Effectiveness and safety comparison of three eye and orbital reconstruction techniques in facial plastic surgery

Effectiveness and safety comparison of three eye and orbital reconstruction techniques in facial plastic surgery

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ANNPLA-1472; No. of Pages 11 Annales de chirurgie plastique esthétique (2018) xxx, xxx—xxx

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ORIGINAL ARTICLE

Effectiveness and safety comparison of three eye and orbital reconstruction techniques in facial plastic surgery ´ et de la tole ´ rance de trois techniques Comparaison de l’efficacite de reconstruction oculaire et orbitaire en chirurgie plastique de la face C. Keilani a,c,d,*, A. Baus b, S. Tick a, J.-A. Sahel a, J. Boumendil a a

Department IV, facial and oculoplastic surgery unit, Quinze-Vingts national center, 28, rue de Charenton, 75571 Paris, France b Department of plastic surgery, Percy military hospital, 101, avenue H.-Barbusse, 92141 Clamart, France c ˆ pital, Faculty of medicine Pierre-et-Marie-Curie, Sorbonne University, Paris VI, 91—105, boulevard de l’Ho 75013 Paris, France d ˆ pitaux de Paris, 75004 Paris, France Assistance publique—Ho Received 27 October 2018; accepted 7 January 2019

KEYWORDS Numeric Pain Rating Scale (NRS); Implant extrusion rate; Surgical eye and orbital reconstruction technique; Facial plastic surgery; Facial deformity

Summary Purpose. — To compare the effectiveness and the safety of three eye reconstruction techniques with porous bioceramic implantation in facial surgery: the ‘‘four petals’’ eye evisceration (EE) technique, the ‘‘russian doll’’ EE technique and the enucleation with ‘‘on-the-table’’ evisceration technique. Methods. — Retrospective review of patients who underwent surgical orbit reconstruction with primary placement of a porous bioceramic orbital implant using three techniques at QuinzeVingts National Center (Paris, France). We compared outcomes of three surgical orbit reconstruction techniques: the ‘‘four petal’’ EE technique, the ‘‘russian doll’’ EE technique and the enucleation with ‘‘on-the-table’’ evisceration technique. The primary endpoint was to determine the rate of implant exposure and the facial cosmetic result during the first year after surgery for each technique. The mean of the Numeric Pain Rating Scale (NRS) after surgery at day

* Corresponding author at: Department IV, facial and oculoplastic surgery unit, Quinze-Vingts national center, 28, rue de Charenton, 75571 Paris, France. E-mail addresses: [email protected], [email protected], [email protected] (C. Keilani). https://doi.org/10.1016/j.anplas.2019.01.003 0294-1260/# 2019 Elsevier Masson SAS. All rights reserved.

Please cite this article in press as: Keilani C, et al. Effectiveness and safety comparison of three eye and orbital reconstruction techniques in facial plastic surgery. Ann Chir Plast Esthet (2019), https://doi.org/10.1016/j.anplas.2019.01.003

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C. Keilani et al. 1 was also a primary endpoint. In addition, data such as analgesic intake and rate of revision surgery were compared for each technique. Results. — One hundred and ten patients were included: 70 patients in the ‘‘four petals’’ procedure group, 31 in the ‘‘on-the-table’’ procedure group and 9 in the ‘‘russian doll’’ procedure group. NRS pain at day 1 was statistically significantly lower in the ‘‘four petals’’ procedure group 0.9 [standard deviation (SD)] (1.8) and in the ‘‘russian doll’’ procedure group 1 (1.7) than in the ‘‘on-the-table’’ procedure group 2.5 (2.4) (P = 0.001). Implant exposure was statistically significantly lower in the ‘‘four petals’’ procedure group (2.9%) and in the ‘‘on-thetable’’ procedure group (3.2%) when compared to the ‘‘russian doll’’ procedure group (22.2%) (P = 0.03). Rate of revision surgery was lower in the ‘‘four petals’’ procedure group (11.5%) than in the ‘‘russian doll’’ procedure group (33.3%) and the ‘‘on-the-table’’ procedure group (22.6%). ‘‘russian doll’’ evisceration procedure group had the highest orbital lipofilling rate due to the highest rate of enophthalmos. Therefore, the cosmetic result was better in the ‘‘four petals’’ and the ‘‘on-the-table’’ procedure group. Conclusion. — The ‘‘four petals’’ EE technique for surgical eye and orbital reconstruction seems to be a method that reduce implant extrusion, postoperative pain and improve facial esthetic result. # 2019 Elsevier Masson SAS. All rights reserved.

MOTS CLÉS Échelle numérique (EN) de la douleur ; Taux d’extrusion d’implant orbitaire ; Technique de reconstruction chirurgicale oculaire et orbitaire ; Chirurgie plastique du visage ; Déformation du visage

Re ´sume ´ Objectif. — Comparer l’efficacité et la tolérance de trois techniques de reconstruction oculaire et orbitaire avec implantation d’un implant poreux en biocéramique en chirurgie faciale : la technique d’éviscération oculaire (EO) dite « quatre pétales », la technique d’EO dite « poupée russe » et la technique « d’énucléation-éviscération sur table ». Me ´thodes. — Étude rétrospective de patients ayant subi une reconstruction chirurgicale oculaire et orbitaire avec mise en place d’un implant orbitaire poreux en biocéramique selon trois techniques au Centre national des Quinze-Vingts (Paris, France). Nous avons comparé les résultats des trois techniques de reconstruction orbitaires : la technique « quatre pétales », la technique « poupée russe » et la technique « d’énucléation-éviscération sur table ». Le critère d’évaluation principal était de déterminer le taux d’extrusion d’implant orbitaire et le résultat esthétique au niveau de la face au cours de la première année postopératoire pour chaque technique. La moyenne de l’échelle numérique (EN) de la douleur le lendemain de la chirurgie était également un critère principal d’évaluation. De plus, des données telles que la consommation d’analgésie et le taux de reprise chirurgicale ont été comparées pour chaque technique. Re ´sultats. — Cent dix patients ont été inclus : 70 patients dans le groupe procédure « quatre pétales », 31 dans le groupe procédure « énucléation-éviscération table » et 9 dans le groupe procédure « poupée russe ». La douleur sur l’EN le lendemain de la chirurgie était statistiquement significativement plus faible dans le groupe « quatre pétales » 0,9 [écart-type ET)] (1,8) et dans le groupe « poupée russe » 1 (1,7) par rapport au groupe « énucléation-éviscération sur la table » 2,5 (2,4) ( p = 0,001). Le taux d’extrusion de l’implant était statistiquement significativement plus faible dans le groupe « quatre pétales » (2,9 %) et dans le groupe « énucléation-éviscération sur la table » (3,2 %) par rapport au groupe « poupée russe » (22,2 %) ( p = 0,03). Le taux de reprise chirurgicale était inférieur dans le groupe « quatre pétales » (11,5 %) par rapport au groupe « poupée russe » (33,3 %) et au groupe « énucléation-éviscération sur table » (22,6 %). Le groupe « poupées russes » affichait le taux de lipofilling orbitaire le plus élevé en raison du taux d’enophtalmie important. Par conséquent, le résultat esthétique était meilleur dans les groupes « quatre pétales » et « énucléation-éviscération sur table ». Conclusion. — La technique d’EO « quatre pétales » pour la reconstruction chirurgicale oculaire et orbitaire semble être une méthode permettant de réduire l’extrusion d’implant, la douleur postopératoire et d’améliorer les résultats esthétiques du visage. # 2019 Elsevier Masson SAS. Tous droits réservés.

Introduction For several ophthalmic and facial diseases such as endophthalmitis, phthisis bulbi, glaucoma and traumatic injury, eye evisceration (EE) or enucleation appear to be one of the possible options to insure better facial appearance and pain relief [1]. However, this orbital reconstruction is

often the endpoint of a long clinical ophthalmologic journey leading to dramatic changes in patients’ lives: facial disfigurement, low health-related quality of life, job disruption, psychological and social difficulties [2]. Observing patients with obvious facial deformity, such as enophthalmos and asymmetry after eye evisceration, new surgical techniques have been developed to reduce those long-term

Please cite this article in press as: Keilani C, et al. Effectiveness and safety comparison of three eye and orbital reconstruction techniques in facial plastic surgery. Ann Chir Plast Esthet (2019), https://doi.org/10.1016/j.anplas.2019.01.003

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Effectiveness and safety comparison of three eye and orbital reconstruction techniques in facial plastic surgery complications [2]. Among all the methods used in plastic and reconstructive surgery, the most commonly used is evisceration coupled with implant insertion [3]. EE involves the complete removal of the eye’s internal contents preserving the scleral shell and the extraocular muscle attachment, and followed usually by placement of an orbital implant to replace the lost ocular volume. EE technique was introduced by Bear at the beginning of the 19th century [4]. At the end of the 20th century, Perry introduced bioceramic implants and used it as a buried integrated orbital implant [5]. It is biocompatible and porous material. The implant is well tolerated by surrounding tissues, and its porous structure can be rapidly infiltrated by host tissue to correct orbital volume loss [6]. Nevertheless, EE coupled with orbital implants can lead to complications. The most common complication of this intervention surgery is the implant’s exposure, which could also lead to infection [7,8]. Pain syndrome after surgery appears as another complication of this procedure and can cause an extended hospitalization [9]. The facial disfigurement following EE is the major point. Despite the placement of an implant during the surgery, lost of orbital volume is frequent and induces enophthalmos. Many studies in the field of plastic and reconstructive surgery have demonstrated the relationship of the orbit to the eyelids [10—15]. Enophthalmos often leads to upper eyelid ptosis [10—15]. One of the main goals of an eye reconstruction technique is to ensure the best orbital volume to reduce the rate of revision surgery. Revision surgeries include ptosis surgery and orbital and eyelid lipofilling. These surgeries can be cumbersome for patients. Until today, various techniques have been developed to reduce these complications as well as to provide a better cosmetic effect [16—19]. Recently in 2007, the ‘‘four petals’’ evisceration technique was described by Sales-Sanz and Sanz-Lopez to facilitate the placement of a larger implant to reduce the postoperative enophthalmos and the facial asymmetry [19]. This technique seems to give good results with low extrusion implant, low pain, low facial revision surgery and better cosmetic effect [19]. The main objective of the present study is to compare the effectiveness and the safety of three surgical eye and orbital reconstruction techniques with porous bioceramic implantation: the ‘‘four petals’’ technique, the ‘‘russian doll’’ technique and the ‘‘on-the-table’’ technique.

Patients and methods We retrospectively reviewed the medical records of patients who underwent EE with primary placement of a porous bioceramic orbital implant using three surgical techniques between November 2011 and October 2016 at Quinze-Vingts National Center, Paris, France. We compared outcomes of three surgical reconstruction techniques: ‘‘four petal’’ EE technique, ‘‘russian doll’’ EE technique and the enucleation with ‘‘on-the-table’’ evisceration technique [19—24]. Preoperative examinations, including ultrasonography and computerized tomography scan when required, were undertaken to exclude the possibility of intraocular and orbital malignancy. The inclusion criteria were: patient age over 16 years old with a surgical indication of EE and a primary placement of a porous bioceramic orbital implant, a surgery performed under general anesthesia which is the common anesthesia for

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this kind of surgery in our center, a patient able to communicate effectively, a hospital stay of at least one day to measure pain score, and an informed consent signed by the patient. Exclusion criteria were: patients undergoing secondary implantation or having less than a 6 months followup, eyes with endophthalmitis, orbital neoplasia, nonFrench-speaker patients, psychiatric or neurologic disorders, and critical condition needing the use of sedation. All surgeries were carried out by five oculoplastic surgeons. Collected data included patient demographics, diagnosis necessitating eye reconstruction, used procedure, size of implant, follow-up duration and any complications encountered and their treatment. Quinze-Vingts ethic committee oversighted and approved this study.

Surgical evisceration techniques ‘‘Four petals’’ technique (Fig. 1) [19] An eyelid speculum was placed between the eyelids. A 360degree conjunctival peritomy was performed just posterior to the corneal limbus with Stevens scissors. Blunt sub-Tenon dissection was performed with Stevens scissors. An incision was made circumferentially in the sclera 1 mm from the limbus with No. 11 scalpel blade, and the cornea was removed. The globe contents were removed with a suction machine. The interior of the scleral shell was scraped with gauze to remove all visible uveal tissue remnants. Haemostasis of central retinal artery and vortex veins were obtained by digital pressure with cotton moistened gauze or with oxidized regenerated cellulose gauze. The sclera was dissected into four equal pieces between the rectus muscles to the papilla optica, avoiding damage to the rectus muscles. The 4 pieces of sclera were set free and transected from the optic nerve, each containing one rectus muscle. A sizing ball was used to assess the residual volume, and an implant size was chosen that would allow tension-free closure of the anterior ocular tissue. Then, a porous bioceramic orbital implant was immersed in an antibiotic solution (10 mL of 1,000,000 UI rifamycin). The implant was then placed into the scleral cavity. After implant insertion, we used 6-0 vicryl sutures to attach the four scleral flaps to the anterior exterior surface of the sphere at the corresponding rectus muscle insertion locations. The edges of the superior and inferior scleral flaps were sutured together, as well as the edges of the medial and lateral scleral flaps, covering the implant with 4 layers of sclera to prevent from implant extrusion. Therefore, we overlapped the scleral flaps. The Tenon capsule and conjunctiva were closed over the implant in layers with 6-0 Vicryl sutures, respectively. A conformer was inserted, and antibiotic ointment was placed on the ocular surface. A temporary tarsorrhaphy was created with a horizontal mattress 4-0 silk suture. A pressure bandage was applied and left in place for one day. The tarsorrhaphy suture was removed one month after surgery. Topical antibiotics and steroid drops were used for the next 3—4 weeks, and oral antibiotics were prescribed for 1 week. Acrylic prosthesis was placed after fabrication 4 weeks after surgery. ‘‘Russian doll’’ technique (Fig. 2) [20] Initial steps of this surgery were similar to the previous technique. The globe contents were removed with a suction

Please cite this article in press as: Keilani C, et al. Effectiveness and safety comparison of three eye and orbital reconstruction techniques in facial plastic surgery. Ann Chir Plast Esthet (2019), https://doi.org/10.1016/j.anplas.2019.01.003

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Figure 1 ‘‘Four petals’’ EE procedure. A. The sclera was dissected into four equal pieces between the rectus muscles to the papilla optica, avoiding damage to the rectus muscles. The 4 pieces of sclera were set free, each containing one rectus muscle. B. Then, a porous bioceramic orbital was placed into the scleral cavity. C. After implant insertion, we used 5-0 vicryl sutures to attach the four scleral flaps to the anterior exterior surface of the sphere at the corresponding rectus muscle insertion locations. The edges of the superior and inferior scleral flaps were sutured together, as well as the edges of the medial and lateral scleral flaps, covering the implant with 4 layers of sclera to prevent from implant extrusion. D. The Tenon capsule and conjunctiva were closed over the implant in layers with 6-0 Vicryl sutures, respectively.

machine. The interior of the scleral shell was scraped with gauze to remove all visible uveal tissue remnants. Haemostasis was performed similarly to the previous technique. Posterior sclerotomy was performed. A porous bioceramic orbital implant was immersed in an antibiotic solution (10 mL of 1,000,000 UI rifamycin) and placed into the scleral cavity. Scleral edges were simply approximated and sutured together with 6-0 Vicryl. The Tenon capsule and conjunctiva were then closed over the implant in layers with 6-0 Vicryl suture, respectively. Last steps of this surgery were performed as the ‘‘four petals’’ technique. The dressing and postoperative treatment were similar to the ‘‘four petals’’ technique. ‘‘On-the-table’’ technique (Fig. 3) [21] First steps of this surgery were similar to the previous techniques. In order to secure the four rectus muscles, a suture was inserted at the end of each of them while the superior and inferior oblique muscles were cut off. Then, removal of the eyeball after optic nerve section with a lasso was performed. Haemostasis of central retinal artery and vortex veins were obtained by digital pressure with cotton

moistened gauze or with oxidized regenerated cellulose gauze. An evisceration spoon was used to separate the uvea from the sclera followed by the intraocular contents of the globe on the operating table (evisceration). A porous bioceramic orbital implant was immersed in an antibiotic solution (10 mL of 1,000,000 UI rifamycin) and the implant was wrapped in the eviscerated sclera and replaced in the orbit with the posterior pole of the sclera facing anteriorly. The rectus muscles were then resutured onto the sclera with 5-0 Vicryl. Last steps of this surgery were performed as the ‘‘four petals’’ and the ‘‘russian doll’’ technique. The dressing and postoperative treatment were similar to the ‘‘four petals’’ and the ‘‘russian doll’’ technique. After surgery, patients were examined at day one, one week, four weeks, three months and one year and then referred to an ocularist for prosthesis fitting. Healing pain was measured at day 1 using a Numeric Pain Rating Scale (NRS): an 11-point numeric scale with 0 representing one pain extreme (‘‘no pain’’) and 10 representing the other pain extreme (‘‘pain as bad as you can imagine’’ and ‘‘worst pain imaginable’’). The patient was asked to make pain ratings, corresponding to current, best and worst pain experienced

Please cite this article in press as: Keilani C, et al. Effectiveness and safety comparison of three eye and orbital reconstruction techniques in facial plastic surgery. Ann Chir Plast Esthet (2019), https://doi.org/10.1016/j.anplas.2019.01.003

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Figure 2 ‘‘Russian doll’’ EE procedure. A. A 360-degree conjunctival peritomy was performed just posterior to the corneal limbus with Stevens scissors. An incision was made circumferentially in the sclera 1 mm from the limbus with No. 11 scalpel blade, and the cornea was removed. B. Scleral edges were sutured together with 5-0 Vicryl. C. The Tenon capsule and conjunctiva were then closed over the implant in layers with 5-0 Vicryl and 6-0 Vicryl suture, respectively.

over the past 24 hours. The NRS is quick, easy to use, and easy to score, and it provides a method to compare the findings to previous results. It also provides ratio-level data, allowing more robust parametric statistical analysis. The NRS is used to measure various subjective clinical phenomena, including pain and anxiety. Validity of the NRS to measure the self-report of anxiety and pain has been demonstrated when scores were compared with Spielberger’s (1983) State Anxiety Inventory [22,23]. The conformer was kept in place until the fourth week appointment. The postoperative follow-up visits were scheduled at 1 week, 4 weeks, 3 months and 1 year after surgery by the same examiner. When it was possible, patient was also examined more than one year after surgery. During follow-up periods, patients were examined for the presence of exposure, infection, deep superior sulcus deformity, enophthalmos, ocular prosthesis motility and cosmetic appearance. The choice of surgical technique depended on the surgeon preferences. The primary endpoint was to determine the NRS mean score after surgery at day 1, implant exposure rate during the first year after surgery for each of the 3 techniques and rate of revision surgery to improve facial disfigurement. The rate of revision surgery was considered to be reflective of the rate of unsatisfactory

cosmetic result as well of the prosthesis motility. In fact, patients with good ocular prosthesis motility and high cosmetic success after the primary reconstruction procedure have usually low rates of revision surgery. Data of each technique were also compared with each other during the same period of time in our hospital. Secondary endpoints were to determine pain medication used in each group and others complications as conjunctiva granuloma, superior sulcus deformity, volume deficit. P-values for the analysis of the primary and secondary endpoints were obtained using the Kruskal—Wallis test, with P < 0.05 considered statistically significant. Institutional review board approval was obtained for this study. Informed consent of all patients was obtained before surgery.

Results One hundred and ten patients were included: 70 patients in the ‘‘four petals’’ procedure group, 31 in the ‘‘on-thetable’’ evisceration procedure group and 9 in the ‘‘russian doll’’ procedure group. In our hospital, the ‘‘four petals’’ procedure was the mostly used for EE (Fig. 4). Patients’ characteristics analysis showed that the average age was 50  20 years [mean  standard deviation (SD)] (3 groups

Please cite this article in press as: Keilani C, et al. Effectiveness and safety comparison of three eye and orbital reconstruction techniques in facial plastic surgery. Ann Chir Plast Esthet (2019), https://doi.org/10.1016/j.anplas.2019.01.003

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Figure 3 ‘‘On-the-table’’ EE procedure. A. An evisceration spoon was used to separate the uvea from the sclera followed by the intraocular contents of the globe on the operating table. A porous bioceramic orbital implant was wrapped in the eviscerated sclera. B. Then, eviscerated sclera with the implant was replaced in the orbit with the posterior pole of the sclera facing anteriorly. C. The rectus muscles were resutured onto the sclera with 5-0 Vicryl. D. The Tenon capsule and conjunctiva were closed over the implant in layers with 6-0 Vicryl sutures, respectively.

combined). There was no significant difference between the 3 groups in term of demographic characteristics, age, ethnicity and eye side. The indications for EE were similar for the three groups: blind and painful eye and the need of a cosmetic improvement in case of facial disfigurement attributable to trauma, retinal detachment, neovascular glaucoma and open-angle glaucoma (Table 1). The mean followup time between three groups was similar: 12.7 (12.3) months in the ‘‘four petals’’ procedure group, 13.4 (11.4) months in the ‘‘on-the-table’’ procedure group and 14.9 (14.7) months in the ‘‘russian doll’’ procedure group. Of the 110 patients that underwent EE, one has had a reported bioceramic implant extrusion due to pseudomonas aeruginosa infection in the ‘‘four petal’’ procedure group. However, this patient has undergone an orthopedic surgery short time after the EE. A hospital-acquired infection is known to be possible. No operative complications were reported. The mean (SD) implant size was 20 mm (1.5) in the ‘‘four petals’’ procedure group, 19.9 mm (1.6) in the ‘‘on-the-table’’ procedure group and 16 mm (1.7) in the ‘‘russian doll’’ procedure group. Concerning the primary endpoints, the mean [standard deviation (SD)] of the NRS after surgery at day 1 was 0.9 (1.8)

in the ‘‘four petals’’ evisceration procedure group, 2.5 (2.4) in the ‘‘on-the-table’’ evisceration procedure group was and 1 (1.7) in the ‘‘russian doll’’ evisceration procedure group (Table 2). Multiple comparison analysis with Kruskal— Wallis test show that NRS at day 1 was statistically significantly lower in the ‘‘four petals’’ evisceration procedure group and in the ‘‘russian doll’’ evisceration procedure group than in the ‘‘on-the-table’’ evisceration procedure group (P = 0.001) (Table 2). The rate of implant exposure during the first year after surgery was 2.9% in the ‘‘four petals’’ evisceration procedure group, 3.2% in the ‘‘on-thetable’’ evisceration procedure group was and 22.2% in the ‘‘Russian doll’’ evisceration procedure group. Implant exposure was statistically significantly lower in the ‘‘four petals’’ evisceration procedure group and in the ‘‘on-thetable’’ evisceration procedure group than in the ‘‘russian doll’’ evisceration procedure group (P = 0.03). Revision surgery rate was lower in the ‘‘four petals’’ procedure group (11.5%) than in the ‘‘russian doll’’ procedure group (33.3%) and the ‘‘on-the-table’’ procedure group (22.6%) (Table 3). The ‘‘russian doll’’ evisceration procedure group had the highest orbital lipofilling rate due to the highest rate of enophthalmos (Table 3). Therefore, the cosmetic result was

Please cite this article in press as: Keilani C, et al. Effectiveness and safety comparison of three eye and orbital reconstruction techniques in facial plastic surgery. Ann Chir Plast Esthet (2019), https://doi.org/10.1016/j.anplas.2019.01.003

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Table 1

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Study flowchart.

Characteristics of the study population.

Eye reconstruction procedure Gender (%) Male Female Age (years) mean (SD)  30 30 < n  60 > 60 Eye side (%) Right Left Ethnicity (%) Central Africa North Africa Europe Middle East Asia EE causes (phthisis bulbi) (%) Open-angle glaucoma Neovascular glaucoma Keratoconus Burn Cataract surgery Retinal detachment Ocular ischemic syndrome Trauma After infection Keratopathy after cataract surgery Lifestyle habits (%) Smoking Alcohol

‘‘Four petals’’ procedure

‘‘On-the-table’’ procedure

‘‘Russian doll’’ procedure

28.6 71.4 51.2 (21.1) 21.4 44.3 34.3

16.1 83.9 49.9 (19.2) 16.1 58.1 25.8

55.5 a 44.4 a 62.7 (22) 0 44.4 a 55.5 a

62.3 37.7

57.7 42.3

57.2 42.8

23 20 54 3 0

13 35 45 3 3

0 22 67 11 0

19 6 4 1 1 22 1 38 4 1

13 3 0 0 0 19 0 58 3 3

11 11 0 0 0 11 0 44 11 0

22.8 8.5

19.3 9.6

55.5 22.2

SD: standard deviation; EE: eye evisceration.

better in the ‘‘four petals’’ and the ‘‘on-the-table’’ procedure group (Fig. 5). The implant motility was satisfactory in the ‘‘four petals’’ and the ‘‘on-the-table’’ procedure group. The rate of revision surgery was correlated with the motility of the ocular prosthesis. Low rates of revision

surgery were correlated with a good motility of the ocular prosthesis. Concerning the secondary endpoints, analgesic intake analysis showed no significant difference. Paracetamol, ketoprofene, and tramadol intake was similar for each group (Table 4).

Please cite this article in press as: Keilani C, et al. Effectiveness and safety comparison of three eye and orbital reconstruction techniques in facial plastic surgery. Ann Chir Plast Esthet (2019), https://doi.org/10.1016/j.anplas.2019.01.003

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C. Keilani et al. Table 2

Primary outcomes.

Eye reconstruction procedure

‘‘Four petals’’ procedure

‘‘On-the-table’’ procedure

‘‘Russian doll’’ procedure

P-value

NRS after surgery at day 1: Mean (SD)

0.9 (1.8a)

2.5 (2.4a)

1 (1.7a)

P = 0.001

EE: eye evisceration; SD: standard deviation. a The more or less correspond to mean values  standard deviation.

Table 3

Revision surgery rate.

Eye reconstruction procedure (%)

‘‘Four petals’’ procedure

‘‘On-the-table’’ procedure

‘‘Russian doll’’ procedure

Revision surgery rate Orbital lipofilling Ptosis eye surgery Granuloma surgery Ectropion/entropion eyelid surgery Oral mucosa graft

11.5 1.4 4.1 2 2 2

22.6 3.2 12.4 3 4 0

33.3 (P  0.05) 22.2 (P  0.05) 0 (P = ns) 11.1 (P = ns) 0 (P = ns) 0 (P = ns)

EE: eye evisceration; ns: not significant; P: P-value.

Discussion In this study, the ‘‘four petals’’ technique seems to be a good procedure in order to reduce bioceramic implant extrusion, to minimize post-surgical pain and revision surgery. In fact, creating and suturing four scleral flaps together insure a thick anterior protection, which reduces mechanic extrusion [19]. We noted a statistically significantly difference of implant extrusion and the NRS at day 1 in favor to the ‘‘four petals’’ procedure. Verhoekx et al. did not find any difference in the frequency of spheric acrylic implant exposure or extrusion in patients who underwent a single- versus double-layered closure technique in anophthalmic surgery. However, this study compared patients with single-layer closure of Tenon’s

Figure 5

Table 4

Phthisis bulbi of right eye.

capsule and conjunctiva compared with patients treated with separate closure of these layers. In our article, we studied multiple-layer closure of sclera, Tenon’s capsule and conjunctiva [24]. This study compares the effectiveness of three common surgical eye reconstruction techniques. Few studies have compared the effectiveness and evaluated analgesic drugs on post-surgical pain between evisceration and enucleation [25—29]. In addition, these studies show better esthetic result when evisceration can be performed. Kim et al. and Coppens et al. have evaluated the effects of analgesic drugs (fentanyl and ketorolac) on pain release after EE but did not compare post-surgical pain score between these 3 surgical techniques [29]. In the ‘‘four petals’’ procedure optic nerve is not sectioned. This could be an explanation to the difference of post-surgical pain between ‘‘four petals’’ and ‘‘on-the-table’’ EE. In fact, section of the optic nerve is painful and can lead to a phantom eye pain syndrome [30]. Limitations of this study are the lack of a randomized procedure and the small number of patients in ‘‘russian doll’’ evisceration technique group. Analgesic drug intake and general anesthesia procedure was similar for the three groups, which reduce bias to evaluate pain after surgery. This study is a retrospective study with low-level evidence; however, our results shows that NRS mean, extrusion rate and facial revision surgery after the ‘‘four petals’’ procedure

Analgesic drugs intake.

During 24 hours after surgery

Analgesic drugs

‘‘Four petals’’ procedure

‘‘On-the-table’’ procedure

‘‘Russian doll’’ procedure

P-value

Paracetamol (g/day) (SD) Ketoprofen (mg/day) (SD) Tramadol (mg/day) (SD)

1.6 (0.9) 45 (60) 34.6 (61.7)

1.9 (1.2) 45 (62) 35.8 (52.3)

1.6 (0.8) 83 (79) 27.7 (66.6)

ns ns ns

ns: not significant; SD: standard deviation.

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Effectiveness and safety comparison of three eye and orbital reconstruction techniques in facial plastic surgery are lower than others procedures. These results could help for statistical future considerations if a randomized controlled study is to be conducted. Here, NRS results are consistent with studies on pain assessment in patients undergoing EE [31]. The use of each type of surgical evisceration technique depended on surgeon preference. Thus, this study aims to standardize and harmonize orbital techniques reconstruction in our center. Nevertheless, the ‘‘four petal’’ procedure cannot be performed in case of scleromalacia because of the high risk of postoperative extrusion. In fact, scleromalacia makes it difficult to create four scleral flaps. In this study, five surgeons performed these three different procedures, which could be a bias. However this bias is reduced by the numerous similar steps between the 3 procedures: similar preoperative and postoperative management, use of rifamycine during surgery, similar vicryl sutures, and temporary tarsorrhaphy created at the end of surgery. According to this study, the ‘‘four petals’’ EE technique seems to be the technique that allows lower extrusion rate and lower post-surgical pain surgery than other techniques. Evisceration is a widely accepted procedure for the treatment of painful eyes such as phthisis bulbi with facial disfigurement. In comparison with enucleation, the advantages of evisceration include relative tissue preservation, better cosmetic results, better motility for the prosthesis, and lower risk of intracranial infection or extrusion of the orbital implant [32]. However, orbital implant extrusion and anophthalmic socket syndrome remain as major risks of evisceration surgery [33]. In our study, no anophtalmic socket syndrome occurred. However, anophtalmic socket syndrome usually occurs after one year. Here, most of our patients were followed-up one year, which is a limitation of this study [34]. To solve problems of inadequate volume replacement with small implants and significant exposure risk, many surgeons recommend sclerotomies to allow the insertion of a larger implant deeper into the orbit, thus minimizing the risk of developing enophthalmos or increasing tension on the wound closure [35—37]. ‘‘Four petals’’ EE technique indeed allows the placement of a large implant (20 mm or larger) while reducing exposure rates [38]. ‘‘Four petals’’ EE

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technique includes quadrisection of the sclera and covering the implant with 4 layers of the sclera, which maintains implant with a solid anterior scleral wall, thus minimizing extrusion rates. Larger implants can be placed while suturing the wound without tension [38]. Both scleral flaps are overlapped anteriorly to avoid exposure. Suturing the Tenon capsule and the conjunctiva carefully in layers without tension is also a key factor for the prevention of implant exposure. Our extrusion or exposure rate after evisceration is similar to the one reported in others studies ranging from 0% to 2% [38]. Although extraocular muscles are positionned anteriorly in patients undergoing the ‘‘four-petal’’ procedure, the motility of the prosthesis remains good as evidenced by the low rate of surgical revision (Fig. 6) [38,39]. Whereas the motility of the ocular prosthesis was reduced in the ‘‘russian doll’’ procedure group, it was satisfactory in the ‘‘four petals’’ (Fig. 6) and the ‘‘on-the-table’’ procedure group (Fig. 7). However, the motility of the ocular prosthesis was better in the ‘‘four petals’’ procedure group than in the ‘‘on-the-table’’ procedure group. The smaller size of the orbital implant in the ‘‘russian doll’’ group seems to be the main explanation to this difference. Although the size of the implant does not appear to be statistically significant in our study, it plays an important role. A difference of 2 mm for the implants between the three groups probably explains the higher enophthalmos rate and the reduced prosthesis motility in the ‘‘russian doll’’ technique [39]. The rate of orbital lipofilling was much more important in the ‘‘russian doll’’ group. Ocular prosthesis has a key role in the final cosmetic result. Indeed, a residual postoperative enophthalmos can be improved by increasing the prosthesis volume [40]. The prosthetist must find a compromise regarding the prosthesis volume. Indeed, a big and ‘‘heavy’’ prosthesis can alter the inferior eyelid motion and decrease the prosthesis motility. In this kind of situation, the prosthetist must refer the patient to an oculoplastic surgeon to discuss an orbital lipofilling or a ptosis surgery. In our study, all the prosthesis worn postoperatively by the patients were made by the same ocular prosthetist. This reduces the bias to compare the final facial cosmetic result for each group.

Figure 6 Extensive motility of prosthesis (patient’s right) after ‘‘four petals’’ EE procedure. Patient is looking straight forward and in the four directions of gaze. Please cite this article in press as: Keilani C, et al. Effectiveness and safety comparison of three eye and orbital reconstruction techniques in facial plastic surgery. Ann Chir Plast Esthet (2019), https://doi.org/10.1016/j.anplas.2019.01.003

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Figure 7 Extensive motility of prosthesis (patient’s right) after ‘‘on-the-table’’ EE procedure. Patient is looking straight forward and in the four directions of gaze.

Conclusion The ‘‘four petals’’ EE technique seems to be a method that improves facial appearance and reduces implant extrusion rate and pain level after surgery. A randomized study is needed to confirm these results.

Financial disclosure The authors have no affiliations with any organization or entity with any financial interest or non-financial interest.

Disclosure of interest The authors declare that they have no competing interest.

Acknowledgments Pr. M. Paques, Dr. A. Beaugrand, H. Keilani, Dr. J. Meney.

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Please cite this article in press as: Keilani C, et al. Effectiveness and safety comparison of three eye and orbital reconstruction techniques in facial plastic surgery. Ann Chir Plast Esthet (2019), https://doi.org/10.1016/j.anplas.2019.01.003