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1.
Surg Laparosc Endosc Percutan Tech ; 33(6): 663-672, 2023 Dec 01.
Article in English | MEDLINE | ID: mdl-37934831

ABSTRACT

PURPOSE: Obesity is one of the most important risk factors for complications after ventral hernia repair (VHR), and minimally invasive (MIS) techniques are preferred in obese patients as they minimize wound complications. It is common practice to attempt weight loss to achieve a specific body mass index (BMI) goal; however, patients are often unable to reach it and fail to become surgical candidates. Therefore, we aim to perform a meta-analysis of studies comparing outcomes of obese and nonobese patients undergoing laparoscopic or robotic VHR. PATIENTS AND METHODS: A literature search of PubMed, Scopus, and Cochrane Library databases was performed to identify studies comparing obese and nonobese patients undergoing MIS VHR. Postoperative outcomes were assessed by means of pooled analysis and meta-analysis. Statistical analysis was performed using RevMan 5.4. Heterogeneity was assessed with I2 statistics. RESULTS: A total of 6483 studies were screened and 26 were thoroughly reviewed. Eleven studies and 3199 patients were included in the meta-analysis. BMI >40 kg/m 2 cutoff analysis included 5 studies and 1533 patients; no differences in hernia recurrence [odds ratios (OR): 1.64; 95% CI: 0.57-4.68; P = 0.36; I2 = 47%), seroma, hematoma, and surgical site infection (SSI) rates were noted. BMI >35 kg/m 2 cutoff analysis included 5 studies and 1403 patients; no differences in hernia recurrence (OR: 1.24; 95% CI: 0.71-2.16; P = 0.58; I2 = 0%), seroma, hematoma, and SSI rates were noted. BMI >30 kg/m 2 cutoff analysis included 4 studies and 385 patients; no differences in hernia recurrence (OR: 2.07; 95% CI: 0.5-8.54; P = 0.32; I2 = 0%), seroma, hematoma, and SSI rates were noted. CONCLUSION: Patients with high BMI undergoing MIS VHR have similar hernia recurrence, seroma, hematoma, and SSI rates compared with patients with lower BMI. Further prospective studies with long-term follow-up and patient-reported outcomes are required to establish optimal management in obese patients undergoing VHR.


Subject(s)
Hernia, Ventral , Seroma , Humans , Body Mass Index , Prospective Studies , Seroma/etiology , Surgical Wound Infection/epidemiology , Surgical Wound Infection/etiology , Hernia, Ventral/surgery , Hernia, Ventral/etiology , Obesity/complications , Obesity/surgery , Herniorrhaphy/adverse effects , Herniorrhaphy/methods , Hematoma/etiology , Retrospective Studies , Surgical Mesh/adverse effects , Postoperative Complications/epidemiology , Postoperative Complications/etiology , Postoperative Complications/surgery
2.
Surg Laparosc Endosc Percutan Tech ; 33(5): 556-564, 2023 10 01.
Article in English | MEDLINE | ID: mdl-37523583

ABSTRACT

BACKGROUND: Parastomal hernia repairs (PHRs) are often complex and challenging, even for experienced abdominal wall surgeons. Although the ideal therapeutic option in the setting of a parastomal hernia is to restore intestinal continuity, this is often not feasible, and numerous techniques have been described for PHR. Current guidelines recommend using mesh for elective PHR, but there is a scarcity of evidence comparing different PHR techniques. We aimed to report a meta-analysis comparing the outcomes of the "Sugarbaker" and "Keyhole" mesh configuration in PHR. METHODS: A literature search of PubMed, Embase, Scopus, and Cochrane Library databases was performed to identify studies comparing Sugarbaker and Keyhole mesh configuration in PHR. Postoperative outcomes were assessed by means of pooled analysis and meta-analysis. Statistical analysis was performed using RevMan 5.4. Heterogeneity was assessed with I2 statistics. RESULTS: A total of 3247 studies were screened, and 27 were fully reviewed. Ten studies and 632 patients were included in the meta-analysis. Three hundred five patients (48.3%) with Keyhole and 327 patients (51.7%) with Sugarbaker mesh configuration. Four hundred thirty-three patients (68.5%) underwent laparoscopic PHR with intraperitoneal onlay mesh. Sugarbaker mesh configuration was associated with lower hernia recurrence compared with Keyhole (odds ratio: 0.39; 95% CI: 0.19-0.83; P = 0.01; I2 = 46%). No differences were seen in overall complications, reoperations, stoma outlet obstruction, mesh infection, and postoperative bleeding. CONCLUSION: PHR with Sugarbaker mesh configuration is associated with decreased hernia recurrence compared with Keyhole and had similar rates of overall complications, reoperations, stoma outlet obstruction, mesh infection, and postoperative bleeding.

3.
Surgery ; 173(4): 1001-1007, 2023 04.
Article in English | MEDLINE | ID: mdl-36623959

ABSTRACT

BACKGROUND: Ventral hernia repair is one of the most common operations performed worldwide, and using mesh is standard of care to decrease recurrence. Biologic meshes are increasingly used to minimize complications associated with synthetic mesh, but with significantly higher cost and unclear efficacy. Until recently, most of the evidence supporting the use of biologic meshes was from retrospective cohorts with high heterogeneity and risk of bias. We aimed to report a meta-analysis of randomized controlled trials comparing the outcomes of synthetic and biologic mesh in elective open ventral hernia repair. METHODS: A literature search of PubMed, Embase, and Cochrane Library databases was performed to identify randomized controlled trials comparing biologic and synthetic mesh in elective open ventral hernia repairs. The postoperative outcomes were assessed by means of pooled analysis and meta-analysis. Statistical analysis was performed using RevMan 5.4. Heterogeneity was assessed with I2 statistics. RESULTS: A total of 1,090 studies were screened, and 22 were fully reviewed. Four randomized controlled trials and 632 patients were included in the meta-analysis. Fifty-eight percent of patients had contaminated wounds (Wound Classification II-IV). Hernia recurrence (odds ratio 2.75; 95% confidence interval 1.76-4.31; P < .00001; I2 = 0%) and surgical site infections (odds ratio 1.53; 95% confidence interval 1.02-2.29; P = .04; I2 = 0%) were significantly more common in patients with biologic mesh. The rates of seroma, hematoma, and mesh removal were similar in both groups. CONCLUSION: As compared to synthetic mesh, biologic meshes resulted in increased hernia recurrences and surgical site infections. Current evidence supports macroporous, uncoated synthetic mesh as the implant of choice for elective open ventral hernia repair, and its use should be considered even in contaminated cases.


Subject(s)
Biological Products , Hernia, Ventral , Humans , Hernia, Ventral/surgery , Herniorrhaphy/adverse effects , Randomized Controlled Trials as Topic , Recurrence , Retrospective Studies , Surgical Mesh/adverse effects , Surgical Wound Infection/etiology , Treatment Outcome
4.
Am J Surg ; 225(2): 383-387, 2023 02.
Article in English | MEDLINE | ID: mdl-36115703

ABSTRACT

BACKGROUND: Concomitant robotic-assisted laparoscopic prostatectomy (RALP) and robotic inguinal hernia repair (RIHR) has been reported. Nevertheless, data on its safety is lacking and some surgeons avoid performing both operations concurrently due to the potential risk of mesh related complications in the setting of a fresh vesicourethral anastomosis. We aimed to investigate differences in 30-day outcomes between patients undergoing RALP+RIHR and those undergoing RIHR alone. METHODS: Patients who have undergone concomitant RALP and RIHR with 30-day follow-up available were identified within the Abdominal Core Health Quality Collaborative. Using a propensity score algorithm, they were matched with a cohort of patients undergoing RIHR alone based on confounders such as body mass index, age, ASA class, smoking, hernia size and recurrent status and prior pelvic operation. The groups were compared for 30-day rates of surgical site infection (SSI), surgical site occurrences (SSO), surgical site occurrences requiring operative intervention (SSOPI) and hernia recurrence. RESULTS: 24 patients underwent RALP + RIHR and were matched to 72 patients who underwent RIHR alone (3:1). Median age was 64 years, 33% were obese and 17% smokers. No significant differences were found on 30-day rates of overall complications (21% RALP + RIHR vs. 15% RIHR, p = 0.53) and surgical site occurrences (12% RALP + RIHR vs.11% RIHR, p = 0.85). No patient in the RALP + RIHR group had a 30-day SSI, SSOPI or early recurrence. CONCLUSION: RALP+RIHR appears not to result in increased rates of wound complications, overall complications or early recurrence when compared to patient undergoing RIHR alone. Prospective, controlled studies with larger number of patients are needed to confirm our findings.


Subject(s)
Hernia, Inguinal , Laparoscopy , Robotic Surgical Procedures , Male , Humans , Middle Aged , Robotic Surgical Procedures/adverse effects , Hernia, Inguinal/surgery , Hernia, Inguinal/complications , Prospective Studies , Herniorrhaphy/adverse effects , Prostatectomy/adverse effects , Laparoscopy/adverse effects , Retrospective Studies , Surgical Mesh
5.
JAMA Surg ; 157(8): 667-674, 2022 08 01.
Article in English | MEDLINE | ID: mdl-35704302

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.


Subject(s)
Hernia, Inguinal , Laparoscopy , Urinary Retention , Adult , Aged , Female , Hernia, Inguinal/complications , Hernia, Inguinal/surgery , Herniorrhaphy/methods , Humans , Laparoscopy/adverse effects , Laparoscopy/methods , Male , Middle Aged , Postoperative Complications/etiology , Postoperative Complications/prevention & control , Postoperative Complications/surgery , Urinary Retention/etiology , Urinary Retention/prevention & control , Urinary Retention/surgery
6.
J Gastrointest Surg ; 26(7): 1490-1494, 2022 07.
Article in English | MEDLINE | ID: mdl-35229252

ABSTRACT

INTRODUCTION: Collecting accurate operative details remains a limitation of surgical research. Surgeon-entered data in clinical registries offers one solution, but natural language processing (NLP) has emerged as a modality for automating manual chart review (MCR). This study aims to compare the accuracy and efficiency of NLP and MCR with a surgeon-entered, prospective registry data in determining the rate of gross bile spillage (GBS) during cholecystectomy. METHODS: Bile spillage rates were abstracted from an institutional, surgeon-entered clinical registry from July 2018 to January 2019. These rates were compared to those documented in the electronic medical record (EMR) using NLP and MCR to determine the sensitivity, specificity, and efficiency of each approach. RESULTS: Of the 782 registry entries, 191 cases (24.4%) had surgeon-reported bile spillage. MCR identified bile spillage in 121 cases (15.6%); however, bile spillage information was either missing or ambiguous in 454 cases (58.1%). NLP identified 99 cases (12.7%) of bile spillage. Data abstraction times for the registry, NLP, and MCR were 3 min, 5 min, and 12 h, respectively. When compared to the registry, MCR was 45% sensitive and 94% specific, while NLP was 27.2% sensitive and 92% specific for detecting bile spillage. These differences were significant (X2 = 19.446, P = < 0.001). CONCLUSION: Operative details, such as GBS, may not be abstracted by NLP or MCR if not clearly documented in the EMR. Clinical registries capture operative details, but they rely on surgeons to input the data.


Subject(s)
Natural Language Processing , Quality Improvement , Electronic Health Records , Humans , Registries
7.
Ann Surg ; 276(2): 224-232, 2022 08 01.
Article in English | MEDLINE | ID: mdl-33273351

ABSTRACT

OBJECTIVE: To study the efficacy of liposomal bupivacaine on postoperative opioid requirement and pain following abdominal wall reconstruction. SUMMARY BACKGROUND DATA: Despite the widespread use of liposomal bupivacaine in transversus abdominis plane block, there is inadequate evidence demonstrating its efficacy in open abdominal wall reconstruction. We hypothesized that liposomal bupivacaine plane block would result in decreased opioid requirements compared with placebo in the first 72 hours after surgery. METHODS: This was a single-center double-blind, placebo-controlled prospective study conducted between July 2018 and November 2019. Adult patients (at least 18 yrs of age) undergoing open, elective, ventral hernia repairs with mesh placed in the retromuscular position were enrolled. Patients were randomized to surgeon-performed transversus abdominis plane block with liposomal bupivacaine, simple bupivacaine, or normal saline (placebo). The main outcome was opioid requirements in the first 72 hours after surgery. Secondary outcomes included total inpatient opioid use, pain scores determined using a 100 mm visual analog scale, length of hospital stay, and patientreported quality of life. RESULTS: Of the 164 patients who were included in the analysis, 57 patients received liposomal bupivacaine, 55 patients received simple bupivacaine, and 52 received placebo. There were no differences in the total opioid used in the first 72 hours after surgery as measured by morphine milligram equivalents when liposomal bupivacaine was compared with simple bupivacaine and placebo (325 ± 225 vs 350 ± 284 vs 310 ± 272, respectively, P = 0.725). Similarly, there were no differences in total inpatient opioid use, pain scores, length of stay, and patient-reported quality of life. CONCLUSIONS: There are no apparent clinical benefits to using liposomal bupivacaine transversus abdominis plane block when compared with simple bupivacaine and placebo for open abdominal wall reconstruction.


Subject(s)
Abdominal Wall , Anesthetics, Local , Abdominal Muscles , Abdominal Wall/surgery , Adult , Analgesics, Opioid/therapeutic use , Bupivacaine , Double-Blind Method , Humans , Pain, Postoperative/drug therapy , Pain, Postoperative/prevention & control , Prospective Studies , Quality of Life
8.
Rev. med. (Säo Paulo) ; 101(1): e-187494, jan.-fev. 2022.
Article in English, Portuguese | LILACS-Express | LILACS | ID: biblio-1381869

ABSTRACT

A cirurgia de hérnia inguinal (HI) é um dos procedimentos mais comuns na prática do cirurgião geral. Estima-se que 20 milhões dessas operações sejam realizadas no mundo anualmente. Com o advento da técnica sem tensão e implante de tela sintética, as taxas de recidiva caíram expressivamente e a recidiva deixou de ser a principal complicação tardia após o reparo da hérnia inguinal. Hoje a principal complicação pós-operatória tardia da cirurgia de HI é a dor crônica inguinal pós-operatória (DCIP). A definição de DCIP é a dor pós-operatória da região inguinal após 3-6 meses da cirurgia. Relatamos o caso de um jovem paciente do sexo masculino que se apresentou com DCIP após ter sido previamente submetido a duas herniorrafias inguinais. Inicialmente apresentava dor inguinal a esquerda sem abaulamento evidente e na ocasião foi submetido a herniorrafia inguinal esquerda pela técnica de Lichtenstein. Não houve resolução da dor após a cirurgia. Após 1 ano foi novamente operado, dessa vez bilateralmente e infelizmente evoluiu com piora da dor apresentava dor predominantemente neuropática (em queimação e com irradiação para região testicular bilateralmente) e intensidade moderada (escala visual analógica 6), sem melhora com anti-inflamatórios não esteroidais ou analgésicos. Apresentava dor ao toque do anel inguinal externo bilateralmente, hiperestesia no teritório de nervos genito-femoral, ílio-hipogástrico e ílio-inguinal do lado esquerdo e hipoestesia no território dos três nervos do lado direito. Apresentou alívio temporário da dor após bloqueio anestésico inguinal bilateral. Paciente foi então submetido a triplo-neurectomia bilateral com remoção das telas de polipropileno. Em seguimento um ano após o tratamento cirúrgico, o paciente permanece sem dor inguinal. [au]


Inguinal hernia (IH) surgery is one of the most common procedures in the practice of the general surgeon. With adoption of tension-free technique and synthetic mesh implantation, recurrence rates decreased and recurrence is no longer the main late complication after IH repair. Currently, the main late postoperative complication of IH repair is chronic postoperative inguinal pain (CPIP). CPIP is defined as postoperative pain in the inguinal region persisting 3-6 months after surgery. We report the case of a young male patient who presented with CPIP after having undergone two inguinal hernia repairs. Initially, he had left inguinal pain without evident bulging and underwent left inguinal herniorrhaphy using the Lichtenstein technique. There was no relief of pain after surgery. After 1 year, he underwent surgery again, this time bilaterally and unfortunately the pain got worse. He had predominantly neuropathic pain (burning and irradiated to the testicular region bilaterally) and moderate intensity (visual analogue scale 6) refractory to medical management. He had hyperesthesia on the territory of the genitofemoral, iliohypogastric and ilioinguinal nerves on the left side and hypoesthesia in the territory of the three nerves on the right side. A local anesthetic inguinal block provided temporary relief. We performed a bilateral triple neurectomy with removal of the polypropylene mesh. Followed up one year after surgical treatment, the patient remains without inguinal pain. [au]

9.
JAMA Surg ; 156(12): 1085-1092, 2021 12 01.
Article in English | MEDLINE | ID: mdl-34524395

ABSTRACT

Importance: Although multiple versions of polypropylene mesh devices are currently available on the market for hernia repair, few comparisons exist to guide surgeons as to which device may be preferable for certain indications. Mesh density is believed to impact patient outcomes, including rates of chronic pain and perception of mesh in the abdominal wall. Objective: To examine whether medium-weight polypropylene is associated with less pain at 1 year compared with heavy-weight mesh. Design, Setting, and Participants: This multicenter randomized clinical trial was performed from March 14, 2017, to April 17, 2019, with 1-year follow-up. Patients undergoing clean, open ventral hernia repairs with a width 20 cm or less were studied. Patients were blinded to the intervention. Interventions: Patients were randomized to receive medium-weight or heavy-weight polypropylene mesh during open ventral hernia repair. Main Outcomes and Measures: The primary outcome was pain measured with the National Institutes of Health (NIH) Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity Short Form 3a. Secondary outcomes included quality of life and pain measured at 30 days, quality of life measured at 1 year, 30-day postoperative morbidity, and 1-year hernia recurrence. Results: A total of 350 patients participated in the study, with 173 randomized to receive heavy-weight polypropylene mesh (84 [48.6%] female; mean [SD] age, 59.2 [11.4] years) and 177 randomized to receive medium-weight polypropylene mesh (91 [51.4%] female; mean [SD] age, 59.3 [11.4] years). No significant differences were found in demographic characteristics (mean [SD] body mass index of 32.0 [5.4] in both groups [calculated as weight in kilograms divided by height in meters squared] and American Society of Anesthesiologists classes of 2-4 in both groups), comorbidities (122 [70.5%] vs 93 [52.5%] with hypertension, 44 [25.4%] vs 43 [24.3%] with diabetes, 17 [9.8%] vs 12 [6.8%] with chronic obstructive pulmonary disease), or operative characteristics (modified hernia grade of 2 in 130 [75.1] vs 140 [79.1] in the heavy-weight vs medium-weight mesh groups). Pain scores for patients in the heavy-weight vs medium-weight mesh groups at 30 days (46.3 vs 46.3, P = .89) and 1 year (30.7 vs 30.7, P = .59) were identical. No significant differences in quality of life (median [interquartile range] hernia-specific quality of life score at 1 year of 90.0 [67.9-96.7] vs 86.7 [65.0-93.3]; median [interquartile range] hernia-specific quality of life score at 30 days, 45.0 [24.6-73.8] vs 43.3 [28.3-65.0]) were found for the heavy-weight mesh vs medium-weight mesh groups. Composite 1-year recurrence rates for patients in the heavy-weight vs medium-weight polypropylene groups were similar (8% vs 7%, P = .79). Conclusions and Relevance: Medium-weight polypropylene did not demonstrate any patient-perceived or clinical benefit over heavy-weight polypropylene after open retromuscular ventral hernia repair. Long-term follow-up of these comparable groups will elucidate any potential differences in durability that have yet to be identified. Trial Registration: ClinicalTrials.gov Identifier: NCT03082391.


Subject(s)
Hernia, Ventral/surgery , Pain, Postoperative/epidemiology , Patient Reported Outcome Measures , Polypropylenes , Surgical Mesh , Female , Humans , Male , Middle Aged , Pain Measurement , Prosthesis Design
10.
J Am Coll Surg ; 232(6): 948-953, 2021 06.
Article in English | MEDLINE | ID: mdl-33831538

ABSTRACT

BACKGROUND: The hernia sac to abdominal cavity volume ratio (VR) on abdominal CT was described previously as a way to predict which hernias would be less likely to achieve fascial closure. The aim of this study was to test the reliability of the previously described cutoff ratio in predicting fascial closure in a cohort of patients with large ventral hernias. METHODS: Patients who underwent elective, open incisional hernia repair of 18 cm or larger width at a single center were identified. The primary end point of interest was fascial closure for all patients. Secondary outcomes included operative details and abdominal wall-specific quality-of-life metrics. We used VR as a comparison variable and calculated the test characteristics (ie, sensitivity, specificity, and positive and negative predictive values). RESULTS: A total of 438 patients were included, of which 337 (77%) had complete fascial closure and 101 (23%) had incomplete fascial closure. The VR cutoff of 25% had a sensitivity of 76% (95% CI, 71% to 80%), specificity of 64% (95% CI, 54% to 74%), positive predictive value of 88% (95% CI, 83% to 91%), and negative predictive value of 45% (95% CI, 36% to 53%). The incomplete fascial closure group had significantly lower quality of life scores at 1 year (83.3 vs 52.5; p = 0.001), 2 years (85 vs 33.3; p = 0.003), and 3 years (86.7 vs 63.3; p = 0.049). CONCLUSIONS: In our study, the VR cutoff of 25% was sensitive for predicting complete fascial closure for patients with ratios below this threshold. Although there is a higher likelihood of incomplete fascial closure when VR is ≥ 25%, this end point cannot be predicted reliably. Additional studies should be done to study this ratio in conjunction with other hernia-related variables to better predict this important surgical end point.


Subject(s)
Abdominal Cavity/anatomy & histology , Elective Surgical Procedures/statistics & numerical data , Hernia, Ventral/diagnosis , Herniorrhaphy/statistics & numerical data , Incisional Hernia/diagnosis , Aged , Female , Hernia, Ventral/pathology , Hernia, Ventral/psychology , Hernia, Ventral/surgery , Humans , Incisional Hernia/pathology , Incisional Hernia/psychology , Incisional Hernia/surgery , Male , Middle Aged , Quality of Life , Reference Values , Reproducibility of Results , Retrospective Studies , Severity of Illness Index , Treatment Outcome
11.
Acta Cir Bras ; 35(10): e202001001, 2020.
Article in English | MEDLINE | ID: mdl-33206869

ABSTRACT

PURPOSE: Incisional hernia (IH) is a frequent complication of median laparotomy. The use of prophylactic mesh to reduce IH incidence has gained increasing attention. We hypothesized that in an animal model, linea alba prophylactic reinforcement with a three-dimensional T-shaped polypropylene mesh results in greater abdominal wall resistance. METHODS: Study was performed in 27 rabbits. After abdominal midline incision, animals were divided into three groups according to the laparotomy closure method used: (1)3D T-shaped coated mesh; (2)3D T-shaped uncoated mesh; and (3) closure without mesh. After 4 months, each animal's abdominal wall was resected and tensiometric tests were applied. Results included IH occurrence, adhesions to the mesh, and wound complications. RESULTS: There was no significant difference between the groups in maximum tensile strength (p=0.250) or abdominal wall elongation under maximum stress (p=0.839). One rabbit from the control group developed IH (p=1.00). Small intestine and colon adhesions occurred only in the uncoated mesh group (p<0.001) and the degree of adhesions was higher in this group compared to the coated mesh group (p<0.05). CONCLUSION: Use of the current 3D T-shaped prophylactic mesh model did not result in a significant difference in tensiometric measurements when compared with simple abdominal wall closure in rabbits.


Subject(s)
Abdominal Wall , Hernia, Ventral , Incisional Hernia , Abdominal Wall/surgery , Animals , Hernia, Ventral/surgery , Polypropylenes , Rabbits , Surgical Mesh , Tissue Adhesions/prevention & control
12.
J Surg Res ; 255: 428-435, 2020 11.
Article in English | MEDLINE | ID: mdl-32619857

ABSTRACT

BACKGROUND: Randomized controlled trials (RCTs) are the gold standard to establish evidence for surgical practice but can be hindered by high costs, complexity, and time requirements. Recently, observational registries have been leveraged as platforms for clinical trials to address these limitations, though few registry-based surgical RCTs have been conducted. Here, we present our group's approach to surgical registry-based RCTs and early results. MATERIALS AND METHODS: To facilitate these trials, we focused on registry integration into surgeons' workflows, routine collection of patient-reported outcomes at clinic visits, and pragmatic trial design featuring broad inclusion criteria and standard of care follow-up. These features maximize generalizability and facilitate follow-up by minimizing visits and tests outside of normal practice. RESULTS: Since 2017, our group has completed enrollment in 4 registry-based RCTs with another 5 trials ongoing. Of these, 4 trials have been multicenter. Over 1000 patients have been enrolled in these studies, with follow-up rates of 90% or greater. Most of these trials are on track to complete enrollment in approximately 2 y from their start date. Beyond salary support, resource utilization is low. None of our trials has been terminated due to lack of resources or futility. CONCLUSIONS: Registry-based RCTs allow for efficient conduct of pragmatic surgical trials. Thoughtful study design, registry integration into surgeons' routines, and a team culture embracing research are paramount. We believe registry-based trials are the future of affordable, high-level, prospective surgical research.


Subject(s)
Randomized Controlled Trials as Topic , Registries , Surgical Procedures, Operative , Humans
13.
JAMA Surg ; 155(5): 380-387, 2020 05 01.
Article in English | MEDLINE | ID: mdl-32186683

ABSTRACT

Importance: Despite 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. Objective: To determine whether the robotic approach to inguinal hernia repair results in improved postoperative outcomes compared with traditional laparoscopic inguinal hernia repairs. Design, Setting, and Participants: This 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. Interventions: Standard laparoscopic transabdominal preperitoneal repair or robotic transabdominal preperitoneal repair. Main Outcomes and Measures: Main 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. Results: A 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 Relevance: Results 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 Registration: ClinicalTrials.gov Identifier: NCT02816658.


Subject(s)
Hernia, Inguinal/surgery , Herniorrhaphy/methods , Laparoscopy , Robotic Surgical Procedures , Abdomen , Adult , Aged , Female , Humans , Male , Middle Aged , Pilot Projects , Prospective Studies , Single-Blind Method , Treatment Outcome
14.
Surgery ; 167(4): 751-756, 2020 04.
Article in English | MEDLINE | ID: mdl-32061401

ABSTRACT

BACKGROUND: There has been increasing media coverage regarding the controversy of using mesh in various operations. At this time, there are no published studies evaluating the potential influence of this controversy on patients' perceptions. Therefore, our study aimed to assess patient perceptions of hernia repair surgery with mesh as well as factors that may influence patient opinions. METHODS: A 16-item questionnaire evaluated each patient's perceptions of the use of mesh in their upcoming hernia repair. The primary outcomes of interest were their level of comfort regarding the possibility of hernia repair surgery with mesh, aversion to hernia surgery with mesh, and positive belief that mesh is a safe product in hernia repair surgery. RESULTS: We included 100 patients presenting for a hernia repair and 100 patients presenting for other operations. Both groups identified the media as their most common influence (37% and 40%, respectively). Factors leading to a high level of comfort regarding the possibility of mesh repair included believing mesh was a safe product (P < .001) and hearing about the advantages of mesh (P = .012) from medical professionals (P = .001). Factors leading to a positive belief that mesh was a safe product included the male sex (P = .015), a high socioeconomic standing (P = .006), and their own personal experience (P = .013). Factors leading to aversion to mesh use included the female sex (P = .006) and hearing about meshes causing mesh-related (P = .028) and wound-related complications (P = .025) as well as chronic pain (.008). CONCLUSION: Despite the high penetration of non-medical information in the population before presentation for medical care, most patients overall do not seem to be opposed to the concept of the use of mesh in a hernia repair, but there are certain factors associated with aversion to the use of mesh that physicians should acknowledge and should address this potential issue.


Subject(s)
Herniorrhaphy/methods , Surgical Mesh , Aged , Female , Humans , Male , Middle Aged , Perception , Prospective Studies , Surveys and Questionnaires
15.
Am J Surg ; 219(3): 425-428, 2020 03.
Article in English | MEDLINE | ID: mdl-31668283

ABSTRACT

BACKGROUND: Chronic postoperative inguinodynia is a challenging long-term complication after inguinal hernia repair. Surgery may be an option for patients who are refractory to non-operative measures. We aim to evaluate the short-term outcomes of surgical treatment for chronic inguinodynia at our institution. METHODS: Consecutive patients undergoing surgical treatment for chronic groin pain were identified in a prospectively maintained database. Outcomes included operative details, intra- and postoperative complications, pain scores, and patient satisfaction. RESULTS: 29 patients were included in the study. All patients were refractory to multimodal pain management. The median pain score on presentation was 8 (IQR 7-10), and after a median follow-up of 6 months (IQR 4-11), there was a statistically significant reduction in pain scores (median 2, IQR 2-6, p < 0.001). Fifty-five percent of patient were pain free or almost pain free and 93 percent reported they would undergo the same operation again. CONCLUSIONS: Chronic groin pain is a complex problem with no universal solution. In our experience, surgical treatment significantly decreased short-term pain scores.


Subject(s)
Chronic Pain/surgery , Hernia, Inguinal/surgery , Herniorrhaphy , Pain, Postoperative/surgery , Patient Satisfaction , Female , Humans , Male , Middle Aged , Pain Management , Pain Measurement , Prospective Studies
17.
Acta cir. bras ; 35(10): e202001001, 2020. tab, graf
Article in English | LILACS | ID: biblio-1130617

ABSTRACT

Abstract Purpose: Incisional hernia (IH) is a frequent complication of median laparotomy. The use of prophylactic mesh to reduce IH incidence has gained increasing attention. We hypothesized that in an animal model, linea alba prophylactic reinforcement with a three-dimensional T-shaped polypropylene mesh results in greater abdominal wall resistance. Methods: Study was performed in 27 rabbits. After abdominal midline incision, animals were divided into three groups according to the laparotomy closure method used: (1)3D T-shaped coated mesh; (2)3D T-shaped uncoated mesh; and (3) closure without mesh. After 4 months, each animal's abdominal wall was resected and tensiometric tests were applied. Results included IH occurrence, adhesions to the mesh, and wound complications. Results: There was no significant difference between the groups in maximum tensile strength (p=0.250) or abdominal wall elongation under maximum stress (p=0.839). One rabbit from the control group developed IH (p=1.00). Small intestine and colon adhesions occurred only in the uncoated mesh group (p<0.001) and the degree of adhesions was higher in this group compared to the coated mesh group (p<0.05). Conclusion: Use of the current 3D T-shaped prophylactic mesh model did not result in a significant difference in tensiometric measurements when compared with simple abdominal wall closure in rabbits.


Subject(s)
Animals , Abdominal Wall/surgery , Incisional Hernia , Hernia, Ventral/surgery , Polypropylenes , Rabbits , Surgical Mesh , Tissue Adhesions/prevention & control
18.
Surgery ; 166(1): 94-101, 2019 07.
Article in English | MEDLINE | ID: mdl-31097319

ABSTRACT

BACKGROUND: We aimed to assess the impact of modifiable comorbidities-obesity, diabetes, and smoking-and their aggregate effect on wound complications after incisional hernia repair. METHODS: Data on all open, elective, incisional hernia repair with permanent synthetic mesh in clean wounds were collected from the Americas Hernia Society Quality Collaborative and reviewed. Three groups were defined: those with 0, 1, or 2+ modifiable comorbidities, with associations described for each specific comorbid condition. Primary outcomes included surgical site occurrences, surgical site infections, and surgical site occurrences requiring procedural intervention. RESULTS: A total of 3,908 subjects met the inclusion criteria. Mean hernia width was 9.6 ± 6.5 cm, mean body mass index was 32.1 ± 6.6 kg/m2, 21% of patients had diabetes, and 9% were smokers. Of those, 31% had no modifiable comorbidities, 49% had 1 modifiable comorbidity, and 20% had 2+ modifiable comorbidities. Compared with having no modifiable comorbidities, having 1 modifiable comorbidity, or 2+ modifiable comorbidities significantly increased the odds of a surgical site occurrence (odds ratios 1.33 and 1.61, respectively). However, only patients with 2+ modifiable comorbidities had significantly increased odds of surgical site occurrences requiring procedural intervention compared with no modifiable comorbidities and 1 modifiable comorbidity (odds ratios 2.02 and 1.65, respectively). Patients with all 3 comorbidities had a two-fold increase in odds for all wound morbidity, followed similarly by obese patients with diabetes. CONCLUSION: The presence of any number of comorbidities (1 modifiable comorbidity or 2+ modifiable comorbidities) increases the odds for wound events. However, having multiple comorbidities was associated with more procedural interventions for wound management. This was most evident in patients with all 3 comorbidities, and, in obese diabetics, underscoring the importance of preoperative counseling on expected recovery in such patients.


Subject(s)
Comorbidity , Elective Surgical Procedures/adverse effects , Herniorrhaphy/adverse effects , Incisional Hernia/surgery , Laparotomy/adverse effects , Surgical Wound Infection/surgery , Adult , Aged , Databases, Factual , Elective Surgical Procedures/methods , Female , Herniorrhaphy/methods , Humans , Laparotomy/methods , Male , Middle Aged , Patient Readmission/statistics & numerical data , Prognosis , Retrospective Studies , Risk Assessment , Surgical Mesh/adverse effects , Surgical Wound Infection/diagnosis , Surgical Wound Infection/epidemiology , Treatment Outcome , Wound Healing/physiology
19.
Am J Surg ; 218(5): 934-939, 2019 11.
Article in English | MEDLINE | ID: mdl-30878218

ABSTRACT

BACKGROUND: We investigate the prevalence of PTSD in patients with an incisional hernia presenting for evaluation at our institution. METHODS: Study patients were screened for PTSD using the PCL-5 checklist for DSM-5. Patient-reported quality of life and pain scores were assessed using validated tools (HerQLes and PROMIS Pain Intensity 3a survey). RESULTS: The prevalence of PTSD in 131 patients was 32.1% [95% CI 24%-40%]. Patients screening positive (PTSD+) reported lower quality of life scores on HerQles (17.3 ± 14.3 vs. 47.7 ± 29.6, P < 0.001), and higher pain scores on the PROMIS scale (54.2 ± 9.1 vs. 44.2 ± 10, p < 0.001). PTSD + patients also reported significantly higher numbers of previous hernia repairs and abdominal operations, as well as a higher rate of a history of an open abdomen. CONCLUSION: Our study found a significant prevalence of positive screening for PTSD in patients seeking consultation regarding an incisional hernia. We have begun routine preoperative evaluations by a behavioral medicine specialist to address some of these complex issues in high-risk patients. Other high volume hernia programs caring for this challenging patient population should consider such assessments.


Subject(s)
Herniorrhaphy/psychology , Incisional Hernia/epidemiology , Stress Disorders, Post-Traumatic/epidemiology , Adult , Aged , Cross-Sectional Studies , Female , Herniorrhaphy/statistics & numerical data , Humans , Incisional Hernia/psychology , Incisional Hernia/surgery , Male , Middle Aged , Patient Reported Outcome Measures , Prevalence , Quality of Life , Risk Factors , Stress Disorders, Post-Traumatic/psychology
20.
Surgery ; 166(1): 88-93, 2019 07.
Article in English | MEDLINE | ID: mdl-30910231

ABSTRACT

BACKGROUND: It is unclear whether a history of surgical site infection is associated with developing a new infection after subsequent operations. We aim to investigate the impact of an earlier abdominal wall surgical site infection on future 30-day infectious wound complications after open incisional hernia repair with mesh. METHODS: Patients undergoing elective, clean open incisional hernia repair were identified within the Americas Hernia Society Quality Collaborative and were divided into those with and without a history of a surgical site infection. Predictors of a surgical site infection and a surgical site infection requiring a procedural intervention were investigated using logistic regression and propensity-matched analysis. A subgroup analysis was done to investigate whether an earlier methicillin-resistant Staphylococcus aureus surgical site infection specifically increases odds for infectious complications. RESULTS: Of 3,168 identified patients, 589 had a history of a surgical site infection and experienced higher rates of postoperative surgical site infection (6.5% vs 2.9%, P < .001) and surgical site infections requiring procedural intervention (5.3% vs 1.9%, P < .001). After adjusting for identified confounders, a previous surgical site infection was independently associated with developing another surgical site infection (odds ratio 2.04, 95% confidence interval 1.32-3.10, P < .001) and a surgical site infection requiring procedural intervention (odds ratio 2.2, 95% confidence interval 1.35-3.55, P = .001). Propensity-matched analysis controlling for additional confounders confirmed the association of an earlier surgical site infection with the outcomes of interest (odds ratio 2.1 and 2.8, respectively). A subgroup analysis found that an earlier methicillin-resistant Staphylococcus aureus infection specifically did not incur higher rates of surgical site infection when compared with non-methicillin-resistant Staphylococcus aureus pathogens. CONCLUSION: History of a surgical site infection increases the odds for new infectious complications after open incisional hernia repair in a clean wound. Investigations on perioperative interventions to ameliorate the negative impact of such association are necessary.


Subject(s)
Elective Surgical Procedures/methods , Hernia, Ventral/surgery , Incisional Hernia/surgery , Surgical Mesh , Surgical Wound Infection/surgery , Wound Healing/physiology , Adult , Cohort Studies , Databases, Factual , Female , Follow-Up Studies , Herniorrhaphy/adverse effects , Herniorrhaphy/methods , Humans , Incisional Hernia/diagnosis , Laparotomy/adverse effects , Laparotomy/methods , Logistic Models , Male , Middle Aged , Multivariate Analysis , Propensity Score , Reoperation/methods , Retrospective Studies , Risk Assessment , Surgical Wound Infection/diagnosis , Surgical Wound Infection/etiology , Treatment Outcome
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