A Retrospective Review of Enseal Laparoscopic Vaginal Assisted Hysterectomy (LAVH) Versus Traditional LAVH
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Retrospective
|Official Title:||A Retrospective Analysis of a Complete Enseal Laparoscopic Vaginal Assisted Hysterectomy Versus a Traditional Suture Laparoscopic Vaginal Hysterectomy|
- Surgical time [ Time Frame: Operating room time in minutes ] [ Designated as safety issue: No ]The total time the subject spent in surgery was compared between the two groups
- Estimated blood loss [ Time Frame: Blood loss during surgery in cc per minute ] [ Designated as safety issue: No ]The total blood loss in cc per minutes operating was compared between the two groups
|Study Start Date:||August 2010|
|Study Completion Date:||February 2011|
|Primary Completion Date:||February 2011 (Final data collection date for primary outcome measure)|
Women aged 35-75 who underwent laparoscopic assisted vaginal hysterectomy via either suture technique vaginally or Enseal coagulation cutting device vaginally
Procedure: Laparoscopic assisted vaginal hysterectomy
Surgical removal of uterus vaginally
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01217866
|Principal Investigator:||Katie O'Keeffe, MD||Glens Falls Hospital|