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

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ClinicalTrials.gov Identifier: NCT01632202
Recruitment Status : Unknown
Verified July 2013 by Rogerio A. Lobo, Columbia University.
Recruitment status was:  Recruiting
First Posted : July 2, 2012
Last Update Posted : July 31, 2013
Sponsor:
Collaborator:
Genzyme, a Sanofi Company
Information provided by (Responsible Party):
Rogerio A. Lobo, Columbia University

Tracking Information
First Submitted Date  ICMJE June 28, 2012
First Posted Date  ICMJE July 2, 2012
Last Update Posted Date July 31, 2013
Study Start Date  ICMJE May 2012
Estimated Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 29, 2012)
Presence of iatrogenic intrauterine adhesions [ Time Frame: 2- 3 months after surgery ]
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01632202 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 29, 2012)
Pregnancy within 12 months of treatment [ Time Frame: Up to 12 months after surgery ]
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Seprafilm Slurry in the Prevention of Uterine Scarring in Patients Undergoing Hysteroscopic Myomectomy
Official Title  ICMJE The Role of Seprafilm Bioresorbable Slurry in the Prevention of Intrauterine Synechiae in Patients Undergoing Hysteroscopic Myomectomy
Brief Summary

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.

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).

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Condition  ICMJE Intrauterine Adhesions
Intervention  ICMJE
  • 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).
  • Device: Sterile Saline Solution
    For those randomized not to receive Seprafilm slurry, a syringe will be filled with 25ml of sterile saline.
Study Arms  ICMJE
  • 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.
    Intervention: Device: Seprafilm
  • Placebo Comparator: Placebo
    For those randomized not to receive Seprafilm slurry, a syringe will be filled with 25ml of sterile saline.
    Intervention: Device: Sterile Saline Solution
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 29, 2012)
328
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 48 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01632202
Other Study ID Numbers  ICMJE AAAF2293
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Rogerio A. Lobo, Columbia University
Study Sponsor  ICMJE Rogerio A. Lobo
Collaborators  ICMJE Genzyme, a Sanofi Company
Investigators  ICMJE
Principal Investigator: Rogerio A Lobo, MD Columbia University
PRS Account Columbia University
Verification Date July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP