy: 30 mg/ml (3%) cross-linked hyaluronan
No anti-adhesion agent applied
Taipei Veterans General Hospital
Taipei, Taiwan
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.
Time frame: 3 months post-operation
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.
Time frame: 14 days, 3, 6, 12, 18, 24 months
The incidence of each adverse event from the baseline and during the study
Divide the number of each adverse event by the number of total adverse events.
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: 3 months post-operation
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a hyaluronate carboxymethylcellulose-based bioresorbable membrane
an oxidized regenerated cellulose absorbable membrane
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 14 days, 3, 6, 12, 18, 24 months