J Korean Surg Soc.  2013 Jun;84(6):321-329. 10.4174/jkss.2013.84.6.321.

Antiadhesive effect and safety of oxidized regenerated cellulose after thyroidectomy: a prospective, randomized controlled study

• Park KS
• Lee KE
• Ku DH
• Kim SJ
• Park WS
• Kim HY
• Kwon MR
• Youn YK

• KMID: 1505181
• DOI: http://doi.org/10.4174/jkss.2013.84.6.321

Abstract

PURPOSE
To evaluate the antiadhesive effects and safety of an oxidized regenerated cellulose (Interceed) after thyroidectomy.
METHODS
Seventy-six thyroidectomized patients were prospectively randomized into two groups with regard to the use of Interceed. We evaluated each group for their adhesive symptoms using four subjective and four objective items at the 2nd week, 3rd and 6th month after thyroidectomy. All patients were examined for vocal cord motility by indirect laryngoscope at each period.
RESULTS
Total adhesion scores at each postoperative follow-up period decreased with time, but were not significantly different in each group. The median score for swallowing discomfort for liquid was significantly lower in the Interceed group than in the control group 2 weeks after surgery. In addition, the severity of skin adhesion to the trachea was reduced in the Interceed group compared with the control group 6 months after surgery. During the study, there were no adverse effects or significant differences in postoperative complications between the groups.
CONCLUSION
Interceed appeared to be safe and effective in improving neck discomfort at early postoperative periods and preventing skin adhesion to the trachea 6 months after thyroidectomy.

Keyword

Adhesion; Neck discomfort; Oxidized regenerated cellulose; Thyroidectomy

MeSH Terms

Adhesives
Cellulose
Cellulose, Oxidized
Deglutition
Follow-Up Studies
Humans
Laryngoscopes
Neck
Postoperative Complications
Postoperative Period
Prospective Studies
Skin
Thyroidectomy
Trachea
Vocal Cords
Adhesives
Cellulose
Cellulose, Oxidized

Figure

• 

  Fig. 1 Flowchart of trial design. a)Both patients and investigator did not know the use of Interceed. b)Due to regional problem: so far to follow-up.

• 

  Fig. 2 Application of Interceed. After considering hemostasis, Interceed was applied to cover the trachea (A) and strap muscle (B) to prevent adhesion between overlying subcutaneous fat and the strap muscle fascia.

• 

  Fig. 3 Skin changes on the cervical area after thyroid surgery. Physicians primarily observed the symmetry and natural aspects of wrinkles and skin changes, such as inflammatory reaction and scar formation in the surgical wound of the neck. For example, since the relative width of skin to show inflammatory reaction such as redness or swelling was about 50%, we scored the patient a "5" in the visual analog scale scoring system (A). During swallowing, a patient showed skin adhesion to the trachea covering about 50% of dissected area 2 weeks after thyroidectomy (B). Since the relative width of skin adherent to the trachea was about 50%, we scored the patient a "5" in the visual analog scale scoring system.

• 

  Fig. 4 Comparison of total adhesion scores. The scores significantly decreased with time in both Interceed and control groups (P < 0.001) (A), but there were no significant different between the groups. Comparison of the total adhesion scores according whether modified radical neck dissection (MRND) was performed (B). There were no significant differences in total adhesion scores with regard to MRND at any time after surgery.

• 

  Fig. 5 Box plots of scores for swallowing difficulty and skin adhesion to the trachea. The swallowing discomfort scores for liquids were significantly lower in the Interceed group than in the control group 2 weeks after surgery (A) (P = 0.047). Fig. 5A showed the difference in median value and interquartile range (IQR): control group (median, 2; IQR, 1 to 4) vs. Interceed group (median, 1; IQR, 0 to 2). Comparison of the scores for skin adhesion to the trachea on swallowing (B). The scores for severity of adhesion to the trachea were reduced in the Interceed group compared with the control group 6 months after surgery (P = 0.02). Fig. 5B showed the difference in IQR, but not in median value; control group (median, 2; IQR, 1 to 2) vs. Interceed group (median, 2; IQR, 1 to 3).

Reference

1. Sipos JA, Mazzaferri EL. Thyroid cancer epidemiology and prognostic variables. Clin Oncol (R Coll Radiol). 2010. 22:395–404.

2. Jung KW, Park S, Kong HJ, Won YJ, Lee JY, Park EC, et al. Cancer statistics in Korea: incidence, mortality, survival, and prevalence in 2008. Cancer Res Treat. 2011. 43:1–11.

3. Jemal A, Siegel R, Ward E, Murray T, Xu J, Thun MJ. Cancer statistics, 2007. CA Cancer J Clin. 2007. 57:43–66.

4. Won YJ, Sung J, Jung KW, Kong HJ, Park S, Shin HR, et al. Nationwide cancer incidence in Korea, 2003-2005. Cancer Res Treat. 2009. 41:122–131.

5. Lombardi CP, D'Alatri L, Marchese MR, Maccora D, Monaco ML, De Crea C, et al. Prospective electromyographic evaluation of functional postthyroidectomy voice and swallowing symptoms. World J Surg. 2012. 36:1354–1360.

6. Safioleas M, Stamatakos M, Rompoti N, Mouzopoulos G, Iannescu R, Salichou V, et al. Complications of thyroid surgery. Chirurgia (Bucur). 2006. 101:571–581.

7. Scerrino G, Inviati A, Di Giovanni S, Paladino NC, Di Paola V, Lo Re G, et al. Esophageal motility changes after thyroidectomy; possible associations with postoperative voice and swallowing disorders: preliminary results. Otolaryngol Head Neck Surg. 2013. 03. 22. [Epub]. http://dx.doi.org/10.1177/0194599813482299.

8. Silva IC, Netto Ide P, Vartanian JG, Kowalski LP, Carrarade Angelis E. Prevalence of upper aerodigestive symptoms in patients who underwent thyroidectomy with and without the use of intraoperative laryngeal nerve monitoring. Thyroid. 2012. 22:814–819.

9. Park JH, Jeong JJ, Kang SW, Nam KH, Chang HS, Chung WY, et al. The efficacy and safety of guardix-sg in patients who are undergoing thyroid surgery: a randomized, prospective, double-blinded study. Korean J Endocr Surg. 2009. 9:127–132.

10. Park WS, Chung YS, Lee KE, Kim HY, Choe JH, Koh SH, et al. Anti-adhesive effect and safety of sodium hyaluronate and sodium carboxymethyl cellulose solution in thyroid surgery. Asian J Surg. 2010. 33:25–30.

11. Yigit O, Uslu Coskun B, Coskun H, Yilmaz B, Alkan S, Cinar U, et al. Efficacy of anti-adhesive barriers in secondary thyroidectomy: an experimental study. Laryngoscope. 2004. 114:1668–1673.

12. Yilmaz O, Genc A, Taneli F, Demireli P, Deliaga H, Taneli C. Assessment of the efficacy of absorbable adhesion barriers on dissection in esophagus operations. Int J Pediatr Otorhinolaryngol. 2007. 71:409–414.

13. Ahmad G, Duffy JM, Farquhar C, Vail A, Vandekerckhove P, Watson A, et al. Barrier agents for adhesion prevention after gynaecological surgery. Cochrane Database Syst Rev. 2008. (2):CD000475.

14. Alpay Z, Saed GM, Diamond MP. Female infertility and free radicals: potential role in adhesions and endometriosis. J Soc Gynecol Investig. 2006. 13:390–398.

15. Brehant O, Pessaux P, Regenet N, Tuech JJ, Panaro F, Mantion G, et al. Healing of stoma orifices: multicenter, prospective, randomized study comparing calcium alginate mesh and polyvidone iodine mesh. World J Surg. 2009. 33:1795–1801.

16. Darmas B. Use of barrier products in the prevention of adhesion formation following surgery. J Wound Care. 2008. 17:405–408. 411

17. Gonzalez-Quintero VH, Cruz-Pachano FE. Preventing adhesions in obstetric and gynecologic surgical procedures. Rev Obstet Gynecol. 2009. 2:38–45.

18. Rosato L, Carlevato MT, De Toma G, Avenia N. Recurrent laryngeal nerve damage and phonetic modifications after total thyroidectomy: surgical malpractice only or predictable sequence? World J Surg. 2005. 29:780–784.

19. Kamer E, Unalp H, Derici H, Akguner T, Erbil Y, Issever H, et al. Flapless conventional thyroidectomy: a prospective, randomized study. Surg Today. 2010. 40:1018–1022.

20. Tae K, Kim KY, Yun BR, Ji YB, Park CW, Kim DS, et al. Functional voice and swallowing outcomes after robotic thyroidectomy by a gasless unilateral axillo-breast approach: comparison with open thyroidectomy. Surg Endosc. 2012. 26:1871–1877.

21. Takamura Y, Miyauchi A, Tomoda C, Uruno T, Ito Y, Miya A, et al. Stretching exercises to reduce symptoms of postoperative neck discomfort after thyroid surgery: prospective randomized study. World J Surg. 2005. 29:775–779.

22. Magill CK, Tuffaha SH, Yee A, Luciano JP, Hunter DA, Mackinnon SE, et al. The short- and long-term effects of Seprafilm on peripheral nerves: a histological and functional study. J Reconstr Microsurg. 2009. 25:345–354.