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

Age Range:18 - 48
Start Date:May 2012
Contact:Rogerio A Lobo, MD

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The Role of Seprafilm Bioresorbable Slurry in the Prevention of Intrauterine Synechiae in Patients Undergoing Hysteroscopic Myomectomy

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.

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).

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
We found this trial at
445 E 69th St
New York, New York 10021
(212) 746-1067
Weill Medical College of Cornell University Founded in 1898, and affiliated with what is now...
New York, NY
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630 W 168th St
New York, New York
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
New York, NY
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