Clinical Trials Directory

Trials / Completed

CompletedNCT01217866

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

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

Status
Completed
Phase
Study type
Observational
Enrollment
79 (actual)
Sponsor
Womens Care · Academic / Other
Sex
Female
Age
35 Years – 75 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDURELaparoscopic assisted vaginal hysterectomySurgical removal of uterus vaginally

Timeline

Start date
2010-08-01
Primary completion
2011-02-01
Completion
2011-02-01
First posted
2010-10-08
Last updated
2012-12-20

Source: ClinicalTrials.gov record NCT01217866. Inclusion in this directory is not an endorsement.