H Tran1, I Turingan, K Tran, M Zajkowska, V Lam, W Hawthorne. 1. Discipline of Surgery, Sydney Medical School, University of Sydney at Westmead Hospital, Hawkesbury Road, Westmead, NSW, Australia, drhmtran@hotmail.com.
Abstract
BACKGROUND: Multiple prospective studies have confirmed safety and efficacy of laparoscopic inguinal herniorraphy with single-port compared to multiport surgery. This prospective randomized controlled trial aimed to assess safety, efficacy and potential benefits of single-port total extraperitoneal inguinal herniorraphy beyond the learning curve. METHODS:All referred patients with inguinal/femoral hernias were enrolled from December 2011 to February 2013. Exclusion criteria included workers compensation cases. Identical balloon dissector, light-weight mesh and non-absorbable tacks were used in all cases. For single-port cases Triport™ was used while structural balloon trocar/inflation bulb for multiport cases. Results were analyzed with IBM(®) SPSS(®) version 22 for Windows. RESULTS:Participation rate was 100 % with 157 inguinal/femoral hernias in 100 patients: 51 randomized to single-port and 49 to multiport group. There was no conversion to open surgery/need for additional ports. There were no statistical differences between single-port and multiport groups with respect to age, sex, body mass index, American Society of Anesthesiologists scores, preoperative pain, hernia defect sizes and length of hospital stay. Operation times were equivalent for single-port and multiport 60.0 vs 61.0 min, P = 0.23, respectively. Significantly, single-port patients ingested fewer pain killers: 6 tablets vs 14 Dextropropoxyphene tablets, P < 0.001, experienced less pain (visual analog scores) on day 1 and 7 post-op op: 2.5 and 0, P < 0.001 compared to 4.5 and 2.5, P < 0.001, respectively, returned to work/normal physical activities 7 days quicker: 7.0 vs 14.0, P < 0.001 and had higher cosmetic scar scores at 6-week follow-up: 24 vs 21, P < 0.001, compared to multiport patients. There were no mortalities, morbidities or recurrences after follow-up of 6-21 months. CONCLUSIONS: Compared to multiport, single-port laparoscopic total extraperitoneal inguinal herniorraphy, when performed by a high-volume and highly dedicated hernia surgeon, resulted in significantly reduced postoperative pain, analgesic requirements, quicker return to work/normal activities, improved cosmesis, and equivalent safety and efficacy.
RCT Entities:
BACKGROUND: Multiple prospective studies have confirmed safety and efficacy of laparoscopic inguinal herniorraphy with single-port compared to multiport surgery. This prospective randomized controlled trial aimed to assess safety, efficacy and potential benefits of single-port total extraperitoneal inguinal herniorraphy beyond the learning curve. METHODS: All referred patients with inguinal/femoral hernias were enrolled from December 2011 to February 2013. Exclusion criteria included workers compensation cases. Identical balloon dissector, light-weight mesh and non-absorbable tacks were used in all cases. For single-port cases Triport™ was used while structural balloon trocar/inflation bulb for multiport cases. Results were analyzed with IBM(®) SPSS(®) version 22 for Windows. RESULTS: Participation rate was 100 % with 157 inguinal/femoral hernias in 100 patients: 51 randomized to single-port and 49 to multiport group. There was no conversion to open surgery/need for additional ports. There were no statistical differences between single-port and multiport groups with respect to age, sex, body mass index, American Society of Anesthesiologists scores, preoperative pain, hernia defect sizes and length of hospital stay. Operation times were equivalent for single-port and multiport 60.0 vs 61.0 min, P = 0.23, respectively. Significantly, single-port patients ingested fewer pain killers: 6 tablets vs 14 Dextropropoxyphene tablets, P < 0.001, experienced less pain (visual analog scores) on day 1 and 7 post-op op: 2.5 and 0, P < 0.001 compared to 4.5 and 2.5, P < 0.001, respectively, returned to work/normal physical activities 7 days quicker: 7.0 vs 14.0, P < 0.001 and had higher cosmetic scar scores at 6-week follow-up: 24 vs 21, P < 0.001, compared to multiport patients. There were no mortalities, morbidities or recurrences after follow-up of 6-21 months. CONCLUSIONS: Compared to multiport, single-port laparoscopic total extraperitoneal inguinal herniorraphy, when performed by a high-volume and highly dedicated hernia surgeon, resulted in significantly reduced postoperative pain, analgesic requirements, quicker return to work/normal activities, improved cosmesis, and equivalent safety and efficacy.
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