Preventing Adhesions in Obgyn Surgery

Total Page:16

File Type:pdf, Size:1020Kb

Preventing Adhesions in Obgyn Surgery THE CUttING EDGE Preventing Adhesions in ObGyn Surgery Víctor Hugo González-Quintero, MD, MPH; Jean Marie Stephan, MD; Francisco E. Cruz-Pachano, MD Adhesive disease represents a ficulty with postoperative interventions FOCUSPOINT such as intraperitoneal chemotherapy, ra- significant cause of morbidity for More than diation, and subsequent complications dur- postoperative patients. ObGyns ing repeat operations. 400,000 surgical should keep up-to-date with data procedures are PreVention OF performed daily concerning adhesion prevention PostoperatiVE ADhesions in the US for lysis Adhesive disease is a major cause of seri- and make a reasonable and of adhesions, informed decision about whether ous morbidity among women undergoing surgical procedures. As such, adhesion with an annual to employ such techniques in their prevention has become an area of interest economic impact individual practices. for many practitioners. Traditionally, good exceeding surgical technique has been advocated as $1.3 billion. the main way to prevent postoperative ad- ost surgical procedures per- hesions. This included strict adherence to formed by ObGyns are associated the basic surgical principles of minimizing with pelvic adhesions, with po- tissue trauma with meticulous hemostasis, tential serious sequelae of small minimization of ischemia and desiccation, Mbowel obstruction, infertility, chronic pelvic and prevention of infection and foreign pain, and difficulty in postoperative treat- body retention. Historically, peritoneal clo- ment, including complexity during subse- sure has been performed to reduce postop- quent surgical procedures. More than erative complications, including adhe- 400,000 surgical procedures for lysis of ad- sions. Review of the ObGyn literature does hesions are performed daily in the United not support the closure of peritoneum to States, with an annual economic impact prevent adhesions.2 exceeding $1.3 billion.1 This article will re- Significant progress has been made on view the adjunctive methods available for the technology of adhesion prevention. the ObGyn to prevent postoperative adhe- Currently, there are 3 methods approved sion formation. by the FDA for the prevention of postopera- tive adhesions: Adept®, Interceed®, and ADHESION-RELATED MORBIDITY Seprafilm®. Adhesion-related morbidity can be divided into 2 main categories: physical- and treat- ADHESION barriers ment-related. Physical-related morbidity in- Adept has been recently added to the arma- cludes small bowel obstruction (SBO), infer- mentarium of adhesion prevention as an tility, chronic pain, and dyspareunia. adjunct to be used intraperitoneally in pa- Treatment-related morbidity deals with dif- tients undergoing gynecologic laparoscopic adhesiolysis. Adept is a 4% icodextrin solu- Víctor Hugo González-Quintero, MD, MPH, is a Clini- tion made of an α(1-4)-linked glucose poly- cal Professor; Jean Marie Stephan, MD, is a Chief mer. Its mechanism of action is that of hy- Resident; and Francisco E. Cruz-Pachano, MD, is a Clinical Instructor, all in the Department of Obstetrics droflotation. However, its efficacy appears and Gynecology, University of Miami School of Medi- to be limited, as evidenced in a clinical trial cine, Miami, FL. that showed only marginal superiority over Follow The Female Patient on and The Female Patient | VOL 35 SEPTEMBER 2010 1 THE CUttINGEDGE Preventing Adhesions in ObGyn Surgery lactated Ringer’s solution (LRS) in the pre- ceed has been studied in more than 13 vention of postoperative adhesions.3 In the clinical studies that included more than study, 402 patients were randomized intra- 600 patients. A meta-analysis of 10 ran- operatively to Adept (n = 203) or LRS (n = domized controlled studies reported a 199), and they returned for a second lapa- 24.2% reduction in adhesion formation on roscopy within 4 to 8 weeks. In the same the side treated with Interceed compared trial, a number of treatment-related compli- with the control side.7 Despite this report, cations were identified, including excessive concerns about Interceed continue, espe- edema of the labia, vulva, and vagina. cially regarding its efficacy in preventing Current adhesion barriers include ex- adhesions and its apparent ineffectiveness panded polytetrafluoroethylene (Gore- in the presence of blood. In this setting, In- Tex®) and the 2 FDA-approved barriers: oxi- terceed may aggravate rather than prevent dized regenerated cellulose (Interceed) and adhesion formation. The safety and effec- sodium hyaluronate and carboxymethyl- tiveness of Interceed in preventing adhe- cellulose (Seprafilm). Interceed and Sepra- sion formation in laparoscopic surgery or film are not FDA approved for laparoscopic any procedures other than open gyneco- use. The Table lists adhesion barriers cur- logic microsurgical procedures have not FOCUSPOINT rently available, with their composition, been established. Adhesive disease peritoneal residence time, and indication/ delivery mode. Sodium Hyaluronate and is a major cause Carboxymethylcellulose (Seprafilm) of serious Expanded Polytetrafluoroethylene Seprafilm is perhaps the most widely stud- morbidity (Gore-Tex) ied adhesion barrier, with more than 20 among women This adhesion barrier has a microscope published studies including more than undergoing structure preventing cellular growth. It is 4,600 patients. Seprafilm is composed of noninflammatory and nonabsorbable. It chemically modified hyaluronic acid and surgery. does not adhere to the tissue and has to be carboxymethylcellulose. It is designed to Significant sutured in place. Data on clinical efficacy separate planes of tissues after surgery for progress has exist but are limited. In a trial of 27 women, 3 to 7 days. been made on the Myomectomy Adhesion Multicenter Writing for the Seprafilm Adhesion Study Study Group reported a significant reduc- Group, Diamond reported on the safety the technology tion in adhesion formation to the uterine and efficacy of Seprafilm in preventing of adhesion surface following Gore-Tex application as postoperative uterine adhesions after myo- prevention. compared with controls.4 In another clini- mectomy.8 This was a prospective, double- cal trial, Haney et al reported an 85% reduc- blinded, multicenter, randomized, con- tion in adhesion formation with Gore- Tex, trolled study. After surgical treatment with compared with 65% with Interceed (n = 32).5 or without Seprafilm, all patients were In a prospective, multicenter, observational evaluated by early second-look laparos- trial, Hurst reported on the long-term fol- copy for the incidence, severity, and extent low-up of patients who received Gore-Tex.6 of adhesions. The subjects were 146 women in whom the The Diamond study also evaluated the membrane was implanted permanently number of adhesion sites throughout the during peritoneal reconstruction from 1991 pelvis and the area of adhesions. In pa- through 1996. There was a single case of tients undergoing myomectomy, Seprafilm postoperative infection that did not neces- reduced the incidence, severity, extent, sitate removal of the membrane; all other and average surface area of uterine adhe- patients did well. These data suggest that the sions. Approximately 48% of patients ran- membrane can probably be left in place domized to Seprafilm had at least one ad- indefinitely. nexa free of adhesions, and there was no increased risk of complications such as Oxidized Regenerated Cellulose ileus, intra-abdominal bleeding, and post- (Interceed) operative fever.8 The adhesion barrier Interceed is made of Bristow and Montz studied the effective- oxidized regenerated cellulose and is avail- ness of Seprafilm (n = 14) in preventing pel- able in 3×4-in sheets. The efficacy of Inter- vic adhesions in women undergoing pri- 2 The Female Patient | VOL 35 SEPTEMBER 2010 All articles are available online at www.femalepatient.com. González-Quintero et al TABLE. Adhesion Barriers Currently Available Adhesion Barrier Composition Peritoneal Residence Time Indication/Delivery Mode Preclude Expanded Permanent Not approved for general (W. L. Gore) polytetrafluoroethlyene adhesion prevention. membrane Pericardial membrane or vessel guard Interceed Oxidized regenerated 1-2 weeks Gynecologic pelvic (Ethicon; cellulose membrane laparotomy. Johnson & Johnson) Not FDA approved for laparoscopic use Seprafilm Hyaluronic acid/ 7 days Abdominal or pelvic (Genzyme) carboxymethylcellulose laparotomy. membrane Not FDA approved for laparoscopic use Adept 4% Icodextrin instillate 3-4 days Gynecologic laparoscopy (Baxter) mary cytoreductive surgery with radical in cesarean delivery rates and the decline oophorectomy.9 In this cohort, Seprafilm in rates of vaginal birth after cesarean in significantly reduced the mean adhesion the United States and worldwide, ObGyns score by 84% compared with the internal should expect to see a rise in complica- controls and by 90% compared with his- tions due to adhesive disease during re- torical control groups. peat cesareans. The authors concluded that 73.2% of Se- Morales et al performed a retrospective prafilm placement sites were free of adhe- study to describe the incidence of adhesions 11 FOCUSPOINT sions, compared with 35.7% for the abdom- after cesarean delivery. The charts of 542 With the rise in inal wall and 14.3% for untreated pelvis. women who had undergone primary (n = Moreover, in those Seprafilm placement 265) or repeat (n = 277) cesarean deliveries cesarean delivery sites that did have adhesions, the adhe- were reviewed. They reported on
Recommended publications
  • The IMPACT of ETHICON INTERCOAT
    ORDERING Information PRODUCT: ETHICON Intercoat Absorbable Adhesion Barrier Gel ORDERING CODE: IC100 HOW SUPPLIED: 2x20 ml Sterile Syringes; 1 Applicator Contact your local representative for information on ETHICON Intercoat Barrier Gel †AMERICAN FERTILITY SOCIETY (AFS) CLASSIFICATION OF ADNEXAL ADHESIONS SEVERITY EXTENT Adhesions NONE <1/3 (Grade 1 Localized) 1/3 - 2/3 (Grade 2 Moderate) 2/3 (Grade 3 Extensive) Tube (0-16) + Not Present 0 Ovary (0-16) Mild (filmy) (1) 1 2 4 Score (0-32) Severe (dense) (2) 4 8 16 INTERCOAT* Absorbable Adhesion Barrier INDICATIONS ETHICON INTERCOAT is intended to be used as an adjunct to peritoneal surgery for reducing the incidence, extent, and severity of postoperative adhesions at the surgical site. EFFICACIOUS CONTRAINDICATIONS Do not use ETHICON INTERCOAT in the presence of infection. WARNINGS Do not inject intravenously. PRECAUTIONS ETHICON INTERCOAT must be used according to the instructions for use. The gel is supplied sterile and for single use only. Do not use if the package is damaged or opened. Do not resterilize ETHICON INTERCOAT. Discard any opened or unused ETHICON INTERCOAT. ETHICON INTERCOAT has not been studied in combination with other adhesion prevention products or in the presence of intraperitoneal medicinal agents, or hemostatic agents. ETHICON INTERCOAT has not been evaluated in children or pregnant or nursing women. Therefore, patients should be advised to avoid conception during the first menstrual cycle after the application of ETHICON INTERCOAT. ETHICON INTERCOAT has not been evaluated in the presence of malignancies in the peritoneal cavity. ETHICON INTERCOAT has not been evaluated following opening of the bowel, bladder, or EASY TO USE other visceral organs.
    [Show full text]
  • Placement of Surgiwrap® Adhesion Barrier Film Around the Protective
    International Journal of Colorectal Disease (2019) 34:513–518 https://doi.org/10.1007/s00384-018-03229-3 ORIGINAL ARTICLE Placement of SurgiWrap® adhesion barrier film around the protective loop stoma after laparoscopic colorectal cancer surgery may reduce the peristomal adhesion severity and facilitate the closure Chao-Wen Hsu1,2 & Min-Chi Chang1 & Jui-Ho Wang1 & Chih-Chien Wu1 & Yu-Hsun Chen1 Accepted: 21 December 2018 /Published online: 7 January 2019 # Springer-Verlag GmbH Germany, part of Springer Nature 2019 Abstract Purpose A temporary loop stoma is often created after laparoscopic colorectal cancer surgery. Peristomal adhesions may make stoma closure into a complicated operation. We demonstrated how to place the SurgiWrap® adhesion barrier film and evaluated the peristomal adhesion severity and feasibility of stoma closure. Methods This is a retrospective case-control study. Patients were divided into a study group (placement of adhesion barrier film) and a control group (no placement). Patient characteristics, operative data, and severity of adhesions were recorded. We used logistic regression to probe the association between the variables and the adhesion severity. Results A total of 180 patients were identified with 60 in the study group and 120 in the control group. In the study group, the adhesion severity (p < 0.001), operative time (p =0.025),andtimetoflatus(p = 0.042) are significantly reduced. In logistic regression analysis, placement of the film (p < 0.001), neoadjuvant concurrent chemoradiotherapy (p = 0.041), and time interval between stoma creation and closure ≧ 12 weeks (p = 0.038) are three significant factors influencing the peristomal adhesion. Conclusion The placement of SurgiWrap® adhesion barrier film around the loop stoma after laparoscopic colorectal cancer surgery may reduce the peristomal adhesion severity and facilitate the stoma closure in terms of operative time and time to flatus.
    [Show full text]
  • Postoperative Adhesions in Gynecologic Surgery: a Committee Opinion
    ASRM PAGES Postoperative adhesions in gynecologic surgery: a committee opinion Practice Committee of the American Society for Reproductive Medicine in collaboration with the Society of Reproductive Surgeons American Society for Reproductive Medicine, Birmingham, Alabama Postoperative adhesions are a natural consequence of surgical tissue trauma and healing and may result in infertility, pain, and bowel obstruction. Adherence to microsurgical principles and minimally invasive surgery may help to decrease postoperative adhesions. Some surgical barriers have been demonstrated to be effective for reducing postoperative adhesions, but there is no substantial evidence that their use improves fertility, decreases pain, or reduces the incidence of postoperative bowel obstruction. This document replaces the document, ‘‘Pathogenesis, consequences, and control of peritoneal adhesions in gynecologic surgery: a committee opinion,’’ last pub- lished in 2013. (Fertil SterilÒ 2019;112:458–63. Ó2019 by American Society for Reproductive Medicine.) Discuss: You can discuss this article with its authors and other readers at https://www.fertstertdialog.com/users/16110-fertility- and-sterility/posts/50136-28463 INTRODUCTION Health Service hospitals and helped to dian women admitted to the hospital fi Postoperative adhesions are a natural de ne the epidemiology and impact of with a diagnosis of small-bowel consequence of surgical tissue trauma postoperative adhesions (1, 2). Overall, obstruction after gynecologic proced- and healing. Peritoneal adhesions may approximately one third of patients ures found that hysterectomy was a sig- fi result in infertility, pain, or bowel who underwent open abdominal or ni cant cause of adhesion-related obstruction and may increase the tech- pelvic surgery were readmitted an small-bowel obstruction and that lapa- nical difficulty of subsequent abdom- average of 2 times over the subsequent roscopic supracervical hysterectomy inal or pelvic surgery.
    [Show full text]
  • Peritoneal Adhesions and Their Prevention - Current Trends
    #1385 Krämer FINAL Gynecology SURGICAL TECHNOLOGY INTERNATIONAL Volume 38 Peritoneal Adhesions and their Prevention - Current Trends BERNHARD KRÄMER , P HD STEFAN KOMMOSS , P HD DEPUTY MEDICAL DIRECTOR & S ENIOR CONSULTANT OF CONSULTANT OF OPERATIVE GYNECOLOGY OPERATIVE GYNECOLOGY FELIX NEIS , MD JÜRGEN ANDRESS , MD CONSULTANT OF OPERATIVE GYNECOLOGY CONSULTANT OF OPERATIVE GYNECOLOGY SARA Y B RUCKER , P HD MEDICAL DIRECTOR SASCHA HOFFMANN , MD PROFESSOR OF WOMEN ’S HEALTH AND GYNECOLOGY CONSULTANT OF OPERATIVE GYNECOLOGY DEPARTMENT FOR WOMEN ’S HEALTH , U NIVERSITY HOSPITAL TÜBINGEN , T ÜBINGEN , G ERMANY ABSTRACT he development of adhesions after gynecologic surgery is a severe problem with ramifications that go Tbeyond the medical complications patients suffer (which most often include pain, obstruction and infer - tility), since they also impose a huge financial burden on the health care system and increase the workload of surgeons and all personnel involved in surgical follow-up care. Surgical techniques to avoid adhesion forma - tion have not proven to be sufficient and pharmaceutical approaches for their prevention are even less effec - tive, which means that the use of adhesion prevention devices is essential for achieving decent prophylaxis. This review explores the wide range of adhesion prevention products currently available on the market. Par - ticular emphasis is put on prospective randomized controlled clinical trials that include second-look inter - ventions, as these offer the most solid evidence of efficacy. We focused on adhesion scores, which are the most common way to quantify adhesion formation. This enables a direct comparison of the efficacies of dif - ferent devices. While the greatest amount of data are available for oxidized regenerated cellulose, the out - comes with this adhesion barrier are mediocre and several studies have shown little efficacy.
    [Show full text]
  • Bologna Guidelines for Diagnosis
    ten Broek et al. World Journal of Emergency Surgery (2018) 13:24 https://doi.org/10.1186/s13017-018-0185-2 REVIEW Open Access Bologna guidelines for diagnosis and management of adhesive small bowel obstruction (ASBO): 2017 update of the evidence-based guidelines from the world society of emergency surgery ASBO working group Richard P. G. ten Broek1,39*†, Pepijn Krielen1†, Salomone Di Saverio2, Federico Coccolini3, Walter L. Biffl4, Luca Ansaloni3, George C. Velmahos5, Massimo Sartelli6, Gustavo P. Fraga7, Michael D. Kelly8, Frederick A. Moore9, Andrew B. Peitzman10, Ari Leppaniemi11, Ernest E. Moore12, Johannes Jeekel13, Yoram Kluger14, Michael Sugrue15, Zsolt J. Balogh16, Cino Bendinelli17, Ian Civil18, Raul Coimbra19, Mark De Moya20, Paula Ferrada21, Kenji Inaba22, Rao Ivatury21, Rifat Latifi23, Jeffry L. Kashuk24, Andrew W. Kirkpatrick25, Ron Maier26, Sandro Rizoli27, Boris Sakakushev28, Thomas Scalea29, Kjetil Søreide30,31, Dieter Weber32, Imtiaz Wani33, Fikri M. Abu-Zidan34, Nicola De’Angelis35, Frank Piscioneri36, Joseph M. Galante37, Fausto Catena38 and Harry van Goor1 Abstract Background: Adhesive small bowel obstruction (ASBO) is a common surgical emergency, causing high morbidity and even some mortality. The adhesions causing such bowel obstructions are typically the footprints of previous abdominal surgical procedures. The present paper presents a revised version of the Bologna guidelines to evidence- based diagnosis and treatment of ASBO. The working group has added paragraphs on prevention of ASBO and special patient groups. Methods: The guideline was written under the auspices of the World Society of Emergency Surgery by the ASBO working group. A systematic literature search was performed prior to the update of the guidelines to identify relevant new papers on epidemiology, diagnosis, and treatment of ASBO.
    [Show full text]
  • Clear Film Adhesion Barrier Use at Cesarean Section: a Retrospective Analysis
    Clear Film Adhesion Barrier Use at Cesarean Section: A Retrospective Analysis The Harvard community has made this article openly available. Please share how this access benefits you. Your story matters Citation Deshpande, Neha A. 2015. Clear Film Adhesion Barrier Use at Cesarean Section: A Retrospective Analysis. Doctoral dissertation, Harvard Medical School. Citable link http://nrs.harvard.edu/urn-3:HUL.InstRepos:17295914 Terms of Use This article was downloaded from Harvard University’s DASH repository, and is made available under the terms and conditions applicable to Other Posted Material, as set forth at http:// nrs.harvard.edu/urn-3:HUL.InstRepos:dash.current.terms-of- use#LAA 2 Abstract: Objective: To evaluate the use of a carboxymethylcellulose-hyaluronate adhesion barrier (Seprafilm) at the time of Cesarean section. Design: Retrospective cohort study. Setting: A tertiary care center in Boston, MA, USA. Population: All women who underwent Cesarean section between the years 2006-2010 and returned for a second pelvic surgical procedure. Methods: All patients who had a Seprafilm barrier placed at the first (index) Cesarean section were matched on a 2:1 basis to those who had no barrier. Effectiveness and surgical outcomes were compared with Chi Square and Wilcoxon tests. Cofounders were identified and controlled with logistic regression models. Main Outcome Measures: The location and severity of pelvic adhesions at the follow-up pelvic surgery. Results: Seventy-seven women who had Seprafilm placed at the index delivery were matched to 154 controls who received no barrier. The two groups had similar rates of any dense adhesions (43% and 42% respectively, p=.78) and those on the anterior uterus (34% and 31%, p=.62) at follow-up surgery.
    [Show full text]
  • Prevention of Adhesion in Laparoscopic Gynaecological Surgery
    International Journal of Reproduction, Contraception, Obstetrics and Gynecology Patel S et al. Int J Reprod Contracept Obstet Gynecol. 2016 Dec;5(12):4099-4105 www.ijrcog.org pISSN 2320-1770 | eISSN 2320-1789 DOI: http://dx.doi.org/10.18203/2320-1770.ijrcog20164311 Review Article Prevention of adhesion in laparoscopic gynaecological surgery Shweta Patel*, Amita Yadav Department of Obstetrics and Gynaecology, M.L.N Medical College, Allahabad, Uttar Pradesh, India Received: 20 September 2016 Accepted: 18 October 2016 *Correspondence: Dr. Shweta Patel, E-mail: [email protected] Copyright: © the author(s), publisher and licensee Medip Academy. This is an open-access article distributed under the terms of the Creative Commons Attribution Non-Commercial License, which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited. ABSTRACT Adhesions have important consequences for patients, surgeons, and health services. Peritoneal tissue injury can be prevented by using careful surgical techniques. A large number of anti-adhesion products have been used experimentally and clinically to prevent postoperative adhesions. The current author reviewed the surgical literature published about epidemiology, pathogenesis, and various prevention strategies of adhesion formation. Several preventive agents against postoperative peritoneal adhesions have been investigated. Bioresorbable membranes are site-specific anti adhesion products but may be more difficult to use laparoscopically. Liquids and gels have the advantage of more-widespread areas of action and increased ease of use, particularly during laparoscopic operations. Effective pharmacologic agents that can reduce release of pro-inflammatory cytokines or activate peritoneal fibrinolysis are under development. Their results are encouraging but most of them are contradictory.
    [Show full text]
  • Surgical Techniques
    SURGICAL TECHNIQUES ■ BY ALAN H. DECHERNEY, MD; WENDY Y. CHANG, MD; and CATHERINE M. MARIN, MD Preventing adhesions after abdominal myomectomy: Tools and techniques Without preventive strategies, adhesions develop in more than half of women who undergo this procedure. Here, a review of protective adjuvants. bdominal myomectomy is the preferred ticularly when peritubal involvement is pres- treatment in women with large or ent (FIGURES 1–3). Abdominopelvic adhesions A numerous intramural myomas, espe- also contribute to significant chronic pelvic cially in the setting of infertility, recurrent pain, bowel obstruction, and technical diffi- pregnancy loss, and preservation of future fer- culty in subsequent surgical or assisted-repro- tility.1,2 However, postoperative adhesions are duction procedures.5 Unfortunately, most distressingly common following this proce- attempts at adhesiolysis meet with less than dure, resulting in significant potential mor- complete success, since adhesions recur in bidity. Fortunately, a number of products can 55% to 100% of patients (FIGURE 4).6 Thus, reduce their occurrence. Proper surgical tech- preventing adhesions in the first place would niques and a thorough knowledge of these seem to be key to successful outcomes in products are invaluable in helping reduce the abdominal myomectomy. incidence of adhesions. This article reviews the evidence on vari- The association between adhesions and ous approaches and products. While the num- diminished fertility is well-established,3,4 par- ber of studies examining
    [Show full text]
  • A New Bioabsorbable Polymer Film to Prevent
    A new bioabsorbable polymer film to prevent peritoneal adhesions validated in a post-surgical animal model Lucie Allègre, Isabelle Le Teuff, Salomé Leprince, Sophie Warembourg, Hubert Taillades, Xavier Garric, Vincent Letouzey, Stephanie Huberlant To cite this version: Lucie Allègre, Isabelle Le Teuff, Salomé Leprince, Sophie Warembourg, Hubert Taillades, et al.. Anew bioabsorbable polymer film to prevent peritoneal adhesions validated in a post-surgical animal model. PLoS ONE, Public Library of Science, 2018, 13 (11), pp.e0202285. 10.1371/journal.pone.0202285. hal-02359782 HAL Id: hal-02359782 https://hal.archives-ouvertes.fr/hal-02359782 Submitted on 25 Feb 2020 HAL is a multi-disciplinary open access L’archive ouverte pluridisciplinaire HAL, est archive for the deposit and dissemination of sci- destinée au dépôt et à la diffusion de documents entific research documents, whether they are pub- scientifiques de niveau recherche, publiés ou non, lished or not. The documents may come from émanant des établissements d’enseignement et de teaching and research institutions in France or recherche français ou étrangers, des laboratoires abroad, or from public or private research centers. publics ou privés. RESEARCH ARTICLE A new bioabsorbable polymer film to prevent peritoneal adhesions validated in a post- surgical animal model Lucie Allègre1,2*, Isabelle Le Teuff1,2, Salome Leprince2, Sophie Warembourg1,2, Hubert Taillades3, Xavier Garric2, Vincent Letouzey1,2, Stephanie Huberlant1,2 1 Department of gynecology and obstetrics, University Hospital of NõÃmes, NõÃmes, France, 2 Department of Artificial Polymers, Max Mousseron Institute of Biomolecules, CNRS UMR 5247, University of Montpellier 1, Montpellier, France, 3 Surgical and Experimental Department, University of Montpellier, Montpellier, France a1111111111 * [email protected] a1111111111 a1111111111 a1111111111 Abstract a1111111111 Background Peritoneal adhesions are a serious surgical postoperative complication.
    [Show full text]
  • Sepra/Film® Rx Only ADHESION BARRIER CHEMICALLY
    sepra/film® Rx Only A summary of all serious adverse events occurring in the pivotal premarket trials (Tables ADHESION BARRIER 1 and 2) and the postmarket study (Tables 3 and 4) are provided in the tables below. CHEMICALLY MODIFIED SODIUM HYALURONATE/CARBOXYMETHYLCELLULOSE Summary of Serious Adverse Events in Clinical Trials ABSORBABLE ADHESION BARRIER SEPRAFILM® ADHESION BARRIER Table 1: Colectomy/Ileal Pouch Anal Anastomosis Patients DESCRIPTION Seprafilm® Adhesion Barrier (membrane) is a sterile, bioresorbable, translucent adhesion Percentage of Percentage of Control barrier composed of two anionic polysaccharides, sodium hyaluronate (HA) and Seprafilm Membrane Patients with Event carboxymethylcellulose (CMC). Together, these biopolymers have been chemically Event Description Patients with Event modified with the activating agent 1-(3-dimethylaminopropyl) -3- ethyl- carbodiimide Number of Colectomy/Ileal hydrochloride (EDC). Seprafilm should be stored between 36°F–86°F (2°C–30°C) until the Pouch Anal Anastomosis N=91 N=92 package expiration date. Patients INDICATIONS Seprafilm Adhesion Barrier is indicated for use in patients undergoing abdominal or pelvic Small bowel obstruction 9% 10% laparotomy as an adjunct intended to reduce the incidence, extent, and severity of Abscess 8% 2% postoperative adhesions between the abdominal wall and the underlying viscera such as omentum, small bowel, bladder, and stomach, and between the uterus and surrounding Generalized Signs and Symptoms structures such as tubes and ovaries, large bowel, and bladder. CONTRAINDICATIONS Nausea/Vomiting/Diarrhea 4% 5% Seprafilm Adhesion Barrier is contraindicated in patients with a history of hypersensitivity Pulmonary embolus 4% 0% to Seprafilm and/or to any component of Seprafilm. Seprafilm Adhesion Barrier is contraindicated for use wrapped directly around a fresh Deep vein thrombosis 2% 1% anastomotic suture or staple line as such use increases the risk of anastomotic leak and Ileus 2% 1% related events (fistula, abscess, leak, sepsis, peritonitis).
    [Show full text]
  • Role of Hyaluronic Acid Barrier Gel in Adhesion Prevention
    ORIGINAL ARTICLE Role of Hyaluronic Acid Barrier Gel in Adhesion Prevention AYESHA SAIF, NABEELA SHAMI, SHAILA ANWAR, SHAHEENA ASIF Department of Obstetrics & Gynaecology, Lahore Medical & Dental College/GTTH, Lahore Correspondence to Dr. Ayesha Saif, Assistant Professor Email: [email protected] Cell: 0320-1770077 ABSTRACT Background: Adhesions after abdominal and pelvic surgery lead to increased morbidity and make the subsequent surgery difficult. Such adhesions can impair the quality of life of patients and surgical treatment is often required which is difficult, hence, adhesion prevention remains the key. To reduce the risk of adhesion formation, meticulous surgical technique is of prime importance. Historically, various agents like antibiotics, steroids, anti-inflammatory agents and barrier agents have been used without conclusive evidence. Recently, an anti-adhesion gel barrier, hyaluronic acid gel, has been introduced. Hyaluronic acid is a natural lubricant in our joints, which can contribute to adhesion prevention by mechanical separation of peritoneal surfaces. Aim: To evaluate the effectiveness of hyaluronic acid gel in adhesion prevention and its side effects. Methods: A multi-center prospective observational study was conducted at Ghurki Trust Teaching Hospital and Surgimed Hospital from April, 2016 to March, 2018. We selected 200 patients who presented in our hospitals by non-probability consecutive sampling technique. The patients were operated for different indications including lower segment cesarean section, total abdominal hysterectomy, ovarian cancer surgery, myomectomy, ovarian cystectomy, and laparotomy for ectopic pregnancy. Patients were informed about the benefits of hyaluronic acid gel prior to the surgery and informed consent was taken. Hyaluronic acid barrier gel was instilled at the incision line before the abdomen was closed.
    [Show full text]
  • Towards Development of Affinity Polymer-Based Adhesion
    TOWARDS DEVELOPMENT OF AFFINITY POLYMER-BASED ADHESION BARRIERS FOR SURGICAL MESH DEVICES by GREG DANIEL LEARN Submitted in partial fulfillment of the requirements for the degree of Doctor of Philosophy Dissertation Advisor: Horst A. von Recum, PhD Department of Biomedical Engineering CASE WESTERN RESERVE UNIVERSITY May 2021 CASE WESTERN RESERVE UNIVERSITY SCHOOL OF GRADUATE STUDIES We hereby approve the thesis/dissertation of Greg Daniel Learn Candidate for the degree of Doctor of Philosophy *. Committee Chair: Jeffrey Capadona, Ph.D. Committee Member: Horst von Recum, Ph.D. Committee Member: Kathleen Derwin, Ph.D. Committee Member: Guang Zhou, Ph.D. Committee Member: Michael Rosen, M.D. Date of Defense: Monday 14 December 2020 *We also certify that written approval has been obtained for any proprietary material contained therein. 2 This dissertation is dedicated to the memory of Jim Simpson. Though not able to see this, as a scientist, engineer, runner, and family friend I looked up to from a young age, he furthered my inspiration and resolve to pursue and complete my degree. Thank you, Jim. 3 TABLE OF CONTENTS TABLE OF CONTENTS .................................................................................................... 4 LIST OF TABLES ............................................................................................................ 12 LIST OF FIGURES .......................................................................................................... 13 PREFACE ........................................................................................................................
    [Show full text]