Telescopic dissection versus balloon dissection for laparoscopic totally extraperitoneal inguinal hernia repair (TEP): a registry-based randomized controlled trial
Laparoscopic totally extraperitoneal inguinal hernia repair (TEP) can be performed using either telescopic (TD) or balloon dissection (BD). The use of a disposable balloon dissector increases the cost of TEP. However, it remains unclear whether BD saves enough time to justify its cost. We hypothesized that BD would consistently save 15 min in operative time. To test this hypothesis, we designed a registry-based randomized controlled trial (RB-RCT) embedded into the Americas Hernia Society Quality Collaborative.
A single-blinded, parallel, RB-RCT was conducted. Adults with inguinal hernias presenting for elective repair were screened. Patients with unilateral hernias deemed fit to undergo TEP were eligible; those with bilateral hernias (BIH) or undergoing open repair were excluded. Individuals were randomized to TD or BD with a disposable device. TEP was performed with synthetic mesh and tacks. Subjects were blinded and followed up for 30 day. Main outcome was operative time.
207 patients were screened: 166 were excluded and 41 were randomized (21 BD, 20 TD). One patient (TD group) was excluded due to the incidental finding of BIH. 40 patients were analyzed (median age 56, median BMI 26 kg/m2, 98% males). Hernias were 72% indirect, 17% direct, 10% pantaloon, and 8% recurrent. Other than obesity (26.5% vs. 0, p = 0.018), there were no baseline differences between the groups. Median operative times were similar (TD 43 min, IQR 33–63; BD 46 min, IQR 35–90, p = 0.490). There were 2 seromas and 2 hematomas in the BD group, and none in the TD (p = 0.108).
BD does not consistently result in 15-min time saving during TEP. Use of a disposable balloon dissector can be deferred in the experienced hands.
KeywordsBalloon Telescopic Inguinal Hernia Extraperitoneal TEP
We acknowledge Erica Linna, RN and Jennifer Mackey, CNP for their participation on subjects follow up.
This work was funded through the Americas Hernia Society Quality Collaborative Resident/Fellow Research Grant Award.
Compliance with ethical standards
Conflict of interest
Luciano Tastaldi has received the AHSQC Resident/Fellow Research Grant Award that is related to this work. Aldo Fafaj has received the AHSQC Resident/Fellow Research Grant Award that is not related to the present work. David Krpata received an educational Grant from W. L. Gore not related to the present work. Ajita S. Prabhu receives personal fees from Medtronic and Intuitive Surgical Inc. and has an ongoing research Grant from Intuitive Inc. Michael Rosen received salary support for his leadership position in the AHSQC, is a board member and has stock/stock options from Ariste Medical and has ongoing research Grants from Pacira Pharmaceuticals Inc. and Intuitive Inc. Remaining authors declare no conflicts of interest.
This study complies with institutional/national ethical standards and was approved by the Institutional Review Board.
Human and animal rights
All procedures performed in studies involving human participants were in accordance with the ethical standards of the Cleveland Clinic Institutional Review Board and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.
Informed consent was obtained from all individual participants included in the study.
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