Prospective randomized comparison of endonasal endoscopic dacryocystorhinostomy and external dacryocystorhinostomy

The Laryngoscope Lippincott Williams & Wilkins, Philadelphia 0 1998 The American Laryn ological,

Rhinological and Otological jociety, IDC.

Prospective Randomized Comparison of Endonasal Endoscopic Dacryocystorhinostomy and External Dacryocystorhinostomy Jouko Hartikainen, MD; Jukka Antila, MD; Matti Varpula, MD; Pauli Puukka, MSc; Heikki Seppa, MD, PhD; Reidar G r h m a n , MD, PhD

Objectives and Study Design: The advent of the rigid endonasal endoscope and the development of functional endoscopic sinus surgery (FESS) technique have awakened interest in an endonasal endoscopic dacryocystorhinostomy (EESC-DCR) in treating nasolacrimal obstruction. This prospective, randomized study compares EESC-DCR with traditional external dacryocystorhinostomy (EXT-DCR)for their success rates, surgical duration, and postoperative symptoms. Patients and Methods: Sixty-four cases in 60 patients with primary acquired nasolacrimal sac or duct obstruction were divided into two subgroups by symptoms (simple epiphord chronic dacryocystitis). These patients were randomized within both subgroups into two operation groups. Altogether 32 EESC-DCRs and 32 Em-DCRa were performed. The final follow-up visit was at 1 year. The patency of the lacrimal passage was investigated by irrigation and patients were questioned about their symptoms. Results: The success rate at 1 year after surgery was 75% for EESC-DCR and 91% for EXT-DCR after primary surgery. The difference was not statistically significant (P = .18). The success rate after secondary

Presented in part a t the IVth International Congress of the International Society of Dacryology in Stockholm, Sweden, June 12, 1996. From the Departments of Ophthalmology (J.H., H.s.) and Otorhinolaryngology (J.A., R.G.), and the Imaging Center (M.v.),University of Turku, and the Social Insurance Institution (P.P.), Research and Development Center, Turku, Finland. Supported in part by a grant from the Turku University Foundation, Turku, Finland. The authors have no proprietary interest in any of the equipment mentioned in this article. Editor's Note: This Manuscript was accepted for publication July 21, 1998. Send Reprint Requests to Reidar Grhman, MD, PhD, Department of Otorhinolaryngology-Head and Neck Surgery, Turku University Central Hospital, FIN-20520 Turku,Finland.

Laryngoscope 108: December 1998

surgery with a follow-up time of 1 year was 97% in both study groups. The average duration for EESCDCR was 38 minutes, and 78 minutes for EXT-DCR, (P < .001). Conchsions: EXT-DCR, when compared with EESC-DCR, appears to give a higher, although not statistically significant, primary success rate, but the secondary success rates are equal, indicating that these two different DCR techniques are acceptable alternatives. Key Words: dacryocystitis, dacryocystorhinostomy, nasolacrimal obstruction. Laryngoscope, 1081861-1866,1998

INTRODUCTION The traditional treatment of nasolacrimal obstruction is external dacryocystorhinostomy (EXT-DCR), often performed by an ophthalmologist. The technique of EXTDCR was originally described in 1904 by Toti,' and later modified by Dupuy-Dutemps and Bourguetz with the addition of suturing of the mucosal flaps, thus forming an epithelium-lined fistula. Success rates of 85% to 95% for EXT-DCR have been reported.3-7 The endonasal approach was introduced in 1893 by Caldwell,* and was later modified by West9 and Halle.10 These techniques have been in limited use mainly because of the difficulty in visualizing the endonasal anatomy during the operation. The advent of the operating microscope awakened sporadic interest among otorhinolaryngologists for endonasal dacryocystorhinostomy (EN-DCR)," but it was the development of the rigid endonasal endoscope and functional endoscopic sinus surgery (FESS)12J3 that reawakened interest in EN-DCR. In previous reports, the success rates for EN-DCRs, with or without laser, have remained lower than the success rates for EXT-DCR.llJP20 The major advantages of EN-DCR include the avoidance of a cutaneous wound and the limitation of tissue injury to the discrete fistula site without disruption of the medial canthal anatomy and function.11 Hartikainen et al: Dacryocystorhinostomy

1861

In this s t u d y we report the results of a randomized prospective comparison between endonasal endoscopic dacryocystorhinostomy (EESC-DCR) without laser and traditional EXT-DCR.

PATIENTS AND METHODS Patients referred to our clinic for nasolacrimal obstruction were investigated using lacrimal irrigation and probing of the canaliculi with a blunt tipped Bangerter lacrimal cannula up to bony contact of the lacrimal sac fossa. The lids were inspected, focusing on the positions of the lacrimal puncta and the function of the orbicularis muscle. Anterior rhinoscopy and Schirmer's test were carried out. Dacryocystography was performed on 62 of 64 cases at the Department of Radiology. Only patients with primary acquired nasolacrimal sac or duct obstruction and with a duration of symptoms longer than 1year were included in this study. Exclusion criteria were presaccal obstruction ascertained with probing, noticeable lower lid laxity, previous lacrimal surgery with the exception of silicone intubation of nasolacrimal duct, age under 15 years, suspicion of malignancy, radiation therapy to the head, posttraumatic bony deformity, and bone diseases affecting the nose and orbit. The patients included were divided into two groups by symptoms: those who had simple epiphora with no discharge, and those who had chronic dacryocystitis with purulent discharge. Altogether 64 cases in 60 patients were randomized within both subgroups for either EESC-DCR or EXT-DCR. Two patients with bilateral nasolacrimal obstruction were randomized for bilateral EESC-DCR and two patients with bilateral nasolacrimal obstruction for both EESC-DCR and EXT-DCR.Thus both groups included 32 cases. Of these cases 13 were men and 51 women. The mean age was 62.9 years (Table I). There was no preoperative selection based on the results of anterior rhinoscopy or dacryocystography. All operations were performed between January 1994 and April 1995. The EESC-DCR operations were carried out under local anesthesia, and the EXT-DCR operations were carried out under general anesthesia. Cotton pledgets soaked with cocaine, 200 mg, (total dose) and epinephrine, 1:10,000 in saline, were applied intranasally between the middle and lower turbinates, as well as up in the dorsum, in order to achieve good anesthesia and hemostasis. Intravenous antibiotics (cefuroxime, 750 mg) were given preceding surgical interventions. In both operations a sili-

cone tube was inserted and tied with several knots without fixating it to the nasal wall. Special care was taken not to tie the tube too tightly. On completion of the operation, antibiotic-corticosteroid ointment was applied into the eye. After the procedure the patients used dexamethasone-chloramphenicol drops three times daily for 2 weeks, and oral cephalexin, 500 mg three times daily, for 1 week. The EESC-DCR operations with video monitoring were performed under local anesthesia by a n otorhinolaryngologist (J.A.) and an ophthalmologist (J.H.). The ophthalmologist injected 1% lidocaine-epinephrine above and below the medial canthal tendon, as well as locally a t the site of the anterior lacrimal crest. The lacrimal passages were probed and a 20-gauge fiberoptic light pipe of the type that is used in pars plana vitrectomies (Storz, Inc., St. Louis, MO) was lubricated with antibiotic ointment and inserted into the lacrimal sac through either of the lacrimal canaliculi into contact with the medial wall of the lacrimal sac. The light was visualized endonasally with a rigid 4-mm Hopkins 30" nasal endoscope (Storz) by the otorhinolaryngologist, who infiltrated 1% lidocaine-epinephrine (1 mL) under the mucosa, guided by the light pipe in the lacrimal sac. Both the nasal mucosa and the thin lacrimal bone as well as the thicker frontal process of the maxillary bone at the nasal wall of the lacrimal sac fossa were removed using a round diamond burr and Rosen curette, creating a bony opening of approximately 10 x 7 mm. The nasal wall of the lacrimal sac was opened separately with a sickle knife and the opening was enlarged to a diameter of approximately 7 mm. The ophthalmologist facilitated the opening of the lacrimal sac wall by tenting the medial sac wall nasally with either the light pipe or a Bangerter lacrimal cannula inserted into the lacrimal sac. The lacrimal sac mucosa was inspected and biopsied. The EXT-DCR operations were performed by one ophthalmologist (J.H.) using the technique of Dupuy-Dutemps and Bourguet. A straight incision of approximately 2 cm in length was made medial to the angular vein, starting at the level of the medial canthal ligament. The orbicularis muscle fibers were separated with blunt dissection, and 4-0 silk traction sutures were used to open the wound. The periosteum overlying and medial to the anterior lacrimal crest was exposed. The periosteum incision was made just medial and inferior to the bony insertion of the medial canthal tendon. The osteotomy, approximately 12 mm in diameter, was created with Kerrison ronguers. The lacrimal sac and nasal mucosa

TABLE I. Patient Data.

Characteristics

Total

Endonasal Endoscopic Dacryocystorhinostomy

External Dacryocystorhinostorny

Operationslpatients (n)

64/60

32/30

32/32

62.9 i 15.1 24-90

61.0 i 16.1 24-90

64.8 i 14.0 25-86

13/51

9/23

4/28

10 1-78 30134 6

11 1-78 19113 4

9 1->50 11/21 2

1

0

1

Age (Y) Mean SD Range Sex Male/female Duration of symptoms (y) Mean Range Laterality of surgery (rightheft) Number of patients with a history of acute dacryocystitis Number of patients with previous silicone intubation performed

*

S D = standard deviation.

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were opened in a longitudinal fashion to form anterior and posterior flaps. The lacrimal sac mucosa was inspected and biopsied for histology. Occasional lacrimal sac and nasolacrimal duct dacryoliths were removed. The site of nasolacrimal obstruction was localized by probing and also the internal punctum was inspected. The posterior flaps were sutured together with two or three 5-0 Dexon (Davis-Geck,Wayne, NJ) sutures, and the silicone tube was inserted and tied with several knots. The anterior flaps were sutured together with running 5-0 Dexon. The periosteum and orbicularis muscle were closed in separate layers with 5-0 Dexon sutures. The skin incision was closed with three 6-0 Novafi (Davis-Geck) sutures. Nasal packing was not performed. The duration of surgery was measured from the dilatation of the lacrimal puncta and irrigation of the lacrimal system to the application of antibiotic-corticosteroid ointment for the EESCDCR, or to the end of the application of the pressure bandage for the EXT-DCR. The first postoperative follow-up visit in both groups was to the ophthalmologist a t 1 month. The operated lacrimal passage was irrigated with a saline solution, and the tightness of the silicone tube was checked. At 6 months the silicone tube was removed and the lacrimal passage irrigated. The tube was removed by cutting the silicone tube between the puncta and by either having the patients blow their nose or by extracting the tube from the nose with forceps in anterior rhinoscopy. The final follow-up visit was at 1 year. Patients were asked, using a questionnaire, about the presence or absence of discharge, and about watering of the eye outdoors or indoors. The EXT-DCR patients were questioned about their satisfaction with the cosmetics of the cutaneous scar and the site was inspected. The patency of the lacrimal passage was investigated by irrigation and by dacryoscintigraphy. The statistical analyses were performed using SAS 6.04 statistical software. The group means were compared with Student's t test. Success rates and other categorical variables were tested with Fisher's exact test. Statistical significances are given as exact P values. P values greater than .05 are regarded as nonsignificant.

RESULTS The results and characteristics of the operations are presented in Table 11. Serious bleeding complications during surgery did not occur. However, one patient in the EESC-DCR group required an anterior nasal tamponage with a Merocel 2000 laminated Kennedy sinus stent dressing (Xomed,Jacksonville, FL) aRer the anterior resection of the middle turbinate. After surgery two patients, one in each group, required anterior nasal tamponage and hospitalization for 3 days because of postoperative nasal hemor-

rhage. Resection of the anterior part of the middle turbinate was necessary in 31% (10/32) in the EESC-DCR group but in no cases in the EXT-DCR group. No decision to convert the EESC-DCR operation to EXT-DCR was necessary. The average duration of surgery was 38 minutes (SD 5 13; range, 19-79 min) for EESC-DCR and 78 minutes (SD 13; range, 60-115 min) for EXT-DCR. The difference was statistically highly significant ( P < .001). Ethmoid sinuses were incorporated within the osteotomy in 19% (6/32) in the EESC-DCR group and in 22% (7/32) in the EXT-DCR group. A proper tissue sample from the lacrimal sac was obtained in all cases in both groups. In this study, three postoperative follow-up visits were scheduled, but additional visits prior to the scheduled follow-up visits became necessary in 10 cases (31%) in the EESC-DCR group and in five cases (16%) in the EXT-DCR SOUP. The operation was classified as successful by the objective demonstration of a patent nasolacrimal system through irrigation. The success rate at 1 year after surgery, on the basis of the primary surgery, was 75% (24/32) for the EESC-DCR and 91% (29/32) for the EXTDCR group. The difference was not statistically significant (P = .18). The patency rates a t 6 months were 75% (24/32) for EESC-DCR and 100% (32/32) for EXT-DCR, as tested by irrigation immediately after removal of the silicone tube. The patency rates in the subgroups are summarized in Table 111. At the final follow-up visit 19 patients (59%) in the EESC-DCR group and 27 patients (84%) in the EXT-DCR group were asymptomatic (P = .05). All these patients were successes to irrigation in the EESC-DCR group, while two of the 27 patients in the EXT-DCR group had obstruction at the common canaliculus. The symptoms are summarized in Table Iv. Dacryoscintigraphy was performed in 22 cases (69%) in the EESC-DCR group and in 28 cases (88%)in the EXT-DCR group 1 year after primary operation. Of the cases that were classified as success by irrigation, dacryoscintigraphy was performed in 88% (21/24) in the EESC-DCR group and in 86% (25/29) in the EXT-DCR group. Of the DCRs that were patent to irrigation and were studied with dacryoscintigraphy, 90%(19/21) in the EESC-DCR group and 76% (19/25) in the EXT-DCR group were found to be patent to dacryoscintigraphy. At the final postoperative follow-up visit, 31 of the 32 patients in the EXT-DCR group did not have any com-

TABLE II.

Results and Characteristics of Endonasal Endoscopic Dacryocystorhinostomyand External Dacryocystorhinostomy Operations. Surgery

EESC-DCR EXT-DCR P value

Primary Success Rate

Secondary Success Rate

Duration of Surgery i SD; Range (min)

75% (24/32) 91% (29/32) .18*

97% (31/32) 97% (31/32) 1.O'

38 13; 19-79 78 13; 60-1 15 c.001t

* *

Resection of Middle Turbinate

Difficulties With Tube Removal

Laceration of Punctum

Additional Visits

31yo (10/32) 0% (0132)