Endoscopic full-thickness resection in the colorectum with a novel over-the-scope device: first experience.

BACKGROUND AND STUDY AIMS: Endoscopic full-thickness resection (EFTR) in the lower gastrointestinal tract may be a valuable therapeutic and diagnostic approach for a variety of indications. Although feasibility of EFTR has been demonstrated, there is a lack of safe and effective endoscopic devices for routine use. The aim of this study was to investigate the efficacy and safety of a novel over-the-scope device for colorectal EFTR. PATIENTS AND METHODS: Between July 2012 and July 2014, 25 patients underwent EFTR at two tertiary referral centers. All resections were performed using the full-thickness resection device (FTRD; Ovesco Endoscopy, Tübingen, Germany). Data were collected retrospectively. RESULTS: Indications for EFTR were: recurrent or incompletely resected adenoma with nonlifting sign (n = 11), untreated adenoma and nonlifting sign (n = 2), adenoma involving the appendix (n = 5), flat adenoma in a patient with coagulopathy (n = 1), diagnostic re-resection after incomplete resection of a T1 carcinoma (n = 2), adenoma involving a diverticulum (n = 1), submucosal tumor (n = 2), and diagnostic resection in a patient with suspected Hirschsprung's disease (n = 1). In one patient, the lesion could not be reached because of a sigmoid stenosis. In the other patients, resection of the lesion was macroscopically complete and en bloc in 20/24 patients (83.3 %). The mean diameter of the resection specimen was 24 mm (range 12 - 40 mm). The R0 resection rate was 75.0 % (18/24), and full-thickness resection was histologically confirmed in 87.5 %. No perforations or major bleeding were observed during or after resection. Two patients developed postpolypectomy syndrome, which was managed with antibiotic therapy. CONCLUSIONS: Full-thickness resection in the lower gastrointestinal tract with the novel FTRD was feasible and effective. Prospective studies are needed to further evaluate the device and technique.

Endoscopic removal of over-the-scope clips using a novel cutting device: a retrospective case series.

BACKGROUND AND STUDY AIMS: Over-the-scope clips (OTSCs; Ovesco Endoscopy, Tübingen, Germany) are extensively used for treatment of gastrointestinal perforations, leakages, fistulas, and bleeding. In this report, a new method of removing OTSCs using a prototype bipolar cutting device is described. PATIENTS AND METHODS: A total of 11 patients underwent endoscopic removal of an OTSC. The OTSC was cut at two opposing sites by a prototype device (DC ClipCutter; Ovesco Endoscopy). The remaining clip fragments were extracted using a standard forceps. RESULTS: Mean procedure time was 47 minutes (range 35 - 75 minutes). Cutting of the OTSC at two opposing sites was successful in all cases (100 %). Complete retrieval of all clip fragments was possible in 10 patients (91 %). The overall success rate for cutting and complete removal of the clip was 91 %. No major complications were observed. CONCLUSIONS: Removal of OTSCs with the prototype device was feasible and effective. The device may be valuable for OTSC removal in emergency as well as elective indications.

Do the blinds smell better?

If people lose a sense organ, there is thought to be an increase in the remaining sensory functions. Previous studies showed ambiguous results on this topic. In a prospective matched pair case-control study on 46 blind and 46 normal-sighted subjects, the olfactory performance was examined using the Sniffin' Sticks Test [threshold-discrimination-identification (TDI) test], determining the olfactory threshold, the identification and the discrimination performance. There was no significant difference between the groups. Neither the overall olfactory performance (TDI score) nor any of its subtests did correlate with the vision or with the duration of blindness. The study could not detect any superior smell abilities of blind subjects as compared to sighted subjects.

Durability of stochastic antireflective structures--analyses on damage thresholds and adsorbate elimination.

We fabricated stochastic antireflective structures (ARS) and analyzed their stability against high power laser irradiation and high temperature annealing. For 8 ps pulse duration and 1030 nm wavelength we experimentally determined their laser induced damage threshold to 4.9 (±0.3) J/cm(2), which is nearly as high as bulk fused silica with 5.6 (±0.3) J/cm(2). A commercial layer stack reached 2.0 (±0.2) J/cm(2). An annealing process removed adsorbed organics, as shown by XPS measurements, and significantly increased the transmission of the ARS. Because of their monolithic build the ARS endure such high temperature treatments. For more sensitive samples an UV irradiation proved to be capable. It decreased the absorbed light and reinforced the transmission.

A time-saving method for recording chemosensory event-related potentials.

The objective of this study was to reduce the recording duration of chemosensory event-related potentials (CSERP) and thereby to make the method more suitable for routine clinical use. Measurements were performed in the Department of Otorhinolaryngology of the university hospital of Cologne. Two protocols with different sequences [inter-stimulus intervals (ISI)-standard sequence: 30 s; PRS-15: pseudo-randomized sequence, mean ISI of 15 s] were applied to 40 volunteers to record CSERPs. To compare CSERP recordings under optimal and adverse test conditions, 20 younger/normosmic adults and 20 older/hyposmic participants were included in this study. Olfactory function was gauged using the "Sniffin'Sticks" test. For CSERP recordings, phenylethyl alcohol, hydrogen sulfide and carbon dioxide were used for olfactory or trigeminal stimulation, respectively. Both ISI protocols allowed recording CSERPs under optimal and adverse test conditions and distinguishing both groups by latencies (p ≤ 0.015). The time requirement for the recording of CSERPs with the PRS-15 sequence was less than 30 min. The pseudo-randomized sequence allowed the recording of diagnostically conclusive CSERPs in both groups and saved approximately 40% of the measuring time. This seems to be especially useful in cases where a yes/no answer (e.g., medical reports, exclusion of anosmia) is required. Shortening the time requirement significantly allows applying CSERPs to larger populations of patients with olfactory impairment.

Pro-inflammatory effects of ochratoxin A on nasal epithelial cells.

Eosinophilic chronic rhinosinusitis (ECRS) largely consists of allergic fungal sinusitis, non-allergic fungal rhinosinusitis, aspirin-exacerbated ECRS, and superantigen-induced ECRS. The pathophysiology of ECRS is not completely understood, in particular, the role of mycotoxins remains unknown. The aim of this study was to evaluate the effects of one of the most widespread mycotoxin, ochratoxin A (OTA), on the release of pro-inflammatory cytokines such as interleukin-(IL)-6 and the CXC-chemokine IL-8 from nasal epithelial cell cultures (NEC) of subjects with and without ECRS. NEC (ECRS group: n = 16; controls: n = 7) were stimulated with OTA for 24 h. Protein concentrations of IL-6 and IL-8 levels were measured in NEC supernatants by ELISA prior and 24 h after addition of OTA. Baseline levels in the supernatants of NEC were 183.3 pg/ml for IL-6 and 384.6 pg/ml for IL-8. Stimulation with OTA induced a significant increase of IL-6 (p < 0.001) and IL-8 (p < 0.001) in both NEC of controls and ECRS, respectively. There were no significant differences between controls and ECRS. This is the first study evaluating the effects of a mycotoxin on epithelial airway cells. Our data show that the ubiquitous mycotoxin OTA has a strong pro-inflammatory effect on NEC resulting in the release of IL-6 and IL-8. Mycotoxins may promote inflammation in nasal mucosa.

Parosmia is Associated with Relevant Olfactory Recovery After Olfactory Training.

OBJECTIVE/HYPOTHESIS: This study aims to determine the association between parosmia and clinically relevant recovery of olfactory function in patients with post-infectious olfactory dysfunction (PIOD) receiving olfactory training. STUDY DESIGN: Retrospective cohort study. METHODS: This was a retrospective cohort study of patients with PIOD that received olfactory training. Adult patients with the major complaint of quantitative smell loss were recruited and treated at several ENT clinics in German between 2008 and 2018. The outcome was based on the association between smell-loss related factors (including parosmia and phantosmia) and clinically relevant changes in overall and subdimension olfactory function of threshold, discrimination, and identification using binary logistic regression analysis. RESULTS: A total of 153 participants with PIOD were included. Clinically relevant improvements in overall olfactory function were more likely in those that had lower baseline olfactory function. Relevant improvements in discrimination function were more likely in those that had lower baseline olfactory function and those that had parosmia at the initial visit. Similarly, relevant improvements in odor identification were more likely in those that had a lower baseline olfactory function and in those who had parosmia at the first visit. Clinically significant improvements in odor threshold were more likely in those who were older in age. CONCLUSIONS: This study demonstrated that the presence of parosmia is associated with clinically relevant recovery in olfactory discrimination and identification function in patients with PIOD receiving olfactory training. LEVEL OF EVIDENCE: 4 Laryngoscope, 131:618-623, 2021.

Game-specific abilities in elite youth football players: validity and sensitivity to change of subjective coach ratings compared to objectively-assessed data.

BACKGROUND: Little is known on the accuracy of coaches' ratings of game-specific physical abilities in elite youth football players. The present study on elite youth football players aims to assess whether: 1) the coaches' subjective assessment of the level of performance of each athlete within the team is in accordance with objectively collected data; and 2) the coaches rate changes in the athletes' performance level accurately or not. METHODS: Data on jumping ability, sprinting speed, change of direction and strength were collected in seven age groups at a football youth academy (N.=150). The diagnostic battery was repeated after seven months (N.=138). Before the second session, the head coaches completed Likert-scaled closed questions on: 1) the importance of running speed and reactive strength components and their relevance to the individual game performance of each of their athletes; 2) the level of performance of their athletes; 3) the change between the first and second performance testing results. Validity and sensitivity of change of their ratings in comparison to the performance data were calculated using analyses of interrelationship. RESULTS: The data of the head coaches showed a low to medium effect size in the agreement with the performance data (Cohen's W=0.33-0.71). The evaluation of the change in level of performance was poorer (Cohen's W=0.04-0.2; not statistically significant). CONCLUSIONS: Our results underline that functional/physical testing twice during a season may be crucial for displaying performance levels of elite youth football players. Simple self-reported ratings by the coach may be valid in recent performance level assessment but not for performance changes.

Long-term results of surgical treatment for recurrent respiratory papillomatosis.

CONCLUSIONS: The presented results add further support to the observation that laser microsurgery is the preferential surgical treatment for recurrent respiratory papillomatosis (RRP). A meticulous follow-up for early recognition of local recurrence and malignant transformation is recommended. OBJECTIVES: Endoscopic microsurgery continues to be the treatment of choice for RRP. The aim of this study was to evaluate the outcome of patients treated surgically. We focused on demographic data, recurrence rates, and treatment-related complications. PATIENTS AND METHODS: The charts of 194 patients treated at our institution between 1963 and 1993 were analyzed retrospectively. RESULTS: In all, 64 patients (33%) underwent a total of 137 operations using the CO2 laser; 130 patients (67%) underwent a total of 565 microlaryngeal operations by surgery with cold instruments. Five percent of the patients treated with conventional microlaryngeal surgery and none of the patients treated with laser surgery required tracheostomy (p<0.05). Postoperative glottic webs and scar formations were found in 6% of all patients after laser surgery and 20% after conventional surgery (p<0.05). The different methods of treatment did not affect the rate of recurrence (p=0.61) Malignant transformation or secondary airway carcinoma were observed in 4% of all patients.

Proinflammatory effects of Staphylococcus aureus exotoxin B on nasal epithelial cells.

OBJECTIVE: The aim of this study was to evaluate the effects of Staphylococcus aureus exotoxin B (SE-B) on proinflammatory cytokine/chemokine releases in primary nasal epithelial cell cultures (NECC) of subjects with and without chronic rhinosinusitis (CRS). STUDY DESIGN AND SETTING: NECC (CRS: n = 14; CONTROLS: n = 11) were stimulated with SE-B. Protein concentrations of interleukin-(IL)-1beta, IL-6, and IL-8 levels were measured in NECC supernatants by ELISA before (T0) and after 24 hr stimulation with SE-B (T1). RESULTS: T0: supernatants of the NECC of CRS patients contained significant lower levels of IL-8 (2.1 ng/ml) compared to CONTROLS (IL-8: 6.2 ng/ml; P < 0.01). T1: SE-B induced a significant increase of IL-6 in NECC (P < 0.001). IL-1beta was not detectable. CONCLUSIONS: This is the first study evaluating the effects of exotoxins on NECC. SE-B showed proinflammatory effects on NECC. SIGNIFICANCE: Our data suggest that resident NECC are involved in immunological responses to Staphylococcus aureus toxins, supplementing the so-called "superantigen hypothesis" in CRS.

Comparison of a centered 32P source wire system with a noncentered 90Sr/Y brachytherapy system for intracoronary beta-radiation following PCI of diffuse in-stent restenosis.

BACKGROUND: We investigated the potential impact of differences in effective radiation dose between the centered Guidant 32P source wire system and the noncentered Novoste 90Sr/Y BetaCath system on clinical and angiographic outcomes of intracoronary brachytherapy for the prevention of in-stent restenosis. METHODS: From 10/00 to 05/04, a total of 400 patients underwent percutaneous coronary intervention (PCI) with brachytherapy for diffuse in-stent restenosis at our institution. Following balloon dilatation, patient Group A (n=200) was treated with the centered 32P Galileo source wire system, patient Group B (n=200) was treated with the noncentered 90Sr/Y BetaCath radiation system. In Group A, the prescribed dose of 20 Gy was applied in 1-mm depth of the vessel wall. In Group B, the prescribed dose of 18.4 Gy was applied for visual reference vessel sizes >2.7 and <3.35 mm, 23 Gy for >3.36 and <4.00 mm, and 25.3 Gy for >4.00 mm, each calculated at a distance of 2 mm from the center line of the radiation source. Patients received aspirin and clopidogrel over 12 months. Primary endpoint was target lesion revascularization (TLR) at 6 months. Secondary endpoints were the binary restenosis rate and major adverse cardiac event (MACE) at 30 days and 6 months. RESULTS: At 30 days, one patient of each group underwent PCI at a nontarget lesion (0.5%). At 6 months, MACEs were equally distributed in both groups. Target lesion revascularization at 6 months was 5.9% in Group A and 9.2% in Group B (P=.08). Binary angiographic restenosis rate at 6 months was 5.5% in Group A and 11.2% in Group B (P=.014). CONCLUSION: Intracoronary beta-radiation using the centered 32P source wire system yielded a significant reduction of recurrence rate compared to the noncentered 90S/Y BetaCath system after PCI of diffuse in-stent restenosis. There was a nonsignificant trend toward reduction of TLR among patients treated with the centered 32P source wire system.

Depth of olfactory sulcus and olfactory function.

The aim of this study was to identify whether the depth of the olfactory sulcus relates to olfactory function in healthy subjects. Forty-four healthy, male volunteers (age range 22-45 years, mean age 28.3 years) were included in this study. Olfactory function was measured for phenyl ethyl alcohol odor thresholds, odor discrimination, and odor identification. Magnetic resonance imaging of the olfactory sulcus was performed immediately following olfactometry. Based on previous investigations the depth of the olfactory sulcus was measured in the plane of the posterior tangent through the eyeballs. Olfactory function correlated significantly with left-sided depth of the olfactory sulcus (r(44)=0.33, P=0.03); no such correlation was seen for the right side. In addition, olfactory sulcus depth was found to be significantly deeper on the right compared to the left side (t=5.61, P<0.001). The present results suggest that there is small, but significant relation between morphological brain structures and measures of olfactory function. Further, lateralization of olfactory sulcus depth may correlate to functional lateralization in the olfactory system. Thus, it may be carefully speculated that sensory input in the olfactory system results in cortical growth in the area of the olfactory sulcus, at least at some developmental stage.

Impact of functional endoscopic sinus surgery on symptoms and quality of life in chronic rhinosinusitis.

OBJECTIVES: Chronic rhinosinusitis restricts the quality of life of millions of involved patients. The aim of the study was to evaluate how functional endoscopic sinus surgery modifies patients symptom profiles and quality of life. STUDY DESIGN: Open prospective clinical trial. METHODS: Questionnaires were given to 279 patients included in the series, who underwent sinus surgery at the Department of Otorhinolaryngology--Head and Neck Surgery, University of Cologne (Cologne, Germany) from 1995 to 1999. Patients assessed typical chronic rhinosinusitis--associated symptoms and restricted quality of life preoperatively and postoperatively using ranking scales (scales ranging from no to intolerable complaints). Statistical analyses were performed with the Wilcoxon test and Spearman rank correlation coefficient. RESULTS: Quality of life was restricted by chronic rhinosinusitis in 94% of all patients preoperatively and ranked as severe or intolerable in 74%. Leading symptoms of chronic rhinosinusitis were nasal obstruction in 92% and postnasal drip in 87%. Furthermore, patients reported dry upper respiratory tract syndrome in 68%, hyposmia in 66%, headache in 64%, and asthmatic complaints in 34%. After a mean postoperative follow-up of 31.7 months, an amelioration of quality of life was achieved in 85%, no change in 12%, and a deterioration in 3%. The ranking of restricted quality of life improved from "severe" to "mild" (P <.01) in the mean. Mainly responsible for this improvement was the postoperative decrease of nasal obstruction (84%), headache (82%), and postnasal drip (78%) (all P <.01), which correlated significantly with nasal obstruction (r = 0.59), headache (r = 0.39), and postnasal drip (r = 0.55), respectively (all P <.01) with better quality of life. CONCLUSIONS: The leading complaints within the symptom profile of patients with chronic rhinosinusitis are airway obstruction and postnasal drip. The restriction of quality of life in patients with chronic rhinosinusitis is mainly caused by these symptoms, which can be improved in excellent fashion by functional endoscopic sinus surgery in the majority of patients, achieving better quality of life in the long term.

Suspension laryngoscopy for endotracheal stenting.

OBJECTIVES/HYPOTHESIS: Airway stents have recently been used to establish and maintain patent airways in patients with malignant central airway obstruction, but insertion modalities remain controversial to date. The study seeks to determine the role of suspension laryngoscopy in interdisciplinary airway stenting. STUDY DESIGN: Retrospective, single-institution analysis of a case series treated by a multidisciplinary airway team. METHODS: Ninety-three consecutive patients with malignant obstruction of the trachea and/or tracheobronchial bifurcation underwent endotracheal stenting through a suspension laryngoscopy approach for the relief of impending respiratory distress. Feasibility, mortality, survival, and complications were analyzed as main outcome measures. RESULTS: Stenting through a suspension laryngoscopy approach was feasible 91 of 93 patients (97.8%). Fifteen patients needed repeated stenting, and in all, 121 stents were implanted during the observation period. This approach allowed for the repeated insertion of rigid bronchoscopes of graded sizes to establish an airway and for precise stent positioning. Optical instruments and stent introducer systems could easily be used while adequate ventilation was continuously maintained. Silicone stents of maximal size were inserted without injury of the vocal cords during intubation. Median survival for all patients was 8 months. No intraoperative airway complications were observed, and no patient died secondary to stenting. CONCLUSIONS: Suspension laryngoscopy and jet ventilation provide an ideal setting for the precise placement of tracheal and bifurcation airway stents. Laryngologists should actively participate in interdisciplinary airway stenting programs.

Clinical assessment of retronasal olfactory function.

OBJECTIVES: To develop a test kit for the simple assessment of retronasal olfactory function and to compare orthonasal and retronasal olfactory function in healthy subjects and patients with olfactory disorders. DESIGN AND PATIENTS: We tested 230 individuals with normosmia, hyposmia, and anosmia using grocery-available powders. Initially, 30 different substances were investigated. Subjects identified each substance using a list with 4 verbal items (forced choice). After preliminary experiments, 20 items were selected according to the degree to which they were identified by normosmic and anosmic subjects. Orthonasal olfactory function was assessed psychophysically using "sniffin' sticks," which includes tests for odor identification, discrimination, and butanol odor thresholds. In addition, anosmia was confirmed electrophysiologically by means of olfactory-evoked potentials. RESULTS: In healthy subjects, there was a test-retest reliability correlation of r(27) = 0.76 for retronasal olfactory function, which is similar to other odor identification tests. Retronasal testing in normosmic subjects allowed for the discrimination of sex-related differences, with women scoring higher than men (P =.007), and the identification of a slight decrease with age (r(120) = -0.20; P =.03). Orthonasal and retronasal identification of odors was found to correlate (r(86) = 0.78; P<.001). Retronasal testing allowed for the discrimination between normosmia, hyposmia, and anosmia (P<.001). In addition, retronasal performance of anosmic patients appeared to improve with duration of anosmia (P =.03). No difference was found between patients with anosmia of different origin. CONCLUSION: Results of the present investigation indicate that the assessment of retronasal olfactory function is possible using oral stimulus presentation.

Nasal colonization with Staphylococcus aureus is not associated with the severity of symptoms or the extent of the disease in chronic rhinosinusitis.

OBJECTIVES: There is an increasing knowledge that the severity of perennial allergic rhinitis is associated with nasal carriage of Staphylococcus aureus (S. aureus). The aim of this study was to evaluate the rate of bacterial colonization with S. aureus in the nose of subjects with and without chronic rhinosinusitis (CRS) and to correlate these findings with the severity of symptoms and the extent of the disease. STUDY DESIGN AND SETTING: Open, prospective controlled trial. METHODS: 190 subjects with CRS and 42 subjects with septal deviation without sinusitis (control subjects) were included in this study. Swabs were taken endoscopically from the middle meatus and bacteria were cultured and identified. Airway symptoms were assessed by subjects in standardized questionnaires and frequencies of respiratory tract infections were noted. The rhinosinusitis extent was graded by CT scan assessment. Analysis of variance, chi-square test, and Pearson's correlation test were applied for statistical analyses. RESULTS: The S. aureus carriage rate was 25.5% in CRS and 31.4% in control subjects. Further facultative pathogens were cultured in 20.6% of subjects with CRS and in 8.5% of controls. 73.8% of S. aureus were ampicillin-resistant, multiresistant strains were cultured in 5.8%. Most airway symptoms and the frequencies of respiratory tract infections were significantly higher in the CRS group compared with control subjects. In post hoc comparison between the subgroups with and without S. aureus colonization, no significant differences were found between the extent of rhinosinusitis and the severity of airway symptoms. CONCLUSIONS: Facultative pathogens were detected in more than 40% of CRS patients without acute respiratory tract infections. In contrast to the findings in atopic dermatitis and perennial allergic rhinitis, the colonization rate with S. aureus is not increased and S. aureus carriage is not a risk factor for the severity or the extent of rhinosinusitis.

Olfactory changes at threshold and suprathreshold levels following septoplasty with partial inferior turbinectomy.

Partial inferior turbinectomy with septoplasty is routinely carried out for airway obstruction. However, its effects on the sense of smell have not been systematically evaluated. The aim of this prospective study was to evaluate the influence of septoplasty with partial inferior turbinectomy on threshold and suprathreshold olfactory acuity. The subjects were 30 patients undergoing septoplasty including partial inferior turbinectomy. Olfactory function was determined by the "Sniffin' Sticks," which allow the assessment of odor thresholds, odor discrimination, and odor identification. The patients rated both olfactory function and nasal airflow using visual analog scales. Nasal airflow was measured by anterior rhinomanometry. Multivariate analyses of variance for repeated measures were used to analyze the results before and after surgery (mean interval, 9.1 weeks). After operation, 87% of the patients had increased airflow, 80% had improved olfactory function in terms of odor identification, and in 70% odor discrimination was found to be improved - but only 54% had improved olfactory function in terms of odor thresholds. Surgery increased ratings of nasal airflow in 93%, and those of olfactory function in 77% (p < .001). Similarly, bilateral inspiratory nasal flow increased (p < .001) and olfactory function was improved (p < .001) after surgical treatment. However, this increase was most pronounced for suprathreshold tests, while it was moderate for odor thresholds (interaction "surgery" x "olfactory test," p = .001). The present investigation suggests that septoplasty in combination with inferior turbinectomy has a beneficial effect on olfaction, mainly on suprathreshold olfactory functions. This effect may be partly due to interactions between the increased perception of nasal airflow and cognitive factors involved in olfactory sensitivity. According to the present results and data from the literature, a moderate decrease of olfactory function appears to occur in as many as 20% of patients. However, anosmia seems to be an extremely rare complication of septoplasty and partial turbinectomy.

Complications of suspension laryngoscopy.

Although suspension laryngoscopy (SL) is routinely used in operative laryngology, no prospectively gathered data on the complications of this procedure have so far been available. We prospectively analyzed 339 consecutive procedures for intervention-related complications. The survey included preoperative dental status and assessment of postoperative dental, mucosal, and nerve injuries. Minor mucosal lesions were found in 75% of all patients. All healed spontaneously within a few days. Dental injuries occurred in 6.5% of all patients. These were more frequent in therapeutic laryngoscopy than in diagnostic procedures (6.8% versus 6.0%). Highly significant correlations were found between dental injury rate and preoperative dental disease (p < .04) and grade of periodontitis (p <.001). Temporary nerve lesions were observed in 13 patients (9 of the lingual nerve and 4 of the hypoglossal nerve). Although minor complications frequently occur during SL, it is a relatively safe procedure with a low risk of significant morbidity.