Seprafilm Slurry in the Prevention of Uterine Scarring in Patients Undergoing Hysteroscopic Myomectomy

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Columbia University
Sponsor:
Collaborator:
Genzyme, a Sanofi Company
Information provided by (Responsible Party):
Rogerio A. Lobo, Columbia University
ClinicalTrials.gov Identifier:
NCT01632202
First received: June 28, 2012
Last updated: July 29, 2013
Last verified: July 2013
  Purpose

Seprafilm is an FDA-approved temporary bioresorbable barrier that physically separates opposing tissue surfaces. The physical presence of the membrane separates adhesiogenic tissue while the normal tissue repair process takes place. When used in the abdominopelvic cavity, it has been shown to reduce the incidence of adhesions.

The intrauterine cavity is a potential space where the walls of the uterus are collapsed upon itself in the normal state. It has been demonstrated that the trauma of removing a submucosal fibroid with electrocautery exposes the uterus to great potential for intrauterine adhesions since the raw charred surface is directly opposed to the opposite endometrial surface. Previous studies have shown that the placement of hyaluronic acid in the intrauterine cavity after a myomectomy is not only safe, but also decreases the incidence of intrauterine adhesions.

The investigators hypothesize that by placing a slurry of Seprafilm in the intrauterine cavity and creating a temporary physical barrier between the walls of the uterus, that they will be able to prevent iatrogenic intrauterine adhesions. Given that approximately 24 to 48 hours after placement, the membrane becomes a hydrated gel that is slowly resorbed within one week, the investigators anticipate that the patient will have minimal to no discomfort; since no physical device is being left in the endometrial cavity, the uterus will not be contracting more than it does in its normal postoperative state.


Condition Intervention Phase
Intrauterine Adhesions
Device: Seprafilm
Device: Sterile Saline Solution
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: The Role of Seprafilm Bioresorbable Slurry in the Prevention of Intrauterine Synechiae in Patients Undergoing Hysteroscopic Myomectomy

Resource links provided by NLM:


Further study details as provided by Columbia University:

Primary Outcome Measures:
  • Presence of iatrogenic intrauterine adhesions [ Time Frame: 2- 3 months after surgery ] [ Designated as safety issue: No ]

    Evidence of uterine scarring will be evaluated by a 3D sonohysterogram.

    A 3D sonohysterogram will be performed in the standard fashion in our ultrasound department by a blinded practitioner. The degree of adhesive disease will be scored by standard convention as:

    • Absent Adhesive Disease: no presence of intrauterine adhesions
    • Mild Adhesive Disease: cavities that are less than or equal to 30% affected
    • Moderate Adhesive Disease: cavities that are greater than 30% but less than or equal to 60% affected
    • Severe Adhesive Disease: cavities that are greater than 60% affected


Secondary Outcome Measures:
  • Pregnancy within 12 months of treatment [ Time Frame: Up to 12 months after surgery ] [ Designated as safety issue: No ]
    In order to determine if Seprafilm helps improve pregnancy rates we will be conducting an additional follow-up phone call up to 12 months from the day of sonohysterogram. In women who have wished to get pregnant we will ask if they have been trying to get pregnant and if they have gotten pregnant. Participation in this follow up call is optional.


Estimated Enrollment: 328
Study Start Date: May 2012
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Seprafilm Slurry
The investigators hypothesize that by placing a slurry of Seprafilm in the intrauterine cavity and creating a temporary physical barrier between the walls of the uterus, that we will be able to prevent iatrogenic intrauterine adhesions. Given that approximately 24 to 48 hours after placement, the membrane becomes a hydrated gel that is slowly resorbed within one week, we anticipate that the patient will have minimal to no discomfort; since no physical device is being left in the endometrial cavity, the uterus will not be contracting more than it does in its normal postoperative state.
Device: Seprafilm
Seprafilm Adhesion Barrier (membrane) is a sterile, bioresorbable, translucent adhesion barrier composed of two anionic polysaccharides, sodium hyaluronate (HA) and carboxymethylcellulose (CMC). Together, these biopolymers have been chemically modified with the activating agent 1-(3-dimethylaminopropyl) -3- ethylcarbodiimide hydrochloride (EDC).
Placebo Comparator: Placebo
For those randomized not to receive Seprafilm slurry, a syringe will be filled with 25ml of sterile saline.
Device: Sterile Saline Solution
For those randomized not to receive Seprafilm slurry, a syringe will be filled with 25ml of sterile saline.

Detailed Description:

The investigators will conduct a randomized controlled trial (RCT) involving patients at NewYork Presbyterian Hospital-Columbia University Medical Center and Weill Medical College of Cornell University. The investigators will enroll 328 pre- menopausal patients (>18years) with documented submucosal myomas undergoing hysteroscopic myomectomy with monopolar resection in this study.

The investigators anticipate that approximately 30% of the patients undergoing myomectomy will form intrauterine adhesions and that administration of the Seprafilm slurry will reduce the incidence to approximately 15%.

Patients will be queried on post-operative days 1, 7, and 30 for pain/discomfort and the degree of intrauterine adhesions will be assessed after the patient's second menses (75-90 days post procedure).

  Eligibility

Ages Eligible for Study:   18 Years to 48 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Reproductive aged women: Age 18-48 years old
  • Non-pregnant
  • Otherwise healthy
  • Regular menstrual cycle
  • Documented submucosal myomas (one or more)
  • Undergoing hysteroscopic myomectomy
  • Patients must have signed an informed consent.

Exclusion Criteria:

  • Age < 18 or in menopause
  • Undergoing a second uterine surgical procedure
  • Other significant uterine pathology (including but not limited to adhesions, septae, or cancerous lesions)
  • Hysteroscopic evidence of synechiae at the time of the procedure
  • Surgeries complicated by excessive bleeding; defined by estimated blood loss > 100cc given that the presence of excessive bleeding may predispose a patient to the formation of intrauterine adhesions
  • Surgeries complicated by uterine perforation
  • Surgeries complicated by postoperative intrauterine infection given that infection may predispose a patient to the formation of intrauterine adhesions (If these patients received Seprafilm Slurry, they will continue to be followed for safety monitoring)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01632202

Contacts
Contact: Rogerio A Lobo, MD 212-305-6337 ral35@columbia.edu
Contact: Luz Sanabria, BA 212-305-9672 ls2328@columbia.edu

Locations
United States, New York
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Luz Sanabria, BA    212-305-9672    ls2328@columbia.edu   
Principal Investigator: Rogerio A Lobo, MD         
Sub-Investigator: Lisa Grossman, MD         
Weill Medical College of Cornell University Recruiting
New York, New York, United States, 10021
Contact: Glenn Schattman, MD    646-962-3836    glschattman@med.cornell.edu   
Contact: Brian Levine, MD    (646) 962-3327    mailto:bal9016@med.cornell.edu   
Principal Investigator: Glenn Schattman, MD         
Sub-Investigator: Brian Levine, MD         
Sponsors and Collaborators
Rogerio A. Lobo
Genzyme, a Sanofi Company
Investigators
Principal Investigator: Rogerio A Lobo, MD Columbia University
  More Information

No publications provided

Responsible Party: Rogerio A. Lobo, Professor of Obstetrics and Gynecology, Columbia University
ClinicalTrials.gov Identifier: NCT01632202     History of Changes
Other Study ID Numbers: AAAF2293
Study First Received: June 28, 2012
Last Updated: July 29, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Columbia University:
submucosal myomas
intrauterine adhesions
hysteroscopic myomectomy
seprafilm

ClinicalTrials.gov processed this record on October 02, 2014