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Telescopic Dissection vs. Balloon Dissection During Laparoscopic TEP Inguinal Hernia Repair

NCT03276871 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2020-07-22

Study results available
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Summary

The purpose of this study is to determine if the surgical technique for creation of extraperitoneal space during laparoscopic TEP inguinal hernia repair (telescopic dissection or balloon dissection) has an impact on operative times, early postoperative pain scores, surgical complications and rate of hernia recurrence following laparoscopic TEP inguinal hernia repair.

Conditions

  • Inguinal Hernia

Interventions

PROCEDURE

Telescopic Dissection

Creation of extraperitoneal space with blunt dissection using the laparoscopic probe

DEVICE

Balloon Dissection

Creation of extraperitoneal space with aid of the disposable Spacemaker balloon dissector

Sponsors & Collaborators

  • The Cleveland Clinic

    lead OTHER

Principal Investigators

  • Michael J Rosen, MD · The Cleveland Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-28
Primary Completion
2019-07-06
Completion
2019-07-06
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03276871 on ClinicalTrials.gov