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      Hyaluronic acid-carboxymethylcellulose reduced postoperative bowel adhesions following laparoscopic urologic pelvic surgery: a prospective, randomized, controlled, single-blind study

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          Abstract

          Background

          To assess the anti-adhesive effect of treatment with hyaluronic acid-carboxymethylcellulose following laparoscopic radical prostatectomy.

          Methods

          This was a randomized, controlled, single-blind, parallel-group study using hyaluronic acid-carboxymethylcellulose in patients who underwent laparoscopic radical prostatectomy. Sixty patients were enrolled in the study. All patients were randomly assigned to either the hyaluronic acid-carboxymethylcellulose treatment group ( n = 30) or the control group ( n = 30). Viscera slide ultrasounds and plain X-rays were obtained at enrollment (V0), postoperative week 12 (V1), and 24 (V2). The primary end point was the difference in the excursion distance in the viscera slide ultrasound between V0 and V2.

          Results

          A total of 50 patients completed this study. The average excursion distance at V2 in the experimental group ( n = 25) was significantly longer than in the control group ( n = 25, 2.7 ± 1.2 vs. 1.3 ± 1.0 cm, respectively; p < 0.001). The differences in the V0 and V2 excursion distances were significantly higher in the control group than in the experimental group (1.48 ± 1.5 vs. 2.9 ± 1.2 cm, respectively; p < 0.001). None of patients showed adverse events associated with the use of hyaluronic acid-carboxymethylcellulose.

          Conclusion

          This randomized study demonstrated that hyaluronic acid-carboxymethylcellulose treatment resulted in a reduction in bowel adhesion to the abdominal wall after laparoscopic pelvic surgery and had good clinical safety.

          Trial registration

          ClinicalTrials.gov Identifier: NCT02773251 Date: May 12, 2016.

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          Most cited references20

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          Pathophysiology and prevention of postoperative peritoneal adhesions.

          Peritoneal adhesions represent an important clinical challenge in gastrointestinal surgery. Peritoneal adhesions are a consequence of peritoneal irritation by infection or surgical trauma, and may be considered as the pathological part of healing following any peritoneal injury, particularly due to abdominal surgery. The balance between fibrin deposition and degradation is critical in determining normal peritoneal healing or adhesion formation. Postoperative peritoneal adhesions are a major cause of morbidity resulting in multiple complications, many of which may manifest several years after the initial surgical procedure. In addition to acute small bowel obstruction, peritoneal adhesions may cause pelvic or abdominal pain, and infertility. In this paper, the authors reviewed the epidemiology, pathogenesis and various prevention strategies of adhesion formation, using Medline and PubMed search. Several preventive agents against postoperative peritoneal adhesions have been investigated. Their role aims in activating fibrinolysis, hampering coagulation, diminishing the inflammatory response, inhibiting collagen synthesis or creating a barrier between adjacent wound surfaces. Their results are encouraging but most of them are contradictory and achieved mostly in animal model. Until additional findings from future clinical researches, only a meticulous surgery can be recommended to reduce unnecessary morbidity and mortality rates from these untoward effects of surgery. In the current state of knowledge, pre-clinical or clinical studies are still necessary to evaluate the effectiveness of the several proposed prevention strategies of postoperative peritoneal adhesions.
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            Intestinal obstruction from adhesions--how big is the problem?

            Apart from one post-mortem study, the incidence of adhesions following laparotomy has not been well documented. 1. In a prospective analysis of 210 patients undergoing a laparotomy, who had previously had one or more abdominal operations, we found that 93% had intra-abdominal adhesions that were a result of their previous surgery. This compared with 115 first-time laparotomies in which 10.4% had adhesions. 2. Over a 25-year period, 261 of 28 297 adult general surgical admissions were for intestinal obstruction from adhesions (0.9%). Of 4502 laparotomies, 148 were for adhesive obstruction (3.3%). 3. Over a 13-year period all laparotomies were followed up for an average of 14.5 months (range 0-91 months). From these 2708 laparotomies, 26 developed intestinal obstruction due to postoperative adhesions within 1 year of surgery (1%). Fourteen did so within 1 month of surgery (0.5%). 4. The majority of the operations producing intestinal obstruction were lower abdominal, principally involving the colon. The volume of general surgical work from adhesions is large and the incidence of early intestinal obstruction is high.
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              Benefits and harms of adhesion barriers for abdominal surgery: a systematic review and meta-analysis.

              Formation of adhesions after peritoneal surgery results in high morbidity. Barriers to prevent adhesion are seldom applied, despite their ability to reduce the severity of adhesion formation. We evaluated the benefits and harms of four adhesion barriers that have been approved for clinical use. In this systematic review and meta-analysis, we searched PubMed, CENTRAL, and Embase for randomised clinical trials assessing use of oxidised regenerated cellulose, hyaluronate carboxymethylcellulose, icodextrin, or polyethylene glycol in abdominal surgery. Two researchers independently identified reports and extracted data. We compared use of a barrier with no barrier for nine predefined outcomes, graded for clinical relevance. The primary outcome was reoperation for adhesive small bowel obstruction. We assessed systematic error, random error, and design error with the error matrix approach. This study is registered with PROSPERO, number CRD42012003321. Our search returned 1840 results, from which 28 trials (5191 patients) were included in our meta-analysis. The risks of systematic and random errors were low. No trials reported data for the effect of oxidised regenerated cellulose or polyethylene glycol on reoperations for adhesive small bowel obstruction. Oxidised regenerated cellulose reduced the incidence of adhesions (relative risk [RR] 0·51, 95% CI 0·31-0·86). Some evidence suggests that hyaluronate carboxymethylcellulose reduces the incidence of reoperations for adhesive small bowel obstruction (RR 0·49, 95% CI 0·28-0·88). For icodextrin, reoperation for adhesive small bowel obstruction did not differ significantly between groups (RR 0·33, 95% CI 0·03-3·11). No barriers were associated with an increase in serious adverse events. Oxidised regenerated cellulose and hyaluronate carboxymethylcellulose can safely reduce clinically relevant consequences of adhesions. None. Copyright © 2014 Elsevier Ltd. All rights reserved.
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                Author and article information

                Contributors
                +82-32-340-2120 , +82-32-340-2124 , gostraight@catholic.ac.kr
                Journal
                BMC Urol
                BMC Urol
                BMC Urology
                BioMed Central (London )
                1471-2490
                10 June 2016
                10 June 2016
                2016
                : 16
                : 28
                Affiliations
                [ ]Department of Urology, Seoul St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea
                [ ]Department of Urology, Bucheon St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea
                [ ]Department of Urology, Catholic Kwandong University, International St. Mary’s Hospital, Incheon, Republic of Korea
                [ ]Department of Urology, St. Paul’s Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea
                [ ]Department of Urology, Bucheon St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, 327, Sosa-ro, Wonmi-gu, Bucheon-si, Gyeonggi-do 14647 Republic of Korea
                Article
                149
                10.1186/s12894-016-0149-3
                4902986
                27286961
                6af020fe-f251-442a-9380-a32b34fdbac8
                © The Author(s). 2016

                Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

                History
                : 4 February 2016
                : 3 June 2016
                Funding
                Funded by: Hanmi Medicare, Seoul, Korea
                Categories
                Research Article
                Custom metadata
                © The Author(s) 2016

                Urology
                postoperative adhesion,laparoscopy,adhesion barrier
                Urology
                postoperative adhesion, laparoscopy, adhesion barrier

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