A Retrospective Review of Enseal Laparoscopic Vaginal Assisted Hysterectomy (LAVH) Versus Traditional LAVH

Benign Uterine Disease Clinical Trial

Official title:

A Retrospective Analysis of a Complete Enseal Laparoscopic Vaginal Assisted Hysterectomy Versus a Traditional Suture Laparoscopic Vaginal Hysterectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01217866
• Other study ID #: 1-44206615
• Status: Completed
• Phase: N/A
• First received: October 6, 2010
• Last updated: December 19, 2012
• Start date: August 2010
• Est. completion date: February 2011

Study information

• Verified date: December 2012
• Source: Womens Care
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 35 Years to 75 Years

Eligibility

Inclusion Criteria:

• none, observational study

Exclusion Criteria:

• none, observational study

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Benign Uterine Disease
• Uterine Diseases

Intervention

Procedure:
• Laparoscopic assisted vaginal hysterectomy
Surgical removal of uterus vaginally

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Womens Care	Ethicon Endo-Surgery

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Surgical time	The total time the subject spent in surgery was compared between the two groups	Operating room time in minutes	No
Primary	Estimated blood loss	The total blood loss in cc per minutes operating was compared between the two groups	Blood loss during surgery in cc per minute	No