Ignite Creation Date:
2025-12-24 @ 4:27 PM
Ignite Modification Date:
2025-12-27 @ 8:23 PM
Study NCT ID:
NCT01217866
Status:
COMPLETED
Last Update Posted:
2012-12-20
First Post:
2010-10-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Retrospective Review of Enseal Laparoscopic Vaginal Assisted Hysterectomy (LAVH) Versus Traditional LAVH
Sponsor:
Womens Care
Organization:
Study Overview
Official Title:
A Retrospective Analysis of a Complete Enseal Laparoscopic Vaginal Assisted Hysterectomy Versus a Traditional Suture Laparoscopic Vaginal Hysterectomy
Status:
COMPLETED
Status Verified Date:
2012-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Retrospective charts review from one surgeon to compare Group A- cases where the laparoscopic portion of the case used an EN\~SEAL device to Group B - the laparoscopic BSO was done using a 3mm EN-SEAL device through 2 lateral 5mm ports.
Detailed Description:
79 women with benign uterine disease underwent laparoscopic assisted vaginal hysterectomy with or without bilateral salpingo-oophorectomy. Subjects charts were divided into two groups based on surgical technique and the following parameters were reviewed retrospectively: surgical time, blood loss, uterine weight, patient weight, patient age, post operative fever \>100.4 F, readmission to hospital within one week, return to operating room within 24 hours, length of hospital stay, and blood transfusion. Group A, N=35 used traditional suture technique vaginally. Group B, N=44 used Enseal coagulation cutting device vaginally.
Study Oversight
Has Oversight DMC:
False
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?: