Outcomes of Immediate versus Delayed Autologous Reconstruction in the Setting of Post-Mastectomy Radiation Therapy: A Meta-analysis.

INTRODUCTION: Post-mastectomy autologous breast reconstruction can be immediate (IBR) or delayed (DBR). The safety of performing IBR and the impact of radiation on the newly reconstructed breast is not yet validated. METHODS: A Pubmed, EMBASE, and Google scholar search was conducted from inception to September 17th 2023. We included comparative studies that assessed complications or aesthetic outcomes of IBR versus DBR in the setting of post-mastectomy radiotherapy (PMRT). RESULTS: The search identified 2693 articles. Thirteen were eligible for inclusion. A total of 565 patients underwent IBR followed by radiotherapy while 699 had DBR. Mean follow-up time and age for both groups were comparable (p > 0.1). None of revision surgery, infection, total flap failure, seroma, hematoma, dehiscence, or delayed wound healing was significantly different across groups (p > 0.1). IBR was found to have a higher risk of flap fibrosis (OR 28.18 [5.15 - 154.12]; p = 0.0001, I 2 of 44%) and skin flap necrosis (OR 6.12 [2.71 - 13.82]; p < 0.0001, I 2 of 27%) but a lower risk of partial flap failure (OR 0.18 [0.06 - 0.58]; p 0.004, I 2 of 0%) when compared to DBR. Results of fat necrosis should be interpreted with caution. Patient-reported as well as objective aesthetic outcomes were mostly comparable between groups. CONCLUSION: IBR in the setting of PMRT is increasingly being performed and poses a specific set of challenges that surgeons usually consider. The choice between IBR or DBR in the setting of PMRT should be an individualized decision based on patient risk factors and desires. LEVEL OF EVIDENCE: III.

Pain and Functional Outcomes following Targeted Muscle Reinnervation: A Systematic Review.

BACKGROUND: It is estimated that by 2050, a total of 3.6 million patients will be living with an amputation in the United States. The objective of this systematic review is to evaluate the effect of targeted muscle reinnervation (TMR) on pain and physical functioning in amputees. METHODS: A literature search was performed on PubMed, Embase, and MEDLINE up to November 28, 2021. Clinical studies assessing the outcomes of TMR (pain, prosthesis control, life quality, limb function, and disability) were included. RESULTS: Thirty-nine articles were included. The total number of patients who underwent TMR was 449, and 716 were controls. Mean follow-up was 25 months. A total of 309 (66%) lower-limb and 159 (34%) upper-limb amputations took place in the TMR group, the most common being below-knee amputations (39%). The control group included a total of 557 (84%) lower-limb and 108 (16%) upper-limb amputations; the greatest proportion being below-knee amputations in this group as well (54%). Trauma was the most common indication for amputation. Phantom limb pain scores were lower by 10.2 points for intensity ( P = 0.01), 4.67 points for behavior ( P = 0.01), and 8.9 points for interference ( P = 0.09). Similarly, residual limb pain measures were lower for cases for intensity, behavior, and interference, but they failed to reach significance. Neuroma symptoms occurred less frequently, and functional and prosthesis control outcomes improved following TMR. CONCLUSION: The literature evidence suggests that TMR is a promising therapy for improving pain, prosthesis use, and functional outcomes after limb amputation.

Preferred Nasolabial Angle in Rhinoplasty: A Cross-Sectional Analysis.

BACKGROUND: The perception of an ideal nose is influenced by a variety of factors, with demographic characteristics playing a significant role in what is considered an ideal nose. The nasolabial angle (NLA) is considered one of the defining features shaping the nose. OBJECTIVES: In this study we set out to capture the perception of the ideal nasolabial angle among Canadian, Saudi, Kuwaiti, and Lebanese populations. METHODS: An online questionnaire-based cross-sectional study was conducted to investigate the ideal nasolabial angle among Canadian, Saudi, Kuwaiti, and Lebanese populations (n = 197). Participants were patients attending outpatient clinics, plastic surgery residents, and medical students. The questionnaire included demographics and the perception of respondents of the ideal NLA for each gender: male (85°, 90°, 95°, 100°, 110°) and females (95°, 100°, 110°, 115°). RESULTS: The majority of respondents were female (81.2%), ages between 20 and 39 (84.3%). The mean and standard deviation of ideal NLA choices in both male and female models were 97.1 ± 6.39 and 109.5 ± 5.32, respectively. The ideal male NLA choices were found to correlate significantly with age (P = .044) and work status (P = .019). In choosing the ideal female NLA, age was a significant factor (P = .012). CONCLUSIONS: Identifying the ideal NLA is essential to establishing aesthetic goals for patient and surgeon alike. It is important to understand the effects of demographics on the choice of the ideal NLA, which ultimately influences the planning and outcome of the rhinoplasty procedure.

Aesthetic Surgery Before-and-After Photography Bias on Instagram.

PURPOSE: This study aims to systematically assess body and facial aesthetic surgery before-and-after photography bias on Instagram. METHODS: An Instagram search using the term "plastic surgeon" was conducted on October 2020. The top 11 plastic surgeons' accounts were selected, and the first 15 images were selected from these profiles pertaining to different anatomical locations. Each photo was analyzed by a blinded board-certified plastic surgeon utilizing a 5-domain clinical photography bias score. The domains covered: (1) photo quality; (2) photo background; (3) position; (4) exposure/coverage; (5) bias. RESULTS: The search strategy identified a total of 161 sets of before and after. The most common anatomical site posted was the nose (n=47), followed by breasts (n=37). The most common angles posted were anterior-posterior view (n=61). The majority of images showed bias toward the post-operative image (70.8%). The main culprit with photo characteristics occurred due to there being a different post-operative background which was more flattering for the post-operative result (n=46, p=0.006) and a different view or angle, which again, flattered the post-operative image (n=36, p=0.02). Other factors that influenced the post-operative bias included photos of the patient covered with clothing (n=15, p=0.014) or standing (n=20, p=0.001), compared to a supine pre-operative image. CONCLUSION: Before-and-after photography conditions in aesthetic surgery is biased toward the post-operative result on Instagram. This observation was noticed across all surgical anatomical areas. Accounts photographer tends to misrepresent the photo background, view of angle, patients pose or position, or covering certain body parts. LEVEL OF EVIDENCE IV: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

Cancer Metastases to the Hand: A Systematic Review and Meta-analysis.

BACKGROUND: Metastatic lesions to the hand or wrist are rare and can mimic inflammatory and benign processes such as gout and infections. This often leads to misdiagnosis, underreporting, and delays in treatment. The purpose of this study was to examine all known cases of metastasis to the hand or wrist available in the literature and to analyze demographic trends, metastasis characteristics, and clinical course, and provide recommendations for management. METHODS: An online systematic review of MEDLINE, Embase, PubMed, and the Cochrane Library from inception to January 7, 2022, was completed. Studies outlining the care of a patient with acrometastases of the hand were included. Data extracted included age, sex, site of primary tumor and metastasis, presence of other metastases, time from primary diagnosis to acrometastasis diagnosis, misdiagnosis, treatment, and survival. RESULTS: Between 1889 and present, 871 lesions were described in 676 patients who met the inclusion criteria. There was no predilection for hand dominance or site of previous trauma. The mean age among patients was 59.5 (1.5-91) years, and male sex was more common (64.6%). The most common primary cancer source was the lung (39.2%), followed by the kidney (10.8%). The distal phalanx was the most frequently cited tumor location (33.7%). Mean survival after diagnosis of acrometastasis was 6.3 months (0.25-50) ± 11.5 months. CONCLUSION: Acrometastasis remains an uncommon presentation of metastatic disease with poor prognosis. Treatment currently focuses on pain management and optimizing functional outcomes. Our review led to the development of 7 treatment recommendations when managing these patients.

Do Plastic Surgery Residents Get Sued? An Analysis of Malpractice Lawsuits.

Trainees may be implicated in malpractice lawsuits. Our study examines malpractice cases involving plastic surgery trainees. Methods: Using the LexisNexis database, verdicts and settlements from appellate state and federal cases between February 1988 and 2020 were queried. A nonrepresentative sample of 300 cases was compiled. Results: During a 32-year period, 21 lawsuits involving plastic surgery trainees were identified. Of these, 14 (66.67%) involved claims when a trainee was directly named as a defendant. Eighteen (85.7%) cases were due to procedural-related adverse outcomes, while three (14.3%) cases were associated with clinical or diagnostic-related adverse outcomes. Of the procedure-related cases, five (27.8%) occurred when the trainee was the lead surgeon. Allegations included lack of informed consent of procedure complications (11, 52.4%), procedural error (11, 52.4%), failure to supervise trainee (11, 52.4%), inexperience of trainee (eight, 38.1%), incorrect diagnosis or treatment (five, 23.8%), delay in evaluation (three, 14.3%), lack of awareness of resident involvement (three, 14.3%), lack of follow-up (three, 14.3%), and prolonged operative time (one, 4.8%). Median time from injury to lawsuit resolution was 3.8 years [interquartile range (IQR), 3-5 years]. Verdicts were ruled in favor of the defense in eight (38.1%) cases and for plaintiff in six (28.6%) cases. A settlement was made in seven (33.3%) cases. Median payout for plaintiff-won cases was $5,100,000 (IQR, $1,530,000-$17,500,000); the median settlement was $2,500,000 (IQR, $262,500-$4,410,000). Conclusions: Procedural error, improper informed consent, improper trainee supervision, and resident inexperience were the most common allegations. These factors can lead to financial and psychological burdens early in a physician's career.

Outcomes of Free Muscle Flaps versus Free Fasciocutaneous Flaps for Lower Limb Reconstruction following Trauma: A Systematic Review and Meta-Analysis.

BACKGROUND: Free flap reconstruction of the lower limb following trauma often suffers higher complication rates than other areas of the body. The choice of muscle or fasciocutaneous free flap is an area of active debate. METHODS: A systematic review of EMBASE, MEDLINE, PubMed, and Cochrane Register from inception to April 1, 2022 was performed. Articles were assessed using the methodological index for non-randomized studies instrument. The primary outcome was to assess and compare the major surgical outcomes of partial or total flap failure, reoperation, and amputation rates. RESULTS: Seventeen studies were included. All studies were retrospective in nature, of level three evidence, and published between 1986 and 2021. The most common muscle and fasciocutaneous free flaps used were latissimus dorsi flap (38.1%) and anterolateral thigh (ALT) flap (64.8%), respectively. Meta-analysis found no significance difference in rates of total flap failure, takeback operations, or limb salvage, whereas partial flap failure rate was significantly lower for fasciocutaneous flaps. The majority of studies found no significant difference in complication rates, osteomyelitis, time to fracture union, or time to functional recovery. Most, 82.4% (14/17), of the included studies were of high methodological quality. CONCLUSION: The rate of total flap failure, reoperation, or limb salvage is not significantly different between muscle and fasciocutaneous free flaps after lower limb reconstruction following trauma. Partial flap failure rates appear to be lower with fasciocutaneous free flaps. Outcomes traditionally thought to be managed better with muscle free flaps, such as osteomyelitis and rates of fracture union, were comparable.

Complications Post Abdominoplasty After Surgical Versus Non-surgical Massive Weight Loss: a Comparative Study.

PURPOSE: This study aims to investigate the rate of short- and long-term complications as well as the need for operative revisions after abdominoplasty for patients following surgical versus non-surgical weight loss methods. METHODS: This is a retrospective chart review that enrolled consecutive patients undergoing abdominoplasty across a 5-year period, aged 18 years and above, opting for abdominoplasty after weight loss achieved through bariatric surgery or diet and exercise alone. RESULTS: A total of 364 patients lost weight through bariatric surgery and 106 by diet and exercise alone. There were no significant differences in comorbidity status, but past body mass index (BMI) was higher for the surgical weight loss (SW) group (47.6 ± 10.2 and 40.4 ± 8.6, respectively; p value < 0.0001). Percent excess weight loss (EWL) was 68 ± 14.5 for the SW group and 55.7 ± 19.4 for the NSW group, p value < 0.0001. Pre- and postoperative blood hemoglobin levels were significantly lower in the SW group (p < 0.05). Neither short-term complications (thromboembolic events, wound complications, or infections) nor long-term complications (umbilical deformity, delayed wound healing, or infection) and operative revisions were significantly different across both groups (p > .05). CONCLUSION: Bariatric surgery does not increase the risk of short- or long-term complications or the need for operative revision after abdominoplasty.

Role of Electrical Stimulation in Peripheral Nerve Regeneration: A Systematic Review.

Functional recovery after peripheral nerve injury is often suboptimal despite the intrinsic permissive growth environment of the peripheral nervous system. The objective of this systematic review is to explore the use of electrical stimulation (ES) for peripheral nerve regeneration. Methods: A systematic literature search was conducted from inception to March 2, 2021 to retrieve articles on ES for peripheral nerve regeneration using the PubMed, Ovid MEDLINE, and Embase databases. Primary outcome measures included objective measures of motor and sensory nerve function. Results: Four randomized control trials, two case reports, and three case series that addressed the aims were identified. The stimulation parameters varied greatly between studies, without an apparent commonality for a given electrical conduit. Outcomes measured included motor (n = 8) and sensory (n = 7) modalities (cold detection, static two-point discrimination, tactile discrimination, and pressure detection), nerve-specific muscle function and bulk, and electromyography (EMG) motor and sensory terminal latency. Different parameters for measurement were utilized and improvement was observed across the studies compared with controls (n = 4) or pre-intervention measurements (n = 5). One randomized control trial reported no benefit of ES and attributed their findings to their stimulation protocol. Complications were documented in three patients only and included wire remnant removal, skin pigmentation, and bone formation. Conclusions: ES in peripheral nerve regeneration is beneficial in improving and accelerating recovery. A meta-analysis was not performed due to the heterogeneity, but all studies showed positive findings and minor to no complications. These results provide a primer for further development of delivery methods.

The Effect of Hypothyroidism on Surgical Outcomes Postabdominoplasty: A Case-control Study.

Hypothyroidism is common in surgical patients. The objective of this study is to determine the rate of short- and long-term complications after abdominoplasty for patients treated for hypothyroidism. METHODS: This is a retrospective chart review that enrolled consecutive patients undergoing abdominoplasty across a 5-year period. Cases had a preoperative diagnosis of overt hypothyroidism requiring thyroid replacement therapy, whereas controls are without thyroid disease. Groups were matched by age, gender, comorbidity status (hypertension and diabetes), smoking, and center of surgery in a 3:1 ratio. RESULTS: There was a total of 61 cases and 183 matched controls followed up for 18 months; most were women (n = 240, 98%) and between the ages of 31 and 45 years (n = 142, 58%). There were no significant differences between cases and controls in any of the sociodemographic and comorbidity status except for current BMI, which was higher for cases than the control (P < 0.05). The proportions of all other infections (4.5% versus 1.6%), wound dehiscence (4.7% versus 0.8%), dermatitis (4.7% versus 1.6%), and necrosis (2.3% versus 0%), hematoma (4.7% versus 2.5%) and seroma (2.3% versus 1.6%) formation were higher in cases but not significant (P > 0.05). LTCs were not statistically different across groups (P > 0.05). CONCLUSION: This study did not find a significantly different higher risk of complications after abdominoplasty for patients treated for hypothyroidism.

Autologous Versus Alloplastic Reconstruction for Patients with Obesity: A Systematic Review and Meta-analysis.

BACKGROUND: Autologous flaps may have superior outcomes when compared to implant breast reconstruction in patients with obesity. To date, no published review has illustrated the superiority of autologous to implant-based reconstruction in this study group in terms of aesthetics outcomes and surgical complications. METHODS: A systematic search was conducted on PubMed, Cochrane, Google Scholar, and Embase from inception to December 31, 2020. Studies comparing the outcomes (patient satisfaction and complications) of autologous versus implant-based reconstruction in patients with BMI > 30 were selected. RESULTS: The search yielded 1633 articles, of which 76 were assessed in full text. A total of 12 articles fit inclusion for qualitative review; of them, 7 were meta-analyzed. Autologous reconstruction had a lower incidence of infection (OR 0.74 [95% CI 0.59, 0.92]), hematoma/seroma formation (OR 0.34 [95% CI 0.23, 0.49]), and reconstructive failure (OR 0.47 [95% CI 0.36, 0.62]), but not skin necrosis (OR 0.95 [95% CI 0.73, 1.25]) or wound dehiscence (OR 1.03 [95% CI 0.72, 1.49]) when compared to implant-based reconstruction. Deep vein thrombosis (DVT) and pulmonary embolism occurred more frequently with autologous versus alloplastic reconstruction (OR 2.21 [95% CI 1.09, 4.49] for DVT and OR 2.49 [95% CI 1.13, 5.48] for PE). BREASTQ scores were higher for the autologous breast reconstruction when compared to implant-based group, but failed to reach significance (p value >0.05). CONCLUSION: The current evidence in the literature suggests that autologous breast reconstruction has lower surgical complication rate when compared to implant-based reconstruction at the expense of higher risk of thrombotic complications for patients with BMI > 30. LEVEL OF EVIDENCE III: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

A Study Examining the Orbera365 Intragastric Balloon Safety and Effects on Weight Loss.

INTRODUCTION: The Orbera365 is a new balloon that can stay in the stomach for up to 12 months. The aim of this study is to investigate the safety and effect of Orbera365. METHOD: Prospective study on our initial experience with a consecutive group of patients who underwent the insertion of Orbera365 in the period between September 2019 and August 2020. The patients were followed up to assess, pain, nausea, and vomiting after procedure, weight loss, and the complication rate. RESULTS: A total of 97 patients underwent Orbera365 placement. Mean weight and BMI before the procedure were 93.8 ± 15.2 kg and 35.2 ± 4.4 kg/m2, respectively, which dropped to 80.6 ± 13.1 kg and 29.8 ± 4.0 kg/m2 by 8.2 months and were 82.4 ± 16.1 and 30.4 ± 4.6 at the last day of follow-up of 12.9 months. Fourteen patients did not tolerate the balloon, and had to have it removed, six of them in the first week, and eight within the first 8 months of insertion. Other than intolerance, two patients had balloon rupture, three patients had leakage at time of insertion requiring balloon replacement, two patient had pancreatitis, one patient had spontaneous balloon hyperinflation, and one patient had balloon deflation and vomited the balloon. At day of last follow-up, total body weight loss % (TBWL%) was 16.2 ± 10.1 and %EWL was 54.6 ± 38.3. CONCLUSION: Orbera365 is safe and effective for weight loss.

Angiotensin-Converting Enzyme (ACE) Inhibitors and Angiotensin Receptor Blockers (ARB) Are Protective Against ICU Admission and Mortality for Patients With COVID-19 Disease.

Introduction: Corona Virus disease 2019 (COVID-19) caused by the Severe Acute Respiratory Syndrome coronavirus 2 (SARS-CoV-2) has become a global pandemic. The aim of this study was to investigate the impact of being on an Angiotensin-Converting Enzyme Inhibitors (ACEI) and/or Angiotensin Receptor Blockers (ARB) on hospital admission, on the following COVID-19 outcomes: disease severity, ICU admission, and mortality. Methods: The charts of all patients consecutively diagnosed with COVID-19 from the 24th of February to the 16th of June of the year 2020 in Jaber Al-Ahmed Al-Sabah hospital in Kuwait were checked. All related patient information and clinical data was retrieved from the hospitals electronic medical record system. The primary outcome was COVID-19 disease severity defined as the need for Intensive Care Unit (ICU) admission. Secondary outcome was mortality. Results: A total of 4,019 COVID-19 patients were included, of which 325 patients (8.1%) used ACEI/ARB, users of ACEI/ARB were found to be significantly older (54.4 vs. 40.5 years). ACEI/ARB users were found to have more co-morbidities; diabetes (45.8 vs. 14.8%) and hypertension (92.9 vs. 13.0%). ACEI/ARB use was found to be significantly associated with greater risk of ICU admission in the unadjusted analysis [OR, 1.51 (95% CI: 1.04-2.19), p = 0.028]. After adjustment for age, gender, nationality, coronary artery disease, diabetes and hypertension, ICU admission was found to be inversely associated with ACEI use [OR, 0.57 (95% CI: 0.34-0.88), p = 0.01] and inversely associated with mortality [OR, 0.56 (95% CI: 0.33-0.95), p = 0.032]. Conclusion: The current evidence in the literature supports continuation of ACEI/ARB medications for patients with co-morbidities that acquire COVID-19 infection. Although, the protective effects of such medications on COVID-19 disease severity and mortality remain unclear, the findings of the present study support the use of ACEI/ARB medication.

Body Contouring Surgery Improves Weight Loss after Bariatric Surgery: A Systematic Review and Meta-Analysis.

INTRODUCTION: Our main objective is to evaluate the effect of body contouring surgery (BCS) on the magnitude and durability of weight loss after bariatric surgery. METHODS: Medline, EMBASE, Cochrane, and Scopus search were conducted from the time of their inception to June 2020. We included comparative studies that assessed weight progression, in terms of Body Mass Index change (∆BMI), Total Body Weight Loss (TBWL%), and Excess Weight Loss (%EWL) for the post-bariatric patient population and the effect of BCS on weight progression. RESULTS: Eleven articles were included. The pooled sample size was 2307, of which 691 were cases who underwent BCS post-bariatric surgery, and 1616 were comparative controls. The mean follow-up time for cases and controls were 61.6 ± 23.8 months and 52.2 ± 23.8 months, respectively. Nine studies reported results of BMI changes, six provided %EWL, and five used %TBWL. Significant improvement in weight loss was observed in the BCS group when measured by either ∆BMI (3 kg/m2 points decrease, p 0.023), %TBWL (6% increase, P < 0.0001), or %EWL (14% increase, P < 0.0001). Sub-group analysis showed that increased follow-up time was associated with higher TBWL% (p 0.02). CONCLUSION: The evidence provided in this review strongly supports the added long-term benefits of body contouring surgery for selected patients after massive weight loss following bariatric surgery. Having a multidisciplinary team that involves a bariatric and a plastic surgeon as well as nutritionists and psychologists for the management of patients with obesity going through the bariatric pathway is recommended. LEVEL OF EVIDENCE III: This journal requires that authors assign a level of evidence to each article. For a full description of these evidence-based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266.

The Safety and Efficacy of One Anastomosis Gastric Bypass as a Revision for Sleeve Gastrectomy.

INTRODUCTION: Failure of sleeve gastrectomy poses a potential challenge for surgeons as variable options exist for revision. One anastomosis gastric bypass (OAGB) is a potential revisional option, and in this study, we sought to determine the safety and efficacy of OAGB post sleeve gastrectomy. METHOD: Prospective study on our initial experience with a consecutive group of patients who underwent OAGB as a revisional surgery for sleeve gastrectomy in the period between January 2015 and December 2018 was carried out. Morbidity and mortality data were recorded as well as the effect on comorbidities and weight loss. RESULTS: A total of 56 patients underwent OAGB as a revision of sleeve gastrectomy. The average weight prior to OAGB was 112 ± 24.6 kg. The minimum weight they have reached after is 85 ± 21.3 kg after a duration of 19 ± 9.2 months. Percentage of total weight loss (TWL%) at 1, 3, 6, and 12 months postoperatively was found to be 7.6%, 9.8%, 14.1%, and 28.8%, respectively. TWL% on the last day of follow-up was 24%. Two patients had marginal ulcers, in which one had a perforation. CONCLUSION: OAGB is safe and effective for weight regain post sleeve gastrectomy.

Endoscopic versus laparoscopic management of an eroded mesh in vertical banded gastroplasty: video case series and literature review.

Vertical banded gastroplasty (VBG) was one of the most common bariatric surgeries worldwide in the beginning of the 21st century. However, recently we have increasingly encountered its long-term complications. We present two cases of VBG mesh erosion, alongside videos for their management. The first is of a 35-year-old female that presented 10 years after her VBG, while the second is of a 38-year-old female presenting 9-years post hers. Patient one presented with weight regain, regurgitation, epigastric pain, and dysphagia. CT imaging showed staple-line dehiscence and foreign body inside the stomach. Patient 2's presentation was of weight regain. Upon further workup, she was diagnosed with mesh erosion. In case 1, an endoscopic approach was taken using Soehendra lithotriptor device, while for case 2, a laparoscopic approach was undertaken. Endoscopic management of mesh erosion post-VBG is not only safe and feasible but also less invasive and time-consuming than the laparoscopic technique.

The Safety and Efficacy of Procedureless Gastric Balloon: a Study Examining the Effect of Elipse Intragastric Balloon Safety, Short and Medium Term Effects on Weight Loss with 1-Year Follow-Up Post-removal.

INTRODUCTION: The Ellipse intragastric balloon (EIGB) is a new swallowable balloon that does not require endoscopy at insertion or removal. The aim of this study is to investigate the safety of EIGB and its efficiency in weight reduction even after 1 year of expulsion. METHOD: Prospective study on our initial experience with a consecutive group of patients who underwent the insertion of EIGB in the period between September 2016 and February 2017. The patients were followed up to assess pain, nausea, and vomiting after procedure. As well as, the time of balloon extraction, route of extraction, and weight loss. RESULTS: Total of 112 patients underwent EIGB placement. A 1-year follow-up was obtained on 85% of patients. Mean weight and BMI before the procedure 92.2 kg and 34.3 kg/m2, respectively. One patient had small bowel obstruction. Six patients did not tolerate EIGB and three patients had early deflation. Total weight loss % (TWL%) 10.7, 10.9, and 7.9% at 3, 6, and at date of last follow-up. When data were stratified according to BMI into two groups: group 1 (BMI 27.5-34.9) and group 2 (BMI 35-49), the TWL% for group 1 at 3 months, 6 months, and last day of follow-up are as follows: 10.2%, 10.6%, and 8.8%, while it was 11.5%, 11.2%, and 6.6% for group 2. CONCLUSION: EIGB are effective, safe, and feasible non-invasive method for weight loss.