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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01217866
Enrollment
79
Registered
2010-10-08
Start date
2010-08-31
Completion date
2011-02-28
Last updated
2012-12-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Benign Uterine Disease

Keywords

laparoscopic, vaginal, hysterectomy

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.

Interventions

Surgical removal of uterus vaginally

Sponsors

Ethicon Endo-Surgery
CollaboratorINDUSTRY
Womens Care
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
35 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* none, observational study

Exclusion criteria

* none, observational study

Design outcomes

Primary

MeasureTime frameDescription
Surgical timeOperating room time in minutesThe total time the subject spent in surgery was compared between the two groups
Estimated blood lossBlood loss during surgery in cc per minuteThe total blood loss in cc per minutes operating was compared between the two groups

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026