Anti-Adhesive Effect of GUARDIX-SL® after Intact Canal Wall Mastoidectomy: Preliminary Study

다국어 초록 (Multilingual Abstract)

Background and Objectives: Adhesion of middle ear and mastoid cavity after mastoidectomy represents a potential source of surgical failure. GUARDIX-SL®, absorbable anti-adhesive material, which is composed of sodium hyaluronate and sodium carboxymethyl cellulose, is an effective agent that widely used as a surgical adjuvant to decrease adhesion in the surgery. Therefore, we evaluated the clinical efficacy of the GUARDIX-SL® for the prevention of adhesion after mastoidectomy.


Subjects and Methods: This study was randomized and double-blinded. Conventional intact canal wall mastoidectomy was conducted in both control (n=14) and study group (n=10). To avoid bias because of different surgeons, we only included patients who were operated on by one surgeon. In the study group, 1.5 g GUARDIX-SL® was applied in the mastoid cavity at the end of mastoidectomy. To evaluate anti-adhesive effect of GUARDIX-SL®, the volume of aerated area in the mastoid cavity was calculated and compared with temporal bone computed tomography performed at preoperatively and postoperatively. Besides, to assess the success of operation, pure tone audiometry was also performed at preoperatively and postoperatively.


Results: The volume of aerated area of mastoid cavity after mastoidectomy was more increased in GUARDIX-SL® group, but was not statistically significant in the GUARDIX-SL® group than the control. And all results of pure tone audiometry satisfied the criteria of successful operation which has been suggested by Otological Society of Korea.


Conclusion: The results suggest that GUARDIX-SL® may be an efficacious and safe material in decreasing the incidence of adhesion after mastoidectomy.

참고문헌 (Reference)

1 변성완, "이과학을 중심으로 본 3차원 컴퓨터 그래픽스의 이용" 대한이비인후과학회 52 (52): 104-112, 2009

2 심희수, "백서에서 수술 후 복부 유착방지용 재료들의 효능평가" 대한외과학회 63 (63): 179-186, 2002

3 심희수, "백서에서 수술 후 복부 유착방지용 재료들의 효능평가" 대한외과학회 63 (63): 179-186, 2002

4 김형종, "만성중이염 수술의 분류와 결과보고의 표준지침" 대한이비인후과학회 49 (49): 2-6, 2006

5 Ahn JY, "Tympanometry and CT Measurement of Middle Ear Volumes in Patients with Unilateral Chronic Otitis Media" 1 : 139-142, 2008

6 Iwano T, "Transmucosal pressure regulation in the middle ear cavity" 86 : 1265-1272, 1993

7 Holmquist J., "The role of the eustachian tube in myringoplasty" 66 : 289-295, 1968

8 Adas G, "The effect of hyaluronic acid carboxymethyl cellulose on the healing of colonic anastomosis in rats" 110 : 210-214, 2009

9 MacKinnon DM, "Relationship of pre-operative eustachian tube function to myringoplasty" 69 : 100-106, 1970

10 Hergils L, "Regulation of negative middle ear pressure without tubal opening" 114 : 1442-1444, 1988

11 Sanna M, "Prevention of recurrent cholesteatoma in closed tympanoplasty" 96 : 273-275, 1987

12 Leitao MM Jr, "Postoperative intra-abdominal collections using a sodium hyaluronate-carboxymethylcellulose (HA-CMC) barrier at the time of laparotomy for uterine or cervical cancers" 119 : 208-211, 2010

13 Paparella MM, "Mastoidectomy and tympanoplasty, In Otolaryngology" W.B Saunders company 1405-1439, 1991

14 Todd NW, "Mastoid size determined with lateral radiographs and computerized tomography" 103 : 226-231, 1987

15 Tanabe M, "Factors affecting recovery of mastoid aeration after ear surgery" 256 : 220-223, 1999

16 Koç A, "Evaluation of the mastoid air cell system by high resolution computed tomography: three-dimensional multiplanar volume rendering technique" 117 : 595-598, 2003

17 Minoda R, "Efficacy of mastoid cortex plasty for middle ear aeration in intact canal wall tympanoplasty for cholesteatoma" 23 : 425-430, 2002

18 Kazama K, "Effect of a large-sized silicone sheet upon recovery of mastoid aeration after mastoidectomy" 138 : 738-742, 2008

19 Kim JH, "Antiadhesive effect of the mixed solution of sodium hyaluronate and sodium carboxymethylcellulose after endoscopic sinus surgery" 21 : 95-99, 2007

20 Park WS, "Anti-adhesive effect and safety of sodium hyaluronate and sodium carboxymethyl cellulose solution in thyroid surgery" 33 : 25-30, 2010

21 Robertson D, "Adhesion prevention in gynaecological surgery" 32 : 598-608, 2010

22 Kawamura H, "A sodium hyaluronate carboxymethylcellulose bioresorbable membrane prevents postoperative small-bowel adhesive obstruction after distal gastrectomy" 40 : 223-227, 2010