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Litigation claims following laparoscopic and open inguinal hernia repairs.

ABSTRACT: PURPOSE:Groin hernia repair is the most frequently performed general surgical operation in the UK. Complications from laparoscopic and open repair are well recognised; however, potential differences are yet to be considered in relation to litigation. METHODS:Administrative data were obtained and analysed from the NHS Litigation Authority for inguinal hernia-related claims from 1995 to 2016. Claims identified as using an open or laparoscopic approach were compared. RESULTS:880 claims were made, 760 had been settled. 88 laparoscopic and 241 open procedures were identified; 65% laparoscopic and 63% open hernia claims were found to be in favour of the claimant. Payouts totalled to 4.1GBP/4.8EUR/5.3USD million and 9.4GBP/11.0EUR/12.1USD million for laparoscopic (mean 82,824GBP/96,579EUR/106,453USD) and open (mean 66,796GBP/77,892EUR/85,852USD) approaches, respectively. The most common reasons for claim initiation were visceral/vascular injury (54%) in the laparoscopic group, and testicular complications or chronic pain (35%) in the open group. Additional procedures were necessary for 48% and 44% of laparoscopic and open claims, respectively. The highest average payouts were associated with visceral injury, (laparoscopic 116,482GBP/135,820EUR/149,715USD; open 199,103GBP/232,246EUR/255,905USD) and vascular injury (laparoscopic 88,624GBP/103,369EUR/113,892USD; open 64,460GBP/75,163EUR/82,870USD). Additional procedures resulted in an average payout of 93,352GBP/108,917EUR/120,008USD (laparoscopic) and 60,408GBP/70,506EUR/77,657USD (open). The most common additional procedures were corrective visceral/vascular repairs, orchidectomy and recurrent hernia repair. CONCLUSIONS:The rate of litigation for clinical negligence in inguinal hernia surgery in the UK is increasing. Whilst there has been a recent increase in laparoscopic hernia repair claims, the volume and burden of claims related to open procedures remain greater.

SUBMITTER: Varley R

PROVIDER: S-EPMC7520411 | biostudies-literature | 2020 Oct

REPOSITORIES: biostudies-literature

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Litigation claims following laparoscopic and open inguinal hernia repairs.

Varley R R Lo C C Alkhaffaf B B

Hernia : the journal of hernias and abdominal wall surgery 20200330 5

<h4>Purpose</h4>Groin hernia repair is the most frequently performed general surgical operation in the UK. Complications from laparoscopic and open repair are well recognised; however, potential differences are yet to be considered in relation to litigation.<h4>Methods</h4>Administrative data were obtained and analysed from the NHS Litigation Authority for inguinal hernia-related claims from 1995 to 2016. Claims identified as using an open or laparoscopic approach were compared.<h4>Results</h4>8 ...[more]

PMID: 32232613

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Project description:PurposeInternational guidelines suggest the use of lapro-endoscopic technique for primary unilateral inguinal hernia (IHR) because of lower postoperative pain and reduction in chronic pain. It is unclear if the primary benefit is due to the minimally invasive approach, the posterior mesh position or both. Further research evaluating posterior mesh placement using open preperitoneal techniques is recommended. A potential benefit of open preperitoneal repair is the avoidance of general anesthesia, as these repairs can be performed under local anesthesia. This study compares clinical and patient-reported outcomes after unilateral laparo-endoscopic, robotic, and open posterior mesh IHRs.MethodsWe performed a propensity score matched analysis of patients undergoing IHR between 2012 and 2021 in the Abdominal Core Health Quality Collaborative registry. 10,409 patients underwent a unilateral IHR via a posterior approach. Hernia repairs were performed via minimally invasive surgery (MIS) which includes laparoscopic and robotic transabdominal preperitoneal (TAPP), laparoscopic totally extraperitoneal (TEP), or open transrectus preperitoneal/open preperitoneal (TREPP/OPP) approaches. Propensity score matching (PSM) utilizing nearest neighbor matching accounted for differences in baseline characteristics and possible confounding variables between groups. We matched 816 patients in the MIS cohort with 816 patients in the TREPP/OPP group. Outcomes included patient reported quality of life, hernia recurrence, and postoperative opioid use.ResultsImprovement was seen after TREPP/OPP as compared to MIS IHR in EuraHS at 30 days (Median(IQR) 7.0 (2.0-16.64) vs 10 (2.0-24.0); OR 0.69 [0.55-0.85]; p = 0.001) and 6 months (1.0 (0.0-4.0) vs 2.0 (0.0-4.0); OR 0.63 [0.46-85]; p = 0.002), patient-reported opioid use at 30-day follow-up (18% vs 45% OR 0.26 [0.19-0.35]; p < 0.001), and rates of surgical site occurrences (0.8% vs 4.9% OR 0.16 [0.06-0.35]; p < 0.001). There were no differences in EuraHS scores and recurrences at 1 year.ConclusionsThis study demonstrates a potential benefit of open posterior mesh placement over MIS repair in short-term quality of life and seroma formation with equivalent rates of hernia recurrence. Further study is needed to better understand these differences and determine the reproducibility of these findings outside of high-volume specialty centers.

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.

Project description:BackgroundLaparoscopic inguinal hernia repair in children is increasingly performed as it allows contralateral inspection and potentially results in shorter operation time and less complications. Evidence from meta-analyses of randomized controlled trials (RCTs) regarding the superiority of laparoscopic versus open hernia repair is lacking.MethodsA systematic literature search was performed querying PubMed, Embase, MEDLINE, and the Cochrane Library databases. RCTs comparing laparoscopic with open hernia repair in children were considered eligible, without year and language restrictions. Cochrane Risk of Bias tool was used for quality assessment. Data were pooled using a random-effects model. Subgroup analyses were performed according to the laparoscopic suturing technique (i.e., intracorporeal or extracorporeal).ResultsEight RCTs (n = 733 patients; age range 4 months-16 years) were included in this meta-analysis. Laparoscopic (LH) and open (OH) hernia repair was performed in 375 and 358 patients, respectively. Complications (seven RCTs, n = 693; pooled OR 0.50, 95% CI 0.14 to 1.79), recurrences (seven RCTs, n = 693; pooled OR 0.88, 95% CI 0.20 to 3.88), and MCIH rates (four RCTs, n = 343; pooled OR 0.28, 95% CI 0.04 to 1.86) were not different between the groups. LH resulted in shorter bilateral operation time (Five RCTs, n = 194; weighted mean difference (WMD) - 7.19, 95% CI - 10.04 to - 4.34). Unilateral operation time, length of hospital stay, and time to recovery were similar. There was insufficient evidence to assess postoperative pain and wound cosmesis, and evidence of substantial heterogeneity between the included studies. Subgroup analyses demonstrated less complications and shorter unilateral operation time for extracorporeal suturing and shorter length of hospital stay for intracorporeal suturing.Conclusions and relevanceNo definite conclusions to decide on the superiority of one of either treatment strategies can yet be drawn from the available literature. There was evidence of substantial heterogeneity and the clinical relevance of most estimated effects is very limited.

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Litigation claims following laparoscopic and open inguinal hernia repairs.

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Litigation claims following laparoscopic and open inguinal hernia repairs.

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