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2,692 result(s) for "Herniorrhaphy - methods"
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Robotic versus laparoscopic ventral hernia repair: multicenter, blinded randomized controlled trial
AbstractObjectiveTo determine whether robotic ventral hernia repair is associated with fewer days in the hospital 90 days after surgery compared with laparoscopic repair.DesignPragmatic, blinded randomized controlled trial.SettingMultidisciplinary hernia clinics in Houston, USA.Participants124 patients, deemed appropriate candidates for elective minimally invasive ventral hernia repair, consecutively presenting from April 2018 to February 2019.InterventionsRobotic ventral hernia repair (n=65) versus laparoscopic ventral hernia repair (n=59).Main outcome measuresThe primary outcome was number of days in hospital within 90 days after surgery. Secondary outcomes included emergency department visits, operating room time, wound complications, hernia recurrence, reoperation, abdominal wall quality of life, and costs from the healthcare system perspective. Outcomes were pre-specified before data collection began and analyzed as intention to treat.ResultsPatients from both groups were similar at baseline. Ninety day follow-up was completed in 123 (99%) patients. No evidence was seen of a difference in days in hospital between the two groups (median 0 v 0 days; relative rate 0.90, 95% confidence interval 0.37 to 2.19; P=0.82). For secondary outcomes, no differences were noted in emergency department visits, wound complications, hernia recurrence, or reoperation. However, robotic repair had longer operative duration (141 v 77 min; mean difference 62.89, 45.75 to 80.01; P≤0.001) and increased healthcare costs ($15 865 (£12 746; €14 125) v $12 955; cost ratio 1.21, 1.07 to 1.38; adjusted absolute cost difference $2767, $910 to $4626; P=0.004). Among patients with robotic ventral hernia repair, two had an enterotomy compared none with laparoscopic repair. The median one month postoperative improvement in abdominal wall quality of life was 3 with robotic ventral hernia repair compared with 15 following laparoscopic repair.ConclusionThis study found no evidence of a difference in 90 day postoperative hospital days between robotic and laparoscopic ventral hernia repair. However, robotic repair increased operative duration and healthcare costs.Trial registrationClinicaltrials.gov NCT03490266.
Laparoscopic inguinal hernia repair with self-fixated meshes: a randomized controlled trial
Background Laparoscopic inguinal hernia surgery leads to rapid recovery and low complication rates. An alternative to fixate the mesh is using a self-fixated mesh. Methods From April 2021 to June 2024, we conducted a randomized controlled trial comparing self-adhesive mesh (Adhesix™) with self-gripping mesh (Progrip™) in laparoscopic inguinal hernia surgery (TAPP and TEP). Adult patients scheduled for day surgery were included in the study with a 1-year follow up. The primary endpoint was the number of analgesics (Paracetamol or Ibuprofen) used during the first post-operative week. Secondary outcomes were pain-related issues, complications, and recurrence rate. Results A total of 174 patients participated; 90 received Adhesix™ (group A) and 84 Progrip™ (Group P). Forty-six (26.4%) patients had recurrent hernia, 68 (39.1%) had unilateral and 60 (34.5%) had bilateral primary hernias. A total of 156 (90%) patients completed follow up. The number of analgesics during the first post-operative week was comparable between groups (P 22.9, A 21.2 tablets,  p  = 0.461). Group P used more analgesics during day 1, after which no difference was observed. In general, all participants used analgesics after surgery regularly for 10.8 days (SD 10.6) and occasionally for 15.9 days (SD 16.9). Time to return to work and normal activities was 16.1 days (SD 10.8) and 16.6 days (SD 9.6), respectively. More patients in group P reported moderate or severe pain (numeric rating scale > 3) during exercise 3 months after surgery (P 15.4%, A 3.1%,  p  = 0.035), although no difference was observed at 1 year after surgery. Both groups had significantly improved quality of life measures in physical aspects of the RAND-36 Item Health Survey after 3 months. Two recurrences, one in each group (1.1%) occurred. Conclusion The use of Adhesix was non-inferior to Progrip in laparoscopic surgery. Surgery using either mesh led to rapid recovery and improved quality of life. This trial was registered in ClinicalTrials.gov (NCT05091853). Graphical abstract
A comparative study on trocar configurations and the use of steerable instruments in totally extraperitoneal inguinal hernia surgery training
Background Totally extraperitoneal (TEP) inguinal hernia surgery is a commonly performed but technically challenging procedure with a long learning curve. As TEP can be executed using two different trocar placements: a midline or a triangular configuration, the question remains which one is technically easier to master. Methods In a multicenter crossover-study, medical students were randomised into two groups and executed tasks on a box trainer that measured time, volume and force parameters. Additionally, the study assessed whether the SATA instrument, a steerable laparoscopic instrument that articulates the instrument’s tip, would reduce the difficulty of performing the tasks in the midline configuration. After training, all participants executed a first experiment using both trocar configurations, followed by a second experiment executed with steerable and non-steerable instruments in the midline configuration. Subjective and objective performances per condition and learning curves were assessed. Results Participants were faster and showed lower peak forces in the triangulated configuration. Learning curve analysis showed a positive improvement in time and path length in the midline configuration. Although participants rated ergonomics and intuitiveness similarly between the instruments, they found the task easier with the SATA instruments, ranking the added value of the steering function as 5 out of 5. Objectively, time and path length showed no significant differences while exerted forces were lower when using conventional instruments. Conclusion Although the midline configuration is preferred in terms of comfort and posture, the findings indicate that, for inexperienced practitioners, performing TEP surgery in midline configuration is both subjectively and objectively more challenging, highlighting the need for extensive training to overcome its difficulties and possibly shorten its learning curve. Although instruments with additional steering functions were preferred over conventional instruments in the more challenging midline configuration, additional steering complexity did not result in better parameter outcomes, showing the need for more extensive training.
Local VS. other forms of anesthesia for open inguinal hernia repair: A meta-analysis of randomized controlled trials
There is variation in the anesthetic technique for open inguinal hernia repair (OIHR) worldwide. Factors determining the anesthetic technique remains equivocal. We hypothesize that outcomes and operative room times are superior with local anesthesia (LA) compared to AO [all others (general and spinal anesthesia)]. Following PRISMA guidelines and set inclusion and exclusion criteria, various databases were reviewed and 18 RCT's were isolated. Using ReviewManager 5.3, multiple parameters were used to test for overall effect between the included studies. Overall complication rate was similar in LA vs. AO (p = 0.06). Wound infection and hematomas were similar between LA vs. OA, but urinary retention was significantly decreased in LA (p = 0.0002). Patient satisfaction was not inferior with LA (p = 0.10). Surgical time was similar in LA vs. AO (p = 0.86), but operating room time was significantly decreased with LA (p < 0.0001). The literature review also showed a decrease in the LOS and cost when LA was used. This meta-analysis demonstrates that LA is a well-tolerated for OIHR with OR times and urinary retention being significantly decreased. •Local anesthesia is a well-tolerated anesthetic technique for open inguinal hernia repairs.•Total operating room times and urinary retention are significantly improved when local anesthesia is utilized.•Local anesthesia is a cost effective anesthetic technique for open inguinal hernia repair.
Comparison of short-term clinical efficacy and safety between biological and synthetic meshes in laparoscopic hiatal hernia repair: a single-center randomized controlled trial
Background The optimal choice of mesh material in laparoscopic hiatal hernia repair (LHHR) is debated. This study aimed to compare the short-term clinical efficacy and safety of biological versus synthetic meshes in LHHR. Methods In a prospective, single-center randomized controlled trial conducted from January 2020 to December 2022, 124 patients undergoing LHHR were enrolled and randomly assigned to either the biological mesh group ( n  = 62) or the synthetic mesh group ( n  = 62). The biological mesh group received non-crosslinked biological mesh, while the synthetic mesh group received polypropylene anti-adhesion mesh for hiatal closure reinforcement. Randomization was computer-generated. Baseline characteristics were collected, and patients were followed up at 6, 12, and 18 months postoperatively through telephone interviews or outpatient visits. The primary outcome was the recurrence rate of hiatal hernia, assessed by gastroscopy and upper gastrointestinal contrast radiography. Secondary outcomes included symptom improvement evaluated using the Visual Analog Scale (VAS) and the Short Form-36 (SF-36) Health Survey Questionnaire, as well as quality of life improvements. The safety of mesh was assessed by recording mesh-related complications. Results Baseline characteristics were comparable between the two groups. At 18 months, the recurrence rate was 1.92% in the synthetic mesh group and 9.26% in the biological mesh group ( P  = 0.225). At 6 months, the biological mesh group reported significantly less early satiety compared to the synthetic mesh group (0.35 ± 1.09 vs. 0.95 ± 1.99; P  = 0.046). Conversely, at 18 months, early satiety was lower in the synthetic mesh group compared to the biological mesh group (0.31 ± 1.35 vs. 1.04 ± 2.21; P  = 0.043). No significant differences were observed between the groups for other symptoms or SF-36 domains at any time point (all P  > 0.05). Both groups showed significant improvements in some symptoms and quality of life from preoperative to postoperative assessments ( P  < 0.05). No mesh-related complications were reported in either group throughout the 18-month follow-up period. Conclusions Both biological and synthetic meshes are effective and safe for use in LHHR, demonstrating similar recurrence rates and improvements in symptoms and quality of life over an 18-month period. The choice of mesh may influence early satiety at different postoperative intervals, suggesting that individualized mesh selection based on patient-specific factors may enhance postoperative outcomes.
A comparative study between ETEP vs. IPOM repair for ventral hernia
Background Enhanced View Totally Extraperitoneal (eTEP) and Intraperitoneal Onlay Mesh (IPOM) are two widely performed laparoscopic approaches for ventral hernia repair. This randomized prospective study aimed to compare these two techniques in terms of various clinical outcomes. Materials and methods A total of 60 patients presenting with ventral hernias at our hospital between June 2022 and December 2023 were included in the study. All patients were fit for general anesthesia and were randomized into two groups, with 30 patients undergoing eTEP and 30 patients undergoing IPOM. Results There were no significant differences in baseline characteristics such as age, sex, or comorbidities between the two groups. The operative time for eTEP was significantly longer, with a mean duration of 211 min compared to 177.5 min for IPOM ( p  < 0.001). Postoperative pain and analgesic requirements were significantly lower in the eTEP group. Two patients in the eTEP group required conversion to IPOM. No intraoperative complications occurred in either group. Two patients developed seromas on the seventh postoperative day, both of which were managed conservatively. The mean hospital stay was shorter for eTEP (3.43 days) compared to IPOM (6.16 days, p  < 0.001). Patients undergoing eTEP had an earlier return to work and reported better abdominal wall quality of life. No recurrences were observed in either group during the six-month follow-up period. Conclusion eTEP repair for ventral hernias offers several advantages over the commonly performed IPOM technique, including reduced postoperative pain, shorter hospital stay, and faster recovery. However, the choice of procedure should be guided by the surgeon’s expertise and confidence in performing either technique.
A multicenter randomized controlled trial comparing short- and medium-term outcomes of novel biologics and lightweight synthetic mesh for laparoscopic inguinal hernia repair
Introduction The use of biological graft in laparoscopic inguinal hernia repair (LIHR) has been controversial, and there is a lack of high-level evidence to confirm the value of biological graft in LIHR. The purpose of this study is to evaluate the effectiveness of a novel composite biologics in LIHR. Methods A multicenter, single-blinded, randomized controlled clinical trial was designed. Fifty patients with unilateral primary inguinal hernia were randomly assigned to the experimental and control group (1:1). The experimental group was repaired with a non-crosslinked composite extracellular matrix from porcine urinary bladder matrix and small intestinal submucosa (UBM/SIS). The control group was repaired with a lightweight, large-pore, synthetic mesh. The primary endpoint was the effectiveness rate of hernia repair. Results The patients were followed up for four years. No significant difference was found between the experimental group and the control group in the effective rate of hernia repair (24/24[100%] vs 21/22[95.45%], RR, 0.4667; 95%CI, 0.3294–2.304; P  = 0.4783). There was no fever, seroma, infection, groin pain, foreign body discomfort or recurrence in the experimental group during the follow-up. In the control group, there were 2 cases of seroma 14 days after operation, 1 case of groin discomfort 60 days after operation and one case of recurrence 410 days after surgery. Conclusion Compared with the lightweight synthetic mesh, the novel UBM/SIS graft has comparable short-term and medium-term effectiveness in LIHR, and the incidence of postoperative complications such as seroma groin discomfort is lower. Trial registration Clinical Trials Registry: ChiCTR1800020173.
Prospective randomized study comparing mesh displacement in enhanced-view totally extraperitoneal versus totally extraperitoneal laparoscopic inguinal hernia repair without mesh fixation
Purpose In laparoscopic inguinal hernia repair, it is thought that the mesh can be displaced more in the enhanced-view totally extraperitoneal (eTEP) technique. The aim of this study was to compare eTEP and totally extraperitoneal (TEP) techniques without mesh fixation in terms of mesh displacement and hernia recurrence. Methods Between December 2022 and April 2023, 60 consecutive patients with unilateral inguinal hernia were randomized into two groups; eTEP group ( n  = 30) and TEP group ( n  = 30). There was without mesh fixation in both groups. Study was registered at http://Clinicaltrials.gov (NCT06070142). The mesh was marked with three radiopaque clips. Pelvic radiographs were performed to evaluate the displacement of the mesh. The primary outcome of this study was mesh displacement. In addition, this is the first study in the literature to compare eTEP and TEP techniques in terms of mesh displacement without fixation in laparoscopic inguinal hernia. Results There was no significant difference between the groups in terms of mesh displacement, recurrence, postoperative VAS scores, length of hospital stay, hematoma, and seroma formation. The operation time was higher in the eTEP group and was statistically significant. Conclusion Without mesh fixation, the eTEP technique does not increase the risk of mesh displacement and recurrence. The eTEP technique can be safely applied without mesh fixation in laparoscopic inguinal hernia repairs. Trial registration ClinicalTrials number: NCT06070142.
A comparative study on optical trocar entry vs. balloon trocar entry in laparoscopic eTEP inguinal hernia repair - a randomised control trial
Background The enhanced Totally Extra-Peritoneal (eTEP) technique is a novel minimally invasive approach to inguinal hernia repair that involves entry into the retro-rectus space and dissection of preperitoneal spaces. Aim of this study is to compare two methods for creating the preperitoneal space: optical trocar dissection (Group A) and balloon trocar dissection (Group B). Materials and methods A prospective, single-blinded, interventional study was conducted with 116 patients, randomized into two groups (58 in each group) undergoing eTEP inguinal hernia repair at SRM Medical College Hospital, India. Key outcomes assessed included the duration of surgery, intraoperative complications, postoperative pain, and postoperative occurences such as seroma and hematoma. Results The study found that balloon trocar dissection resulted in significantly shorter surgery duration (mean 62 min vs. 75 min, p <0.001) and quicker preperitoneal space creation (13 min vs. 19 min, p <0.0001). Balloon dissection also showed fewer incidents of peritoneal breaches (0% vs. 10.34%, p <0.002), lower postoperative pain scores, and a lower incidence of seroma and hematoma formation (1.72% vs. 17.24%, p <0.004). Conclusion These findings suggest that balloon trocar dissection is a safer, more efficient method for eTEP inguinal hernia repair, offering a smoother learning curve for surgeons, especially during the early stages of the procedure.
Penetrating fixation device versus fibrin sealant for mesh fixation in laparoscopic repair of ventral hernia: a randomized controlled trial
Purpose Post-operative pain following intra peritoneal onlay mesh (IPOM) repair of ventral hernia is commonly attributed to mechanical fixation devices. Fibrin sealant is a novel technique of mesh fixation purported to cause less pain. The aim of this study was to compare postoperative pain in these two methods of mesh fixation. Methods This was a double-blinded, randomized controlled trial. Eighty patients with primary ventral hernia underwent laparoscopic IPOM repair using PROCEED™ mesh, which was fixed with either mechanical fixation device, SECURESTRAP™ (MF group) or fibrin sealant, TISSEEL™ (FS group). Primary end point was postoperative pain at rest and movement on a Visual Analogue Scale (VAS) of 0–10. Operative time, recurrence, seroma and quality of life (QoL) were secondary outcomes. Patients were followed up for one year. Results There was no significant difference in pain score at 12 h, 24 h, 7 days, 1, 3 and 12 months between the groups, except pain on movement, which was significantly less in the FS group on the seventh day (median VAS 3 vs. 2, p  = 0.01). Mean operative time was 8 min longer in the FS group ( p  = 0.001). Two patients in the FS and none in the MF group had recurrence at one year ( p  = 0.18). Seroma formation, postoperative QoL and patient satisfaction scores were similar in both groups. Conclusions Use of fibrin sealant for mesh fixation does not provide significant advantage over mechanical fixation in laparoscopic IPOM repair.