Ignite Creation Date:
2025-12-25 @ 3:55 AM
Ignite Modification Date:
2025-12-26 @ 2:46 AM
Study NCT ID:
NCT01632202
Status:
TERMINATED
Last Update Posted:
2020-12-03
First Post:
2012-06-28
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Seprafilm Slurry in the Prevention of Uterine Scarring in Patients Undergoing Hysteroscopic Myomectomy
Sponsor:
Weill Medical College of Cornell University
Organization:
Study Overview
Official Title:
The Role of Seprafilm Bioresorbable Slurry in the Prevention of Intrauterine Synechiae in Patients Undergoing Hysteroscopic Myomectomy
Status:
TERMINATED
Status Verified Date:
2020-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
No subjects were recruited at the Weill Cornell site.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Seprafilm
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.
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).
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: