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Three-dimensional versus two-dimensional high-definition laparoscopy in transabdominal preperitoneal inguinal hernia repair: a prospective randomized controlled study.

ABSTRACT: BACKGROUND:Three-dimensional (3D) laparoscopy improves technical efficacy in laboratory environment, but evidence for clinical benefit is lacking. The aim of this study was to determine whether the 3D laparoscopy is beneficial in transabdominal preperitoneal laparoscopic inguinal hernia repair (TAPP). METHOD:In this prospective, single-blinded, single-center, superior randomized trial, patients scheduled for TAPP were randomly allocated to either 3D or two-dimensional (2D) TAPP laparoscopic approaches. Patients were excluded if secondary operation was planned, the risk of conversion was high, or the surgeon had less than five previous 3D laparoscopic procedures. Patients were operated on by 13 residents and 3 attendings. The primary endpoint was operation time. The study was registered in ClinicalTrials.gov (NCT02367573). RESULTS:Total 278 patients were randomized between 5th February 2015 and 23rd October 2017. Median operation time was shorter in the 3D group (56.0 min vs. 68.0 min, p??50 3D laparoscopic procedures, surgeons with any experience in TAPP, patients with body mass indices

SUBMITTER: Koppatz HE

PROVIDER: S-EPMC7572346 | biostudies-literature | 2020 Nov

REPOSITORIES: biostudies-literature

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Three-dimensional versus two-dimensional high-definition laparoscopy in transabdominal preperitoneal inguinal hernia repair: a prospective randomized controlled study.

Koppatz Hanna E HE Harju Jukka I JI Sirén Jukka E JE Mentula Panu J PJ Scheinin Tom M TM Sallinen Ville J VJ

Surgical endoscopy 20191121 11

<h4>Background</h4>Three-dimensional (3D) laparoscopy improves technical efficacy in laboratory environment, but evidence for clinical benefit is lacking. The aim of this study was to determine whether the 3D laparoscopy is beneficial in transabdominal preperitoneal laparoscopic inguinal hernia repair (TAPP).<h4>Method</h4>In this prospective, single-blinded, single-center, superior randomized trial, patients scheduled for TAPP were randomly allocated to either 3D or two-dimensional (2D) TAPP la ...[more]

PMID: 31754852

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Project description:ImportanceDespite rapid adoption of the robotic platform for inguinal hernia repair in the US, to date, no level I trials have ever compared robotic inguinal hernia repair to laparoscopic repair. This multicenter randomized clinical trial is the first to compare the robotic platform to laparoscopic approach for minimally invasive inguinal hernia repair.ObjectiveTo determine whether the robotic approach to inguinal hernia repair results in improved postoperative outcomes compared with traditional laparoscopic inguinal hernia repairs.Design, setting, and participantsThis multicenter, single-blinded, prospective randomized clinical pilot study was conducted from April 2016 to April 2019, with a follow-up duration of 30 days in 6 academic and academic-affiliated sites. Enrolled in this study were 113 patients with a unilateral primary or recurrent inguinal hernia. After exclusions 102 remained for analysis.InterventionsStandard laparoscopic transabdominal preperitoneal repair or robotic transabdominal preperitoneal repair.Main outcomes and measuresMain outcomes included postoperative pain, health-related quality of life, mobility, wound morbidity, and cosmesis. Secondary outcomes included cost, surgeon ergonomics, and surgeon mental workload. A primary outcome was not selected because this study was designed as a pilot study. The hypothesis was formulated prior to data collection.ResultsA total of 102 patients were included in the study (54 in the laparoscopic group, mean [SD] age, 57.2 [13.3] years and 48 [88.9%] male; 48 in the robotic group, mean [SD] age, 56.1 [14.1] years and 44 [91.6%] male). There were no differences at the preoperative, 1-week, or 30-day points between the groups in terms of wound events, readmissions, pain as measured by the Visual Analog Scale, or quality of life as measured by the 36-Item Short Form Health Survey. Compared with traditional laparoscopic inguinal hernia repair, robotic transabdominal preperitoneal repair was associated with longer median (interquartile range) operative times (75.5 [59.0-93.8] minutes vs 40.5 [29.2-63.8] minutes, respectively; P?<?.001), higher median (interquartile range) cost ($3258 [$2568-$4118] vs $1421 [$1196-$1930], respectively; P?<?.001), and higher mean (SD) frustration levels on the NASA Task Load Index Scale (range, 1-100, with lower scores indicating lower cognitive workload) (32.7 [23.5] vs 20.1 [19.2], respectively; P?=?.004). There were no differences in ergonomics of the surgeons between the groups as measured by the Rapid Upper Limb Assessment instrument.Conclusions and relevanceResults of this study showed no clinical benefit to the robotic approach to straightforward inguinal hernia repair compared with the laparoscopic approach. The robotic approach incurred higher costs and more operative time compared with the laparoscopic approach, with added surgeon frustration and no ergonomic benefit to surgeons.Trial registrationClinicalTrials.gov Identifier: NCT02816658.

Dataset Information

Three-dimensional versus two-dimensional high-definition laparoscopy in transabdominal preperitoneal inguinal hernia repair: a prospective randomized controlled study.

Publications

Three-dimensional versus two-dimensional high-definition laparoscopy in transabdominal preperitoneal inguinal hernia repair: a prospective randomized controlled study.

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