L Tastaldi1, K Bencsath2, D Alaedeen3, S Rosenblatt4, H Alkhatib4, C Tu5, A Fafaj4, D M Krpata4, A S Prabhu4, C C Petro4, M J Rosen4. 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. tastall@ccf.org. 2. Department of General Surgery, Digestive Disease and Surgery Institute, Hillcrest Hospital, The Cleveland Clinic Foundation, 6770 Mayfield Road, Mayfield Heights, OH, 44124, USA. 3. Department of General Surgery, Digestive Disease and Surgery Institute, Fairview Hospital, The Cleveland Clinic Foundation, 18101 Lorain Avenue, Cleveland, OH, 44111, USA. 4. 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. 5. Department of Quantitative Health Sciences, Lerner Research Institute, The Cleveland Clinic Foundation, 9500 Euclid Avenue, Cleveland, OH, 44195, USA.
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).
RCT Entities:
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).
Authors: Simone Augustinus; Iris W J M van Goor; Johannes Berkhof; Lois A Daamen; Bas Groot Koerkamp; Tara M Mackay; I Q Molenaar; Hjalmar C van Santvoort; Helena M Verkooijen; Peter M van de Ven; Marc G Besselink Journal: Ann Surg Date: 2022-07-22 Impact factor: 13.787