Gynecologic Surgery, Tissue Adhesion
Conditions
Keywords
Hyaluronan, gel, adhesion agent
Brief summary
The aim of this study is to assess the safety and effectiveness of PROTAHERE Absorbable Adhesion Barrier to prevent pelvic postoperative adhesions.
Detailed description
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.
Interventions
DEVICEPROTAHERE Absorbable Adhesion Barrier
40 mg/ml (4%) cross-linked hyaluronan
DEVICEHyalobarrier Gel
Laparotomy: 40 mg/ml (4%) cross-linked hyaluronan Endoscopy: 30 mg/ml (3%) cross-linked hyaluronan
OTHERNo treatment
No anti-adhesion agent applied
DEVICESeprafilm Adhesion Barrier
a hyaluronate carboxymethylcellulose-based bioresorbable membrane
DEVICEGynecare Interceed (TC7) Absorbable Adhesion Barrier
an oxidized regenerated cellulose absorbable membrane
Sponsors
Taipei Veterans General Hospital, Taiwan
SciVision Biotech Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of postoperative adhesion at 3 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of each adverse event from the baseline and during the study | 14 days, 3, 6, 12, 18, 24 months | Divide the number of each adverse event by the number of total adverse events. |
| The severity of adverse events | 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) |
| The change of medication or treatment related to adverse event | 14 days, 3, 6, 12, 18, 24 months | The change of time or dose of the medication or treatment in each group are evaluated by blinded evaluators. |
| The proportion of sites with adhesions at 3 months | 3 months post-operation | Divide the number of sites with adhesions by the total number of sites observed. |
| The score of adhesion severity and extent at each sites at 3 months | 3 months post-operation | 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. |
| The incidence of adverse events in each group from the baseline and during the study period | 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. |
| The incidence of postoperative adhesion from the baseline and during the study period | 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. |
| The change of CA125 value in each group during the study period | 3, 6, 12, 18, 24 months | CA125 value (U/ml) is considered as one of the indexes of pelvic inflammation. |
| The change of the results of SF-36 questionnaire in each group from the baseline and during the study period | 14 days, 3, 6, 12, 18, 24 months | 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. |
| The residual status of anti-adhesion agents at 3 months | 3 months post-operation | 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. |
| Visual analog scale (VAS) score for pain change | 14 days, 3, 6, 12, 18, 24 months | 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. |
| The total score of America Fertility Society classifications of adhesions at all sites in each group at 3 months | 3 months post-operation | 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. |
Countries
Taiwan
Outcome results
None listed