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Telescopic dissection versus balloon dissection for laparoscopic totally extraperitoneal inguinal hernia repair (TEP): a registry-based randomized controlled trial

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Abstract

Objective

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.

Methods

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.

Results

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).

Conclusions

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.

Trial registration

ClinicalTrials.gov (NCT03276871).

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Acknowledgements

We acknowledge Erica Linna, RN and Jennifer Mackey, CNP for their participation on subjects follow up.

Funding

This work was funded through the Americas Hernia Society Quality Collaborative Resident/Fellow Research Grant Award.

Author information

Authors and Affiliations

  1. Department of General Surgery, Cleveland Clinic Center for Abdominal Core Health, Digestive Disease and Surgery Institute, The Cleveland Clinic Foundation, 9500 Euclid Avenue, A100-133, Cleveland, OH, 44195, USA

    L. Tastaldi, S. Rosenblatt, H. Alkhatib, A. Fafaj, D. M. Krpata, A. S. Prabhu, C. C. Petro & M. J. Rosen

  2. Department of General Surgery, Digestive Disease and Surgery Institute, Hillcrest Hospital, The Cleveland Clinic Foundation, 6770 Mayfield Road, Mayfield Heights, OH, 44124, USA

    K. Bencsath

  3. Department of General Surgery, Digestive Disease and Surgery Institute, Fairview Hospital, The Cleveland Clinic Foundation, 18101 Lorain Avenue, Cleveland, OH, 44111, USA

    D. Alaedeen

  4. Department of Quantitative Health Sciences, Lerner Research Institute, The Cleveland Clinic Foundation, 9500 Euclid Avenue, Cleveland, OH, 44195, USA

    C. Tu

Authors
  1. L. Tastaldi
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  2. K. Bencsath
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  7. A. Fafaj
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  8. D. M. Krpata
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  9. A. S. Prabhu
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Corresponding author

Correspondence to L. Tastaldi.

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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.

Ethical standards

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

Informed consent was obtained from all individual participants included in the study.

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Tastaldi, L., Bencsath, K., Alaedeen, D. et al. Telescopic dissection versus balloon dissection for laparoscopic totally extraperitoneal inguinal hernia repair (TEP): a registry-based randomized controlled trial. Hernia 23, 1105–1113 (2019). https://doi.org/10.1007/s10029-019-02001-y

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