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The Assessment of the Use of Anti-Adhesion Agents to Prevent Pelvic Postoperative Adhesions

Primary Purpose

Tissue Adhesion, Gynecologic Surgery

Status
Active
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
PROTAHERE Absorbable Adhesion Barrier
Hyalobarrier Gel
No treatment
Seprafilm Adhesion Barrier
Gynecare Interceed (TC7) Absorbable Adhesion Barrier
Sponsored by
SciVision Biotech Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Tissue Adhesion focused on measuring Hyaluronan, gel, adhesion agent

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Taipei Veterans General Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Active Comparator

Sham Comparator

Active Comparator

Active Comparator

Arm Label

PROTAHERE group

Hyalobarrier group

No treatment group

Seprafilm group

Interceed group

Arm Description

The PROTAHERE group received intra-pelvic PROTAHERE Absorbable Adhesion Barrier during the scheduled pelvic surgery and be followed for 24 months.

The Hyalobarrier group received intra-pelvic Hyalobarrier Gel during the scheduled pelvic surgery and be followed for 24 months.

The no treatment group did not receive any anti-adhesion agent during the scheduled pelvic surgery and be followed for 24 months.

The Seprafilm group received intra-pelvic Seprafilm Adhesion Barrier during the scheduled pelvic surgery and be followed for 24 months.

The Interceed group received intra-pelvic Gynecare Interceed (TC7) Absorbale Adhesion Barrier during the scheduled pelvic surgery and be followed for 24 months.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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)
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.
The proportion of sites with adhesions at 3 months
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
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 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.
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.
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.
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.
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.
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.

Full Information

First Posted
August 19, 2019
Last Updated
September 11, 2023
Sponsor
SciVision Biotech Inc.
Collaborators
Taipei Veterans General Hospital, Taiwan
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1. Study Identification

Unique Protocol Identification Number
NCT04063085
Brief Title
The Assessment of the Use of Anti-Adhesion Agents to Prevent Pelvic Postoperative Adhesions
Official Title
The Assessment of the Use of Anti-Adhesion Agents to Prevent Pelvic Postoperative Adhesions
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 25, 2018 (Actual)
Primary Completion Date
January 5, 2022 (Actual)
Study Completion Date
October 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SciVision Biotech Inc.
Collaborators
Taipei Veterans General Hospital, Taiwan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tissue Adhesion, Gynecologic Surgery
Keywords
Hyaluronan, gel, adhesion agent

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
220 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PROTAHERE group
Arm Type
Experimental
Arm Description
The PROTAHERE group received intra-pelvic PROTAHERE Absorbable Adhesion Barrier during the scheduled pelvic surgery and be followed for 24 months.
Arm Title
Hyalobarrier group
Arm Type
Active Comparator
Arm Description
The Hyalobarrier group received intra-pelvic Hyalobarrier Gel during the scheduled pelvic surgery and be followed for 24 months.
Arm Title
No treatment group
Arm Type
Sham Comparator
Arm Description
The no treatment group did not receive any anti-adhesion agent during the scheduled pelvic surgery and be followed for 24 months.
Arm Title
Seprafilm group
Arm Type
Active Comparator
Arm Description
The Seprafilm group received intra-pelvic Seprafilm Adhesion Barrier during the scheduled pelvic surgery and be followed for 24 months.
Arm Title
Interceed group
Arm Type
Active Comparator
Arm Description
The Interceed group received intra-pelvic Gynecare Interceed (TC7) Absorbale Adhesion Barrier during the scheduled pelvic surgery and be followed for 24 months.
Intervention Type
Device
Intervention Name(s)
PROTAHERE Absorbable Adhesion Barrier
Intervention Description
40 mg/ml (4%) cross-linked hyaluronan
Intervention Type
Device
Intervention Name(s)
Hyalobarrier Gel
Intervention Description
Laparotomy: 40 mg/ml (4%) cross-linked hyaluronan Endoscopy: 30 mg/ml (3%) cross-linked hyaluronan
Intervention Type
Other
Intervention Name(s)
No treatment
Intervention Description
No anti-adhesion agent applied
Intervention Type
Device
Intervention Name(s)
Seprafilm Adhesion Barrier
Intervention Description
a hyaluronate carboxymethylcellulose-based bioresorbable membrane
Intervention Type
Device
Intervention Name(s)
Gynecare Interceed (TC7) Absorbable Adhesion Barrier
Intervention Description
an oxidized regenerated cellulose absorbable membrane
Primary Outcome Measure Information:
Title
The incidence of postoperative adhesion at 3 months
Description
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
Secondary Outcome Measure Information:
Title
The incidence of adverse events in each group from the baseline and during the study period
Description
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
Title
The incidence of each adverse event from the baseline and during the study
Description
Divide the number of each adverse event by the number of total adverse events.
Time Frame
14 days, 3, 6, 12, 18, 24 months
Title
The severity of adverse events
Description
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
Title
The change of medication or treatment related to adverse event
Description
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
Title
The proportion of sites with adhesions at 3 months
Description
Divide the number of sites with adhesions by the total number of sites observed.
Time Frame
3 months post-operation
Title
The score of adhesion severity and extent at each sites at 3 months
Description
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
Title
The total score of America Fertility Society classifications of adhesions at all sites in each group at 3 months
Description
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
Title
The incidence of postoperative adhesion from the baseline and during the study period
Description
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
Title
The change of CA125 value in each group during the study period
Description
CA125 value (U/ml) is considered as one of the indexes of pelvic inflammation.
Time Frame
3, 6, 12, 18, 24 months
Title
The change of the results of SF-36 questionnaire in each group from the baseline and during the study period
Description
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
Title
The residual status of anti-adhesion agents at 3 months
Description
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
Title
Visual analog scale (VAS) score for pain change
Description
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Taipei Veterans General Hospital
City
Taipei
Country
Taiwan

12. IPD Sharing Statement

Learn more about this trial

The Assessment of the Use of Anti-Adhesion Agents to Prevent Pelvic Postoperative Adhesions

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