Dataset Information

Effect of Intraoperative Urinary Catheter Use on Postoperative Urinary Retention After Laparoscopic Inguinal Hernia Repair: A Randomized Clinical Trial.

ABSTRACT:

Importance

Urinary catheters are commonly placed during laparoscopic inguinal hernia repair as a presumed protection against postoperative urinary retention (PUR), one of the most common complications following this operation. Data from randomized clinical trials evaluating the effect of catheters on PUR are lacking.

Objective

To investigate the effect of intraoperative catheters on PUR after laparoscopic inguinal hernia repair.

Design, setting, and participants

This 2-arm registry-based single-blinded randomized clinical trial was conducted at 6 academic and community hospitals in the US from March 2019 to March 2021 with a 30-day follow-up period following surgery. All patients who presented with inguinal hernias were assessed for eligibility, 534 in total. Inclusion criteria were adult patients undergoing laparoscopic, elective, unilateral, or bilateral inguinal hernia repair. Exclusion criteria were inability to tolerate general anesthesia and failure to understand and sign the written consent form. A total of 43 patients were excluded prior to intervention.

Interventions

Patients in the treatment arm had placement of a urinary catheter after induction of general anesthesia and removal at the end of procedure. Those in the control arm had no urinary catheter placement.

Main outcomes and measures

PUR rate.

Results

Of the 491 patients enrolled, 241 were randomized to catheter placement, and 250 were randomized to no catheter placement. The median (IQR) age was 61 (51-68) years, and 465 participants (94.7%) were male. Overall, 44 patients (9.1%) developed PUR. There was no difference in the rate of PUR between the catheter and no-catheter groups (23 patients [9.6%] vs 21 patients [8.5%], respectively; P = .79). There were no intraoperative bladder injuries. In the catheter group, there was 1 incident of postoperative urethral trauma in a patient who presented to the emergency department with PUR leading to a suprapubic catheter placement.

Conclusions and relevance

Intraoperative urinary catheters did not reduce the risk of PUR after laparoscopic inguinal hernia repair. While their use did not appear to be associated with a high rate of iatrogenic complications, there may be a low rate of catastrophic complications. In patients who voided urine preoperatively, catheter placement did not appear to confer any advantage and thus their use may be reconsidered.

Trial registration

ClinicalTrials.gov Identifier: NCT03835351.

SUBMITTER: Fafaj A

PROVIDER: S-EPMC9201739 | biostudies-literature | 2022 Aug

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Effect of Intraoperative Urinary Catheter Use on Postoperative Urinary Retention After Laparoscopic Inguinal Hernia Repair: A Randomized Clinical Trial.

Fafaj Aldo A Lo Menzo Emanuele E Alaedeen Diya D Petro Clayton C CC Rosenblatt Steven S Szomstein Samuel S Massier Christian C Prabhu Ajita S AS Krpata David M DM Cha Walter W Montelione Katherine K Tastaldi Luciano L Alkhatib Hemasat H Zolin Samuel J SJ Okida Luis Felipe LF Rosen Michael J MJ

JAMA surgery 20220801 8

<h4>Importance</h4>Urinary catheters are commonly placed during laparoscopic inguinal hernia repair as a presumed protection against postoperative urinary retention (PUR), one of the most common complications following this operation. Data from randomized clinical trials evaluating the effect of catheters on PUR are lacking.<h4>Objective</h4>To investigate the effect of intraoperative catheters on PUR after laparoscopic inguinal hernia repair.<h4>Design, setting, and participants</h4>This 2-arm ...[more]

PMID: 35704302

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Project description:ImportancePostoperative urinary retention (POUR) is a well-recognized complication of inguinal hernia repair (IHR). A variable incidence of POUR has previously been reported in this context, and contradictory evidence surrounds potential risk factors.ObjectiveTo ascertain the incidence of, explore risk factors for, and determine the health service outcomes of POUR following elective IHR.Design, setting, and participantsThe Retention of Urine After Inguinal Hernia Elective Repair (RETAINER I) study, an international, prospective cohort study, recruited participants between March 1 and October 31, 2021. This study was conducted across 209 centers in 32 countries in a consecutive sample of adult patients undergoing elective IHR.ExposureOpen or minimally invasive IHR by any surgical technique, under local, neuraxial regional, or general anesthesia.Main outcomes and measuresThe primary outcome was the incidence of POUR following elective IHR. Secondary outcomes were perioperative risk factors, management, clinical consequences, and health service outcomes of POUR. A preoperative International Prostate Symptom Score was measured in male patients.ResultsIn total, 4151 patients (3882 male and 269 female; median [IQR] age, 56 [43-68] years) were studied. Inguinal hernia repair was commenced via an open surgical approach in 82.2% of patients (n = 3414) and minimally invasive surgery in 17.8% (n = 737). The primary form of anesthesia was general in 40.9% of patients (n = 1696), neuraxial regional in 45.8% (n = 1902), and local in 10.7% (n = 446). Postoperative urinary retention occurred in 5.8% of male patients (n = 224), 2.97% of female patients (n = 8), and 9.5% (119 of 1252) of male patients aged 65 years or older. Risk factors for POUR after adjusted analyses included increasing age, anticholinergic medication, history of urinary retention, constipation, out-of-hours surgery, involvement of urinary bladder within the hernia, temporary intraoperative urethral catheterization, and increasing operative duration. Postoperative urinary retention was the primary reason for 27.8% of unplanned day-case surgery admissions (n = 74) and 51.8% of 30-day readmissions (n = 72).ConclusionsThe findings of this cohort study suggest that 1 in 17 male patients, 1 in 11 male patients aged 65 years or older, and 1 in 34 female patients may develop POUR following IHR. These findings could inform preoperative patient counseling. In addition, awareness of modifiable risk factors may help to identify patients at increased risk of POUR who may benefit from perioperative risk mitigation strategies.

Project description:IntroductionPost-operative prescription opioid use is a known risk factor for persistent opioid use. Despite the increased utilization of robotic-assisted surgery (RAS) for inguinal hernia repair (IHR), little is known whether this minimally invasive approach results in less opioid consumption. In this study, we compare long-term opioid use between RAS versus laparoscopic (Lap) versus open surgery for IHR.MethodsA retrospective cohort study of opioid-naïve patients who underwent outpatient primary IHR was conducted using the Merative™ MarketScan® (Previously IBM MarketScan®) Databases between 2016 and 2020. Patients not continuously enrolled 180 days before/after surgery, who had malignancy, pre-existing chronic pain, opioid dependency, or invalid prescription fill information were excluded. Among patients exposed to opioids peri-operatively, we assessed long-term opioid use as any opioid prescription fill within 90 to 180 days post-surgery. Secondary outcomes were controlled substance schedule II/III opioid fill, and high-dose opioid fill defined as > 50 morphine milligram equivalent per day. An Inverse-probability of treatment weighted logistic regression was used to compare outcomes between groups with p-value of < 0.05 considered statistically significant.ResultsA total of 41,271 patients were identified (2070 (5.0%) RAS, 16,704 (40.5%) Lap, and 22,497 (54.5%) open surgery). RAS was associated with less likelihood of prescription fills for any opioid (OR 0.78, 95% CI 0.60 to 0.98 versus Lap; OR 0.67, 95% CI 0.52 to 0.85 versus open), and schedule II/III opioid (OR 0.74, 95% CI 0.56 to 0.96 versus Lap; OR 0.68, 95% CI 0.51 to 0.88 versus open), but comparable high-dose opioid fill (OR 0.95, 95% CI 0.54 to 1.55 versus Lap; OR 0.96, 95% CI 0.56 to 1.52 versus open). Lap and open surgery had no significant difference.ConclusionIn this cohort of patients derived from a national commercial claims dataset, patients undergoing RAS had a decreased risk of long-term opioid use compared to laparoscopic and open surgery patients undergoing IHR.

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:PurposeThe aim of this study is to investigate the technique and practical significance of using a simple hernia needle in single-port laparoscopic herniorrhaphy in pediatric patients.MethodsThe study conducted a retrospective analysis of all pediatric patients who underwent treatment for inguinal hernia using single-port laparoscopic herniorrhaphy with a simple hernia needle at Yellow River Sanmenxia Hospital from June 2018 to May 2023. The medical records of all the children were collected, and clinical characteristics, procedural information, and follow-up data were carefully reviewed.ResultsA total of 848 patients underwent inguinal hernia repair, with ages ranging from 7 months to 13 years (2.99 ± 2.49 years), including 756 males and 92 females. A total of 528 cases of unilateral hernia and 310 cases of bilateral hernia were reported, with intra-operative findings revealing contralateral occult hernia in 253 cases. Single-port laparoscopic herniorrhaphy was successfully completed in all patients, with no instances of conversion to open surgery. The mean operation time for unilateral hernia repair was (7.50 ± 4.80) min, while for bilateral hernia repair it was (11.55 ± 7.27) min. Five patients presented with subcutaneous emphysema, while two patients experienced a recurrence of inguinal hernia. No complications, such as scrotal hematoma, trocar umbilical hernia and testicular atrophy, were observed. The duration of the follow-up period ranged from 3 to 24 months.ConclusionThe promotion and utilization of single-port laparoscopy combined with a simple hernia needle in clinical practice are justified. Our initial investigation indicates that this surgical approach is both safe and dependable for the management of pediatric inguinal hernia. The procedure presents numerous benefits, including the utilization of uncomplicated instruments, straightforward operation, a clear curative impact, minimal tissue damage, rapid recovery, and the absence of scarring.

Dataset Information

Effect of Intraoperative Urinary Catheter Use on Postoperative Urinary Retention After Laparoscopic Inguinal Hernia Repair: A Randomized Clinical Trial.

Importance

Objective

Design, setting, and participants

Interventions

Main outcomes and measures

Results

Conclusions and relevance

Trial registration

Publications

Effect of Intraoperative Urinary Catheter Use on Postoperative Urinary Retention After Laparoscopic Inguinal Hernia Repair: A Randomized Clinical Trial.

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