N/A N=40 Randomized Single-blind Treatment

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

Inguinal Hernia

Bottom Line

View on ClinicalTrials.gov: NCT03276871 ↗

Enrolled (actual)

Serious AEs

2.5%

Results posted

Jul 2020

Primary outcome: Primary: Operative Time — 46; 43 minutes

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Telescopic Dissection (Procedure); Balloon Dissection (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: The Cleveland Clinic
Primary completion: Jul 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Operative Time	46; 43	—
SECONDARY NRS-11 Pain Scores	3; 4; 2; 1.5; 0.5; 0	—
SECONDARY Number of Participants With Intra-operative Complications	1; 0	—
SECONDARY 30-day SSO (Surgical Site Occurrences) Rate	4; 0	—

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.

Eligibility Criteria

Inclusion Criteria

18 years of age or older
Able to give informed consent
Unilateral inguinal hernia
Scheduled for elective inguinal hernia repair
Eligible to tolerate general anesthesia
Eligible to undergo minimally invasive inguinal hernia repair
Willing to undergo mesh-based repair

Exclusion Criteria

Younger than 18 years old
Unable to give informed consent
Bilateral Inguinal hernias
Emergent inguinal hernia repairs ( acute incarceration or strangulation)
Recurrent inguinal hernia with prior preperitoneal mesh
Unable to tolerate general anesthesia
Not eligible for minimally invasive inguinal hernia repair
Not willing to undergo mesh-based repair

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03276871). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.