Skip to main content
Log in

Evaluation of SprayShield™ Adhesion Barrier in a single center: randomized controlled study in 15 women undergoing reconstructive surgery after laparoscopic myomectomy

  • General Gynecology
  • Published:
Archives of Gynecology and Obstetrics Aims and scope Submit manuscript

Abstract

Objective

The objective of this study was to evaluate the safety and efficacy of SprayShield™ Adhesion Barrier in preventing and/or reducing postoperative adhesion during gynecological surgery.

Design

This was a prospective, controlled, blinded, and randomized study. Patient blinding was performed intraoperatively. Subjects were randomly assigned to the SprayShield™ or the control group in a 2:1 ratio.

Setting

The study was conducted at the Clinic of Gynaecology and Obstetrics, at the University Hospital for Gynecology in Germany.

Patients

Fifteen patients participated in this study; nine patients were assigned to the SprayShield™ and six patients to the control group.

Interventions

During first operation (FLL) in the SprayShield™ group, the agent was applied to all myomectomy suture lines. Patients in the control group did not receive any anti-adhesion treatment, only good surgical practice. A second-look laparoscopy (SLL) was performed 8–12 weeks after myomectomy to evaluate adhesion formation.

Main outcome measures

Main outcome measures were incidence, severity, and extent of uterine adhesions.

Results

No significant differences were found between the two study groups.

Conclusions

SprayShield™ is easy to use. No serious adverse event related to SprayShield™ was observed. Efficacy data are inconclusive regarding the performance of SprayShield™. Further studies are needed to better understand this performance.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Subscribe and save

Springer+ Basic
EUR 32.99 /Month
  • Get 10 units per month
  • Download Article/Chapter or Ebook
  • 1 Unit = 1 Article or 1 Chapter
  • Cancel anytime
Subscribe now

Buy Now

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Fig. 1
Fig. 2

Similar content being viewed by others

References

  1. Practice committee of the American society for reproductive medicine in collaboration with the society of reproductive surgeons (2006) Pathogenesis, consequences, and control of peritoneal adhesions in gynecologic surgery. Fertil Steril 86(Suppl 4):S1–S5

    Google Scholar 

  2. Wilson MS, Menzies D, Knight A, Crowe AM (2002) Demonstrating the clinical and cost-effectiveness of adhesion reduction strategies. Colorectol Dis 4:355–360

    Article  Google Scholar 

  3. De Wilde RL, Trew G (2007) Postoperative abdominal adhesions and their prevention in gynecological surgery. Gynecol Surg 4:161–168

    Article  Google Scholar 

  4. Mais V, Cirronis MG, Peiretti M, Ferrucci G, Cossu E, Melis GB (2012) Efficacy of auto-crosslinked hyaluronan gel for adhesion prevention in laparoscopy and hysteroscopy: a systematic review and meta-analysis of randomized controlled trials. Eur J Obstet Gynaecol Reprod Biol 160(1):1–5

    Article  CAS  Google Scholar 

  5. Brochhausen C, Schmitt VH, Planck CNE, Rajab TK, Hollemann D, Tapprich C, Krämer B, Wallwiener C, Hierlemann H, Zehbe R, Planck H, Kirkpatrick CJ (2012) Current strategies and future perspectives for intraperitoneal adhesion prevention. J Gastrointest Surg 16(6):1256–1274

    Article  PubMed  Google Scholar 

  6. Ferland R, Campbell PK (2009) Pre-clinical evaluation of a next-generation spray adhesion barrier for multiple site adhesion protection. Surg Technol Int 18:137–143

    PubMed  Google Scholar 

  7. Trew G, Pistofidis G, Pados G, Lower A, Mettler L, Wallwiener D, Korell M, Pouly JL, Coccia ME, Audebert A, Nappi C, Schmidt E, McVeigh E, Landi S, Degueldre M, Konincxk P, Rimbach S, Chapron C, Dallay D, Röemer T, McConnachie A, Ford I, Crowe A, Knight A, Dizerega G, Dewilde R (2011) Gynaecological endoscopic evaluation of 4% icodextrin solution: a European, multicentre, double-blind, randomized study of the efficacy and safety in the reduction of de novo adhesions after laparoscopic gynaecological surgery. Hum Reprod 26(8):2015–2027

    Article  CAS  PubMed  Google Scholar 

  8. De Wilde RL, Trew G (2007) Postoperative abdominal adhesions and their prevention in gynaecological surgery: expert consensus position. Part 1 & 2—steps to reduce adhesions. Gynecol Surg. Gynecol Surg 4:243–253

    Article  Google Scholar 

  9. Ellis H (1971) The cause and prevention of postoperative intraperitoneal adhesions. Surg Gynecol Obstet 133(3):497–511

    CAS  PubMed  Google Scholar 

  10. ten Broek RPG, Issa Y, van Santbrink EJP, Bouvy ND, Kruitwagen RFPM, Jeekel J, Bakkum EA, Rovers MM, van Goor H (2013) Burden of adhesions in abdominal and pelvic surgery: systematic review and met-analysis. BMJ 347:f5588. doi:10.1136/bmj.f5588

    Article  PubMed Central  PubMed  Google Scholar 

  11. Okabayashi K, Ashrafian H, Zacharakis E, Hasegawa H, Kitagawa Y, Athanasiou T, Darzi A (2013) Adhesions after abdominal surgery: a systematic review of the incidence, distribution and severity. Surg Today. [Epub ahead of print]

  12. Lower AM, Hawthorn RJ, Clark D, Boyd JH, Finlayson AR, Knight AD, Crowe AM, Surgical and Clinical Research Group (2004) Adhesion-related readmissions following gynecological laparoscopy or laparotomy in Scotland: an epidemiological study of 24,046 patients. Hum Reprod 19(8):1877–1885

    Article  CAS  PubMed  Google Scholar 

  13. Ellis H, Moran BJ, Thompson JN, Parker MC, Wilson MS, Menzies D, McGuire A, Lower AM, Hawthorn RJ, O’Brien F, Buchan S, Crowe AM (1999) Adhesion related hospital readmissions after abdominal pelvic surgery: a retrospective cohort study. Lancet 353:1476–1480

    Article  CAS  PubMed  Google Scholar 

  14. Jin C, Hu Y, Chen XC, Zheng FY, Lin F, Zhou K, Chen FD, Gu HZ (2009) Laparoscopic versus open mymectomy: a meta-analysis of randomized controlled trials. Eur J Obstet Gynecol Reprod Biol 145(1):14–21

    Article  PubMed  Google Scholar 

  15. Kasum M (2009) Fertility following myomectomy. Acta Clin Croat 48:137–143

    PubMed  Google Scholar 

  16. Wallwiener M, Brölmann H, Koninckx PR, Lundorff P, Lower AM, Wattiez A, Mara M, De Wilde RL (2012) Adhesions after abdominal, pelvic and intra-uterine surgery, and their prevention. Gynecol Surg 9:465–466

    Article  PubMed Central  PubMed  Google Scholar 

  17. Takeuchi H, Kinoshita K (2002) Evaluation of adhesion formation after laparoscopic myomectomy by systematic second-look microlaparoscopy. J Am Assoc Gynecol Laparosc 9(4):442–446

    Article  PubMed  Google Scholar 

  18. Takeuchi H, Kitade M, Kikuchi I, Shimanuki H, Kumakiri J, Kinoshita K (2005) Adhesion-prevention effects of fibrin sealants after laparoscopic myomectomy as determined by second-look laparoscopy. J Reprod Med 50(8):571–577

    CAS  PubMed  Google Scholar 

  19. Hirschelmann A, Tchartchian G, Wallwiener M, Hackethal A, De Wilde RL (2012) A review of the problematic adhesion prophylaxis in gynaecological surgery. Arch Gynecol Obstet 285:1089–1097

    Article  PubMed Central  PubMed  Google Scholar 

  20. Buletti C, Polli V, Negrini V (1996) Adhesion formation after laparoscopic myomectomy. J Am Assoc Gynecol Laparosc 3:533–536

    Article  Google Scholar 

  21. Myomectomy Adhesion Multicenter Study Group (1995) An expanded polytetrafluoroethylene barrier (gore-tex surgical membrane) reduces post-myomectomy adhesion formation. Fertil Steril 63:491–493

    Google Scholar 

  22. Tulandi T, Murray C, Guralnick M (1993) Adhesion formation and reproductive outcome after myomectomy and second look laparoscopy. Obstet Gynecol 82:213–215

    CAS  PubMed  Google Scholar 

  23. Dubuisson J-B, Fauconnier A, Chapron C, Kreiker G, Nörgaard C (1998) Second look after laparoscopic myomectomy. Hum Reprod 13(8):2102–2106

    Article  CAS  PubMed  Google Scholar 

  24. Di Gregorio A, Maccario S, Raspollini M (2002) The role of laparoscopic myomectomy in women of reproductive age. Reprod Biomed Online 4(Suppl 3):55–58

    Article  PubMed  Google Scholar 

  25. Wiseman DM, Trout JR, Diamond MP (1998) The rates of adhesion development and the effects of crystalloid solutions on adhesion development in pelvic surgery. Fertil Steril 70(4):702–711

    Article  CAS  PubMed  Google Scholar 

  26. Di Zerega GS, Verco SJ, Young P, Kettel M, Kobak W, Martin D, Sanfilippo J, Peers EM, Scrimgeour A, Brown CB (2002) A randomized, controlled pilot study of the safety and efficiacy of 4% Icodextrin solution in the reduction of adhesions following laparoscopic gynaecological surgery. Hum Reprod 17(4):1031–1038

    Article  Google Scholar 

  27. Mettler L, Audebert A, Lehmann-Willenbrock E, Schive-Peterhansl K, Jacobs VR (2004) A randomized, prospective, controlled, multicenter clinical trial of a sprayable, site-specific adhesion barrier system in patients undergoing myomectomy. Fertil Steril 82(2):398–404

    Article  PubMed  Google Scholar 

Download references

Acknowledgments

This study was sponsored by Covidien.

Conflict of interest

None.

Author information

Authors and Affiliations

Authors

Corresponding author

Correspondence to Rudy Leon De Wilde.

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Tchartchian, G., Hackethal, A., Herrmann, A. et al. Evaluation of SprayShield™ Adhesion Barrier in a single center: randomized controlled study in 15 women undergoing reconstructive surgery after laparoscopic myomectomy. Arch Gynecol Obstet 290, 697–704 (2014). https://doi.org/10.1007/s00404-014-3251-3

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s00404-014-3251-3

Keywords

Navigation