Identifying postoperative complications after inguinal hernia repair with a smartphone application: a comparative cohort study.

PURPOSE: The Q1.6 Inguinal Hernia application continuously measures patient-reported outcomes (PROs) by sampling experiences through brief, digital and condition-specific questions, utilising micro-moments. This can overcome the limitations of current paper questionnaires and give real-time insight into patient recovery. This exploratory study compares data from the application with retrospective data from electronic medical records (EMRs) to provide information on its accuracy in detecting postoperative complications after inguinal hernia repair. METHODS: Patients were asked to use the application in addition to their usual care. The application employs twitch crowdsourcing to gather PROs. Questions from validated and frequently used questionnaires were integrated. A retrospective assessment of EMRs was combined with an additional telephone interview. The primary endpoints were the sensitivity and specificity of the application in detecting chronic postoperative inguinal pain, recurrence and surgical-site infection (SSI). RESULTS: A total of 215 patients were analysed. The sensitivity and specificity for detecting chronic postoperative inguinal pain were 100% (95% CI [47.8%, 100%]) and 93.7% (95% CI [88.3%, 97.1%]), respectively. For recurrence, the sensitivity was 77.8% (95% CI [40.0%, 97.2%]), and the specificity was 81.3% (95% CI [75.0%, 86.5%]). For SSI, the sensitivity and specificity were 75.0% (95% CI [19.4%, 99.4%]) and 89.8% (95% CI [84.8%, 93.6%]), respectively. CONCLUSION: This study demonstrates satisfactory measurement capabilities of the Q1.6 Inguinal Hernia application for identifying postoperative complications following inguinal hernia repair. However, certain aspects require further improvement, such as addressing error-prone questions, enhancing long-term compliance, and validating (pain) measurements through prospective control data. TRAIL REGISTRATION NUMBER: NL7813 (Dutch Trial Registry), 19 May 2019.

Clinical feasibility of the Q1.6 Inguinal Hernia application: a prospective cohort study.

PURPOSE: Patient-reported outcomes (PROs) are essential to evaluate inguinal hernia surgery. There is a need for digital and disease-specific PRO measurement. Current measuring instruments (PROMs) have several disadvantages, for example, fixed measuring moments with a chance of recall bias. The Q1.6 Inguinal Hernia application has been developed to overcome these challenges. This pilot study reports the first clinical feasibility results. METHODS: All surgically treated inguinal hernia patients were eligible for inclusion. The application uses "twitch crowdsourcing"; after unlocking a smartphone or tablet, a single short question is asked. This can easily be repeated multiple times a day/week/month. Questions from validated questionnaires were implemented. The adaptive question engine generates an individualised set of questions. Alerts are generated when a complication is suspected. RESULTS: A total of 229 patients were given over 50.000 questions of which 92% were answered. Pre- and postoperative patient characteristics and their reported clinical outcomes confirmed a standard inguinal hernia population. Compliance with the application was 91.7% after 14 days, 69.0% after 3 months and 28.8% after one year. After months 3, 6 and 11, respectively, 3.0%, 4.4% and 4.5% of patients reported inguinal pain or discomfort (NRS ≥ 4). Patients were highly satisfied (92.8% preferred the app over standard care). CONCLUSIONS: This smartphone application shows promising results for clinical practice. It might allow for continuous digital patient-reported outcome measurement using non-intrusive, concise questions. Remote monitoring may become standard postoperative care after (inguinal hernia) surgery. The current application will be further improved and evaluated for cost-effectiveness, safety and validity.

A Comparison of Health Status and Quality of Life in Patients with Intermittent Claudication.

BACKGROUND: Patient reported outcome measures (PROMs) such as health status (HS) and quality of life (QOL) are frequently used interchangeably while they represent different outcomes. Whether a discrepancy exists in patients with intermittent claudication (IC) in changes over time between HS and QOL is unclear. This study aimed to investigate the strength and the direction of the association between HS and QOL over time in patients with IC that underwent supervised exercise therapy (SET). MATERIAL AND METHODS: Patients were part of the ELECT multi-center prospective cohort study. One goal of this study was to obtain data on HS and QOL at different time intervals of patients with IC that underwent SET. HS (VascuQOL-6) and QOL (WHOQOL-BREF) were completed at baseline, 3 months, and 6 months follow up. Pearson's correlation coefficients and the associated common variances (R2) were calculated to measure the strength and the direction of the association between HS and QOL in changes between baseline and follow-up moments. RESULTS: In total, 177 patients were included in data analyses. Only changes in physical QOL and overall QOL had a small correlation with changes over time in HS, at both 3- and 6 months follow up (respectively R2=.14; P < 0.001 and R2 = 0.12; P < 0.001 for physical QOL and R2 = 0.18; P < 0.001 and R2 = 0.13; P < 0.001 for overall QOL). CONCLUSIONS: This study showed that HS and QOL provide different outcomes in patients with IC that underwent SET. Future studies should be aware of these differences before PROMs are being incorporated as an outcome measure in clinical studies.

Treatment of recurrent inguinal hernia after TransInguinal PrePeritoneal (TIPP) surgery: feasibility and outcomes in a case series.

BACKGROUND: TransInguinal PrePeritoneal (TIPP) inguinal hernia repair (IHR) combines an open anterior approach with a preperitoneal position of the mesh. Advantages include reduced chronic postoperative inguinal pain, low recurrence rates and quick recovery. Critics have expressed concerns that recurrent IHR after TIPP could be difficult and with an increased risk of complications due to the formation of scar tissue in both the anterior and posterior anatomical inguinal planes. This study reports feasibility and outcomes of recurrent IHR after TIPP repair. METHODS: Patients who underwent recurrent IHR after TIPP between January 2013 and January 2015 in a single hernia-dedicated teaching hospital were included. Exclusion criteria were femoral hernia, incarcerated hernia and reasons for unreliable follow-up. Electronic medical records were assessed retrospectively to register surgical outcomes and complications. RESULTS: Thirty-three patients underwent surgical repair of recurrent inguinal hernia after TIPP. Twenty patients were treated with a "re-TIPP when possible" strategy; resulting in 13 successful re-TIPPs and 7 conversions to Lichtenstein repair. Eleven patients underwent a primary Lichtenstein's repair, the remaining two patients underwent recurrent IHR using other techniques (TransREctus sheath PrePeritoneal and TransAbdominal PrePeritoneal repair). Mean time of surgery was 44.7 min (standard deviation 16.7). There was one patient (3.0%) with a re-recurrent inguinal hernia during follow-up. Other minor complications included urinary tract infection. CONCLUSION: These results indicate that after TIPP it is feasible and safe to perform re-surgery for recurrent inguinal hernia with an anterior approach again. For these recurrences, a Lichtenstein repair can be performed, or a "re-TIPP if possible" strategy can be applied by experienced TIPP surgeons, tailored to the intraoperative findings. Whether a re-TIPP has advantages over Lichtenstein should be evaluated in a prospective manner.

Plexus anesthesia versus general anesthesia for carotid endarterectomy: A systematic review with meta-analyses.

INTRODUCTION: Traditional carotid endarterectomy is considered to be the standard technique for prevention of a new stroke in patients with a symptomatic carotid stenosis. Use of plexus anesthesia or general anesthesia in traditional carotid endarterectomy is, to date, not unequivocally proven to be superior to one other. A systematic review was needed for evaluation of benefits and harms to determine which technique, plexus anesthesia or general anesthesia is more effective for traditional carotid endarterectomy in patients with symptomatic carotid stenosis. METHODS: The review was conducted according to our protocol following the recommendations of Cochrane and reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses. Searches were updated on the October 1, 2020. We did not find any randomized clinical trial comparing plexus anesthesia and general anesthesia in carotid endarterectomy with patch angioplasty matching our protocol criteria in patients with a symptomatic and significant (≥50%) carotid stenosis. CONCLUSIONS: Based on the current, high risk of bias evidence, we concluded there is a need for new randomized clinical trials with overall low risk of bias comparing plexus anesthesia with general anesthesia in carotid endarterectomy with patch closure of the arterial wall in patients with a symptomatic and significant (≥50%) stenosis of the internal carotid artery.Protocol unique identification number (UIN): CRD42019139913, (https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=139913).

Plexus anesthesia versus general anesthesia in patients for carotid endarterectomy with patch angioplasty: Protocol for a systematic review with meta-analyses and Trial Sequential Analysis of randomized clinical trials.

INTRODUCTION: Traditional carotid endarterectomy is considered to be the standard technique for prevention of a new stroke in patients with a symptomatic carotid stenosis. Use of plexus anesthesia or general anesthesia in traditional carotid endarterectomy is, to date, not unequivocally proven to be superior to one other. A systematic review is needed for evaluation of benefits and harms to determine which technique, plexus anesthesia or general anesthesia is more effective for traditional carotid endarterectomy in patients with symptomatic carotid stenosis. METHODS AND OUTCOMES: The review will be conducted according to this protocol following the recommendations of the 'Cochrane Handbook for Systematic Reviews' and reported according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses. Randomized Clinical Trials comparing plexus anesthesia versus general anesthesia in traditional carotid endarterectomy will be included. Primary outcomes will be postoperative death and/ or stroke (<30 days) and serious adverse events. Secondary outcomes will be non-serious adverse events.We will primarily base our conclusions on meta-analyses of trials with overall low risk of bias. We will use Trial Sequential Analysis to assist the evaluation of imprecision in Grading of Recommendations Assessment, Development and Evaluation. However, if pooled point-estimates of all trials are similar to pooled point-estimates of trials with overall low risk of bias and there is lack of a statistical significant interaction between estimates from trials with overall high risk of bias and trials with overall low risk of bias we will consider the Trial Sequential Analysis adjusted confidence interval precision of the estimate achieved in all trials as the result of our meta-analyses. ETHICS AND DISSEMINATION: The proposed systematic review will collect and analyze secondary data from already performed studies therefore ethical approval is not required. The results of the systematic review will be disseminated by publication in a peer-review journal and submitted for presentation at relevant conferences.

Perioperative monitoring of inguinal hernia patients with a smartphone application.

INTRODUCTION: Patient Reported Outcomes have become standard in the evaluation of inguinal hernia repair. However, the chosen outcomes remain heterogeneous and the measurements time-consuming or inadequate. Perioperative measurement of pain and recovery could benefit from the contemporary possibilities that mobile health applications offer. METHODS: An application for smartphones and tablets was developed using the twitch crowdsourcing concept, classical questionnaires, experiences from randomised clinical trials, and patients' input. RESULTS: Dichotomous questions and numeric rating scales, both pre- and post-operative, were implemented in the freely available Q1.6 application. Content, timing and frequencies were adapted to the inguinal hernia patient's daily life and assumed recovery. Certain combinations of answers were set as alert notifications to detect adverse events. Data are displayed on a web-based dashboard enabling real-time monitoring. Legal aspects were examined and taken into account. DISCUSSION: The Q1.6 inguinal hernia app is an innovative tool for perioperative monitoring of pain and recovery of inguinal hernia patients. Previous limitations of classical measurements such as a large heterogeneity, retrospective data recording and different forms of bias can be eliminated. The `big data´ generated in this manner might be used for large-scale research to improve inguinal hernia surgery. The Q1.6 platform is not only hernia specific; it is also an innovative tool to measure PROs in any other domain.

Long-term results from a randomized comparison of open transinguinal preperitoneal hernia repair and the Lichtenstein method (TULIP trial).

BACKGROUND: The short-term results of the TULIP trial comparing transinguinal preperitoneal (TIPP) inguinal hernia repair with the Lichtenstein method have been reported with follow-up of 1 year. After TIPP repair, fewer patients had chronic postoperative inguinal pain (CPIP); they had better health status and lower costs. The present study reports the long-term outcomes of this trial. METHODS: All surviving patients initially randomized in the TULIP trial were contacted. Patients were interviewed by telephone and sent a questionnaire. Those reporting any complaints were invited for outpatient review. Chronic pain, hernia recurrence and reoperation were documented, along with any sensory change or disturbance of sexual activity. RESULTS: Of 302 patients initially randomized, 251 (83·1 per cent) were included in the analysis (119 TIPP, 132 Lichtenstein), with a median follow-up of 85 (range 74-117) months. Of 25 patients with chronic postoperative inguinal pain after 1 year, only one, who underwent Lichtenstein repair, still had groin pain at long-term follow-up. The overall hernia recurrence rate was 2·8 per cent (7 patients), with no difference between the groups. CONCLUSION: Both TIPP and Lichtenstein hernia repairs are durable. Patients with chronic postoperative inguinal pain after 1 year can be reassured that the groin pain tends to fade over time.

Outcomes of surgery on patients with a clinically inapparent inguinal hernia as diagnosed by ultrasonography.

BACKGROUND: Chronic post-operative inguinal pain (CPIP) is the most significant complication following inguinal hernia repair. Patients without a palpable hernia prior to surgery seemed to report more CPIP. Our aim was to evaluate the effects of surgery on patients with a clinically inapparent inguinal hernia as diagnosed using ultrasonography. METHODS: A total of 179 hernia repairs in patients with a positive ultrasonography but negative physical examination were analysed retrospectively. Patients with recurrent hernias, femoral hernias or previous surgery to the inguinal canal were excluded. The primary outcome was the presence of chronic postoperative inguinal pain (pain > 3 months postoperatively). Data on preoperative complaints, surgical technique and findings during ultrasonography and surgery were also studied in relation to the development of CPIP. RESULTS: A quarter (25.1%) of the patients reported chronic postoperative pain. Female gender (p = 0.03), high BMI (p = 0.04) and atypical symptoms prior to surgery (p < 0.001) were significant univariate risk factors for developing CPIP. Logistic regression showed a significant association between atypical symptoms and CPIP [OR = 6.31, p < 0.001, 95% CI (2.32, 17.16)], which was still present after correction for the significant univariate variables [OR = 4.23, p = 0.02, 95% CI (1.26, 14.21)]. CONCLUSION: Patients with a clinically inapparent inguinal hernia as diagnosed using ultrasonography report a high incidence of CPIP after elective hernia repair. Patients with atypical groin pain prior to surgery are especially prone to CPIP. It is questionable whether these hernias should be classified and treated as symptomatic inguinal hernias. The results advocate taking other causes of groin pain into consideration before choosing surgical treatment.

[Acute dyspnoea during brachial plexus blockade]. / Acute dyspneu tijdens plexus-brachialisblokkade.

A 73-year-old woman was scheduled for brachial shunt surgery. She received regional anaesthesia of the right brachial plexus via a supraclavicular approach. During surgery we noticed acute dyspnoea with a saturation reduction. A postoperative chest X-ray showed a high position of the right diaphragm, which was caused by a phrenic nerve blockade due to the anaesthesia. This completely disappeared within 24 hours.

Health status one year after TransInguinal PrePeritoneal inguinal hernia repair and Lichtenstein's method: an analysis alongside a randomized clinical study.

BACKGROUND: The Lichtenstein technique is the treatment of first choice according to guidelines for primary inguinal hernia treatment. Postoperative chronic pain has been reported as complication in 15-40 % after Lichtenstein's repair. The postoperative effects on health status after open preperitoneal hernia repair have hardly been examined. Development of an open technique that combines the safe anterior approach of the Lichtenstein with the 'promising' preperitoneal soft mesh position was done; the transinguinal preperitoneal (TIPP) mesh repair. A double-blind prospective randomized controlled trial (TULIP trial, ISRCTN93798494) was conducted to compare different outcome parameters after TIPP or Lichtenstein, one parameter is topic of evaluation in this paper; the health status after TIPP and Lichtenstein for inguinal hernia repair. METHODS: The study protocol has been published. It was hypothesized that the health status of inguinal hernia patients would be better after the TIPP repair compared with the Lichtenstein technique. The size of this study was based on chronic pain as primary outcome measure. Three hundred and two patients were randomized. Patients and the outcome assessors were blinded. Follow-up was scheduled after 14 days, 3 months, and 1 year. The three dimensions of possible errors were warranted. RESULTS: With regard to health status, significant differences were found in the dimensions 'physical pain' [difference: 6.1 (95 % CI 2.3-9.9, p = 0.002)] and 'physical functioning' [difference: 3.5 (95 % CI 0.5-6.7, p = 0.023)], favoring the TIPP patients after 1 year. CONCLUSION: In conclusion, the SF-36 'physical function' and 'physical pain' dimensions after TIPP show significant better patient outcomes at 1 year compared with the Lichtenstein patients in this trial. These differences are in line with reported significant differences in less patients with postoperative chronic pain after TIPP compared with Lichtenstein at 1 year.

Randomized clinical trial of chronic pain after the transinguinal preperitoneal technique compared with Lichtenstein's method for inguinal hernia repair.

BACKGROUND: Preliminary experience has suggested that preperitoneal mesh positioning causes less chronic pain than Lichtenstein's technique for inguinal hernia repair. Therefore, a randomized clinical trial was conducted with the aim of evaluating the incidence of postoperative chronic pain after transinguinal preperitoneal (TIPP) mesh repair versus Lichtenstein's technique. METHODS: Patients with a primary unilateral inguinal hernia were randomized to either TIPP or Lichtenstein's repair in two training hospitals. The primary outcome was the number of patients with chronic pain after surgery. Secondary outcomes were adverse events. Follow-up was scheduled after 14 days, 3 months and 1 year. Patients and outcome assessors were blinded. RESULTS: A total of 302 patients were randomized to TIPP (143) or Lichtenstein (159) repair. Baseline characteristics were comparable in the two groups. Some 98.0 per cent of the patients were included in the analysis (141 in the TIPP group and 155 in the Lichtenstein group). Significantly fewer patients in the TIPP group had continuous chronic pain 1 year after surgery: five patients (3.5 per cent) versus 20 patients (12.9 per cent) in the Lichtenstein group (P = 0.004). An additional 12 patients (8.5 per cent) in the TIPP group and 60 (38.7 per cent) in the Lichtenstein group experienced pain during activity (P = 0.001). There were two patients with recurrence in the TIPP group and four in the Lichtenstein group, but no significant differences were found in other severe adverse events between the groups. CONCLUSION: Fewer patients had continuous chronic pain at 1 year after the TIPP mesh inguinal hernia repair compared with Lichtenstein's repair.

Spiral vein reconstruction of the infected abdominal aorta using the greater saphenous vein: preliminary results of the Tilburg experience.

OBJECTIVES: The aim of this study was to evaluate patients, who underwent spiral vein reconstruction of the abdominal aorta to repair infected aneurysms or replace infected aortic grafts. METHODS: All spiral vein reconstructions between March 2005 and May 2010 because of vascular infections of the abdominal aorta were retrospectively included. Diagnosis was determined by clinical examination, laboratory results, computed tomography (CT) and positron emission tomography (PET) scan, and microbiological tests. Spiral vein reconstruction consisted of harvesting the greater saphenous vein (GSV) and construction into a spiral graft, aortic reconstruction and a transmesenteric omentumplasty. Primary outcomes were survival and limb salvage. Secondary outcomes included technical, clinical and ongoing success, re-infection, ongoing infection and patency. RESULTS: All five patients survived surgery, and there were no in-hospital deaths. Survival and limb salvage were 100% after median follow-up of 13 months (6-67 months). Further, technical, clinical and continuing success was 100%. There were no re-infections or ongoing infections. CONCLUSIONS: Spiral vein reconstruction using the GSV showed good short-term survival and limb salvage. It, therefore, might be considered as an attractive treatment method for vascular infections of the abdominal aorta. Still, more follow-up is needed to evaluate long-term results.

The transinguinal preperitoneal hernia correction vs Lichtenstein's technique; is TIPP top?

BACKGROUND: Chronic pain is the main drawback of the Lichtenstein procedure for inguinal hernia repair, with a reported incidence of 15-40%. The transinguinal pre-peritoneal (TIPP) technique seems to be associated with less chronic pain, comparable to the total extra peritoneal (TEP) technique. The aim of this study was to evaluate 3 years of TIPP and Lichtenstein experience since the start of our Hernia Center Brabant in January 2006. METHODS: Patient records of unilateral primary inguinal anterior hernia corrections (TIPP and Lichtenstein) performed since the opening of Hernia Center Brabant (2006-2008) were evaluated in a retrospective study. ASA class 4 and 5, <18 years, recurrences and bilateral hernias were excluded. In the TIPP technique, a Polysoft™ Hernia Patch was placed into the preperitoneal space using an anterior protocol led approach. The Lichtenstein technique was performed as described by Amid [Amid et al (1996) Eur J Surg 162:447-453] and modified with a soft mesh. One of the hernia surgeons decided peroperatively which technique to perform. Baseline characteristics and postoperative complications were assessed retrospectively. The attempted follow up period was 6 months. Chronic pain was assessed in both groups as mild (VAS 1-3), moderate (VAS 4-6) or severe (VAS 7-10). Chronic pain was defined in both groups as any pain sensation lasting longer than 3 months postoperatively, or when local injection of analgesia was necessary. Patients who did not come back because of chronic pain after regular follow up were regarded as free of pain. RESULTS: A total of 496 patients were included in this study; 225 TIPP and 271 Lichtenstein anterior inguinal hernia operations were analyzed. Data from one TIPP-patient were lost. Both groups were comparable with regard to baseline characteristics regarding age (p = 0.059), gender (p = 0.478) and ASA-classification (p = 0.104). TIPP: mean age 52.7 years, ASA-classification I: 54%, II: 36% and III: 5.3%. A total of 7.6% complications were assessed; recurrence (n = 1), bleeding (and re-operation) (n = 4); 10 patients (4.4%) experienced chronic pain. Persisting sensation loss occurred in 0.9%. Lichtenstein: mean age 57.3 years, ASA-classification I: 51%, II: 38% and III: 11%. A total of 8.5% complications were assessed; recurrence (n = 3), bleeding (and re-operation) (n = 3); 11 Lichtenstein patients (4.1%) experienced chronic pain. Persisting sensation loss occurred in 2.2%. Limitations of this retrospective study were incomplete follow up (31.3% had only one post operative visit 14 days after surgery) and these patients were further regarded as free of pain. Therefore, possible under-reporting of chronic pain could be present. The study was not double blind. CONCLUSION: This retrospective study design revealed no significantly better results for the TIPP procedure as compared to the Lichtenstein technique. The incidence of chronic pain reported in this retrospective study has been low in both groups since the opening of the Hernia Center Brabant. These results form the basis for a prospective randomized clinical trial comparing the TIPP and Lichtenstein techniques.

Adhesive bonds or percutaneous absorbable suture for closure of surgical wounds in children. Results of a prospective randomized trial.

BACKGROUND: Surgeons have become increasingly interested in replacing conventional sutures by means of adhesive bonds for the closure of skin wounds. There are several advantages to the use of adhesive bonds compared with the conventional sutures. METHODS: Between January and August 2001, all the wounds in children after groin surgery were closed with an adhesive, N-butylcyanoacrylate (Indermil, Locite Corp, 's-Hertogenbosch, The Netherlands), or with a suture, polyglactin 5-0 (Vicryl), intracutaneously. Fifty Inguinal wounds were treated with Indermil and 50 with Vicryl. Wounds were evaluated for hematoma, infection, dehiscence, or formation of granuloma. A scale from 1 to 10 expressed the cosmesis by patient and surgeon. RESULTS: The most remarkable difference in wound healing was dehiscence of the wound in 26% of cases in the adhesive group and no dehiscence in the suture group. The cosmesis of the wounds was marked with an 8.6 in the suture group and in the adhesive group with a 6.8. CONCLUSIONS: Wound dehiscence was seen significantly more frequent in the patients in whom the wound was closed with N-butylcyanoacrylate. The cosmesis of wounds closed with tissue glue was significantly lower then the cosmesis after suturing. Therefore, the authors advise, on the basis of this prospective randomized trial, that surgical wounds in children should be closed with a intracutaneous absorbable suture.