The Laryngoscope C 2014 The American Laryngological, V

Rhinological and Otological Society, Inc.

Turbinate-Septal Suture for Middle Turbinate Medialization: A Prospective Randomized Trial Weihu Chen, MD; Yonggan Wang, MS; Yonghua Bi, MD; Wenwen Chen, MS Objectives/Hypothesis: One of the primary goals of endoscopic sinus surgery (ESS) is to create widely patent paranasal sinus ostia, but lateralization of the middle turbinate (MT) after ESS can obstruct otherwise patent ethmoid and maxillary sinuses. The aim of this study was to evaluate the effectiveness of turbinate-septal suturing in preventing lateralization of the MT. Study Design: A prospective, randomized, blinded controlled study. Methods: The study was performed in 120 patients who had undergone ESS. The patients were randomized to receive nasal (group A) or turbinate-septal suture plus nasal packing (group B). Postoperative lateralization of the MT and synechia formation were assessed as the primary outcome 3 months post-ESS. The Lund-Kennedy Scores at 1 week, 2 week, and 1 month after ESS were assessed as the secondary outcomes. Results: A total of 120 patients were enrolled (60 patients in each group). Group B had a significantly lower rate of MT lateralization compared to group A after 3 months of surgery (6 of 120 sides vs. 19 of 120 sides; P < 0.01). Synechia formation rates in groups B were also significantly lower than those in group A (4 of 120 sides vs. 13 of 120 sides; P 5 0.023). Conclusion: Middle turbinate-septal suturing medialization during ESS is an effective method for preventing lateralization of the MT. Key Words: Endoscopic sinus surgery, middle turbinate, lateralization, suture. Level of Evidence: 1b. Laryngoscope, 00:000–000, 2014

INTRODUCTION The goal of endoscopic sinus surgery (ESS) is to enlarge the sinus ostia to allow for adequate sinus aeration. An open and patent sinus cavity allows for the improved delivery of topical medical therapies to reduce mucosal inflammation. Of the various complications, one of the most common resulting from ESS is lateralization of the middle turbinate (MT), with the formation of synechia to the lateral nasal wall. This complication has been reported in 1% to 27% of patients.1–4 However, despite the surgeon’s best intentions, it is not unusual for the mucosal surface of the MT to become traumatized during the course of ESS. Furthermore, resection of the horizontal portion of the basal lamella can result in an unstable MT. In combination, these factors predispose the MT to lateralization with or without synechiae formation. This scar tissue formation and synechiae formation can lead to outflow tract obstruction from the ethmoid cavity and ultimately will require additional surgery.

From the Department of Otorhinolaryngology–Head and Neck Surgery, Tongling People’s Hospital, Tongling, Anhui, People’s Republic of China Editor’s Note: This Manuscript was accepted for publication June 13, 2014. The authors have no funding, financial relationships, or conflicts of interest to disclose. Send correspondence to Weihu Chen, MD, Department of Otorhinolaryngology–Head and Neck Surgery, Tongling People’s Hospital, Anhui 244000, People’s Republic of China. E-mail: [email protected] DOI: 10.1002/lary.24820

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Various techniques are described to prevent MT lateralization following ESS. The primary technique for medializing the MT is the placement of nasal packing in the middle meatus. Postoperative nasal packing prevents adhesions, improves wound healing, and controls postoperative bleeding.5–7 For patients, however, removable nasal packing is very uncomfortable and creates local pain and pressure. Due to their fine hemostatic properties and ability to improve patient comfort, some biodegradable and absorbable materials are now routinely used after ESS.8,9 Other techniques include prophylactic partial turbinate resection,10 “controlled” synechiae formation,11,12 and middle turbinate-septum clipping.13 However, most experts would not advocate for unnecessary resection or further trauma to an already fragile anatomic structure. Turbinate-septal suturing techniques have been evaluated and are of use.14–16 The techniques are simple to implement and effective at preventing MT lateralization. However, the methods have not been assessed in detailed studies. Therefore, we conducted a prospective, randomized, blinded controlled trial to examine whether the turbinate-septal suture can be used to improve the MT medialization. Postoperative lateralization of the MT and the synechia formation as the primary outcomes were assessed.

MATERIALS AND METHODS Subjects This study was designed to be a prospective, randomized, blinded controlled trial with a total of 120 patients who

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TABLE I. Patients’ Demographic Data.

Age (years) Sex Male Female Endoscopic score CT score

TABLE III. Postoperative Endoscopic Findings (3 months after the ESS).

Group A (n 5 60)

Group B (n 5 60)

P Value

43.5 6 l2.4

42.8 6 13.2

0.885

38

35

22

25

11.2 6 2.35 14.9 6 6.6

10.8 6 3.2 15.3 6 6.9

0.574* 0.386 0.478

had undergone ESS from September 2011 to September 2012. The institutional review board approved this study before patient enrollment. Each patient signed an approved consent form before each operation to participate in the study. Patients included in the study were 18 years or older and had failed medical therapy and undergone elective primary ESS for chronic rhinosinusitis (CRS). The diagnosis of CRS was defined as a symptomatic inflammation of the sinuses for at least 3 months. The diagnosis, presence of bilateral sinusitis, and candidacy for ESS were confirmed by CT scan examination. Prior to surgery, sinus cavities were graded blindly according to the Lund-Kennedy staging system17 based on endoscopic appearance and preoperative CT scan findings. Exclusion criteria included patients who should have a simultaneous performed inferior turbinate surgery, septoplasty, and other nasal surgery. Additional exclusion criteria were a history of previous ESS, allergies, asthma, and aspirin intolerance; the presence of systemic diseases, bleeding disorders, or anticoagulant therapy; pregnancy; and the presence of a severe medical or neuropsychiatric disorder.

Surgical Procedure and Intervention Randomization was performed before the initiation of treatment and by means of a coin toss. Patients were randomized to receive absorbable nasal packing following ESS (group A), or to receive absorbable nasal packing and turbinate-septal suturing (group B). For patients in group A, the biodegradable absorbable nasal-packing material, Nasopore (Polyganics; Rozenburglaan, Groningen, the Netherlands), was packed in both ethmoid cavities after completion of ESS. For patients in group B, transseptal suturing was performed after ESS. A 4-0 polyglactin suture was passed from the lateral aspect of one MT medially, traversing the nasal septum and the MT of the contralateral side, and then traversed the MT, the nasal septum and the first MT. The suture was then tied extracorporeally and passed endoscopically into the nose and tightened with a needle driver. Next, both side ethmoid cavities were packed with Nasopore (Polyganics). The postoperative regimens for the patients were identical, including 2 weeks oral antibiotic therapy and the adminisTABLE II. Lund-Kennedy Scores Between Group A and Group B. Group A (n 5 60)

Group B (n 5 60)

P Value

7

2.6 6 1.3

2.6 6 1.2

0.632

14

2.9 6 1.1

2.8 6 1.6

0.557

30

2.8 6 1.1

2.8 6 1.3

0.803

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Group B (120 nasal cavities)

P Value*

Synechia

13

4

0.023

Middle turbinate lateralization

19

6

0.006

*Chi square test.

tration of a topical nasal steroid. Nasopore (Polyganics) was left in place until it was suctioned out during the patient’s follow-up visit 7 days after ESS.

*Chi square test.

Postoperative Day

Group A (120 nasal cavities)

Postoperative Outcomes and Measures To evaluate effectiveness of the medialization maneuver, patients underwent endoscopic examination of the nasal cavity for a baseline comparison before surgery. Assessments of postoperative lateralization of the MT and synechia formation at 3 months after ESS were conducted as the primary outcome. The Lund-Kennedy Scores at 1 week, 2 week, and 1 month after ESS were assessed as the secondary outcomes. At each postoperative visit, patients were assessed for MT positioning, synechia formation, and recurrence of sinusitis.

Sample Size The power and sample size were calculated based on the outcomes of sinonasal cavities using a comparison of postoperative 3-month Lund-Kennedy endoscopy scores. The sensitivity analysis and power calculation illustrated that a sample size of at least 48 patients (96 cavities) would provide the ability to detect significant differences in the means of Lund-Kennedy endoscopy scores between the Nasopore (Polyganics) packing and the turbinate-septal suture plus Nasopore (Polyganics) packing groups (power 5 80%; a < 0.01). Statistical analysis was performed using SPSS Version 17 for Windows (SPSS, Chicago Inc., IL). The difference between the two groups was measured using the independent t test. A P value less than or equal to 0.05 was considered significant.

RESULTS Complete data sets from 120 patients (60 in each group) were statistically analyzed. There were 38 men and 22 women in group A and 35 men and 25 women in group B. The mean age in group A was 43.5 6 12.4 years (range 18–61 years) and 42.8 6 13.2 years (range 18–62 years) in group B. The objective preoperative endoscopic scores and CT scores between the two groups were compared without a statistically significant difference (Table I). Both groups received a postoperative endoscopic examination at 1 week, 2 weeks, and 1 month. After comparing postoperative endoscopic scores between group A and group B, there was no statistically significant difference (Table II). Three months following the ESS, MT lateralization rates in groups A and B were compared. Middle turbinate lateralization rates in group A were significantly higher than those in group B after 3 months of surgery (19 of 120 sides vs. 6 of 120 sides; P < 0.01). Synechia Chen et al.: Middle Turbinate Medialization

formation rates in group A were also significantly higher than in group B (13 of 120 sides vs. 4 of 120 sides; P 5 0.023) (Table III).

DISCUSSION Adhesion of the MT to the lateral nasal wall is a common complication of ESS. Lateralization of the MT can occur even in the most experienced hands. With the removal of the uncinate process, a raw surface is created on the lateral wall of the nasal cavity. Instrumentation of the lateral aspect of the MT, whether as a result of repeated scraping or debunking of the MT, results in a raw and denuded surface of the area. Mobilization of the MT can contribute to instability, and lateralization with scarring is likely to occur. Furthermore, the mobilization of the MT for better visualization during the operation allows it to move more freely in the nasal cavity, leaving this “floppy” MT more susceptible to lateral synechiae formation. The potential sequela of MT lateralization and the synechiae formation can be obstruction of the middle meatus and the maxillary, ethmoid, or frontal sinuses, which can result in recurrent sinus disease and often necessitate revision surgery. During ESS, the MT is out-fractured (medialized) to allow access to the middle meatus. After out- fracturing, the tendency of the MT is to return to its natural anatomic position. This phenomenon is attributed to the structural memory of the turbinate. As a result, various studies have been performed to assess the many techniques used in the prevention of these synechia. Partial MT resection was recommended by LaMear et al. after their study indicated that this technique improved surgical exposure and prevented synechiae formation and obstruction of the middle meatal antrostomy.18 However, this technique has been scrutinized over the years because of the functional importance of the MT in humidifying inspired air and creating laminar airflow.14 Controlled synechiae formation, in which a microdebrider is used to abrade the medial aspect of the MT and lateral aspect of the nasal septum, has been shown to be effective in preventing lateralization.11 However, if the MT is “floppy,” either congenitally or from manipulation during surgery, the turbinate may still lateralize despite the medial abrasions created with this technique. Suture medialization of the MT is another technique suggested by several authors as the most definitive method for preventing lateralization. In our experience of 60 patients with a turbinate-septal t suture, we found it to be effective in preventing synechiae formation while also facilitating access to the middle meatus for postoperative debridement. There were no complications associated with placement of the stitch other than the accumulation of some mucous crusts on the knotted portion of the suture material where it is tied against the nasal septum. This was easily removed

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as part of the routine postoperative debridements. The polyglactin suture material is absorbable; however, the stitch is generally removed approximately 4 weeks after surgery when the MT and lateral nasal wall are mucosalized and no longer prone to scar formation. Having maintained the MT in a medial position for an extended period of time, the structural memory is effectively erased, and the turbinate does not tend to lateralize. However, in this study only short-term primary outcomes were assessed. The further study is needed for evaluation of the effect of Middle turbinate-septal suturing on long term (12 months) outcomes.

CONCLUSION Middle turbinate-septal suturing technique is a quick and easy alternative to medialize and stabilize the MT. This technique is especially encouraged when surgeons encounter unstable MT after removing massive pathologic mucosal lesions. It is associated with a low rate of lateral synechia formation. Further investigation is being carried out to demonstrate the technique and its effects on nasal function.

BIBLIOGRAPHY 1. Ramadan HH, Allen GC. Complications of endoscopic sinus surgery in a residency training program. Laryngoscope 1995;105:376–379. 2. Gross RD, Sheridan MF, Burgess LP. Endoscopic sinus surgery complications in residency. Laryngoscope 1997;107:1080–1085. 3. Fernandes SV. Postoperative care in functional endoscopic sinus surgery. Laryngoscope 1999;109:945– 948. 4. Lasar RH, Younis RT, Long TE, Gross CW. Revision functional endonasal sinus surgery. Ear Nose Throat J 1992;71:131–133. 5. Miller RS, Steward DL, Tami TA, et al. The clinical effects of hyaluronic acid ester nasal dressing (Merogel) on intranasal wound healing after functional endoscopic sinus surgery. Otolaryngol Head Neck Surg 2003; 128:862–869. 6. Chandra RK, Kern RC. Advantages and disadvantages of topical packing in endoscopic sinus surgery. Curr Opin Otolaryngol Head Neck Surg 2004;12:21–26. 7. Weitzel EK, Wormald PJ. A scientific review of middle meatal packing/ stents. Am J Rhinol 2008;22:302–307. 8. Franklin JH, Wright ED. Randomized, controlled, study of absorbable nasal packing on outcomes of surgical treatment of rhinosinusitis with polyposis. Am J Rhinol 2007;21:214–217. 9. Cho KS, Shin SK, Lee JH, et al. The efficacy of Cutanplast nasal packing after endoscopic sinus surgery: a prospective, randomized, controlled trial. Laryngoscope 2013;123:564–568. 10. Bolger WE, Kuhn FA, Kennedy DW. Middle turbinate stabilization after functional endoscopic sinus surgery: the controlled synechiae technique. Laryngoscope 1999;109:1852–1853. 11. Friedman M, Landsberg R, Tanyeri H. Middle turbinate medialization and preservation in endoscopic sinus surgery. Otolaryngol Head Neck Surg 2000;123:76–80. 12. Lindemann J, Keck T, Rettinger G. Septal-turbinate suture in endonasal sinus surgery. Rhinology 2002;40:92–94. 13. Moukarzel N, Nehme A, Mansour S, Yammine FG, Moukheiber A. Middle turbinate medialization technique in functional endoscopic sinus surgery. J Otolaryngol 2000;29:144–147. 14. Thorton RS. Middle turbinate stabilization technique in endoscopic sinus surgery. Arch Otolaryngol Head Neck Surg 1996;122:869–872. 15. Hewitt KM, Orlandi RR. Suture medialization of the middle turbinates during endoscopic sinus surgery. Ear Nose Throat J 2008;87:E11. 16. Lee MR, Marple BF. Middle turbinate medialization for improved access during endoscopic sinus surgery. Int Forum Allergy Rhinol 2011;1:187– 190. 17. Lund VJ, Mackay IS. Staging in rhinosinusitis. Rhinology 1993;31:183– 184. 18. LaMear WR, Davis WE, Templer JW, et al. Partial endoscopic middle turbinectomy augmenting functional endoscopic sinus surgery. Otolaryngol Head Neck Surg 1992;107:382–389.

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Turbinate-septal suture for middle turbinate medialization: a prospective randomized trial.

One of the primary goals of endoscopic sinus surgery (ESS) is to create widely patent paranasal sinus ostia, but lateralization of the middle turbinat...
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