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      A feasibility study to investigate the use of a bupivacaine-collagen implant (XaraColl) for postoperative analgesia following laparoscopic surgery

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          Abstract

          Background

          XaraColl, a collagen-based implant that delivers bupivacaine to sites of surgical trauma, has been shown to reduce postoperative pain and use of opioid analgesia in patients undergoing open surgery. We therefore designed and conducted a preliminary feasibility study to investigate its application and ease of use for laparoscopic surgery.

          Methods

          We implanted four XaraColl implants each containing 50 mg of bupivacaine hydrochloride (200 mg total dose) in ten men undergoing laparoscopic inguinal or umbilical hernioplasty. Postoperative pain intensity and use of opioid analgesia were recorded through 72 hours for comparison with previously reported data from efficacy studies performed in men undergoing open inguinal hernioplasty. Safety was assessed for 30 days.

          Results

          XaraColl was easily and safely implanted via a laparoscope. The summed pain intensity and total use of opioid analgesia through the first 24 hours were similar to the values observed in previously reported studies for XaraColl-treated patients after open surgery, but were lower through 48 and 72 hours.

          Conclusion

          XaraColl is suitable for use in laparoscopic surgery and may provide postoperative analgesia in laparoscopic patients who often experience considerable postoperative pain in the first 24–48 hours following hospital discharge. Randomized controlled trials specifically to evaluate its efficacy in this application are warranted.

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          Most cited references 44

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          Open mesh versus laparoscopic mesh repair of inguinal hernia.

           James Gibbs,  O. Jonasson,   (2004)
          Repair of inguinal hernias in men is a common surgical procedure, but the most effective surgical technique is unknown. We randomly assigned men with inguinal hernias at 14 Veterans Affairs (VA) medical centers to either open mesh or laparoscopic mesh repair. The primary outcome was recurrence of hernias at two years. Secondary outcomes included complications and patient-centered outcomes. Of the 2164 patients who were randomly assigned to one of the two procedures, 1983 underwent an operation; two-year follow-up was completed in 1696 (85.5 percent). Recurrences were more common in the laparoscopic group (87 of 862 patients [10.1 percent]) than in the open group (41 of 834 patients [4.9 percent]; odds ratio, 2.2; 95 percent confidence interval, 1.5 to 3.2). The rate of complications was higher in the laparoscopic-surgery group than in the open-surgery group (39.0 percent vs. 33.4 percent; adjusted odds ratio, 1.3; 95 percent confidence interval, 1.1 to 1.6). The laparoscopic-surgery group had less pain initially than the open-surgery group on the day of surgery (difference in mean score on a visual-analogue scale, 10.2 mm; 95 percent confidence interval, 4.8 to 15.6) and at two weeks (6.1 mm; 95 percent confidence interval, 1.7 to 10.5) and returned to normal activities one day earlier (adjusted hazard ratio for a shorter time to return to normal activities, 1.2; 95 percent confidence interval, 1.1 to 1.3). In prespecified analyses, there was a significant interaction between the surgical approach (open or laparoscopic) and the type of hernia (primary or recurrent) (P=0.012). Recurrence was significantly more common after laparoscopic repair than after open repair of primary hernias (10.1 percent vs. 4.0 percent), but rates of recurrence after repair of recurrent hernias were similar in the two groups (10.0 percent and 14.1 percent, respectively). The open technique is superior to the laparoscopic technique for mesh repair of primary hernias. Copyright 2004 Massachusetts Medical Society
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            Ambulatory surgery in the United States, 2006.

            This report presents national estimates of surgical and nonsurgical procedures performed on an ambulatory basis in hospitals and freestanding ambulatory surgery centers in the United States during 2006. Data are presented by types of facilities, age and sex of the patients, and geographic regions. Major categories of procedures and diagnoses are shown by age and sex. Selected estimates are compared between 1996 and 2006. The estimates are based on data collected through the 2006 National Survey of Ambulatory Surgery by the Centers for Disease Control and Prevention's National Center for Health Statistics (NCHS). The survey was conducted from 1994-1996 and again in 2006. Diagnoses and procedures presented are coded using the International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM). In 2006, an estimated 57.1 million surgical and nonsurgical procedures were performed during 34.7 million ambulatory surgery visits. Of the 34.7 million visits, 19.9 million occurred in hospitals and 14.9 million occurred in freestanding ambulatory surgery centers. The rate of visits to freestanding ambulatory surgery centers increased about 300 percent from 1996 to 2006, whereas the rate of visits to hospital-based surgery centers remained largely unchanged during that time period. Females had significantly more ambulatory surgery visits (20.0 million) than males (14.7 million), and a significantly higher rate of visits (132.0 per 1000 population) compared with males (100.4 per 1000 population). Average times for surgical visits were higher for ambulatory surgery visits to hospital-based ambulatory surgery centers than for visits to freestanding ambulatory surgery centers for the amount of time spent in the operating room (61.7 minutes compared with 43.2 minutes), the amount of time spent in surgery (34.2 minutes compared with 25.1 minutes), the amount of time spent in the postoperative recovery room (79.0 minutes compared with 53.1 minutes), and overall time (146.6 minutes compared with 97.7 minutes). Although the majority of visits had only one or two procedures performed (56.3 percent and 28.5 percent, respectively), 2.6 percent had five or more procedures performed. Frequently performed procedures on ambulatory surgery patients included endoscopy of large intestine (5.8 million), endoscopy of small intestine (3.5 million), extraction of lens (3.1 million), injection of agent into spinal canal (2.7 million), and insertion of prosthetic lens (2.6 million). The leading diagnoses at ambulatory surgery visits included cataract (3.0 million); benign neoplasms (2.0 million), malignant neoplasms (1.2 million), diseases of the esophagus (1.1 million), and diverticula of the intestine (1.1 million).
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              Laparoscopic techniques versus open techniques for inguinal hernia repair.

               K McCormack,  Jeffrey Ross,   (2002)
              Inguinal hernia repair is the most frequently performed operation in general surgery. The standard method for inguinal hernia repair had changed little over a hundred years until the introduction of synthetic mesh. This mesh can be placed by either using an open approach or by using a minimal access laparoscopic technique. Although many studies have explored the relative merits and potential risks of laparoscopic surgery for the repair of inguinal hernia, most individual trials have been too small to show clear benefits of one type of surgical repair over another. The objective of this review was to compare minimal access laparoscopic mesh techniques with open techniques. Comparisons of open mesh techniques versus open non-mesh techniques have been considered in a separate Cochrane review. We searched MEDLINE, EMBASE, and The Cochrane Central Controlled Trials Registry for relevant randomised controlled trials. The reference list of identified trials, journal supplements, relevant book chapters and conference proceedings were searched for further relevant trials. Through the EU Hernia Trialists Collaboration (EUHTC) communication took place with authors of identified randomised controlled trials to ask for information on any other recent and ongoing trials known to them. Specialists involved in research on the repair of inguinal hernia were contacted to ask for information about any further completed and ongoing trials. The world wide web was also searched. All published and unpublished randomised controlled trials and quasi-randomised controlled trials comparing laparoscopic groin hernia repair with open groin hernia repair were eligible for inclusion. Trials were included irrespective of the language in which they were reported. Individual patient data were obtained, where possible, from the responsible trialist for all eligible studies. All reanalyses were cross-checked by the reviewers and verified by the trialists before inclusion. Where IPD were unavailable additional aggregate data were sought from trialists and published aggregate data checked and verified by the trialists. IPD were available for 25 trials, additional aggregated data for seven and published data only for nine. Where possible, time to event analysis for hernia recurrence and return to usual activities were performed on an intention to treat principle. The main analyses were based on all trials. Sensitivity analyses based on the data source and trial quality were also performed. Pre-defined subgroup analyses based on recurrent hernias, bilateral hernias and femoral hernias were also carried out. 41 published reports of eligible trials were included involving 7161 participants. Sample sizes ranged from 38 to 994, with follow-up from 6 weeks to 36 months. Duration of operation was longer in the laparoscopic groups (WMD 14.81 minutes, 95% CI 13.98 to 15.64; p<0001). Operative complications were uncommon for both methods but more frequent in the laparoscopic group for visceral (Overall 8/2315 versus 1/2599) and vascular (Overall 7/2498 versus 5/2758) injuries. Length of hospital stay did not differ between groups (WMD -0.04 days, 95% CI -0.08 to 0.00; p=0.05, but return to usual activity was earlier for laparoscopic groups (HR 0.56, 95%CI 0.51 to 0.61; p<0.0001 - equivalent to 7 days). The data available showed less persisting pain (Overall 290/2101 versus 459/2399; Peto OR 0.54, 95% CI 0.46 to 0.64; p<0.0001), and less persisting numbness (Overall 102/1419 versus 217/1624; Peto OR 0.38, 95% CI 0.4286 to 0.49; p<0.0001) in the laparoscopic groups. In total, 86 recurrences were reported amongst 3138 allocated laparoscopic repair and 109 amongst 3504 allocated to open repair (Peto OR 0.81, 95% CI 0.61 to 1.08; p = 0.16). The use of mesh during laparoscopic hernia repair is associated with a reduction in the risk of hernia recurrence, significantly so for the transabdominal preperitoneal repair (TAPP) versus open non-mesh repair (overall 26/1440 versus preperitoneal repair (TAPP) versus open non-mesh repair (overall 26/1440 versus 47/1119; Peto OR 0.45, 95% CI 0.28 to 0.72; p=0.0009). However, no difference was detected when comparing laparoscopic methods with open mesh methods of hernia repair. The use of mesh during laparoscopic hernia repair is associated with a relative reduction in the risk of hernia recurrence of around 30-50%. However, there is no apparent difference in recurrence between laparoscopic and open mesh methods of hernia repair. The data suggests less persisting pain and numbness following laparoscopic repair. Return to usual activities is faster. However, operation times are longer and there appears to be a higher risk of serious complication rate in respect of visceral (especially bladder) and vascular injuries.
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                Author and article information

                Journal
                J Pain Res
                J Pain Res
                Journal of Pain Research
                Dove Medical Press
                1178-7090
                2013
                01 February 2013
                : 6
                : 79-85
                Affiliations
                [1 ]Innocoll Technologies, Athlone, Ireland
                [2 ]Cusack Pharmaceutical Consulting, Burlington, NJ, USA
                [3 ]Memorial Hermann Memorial City Medical Center, Houston, TX, USA
                [4 ]Premier Research Group, Austin, TX, USA
                Author notes
                Correspondence: Lisa Hemsen Innocoll Technologies, Dublin Road, Athlone, Westmeath, Ireland Tel +353 90 6486834 Email lhemsen@ 123456innocollinc.com
                Article
                jpr-6-079
                10.2147/JPR.S40158
                3564459
                23390367
                © 2013 Hemsen et al, publisher and licensee Dove Medical Press Ltd

                This is an Open Access article which permits unrestricted noncommercial use, provided the original work is properly cited.

                Categories
                Original Research

                Anesthesiology & Pain management

                hernia repair, hernioplasty, laparoscopic

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