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BACKGROUND: Pelvic organ prolapse (POP) is a significant issue requiring surgical correction in 19% of the female population by age 85 years. Complications of POP, especially in women who have undergone hysterectomy, include vaginal evisceration-a serious complication that carries high morbidity and mortality rates. Rarely, vaginal evisceration occurs after colpocleisis. CASE: A 69-year-old female with recurrent vaginal evisceration following colpocleisis underwent surgical repair using a vertical rectus abdominis myocutaneous (VRAM) flap. CONCLUSION: Recurrent cases of POP and vaginal evisceration that are refractory to conventional treatment require consideration of novel management options. To our knowledge, this is the first case using a VRAM flap for the management of vaginal evisceration.
Subject(s)
Myocutaneous Flap , Plastic Surgery Procedures , Aged , Aged, 80 and over , Female , Humans , Myocutaneous Flap/transplantation , Rectus Abdominis/surgery , Vagina/surgeryABSTRACT
PURPOSE: Prostate specific membrane antigen-targeted positron emission tomography/computerized tomography has the potential to improve the detection and localization of prostate cancer. OSPREY was a prospective trial designed to determine the diagnostic performance of 18F-DCFPyL-positron emission tomography/computerized tomography for detecting sites of metastatic prostate cancer. MATERIALS AND METHODS: Two patient populations underwent 18F-DCFPyL-positron emission tomography/computerized tomography. Cohort A enrolled men with high-risk prostate cancer undergoing radical prostatectomy with pelvic lymphadenectomy. Cohort B enrolled patients with suspected recurrent/metastatic prostate cancer on conventional imaging. Three blinded central readers evaluated the 18F-DCFPyL-positron emission tomography/computerized tomography. Diagnostic performance of 18F-DCFPyL-positron emission tomography/computerized tomography was based on imaging results compared to histopathology. In cohort A, detection of pelvic nodal disease (with specificity and sensitivity as co-primary end points) and of extrapelvic metastases were evaluated. In cohort B, sensitivity and positive predictive value for prostate cancer within biopsied lesions were evaluated. RESULTS: A total of 385 patients were enrolled. In cohort A (252 evaluable patients), 18F-DCFPyL-positron emission tomography/computerized tomography had median specificity of 97.9% (95% CI: 94.5%-99.4%) and median sensitivity of 40.3% (28.1%-52.5%, not meeting prespecified end point) among 3 readers for pelvic nodal involvement; median positive predictive value and negative predictive value were 86.7% (69.7%-95.3%) and 83.2% (78.2%-88.1%), respectively. In cohort B (93 evaluable patients, median prostate specific antigen 11.3 ng/ml), median sensitivity and positive predictive value for extraprostatic lesions were 95.8% (87.8%-99.0%) and 81.9% (73.7%-90.2%), respectively. CONCLUSIONS: The primary end point for specificity was met while the primary end point for sensitivity was not. The high positive predictive value observed in both cohorts indicates that 18F-DCFPyL-positive lesions are likely to represent disease, supporting the potential utility of 18F-DCFPyL-positron emission tomography/computerized tomography to stage men with high-risk prostate cancer for nodal or distant metastases, and reliably detect sites of disease in men with suspected metastatic prostate cancer.
Subject(s)
Lysine/analogs & derivatives , Positron Emission Tomography Computed Tomography , Prostate-Specific Antigen , Prostatic Neoplasms/diagnostic imaging , Urea/analogs & derivatives , Aged , Aged, 80 and over , Humans , Male , Middle Aged , Neoplasm Metastasis , Positron Emission Tomography Computed Tomography/methods , Prospective Studies , Prostatic Neoplasms/pathology , Reproducibility of ResultsABSTRACT
PURPOSE: The aim of this study was to assess the association between four-dimensional translabial ultrasound (4D-TLUS) features of the retropubic mid-urethral sling (MUS) and post-operative pelvic floor symptoms. METHODS: A prospective cohort study was performed involving 100 women who had a solitary retropubic MUS (TVT Exact™) between Jan 2013 and Dec 2017 for urodynamic stress incontinence (SI) at a tertiary urogynaecological centre. All patients completed a standardised interview and had free flowmetry, prolapse evaluation and assessment for mesh exposure and tenderness. 4D-TLUS parameters measured included pelvic organ descent, levator ani status, sling-symphysis pubis (SP) gap at rest and Valsalva, angle formed by cranial and caudal ends of the sling, cranio-caudal and dorso-ventral sling-symphysis pubis distance at Valsalva. The primary outcome was treatment success as defined by patient report of cure or improvement and no objective demonstrable SI. RESULTS: Eighty-nine (89%) patients reported treatment success. Two patients (2%) had mesh exposure; one was symptomatic with pain, requiring complete sling removal. There was a significant association between treatment success and a SP gap at Valsalva of 10-12 mm (p = 0.001); and independently with a SP angle at Valsalva of 45°-80° (p = 0.007). A narrower SP gap at Valsalva closer to 10 mm was associated with voiding symptoms (p = 0.036). CONCLUSION: Sling-pubis gap and sling-pubis angle at Valsalva appear to be significantly associated with treatment success in retropubic MUS. There is a significant association between a narrower sling-pubis gap at Valsalva and voiding symptoms.
Subject(s)
Suburethral Slings , Urinary Incontinence, Stress/surgery , Adult , Correlation of Data , Female , Humans , Middle Aged , Predictive Value of Tests , Prospective Studies , Treatment Outcome , Ultrasonography/methods , VulvaABSTRACT
Background: Improving linkage to opioid use disorder (OUD) treatment and services is a public health priority. Public libraries, a community resource for health information, may be well positioned to support and guide people who use drugs, as well as their families and friends. In this study, we sought to evaluate the availability and types of resources offered to patrons inquiring about OUD information, OUD treatment, and naloxone access. Methods: We conducted an audit (secret shopper) study from April 2019 to June 2019 in which an auditor anonymously called Pennsylvania public libraries. We used a purposive sampling strategy to select libraries located in geographically diverse regions across the urban-rural continuum. We categorized responses and verified via phone or website whether referrals to treatment centers and other organizations provided OUD treatment or services. Results: We obtained responses from 100 public libraries located across 48 of the 67 counties in Pennsylvania. Among the libraries that responded, 57 provided health information resources (e.g., books, websites) and 82 provided "next step" referrals to an organization that could provide further assistance. Among the libraries that provided referrals, 39 were to treatment centers, of which 33 were specifically to treatment centers that offer medications for OUD. Of the responding libraries, 28 communicated information about naloxone access. Conclusion: Public libraries can and do connect patrons to OUD treatment and support services; however, there is wide interlibrary variation in the resources presented, demonstrating opportunities for improvement in how libraries engage and refer patrons with substance use needs.
Subject(s)
Opioid-Related Disorders , Humans , Naloxone/therapeutic use , Opiate Substitution Treatment , Opioid-Related Disorders/drug therapy , Public Health , Referral and Consultation , Rural PopulationABSTRACT
BACKGROUND: Despite the importance of high-quality and patient-centered substance use disorder treatment, there are no standardized ratings of specialized drug treatment facilities and their services. Online platforms offer insights into potential drivers of high and low patient experience. OBJECTIVE: We sought to analyze publicly available online review content of specialized drug treatment facilities and identify themes within high and low ratings. DESIGN: This was a retrospective analysis of online ratings and reviews of specialized drug treatment facilities in Pennsylvania listed within the 2016 National Directory of Drug and Alcohol Abuse Treatment Facilities. Latent Dirichlet Allocation, a machine learning approach to narrative text, was used to identify themes within reviews. Differential Language Analysis was then used to measure correlations between themes and star ratings. SETTING: Online reviews of Pennsylvania's specialized drug treatment facilities posted to Google and Yelp (July 2010-August 2018). RESULTS: A total of 7823 online ratings were posted over 8 years. The distribution was bimodal (43% 5-star and 34% 1-star). The average weighted rating of a facility was 3.3 stars. Online themes correlated with 5-star ratings were the following: focus on recovery (r = 0.53), helpfulness of staff (r = 0.43), compassionate care (r = 0.37), experienced a life-changing moment (r = 0.32), and staff professionalism (r = 0.29). Themes correlated with a 1-star rating were waiting time (r = 0.41), poor accommodations (0.26), poor phone communication (r = 0.24), medications given (0.24), and appointment availability (r = 0.23). Themes derived from review content were similar to 9 of the 14 facility-level services highlighted by the Substance Abuse and Mental Health Services Administration's National Survey of Substance Abuse Treatment Services. CONCLUSIONS: Individuals are sharing their ratings and reviews of specialized drug treatment facilities on online platforms. Organically derived reviews of the patient experience, captured by online platforms, reveal potential drivers of high and low ratings. These represent additional areas of focus which can inform patient-centered quality metrics for specialized drug treatment facilities.
Subject(s)
Patient Satisfaction , Pharmaceutical Preparations , Humans , Internet , Pennsylvania , Quality of Health Care , Retrospective StudiesABSTRACT
BACKGROUND AND AIMS: Peroral endoscopic myotomy (POEM) has become the mainstay for the treatment of achalasia at many institutions around the world since its inception in 2008. POEM can be performed using either the anterior or posterior approach. The primary aim of this study was to compare the efficacy of the anterior and posterior approaches at 1 year after POEM. METHODS: This is a single-blinded, randomized, noninferiority international clinical trial. Eligible participants were adult patients with a confirmed diagnosis of achalasia via high-resolution esophageal manometry. Patients were randomly allocated with a 1:1 ratio to receive POEM with anterior or posterior approach. The primary aim was to compare the rate of clinical success (Eckardt score <3) of anterior and posterior approaches at 1 year. RESULTS: One hundred fifty patients were randomized to receive either anterior (n = 73) or posterior (n = 77) POEM. One hundred forty-eight patients received the POEM treatment, and 138 patients completed the 1-year follow-up and were included in the primary efficacy analysis. Technical success was achieved in 71 patients (97.3%) in the anterior group versus 77 patients (100%) in the posterior group (P = .23). The median (interquartile range) length of hospital stay after the procedure was 2 (1-3) days for both groups. Adverse events occurred in 15 patients (10%), 8 patients (11%) in the anterior group and 7 patients (9%) in the posterior group (P = .703). Clinical success was achieved in 90% of patients in the anterior group and 89% of patients in the posterior group. Abnormal esophageal acid exposure was detected in 29 of 59 patients (49%) and 25 of 60 patients (42%) in the anterior and posterior groups, respectively (P = .67). GERD questionnaire scores were also not significantly different between the study groups. In both groups, quality of life improved after POEM for all 36-Item Short-Form Health Survey measures and was similar between both groups. CONCLUSIONS: Posterior myotomy during POEM was not inferior to anterior myotomy in terms of efficacy and safety in the treatment of patients with achalasia. (Clinical trial registration number: NCT02454335.).
Subject(s)
Endoscopy, Digestive System/methods , Esophageal Achalasia/surgery , Gastroesophageal Reflux/epidemiology , Myotomy/methods , Postoperative Complications/epidemiology , Quality of Life , Adult , Aged , Deglutition Disorders/physiopathology , Esophageal Achalasia/physiopathology , Esophageal pH Monitoring , Female , Gastroesophageal Reflux/drug therapy , Humans , Length of Stay/statistics & numerical data , Male , Manometry , Middle Aged , Postoperative Complications/drug therapy , Proton Pump Inhibitors/therapeutic use , Single-Blind Method , Treatment OutcomeABSTRACT
BACKGROUND: Endoscopic submucosal tunneling has evolved to allow endoscopic resection of subepithelial tumors of gastrointestinal tract without full-thickness perforation. This study aimed to investigate safety and efficacy of submucosal tunnel resection for these tumors. METHOD: Patients with subepithelial tumors (SET) located in esophagus, gastric cardia, lesser curvature, and antrum were recruited. The size of tumor was limited to < 40 mm. The procedures were performed under general anesthesia. A mucosal entrance was created 2 cm proximal to the SET after submucosal injection. Submucosal tunnel was then extended and the tumor was dissected and mobilized with intact overlying mucosa. After complete dissection, the tumors would be retrieved per orally and mucosal entrance closed by endoclips. RESULTS: From June 2012 to December 2016, 51 patients with subepithelial tumors received POET. 39 patients had SET in stomach, 11 located in esophagus, and 1 in duodenum. The mean operative time was 90.46 ± 46.49 min, while the mean size of the tumors was 20.71 ± 14.05 mm. The POET was converted to endoscopic full-thickness resection (EFTR) in three patients with gastric subepithelial tumors located at greater curvature. The overall complication rate was 4.0%, and there was no bleeding, mucosal dehiscence, or leakage. The time to resume diet was 1.7 days, while the average hospital stay was 3.2 ± 1.0 days. The mean follow-up period was 19 ± 16 months, and only 1 patient developed recurrence of leiomyoma. CONCLUSION: Per oral endoscopic tumor resection is safe and effective treatment for esophageal and gastric SET located at cardia, lesser curvature, and antrum. Currently, POET for treatment of upper GI SET is limited by the size and location of the tumor.
Subject(s)
Endoscopic Mucosal Resection , Esophageal Neoplasms , Gastrointestinal Stromal Tumors , Natural Orifice Endoscopic Surgery , Neoplasm Recurrence, Local , Stomach Neoplasms , Endoscopic Mucosal Resection/adverse effects , Endoscopic Mucosal Resection/methods , Esophageal Neoplasms/pathology , Esophageal Neoplasms/surgery , Female , Gastrointestinal Stromal Tumors/pathology , Gastrointestinal Stromal Tumors/surgery , Hong Kong/epidemiology , Humans , Male , Middle Aged , Natural Orifice Endoscopic Surgery/adverse effects , Natural Orifice Endoscopic Surgery/methods , Neoplasm Recurrence, Local/epidemiology , Neoplasm Recurrence, Local/pathology , Stomach Neoplasms/pathology , Stomach Neoplasms/surgery , Treatment OutcomeABSTRACT
INTRODUCTION AND HYPOTHESIS: Female pelvic organ prolapse recurrence has been shown to be associated with levator hiatal distensibility. Reducing hiatal size surgically may reduce recurrence risk. This study aims to demonstrate a novel surgical procedure, the puborectalis sling (PR sling), designed to reduce the levator hiatal area, and to assess the medium-term safety and efficacy of this procedure. METHODS: One hundred fifteen women undergoing prolapse repair with a pre-operative hiatal area on Valsalva of ≥ 35 cm2 were recruited into this phase 1 prospective multicentre pilot study. All underwent a PR sling procedure after completion of standard repairs. Primary outcome was levator hiatal area measured on ultrasound. RESULTS: One hundred ten patients were evaluated at least 3 months post-operatively. At 2.5 years average follow-up, there was an average of 12 cm2 (range 6-16 cm2) reduction in hiatal area from a mean pre-operative hiatal area of 43.9 (35-63) cm2. Thirty per cent (28/93) were symptomatic of prolapse, 66% (61/93) had clinical prolapse recurrence whilst 49% (46/93) had sonographic recurrence. Three patients required a return to theatre; one case of infection resulted in mesh removal, one had severe obstructed defecation requiring sling loosening and another had buttock pain with faecal impaction that resolved after manual disimpaction. There were no long-term sequelae. CONCLUSIONS: The levator hiatal area can be reduced surgically, with almost 30% reduction in area seen in this pilot study. The reduction was significant and sustained up to 2 years with no major long-term complications.
Subject(s)
Anal Canal/surgery , Pelvic Floor/surgery , Pelvic Organ Prolapse/surgery , Rectum/surgery , Suburethral Slings , Adult , Aged , Aged, 80 and over , Female , Humans , Middle Aged , Pilot Projects , Prospective Studies , Plastic Surgery Procedures , Recurrence , Treatment OutcomeABSTRACT
BACKGROUND: While pelvic floor ultrasound is commonly utilised in high-resource locations, our understanding of pelvic floor characteristics in women suffering with obstetric fistula and unrepaired fourth degree obstetric tears in low-resource areas is limited. AIMS: This study aimed to assess the pelvic floor ultrasound characteristics of Ugandan women suffering with obstetric fistula, unrepaired fourth degree obstetric tears and pelvic organ prolapse, and determine whether obstructed labour resulting in obstetric fistula causes more levator muscle defects compared to parous women without a history of obstructed labour. MATERIALS AND METHODS: This was a prospective study in western Uganda assessing 82 women with obstetric fistula, unrepaired fourth degree obstetric tears and pelvic organ prolapse with a pelvic floor ultrasound scan. RESULTS: Demographic characteristics were significantly different, with women suffering pelvic organ prolapse being older and more parous. Hiatal area on Valsalva was significantly smaller in the obstetric fistula group (mean 21.45 cm2 ) compared to non-obstetric fistula group (unrepaired fourth degree obstetric tears and pelvic organ prolapse; mean 30.44 cm2 ); a mean difference of 9.0 cm2 (95% CI: 5.4-12.6 cm2 , P < 0.001). Overall, levator muscle defects were significantly more common in women with obstetric fistula (66.7%) compared to the non-obstetric fistula group (44.7%) with P = 0.048; however, there were no significant differences in complete levator muscle defects between obstetric fistula (28.6%) and non-obstetric fistula (23.7%). CONCLUSIONS: Increased hiatal area on Valsalva was noted in the non-obstetric fistula group compared to women with obstetric fistula; however, there were no differences in proportions of complete levator muscle defects.
Subject(s)
Anal Canal/injuries , Lacerations/diagnostic imaging , Pelvic Floor/diagnostic imaging , Pelvic Organ Prolapse/diagnostic imaging , Vagina/injuries , Vaginal Fistula/diagnostic imaging , Adolescent , Adult , Delivery, Obstetric/adverse effects , Female , Humans , Lacerations/epidemiology , Middle Aged , Obstetric Labor Complications , Pelvic Organ Prolapse/epidemiology , Pregnancy , Uganda , Ultrasonography , Vaginal Fistula/epidemiology , Young AdultABSTRACT
Importance: Case series suggest favorable results of peroral endoscopic myotomy (POEM) for treatment of patients with achalasia. Data comparing POEM with pneumatic dilation, the standard treatment for patients with achalasia, are lacking. Objective: To compare the effects of POEM vs pneumatic dilation as initial treatment of treatment-naive patients with achalasia. Design, Setting, and Participants: This randomized multicenter clinical trial was conducted at 6 hospitals in the Netherlands, Germany, Italy, Hong Kong, and the United States. Adult patients with newly diagnosed achalasia and an Eckardt score greater than 3 who had not undergone previous treatment were included. The study was conducted between September 2012 and July 2015, the duration of follow-up was 2 years after the initial treatment, and the final date of follow-up was November 22, 2017. Interventions: Randomization to receive POEM (n = 67) or pneumatic dilation with a 30-mm and a 35-mm balloon (n = 66), with stratification according to hospital. Main Outcomes and Measures: The primary outcome was treatment success (defined as an Eckardt score ≤3 and the absence of severe complications or re-treatment) at the 2-year follow-up. A total of 14 secondary end points were examined among patients without treatment failure, including integrated relaxation pressure of the lower esophageal sphincter via high-resolution manometry, barium column height on timed barium esophagogram, and presence of reflux esophagitis. Results: Of the 133 randomized patients, 130 (mean age, 48.6 years; 73 [56%] men) underwent treatment (64 in the POEM group and 66 in the pneumatic dilation group) and 126 (95%) completed the study. The primary outcome of treatment success occurred in 58 of 63 patients (92%) in the POEM group vs 34 of 63 (54%) in the pneumatic dilation group, a difference of 38% ([95% CI, 22%-52%]; P < .001). Of the 14 prespecified secondary end points, no significant difference between groups was demonstrated in 10 end points. There was no significant between-group difference in median integrated relaxation pressure (9.9 mm Hg in the POEM group vs 12.6 mm Hg in the pneumatic dilation group; difference, 2.7 mm Hg [95% CI, -2.1 to 7.5]; P = .07) or median barium column height (2.3 cm in the POEM group vs 0 cm in the pneumatic dilation group; difference, 2.3 cm [95% CI, 1.0-3.6]; P = .05). Reflux esophagitis occurred more often in the POEM group than in the pneumatic dilation group (22 of 54 [41%] vs 2 of 29 [7%]; difference, 34% [95% CI, 12%-49%]; P = .002). Two serious adverse events, including 1 perforation, occurred after pneumatic dilation, while no serious adverse events occurred after POEM. Conclusions and Relevance: Among treatment-naive patients with achalasia, treatment with POEM compared with pneumatic dilation resulted in a significantly higher treatment success rate at 2 years. These findings support consideration of POEM as an initial treatment option for patients with achalasia. Trial Registration: Netherlands Trial Register number: NTR3593.
Subject(s)
Dilatation/methods , Esophageal Achalasia/therapy , Esophageal Sphincter, Lower/surgery , Sphincterotomy/methods , Adult , Dilatation/adverse effects , Esophageal Achalasia/classification , Esophageal Achalasia/surgery , Female , Follow-Up Studies , Gastroesophageal Reflux/etiology , Humans , Male , Manometry , Middle Aged , Natural Orifice Endoscopic Surgery , Quality of Life , Severity of Illness Index , Sphincterotomy/adverse effects , Treatment OutcomeABSTRACT
This article has been retracted: please see Elsevier Policy on Article Withdrawal (https://www.elsevier.com/about/our-business/policies/article-withdrawal). This article has been retracted due to overlapping/duplicate material. Data from some patients from this study have previously been published in other journals without cross-referencing. Twenty patients overlap with a paper by Kumbhari et al.1 Thirty-five patients overlap with the study by Ngamruengphong et al.2.
ABSTRACT
INTRODUCTION: A robotic laparoendoscopic single-site access surgery (R-LESS) platform that incorporates the EndoWrist function of robotic instruments may provide better triangulation and retraction during LESS. The aim of the study is to assess if R-LESS is feasible with standard robotic instruments via a single incision and whether the approach could reduce the difficulty of the procedure and confer additional benefits over conventional LESS. METHODS: This was a prospective randomized controlled study investigating the workload performance, efficacy, and risks of performing R-LESS when compared with human LESS (H-LESS) in a survival porcine model for cholecystectomy and gastrojejunostomy. The primary outcome is the NASA task load index. Secondary outcomes included the difficulty of the procedures, procedural time, morbidities, and mortalities. RESULTS: Twenty-four cholecystectomies and gastrojejunostomies using the R-LESS or H-LESS approach (12:12) were performed. None of the swine suffered from procedural adverse events and none of the procedures required conversion. In both the cholecystectomy and gastrojejunostomy groups, R-LESS was associated with significantly lower NASA task load index (P < 0.001) and reduced difficulties in various steps of the procedures. No differences in the overall procedure times of the two procedures were observed (P = 0.315). CONCLUSION: The R-LESS approach significantly reduced the workload and difficulties of LESS cholecystectomies and gastrojejunostomies. A dedicated single-site platform that could reduce instrument clashing while retaining the EndoWrist function is eagerly awaited.
Subject(s)
Cholecystectomy/methods , Gastric Bypass/methods , Laparoscopy/methods , Robotic Surgical Procedures/methods , Animals , Cholecystectomy/instrumentation , Feasibility Studies , Follow-Up Studies , Gastric Bypass/instrumentation , Humans , Laparoscopy/instrumentation , Outcome Assessment, Health Care , Prospective Studies , Random Allocation , Robotic Surgical Procedures/instrumentation , Sus scrofaABSTRACT
BACKGROUND: Sacrospinous colpopexy is an effective vaginal apical support operation. Due to morbidity associated with traditional approaches which require wide dissection, slim-line suture delivery devices have been introduced in the hope of reducing morbidity without compromise to outcomes. AIM: The aim of our series was to report outcomes and complications (particularly buttock pain and blood loss) of the sacrospinous colpopexy using the Capio suturing device and evaluate it against published results using the Miya hook. METHODS: This is a prospective, multi-centre descriptive study. The primary outcome is objective success at 12 months. Secondary outcomes include subjective success at 12 months, patient-reported outcomes at 12 months, operating time, estimated blood loss and post-operative buttock pain. RESULTS: Fifty-one consenting patients undergoing sacrospinous colpopexy were recruited at four Queensland hospitals. Objective success at 12 months was 95% (41/43) and subjective success at 12 months was 92% (44/48). Eighty-four percent of patients reported buttock pain at one week, reducing to 16% by six weeks, of which 7% required analgesia. CONCLUSIONS: At a mean of 17 months follow up, we found that the sacrospinous colpopexy using the Capio suturing device provided excellent apical support with a low requirement for blood transfusion and an average operating time of seven minutes. We found a high rate of buttock pain immediately post-operatively, but our rates became consistent with previous reports by six weeks post-operation.
Subject(s)
Gynecologic Surgical Procedures/instrumentation , Pain, Postoperative , Suture Techniques/instrumentation , Uterine Prolapse/surgery , Vagina/surgery , Aged , Aged, 80 and over , Blood Loss, Surgical/statistics & numerical data , Buttocks , Female , Gynecologic Surgical Procedures/methods , Humans , Ligaments/surgery , Middle Aged , Postoperative Complications , Prospective Studies , Treatment OutcomeABSTRACT
BACKGROUND & AIMS: In patients with persistent symptoms after Heller myotomy (HM), treatment options include repeat HM, pneumatic dilation, or peroral endoscopic myotomy (POEM). We evaluated the efficacy and safety of POEM in patients with achalasia with prior HM vs without prior HM. METHODS: We conducted a retrospective cohort study of 180 patients with achalasia who underwent POEM at 13 tertiary centers worldwide, from December 2009 through September 2015. Patients were divided into 2 groups: those with prior HM (HM group, exposure; n = 90) and those without prior HM (non-HM group; n = 90). Clinical response was defined by a decrease in Eckardt scores to 3 or less. Adverse events were graded according to criteria set by the American Society for Gastrointestinal Endoscopy. Technical success, clinical success, and rates of adverse events were compared between groups. Patients were followed up for a median of 8.5 months. RESULTS: POEM was technically successful in 98% of patients in the HM group and in 100% of patients in the non-HM group (P = .49). A significantly lower proportion of patients in the HM group had a clinical response to POEM (81%) than in the non-HM group (94%; P = .01). There were no significant differences in rates of adverse events between the groups (8% in the HM group vs 13% in the non-HM group; P = .23). Symptomatic reflux and reflux esophagitis after POEM were comparable between groups. CONCLUSIONS: POEM is safe and effective for patients with achalasia who were not treated successfully by prior HM. Although the rate of clinical success in patients with prior HM is lower than in those without prior HM, the safety profile of POEM is comparable between groups.
Subject(s)
Endoscopy/adverse effects , Endoscopy/methods , Esophageal Achalasia/surgery , Myotomy/adverse effects , Myotomy/methods , Adult , Aged , Female , Follow-Up Studies , Humans , Male , Middle Aged , Retrospective Studies , Tertiary Care Centers , Treatment OutcomeABSTRACT
OBJECTIVES: The safety of peroral endoscopic myotomy (POEM) is still debated since comprehensive analysis of adverse events (AEs) associated with the procedure in large multicenter cohort studies has not been performed. To study (1) the prevalence of AEs and (2) factors associated with occurrence of AEs in patients undergoing POEM. METHODS: Patients who underwent POEM at 12 tertiary-care centers between 2009 and 2015 were included in this case-control study. Cases were defined by the occurrence of any AE related to the POEM procedure. Control patients were selected for each AE case by matching for age, gender, and disease classification (achalasia type I and II vs. type III/spastic esophageal disorders). RESULTS: A total of 1,826 patients underwent POEM. Overall, 156 AEs occurred in 137 patients (7.5%). A total of 51 (2.8%) inadvertent mucosotomies occurred. Mild, moderate, and severe AEs had a frequency of 116 (6.4%), 31 (1.7%), and 9 (0.5%), respectively. Multivariate analysis demonstrated that sigmoid-type esophagus (odds ratio (OR) 2.28, P=0.05), endoscopist experience <20 cases (OR 1.98, P=0.04), use of a triangular tip knife (OR 3.22, P=0.05), and use of an electrosurgical current different than spray coagulation (OR 3.09, P=0.02) were significantly associated with the occurrence of AEs. CONCLUSIONS: This large study comprehensively assessed the safety of POEM and highly suggests POEM as a relatively safe procedure when performed by experts at tertiary centers with an overall 7.5% prevalence of AEs. Severe AEs are rare. Sigmoid-type esophagus, endoscopist experience, type of knife, and current used can be considered as predictive factors of AE occurrence.
Subject(s)
Endoscopy/adverse effects , Esophageal Achalasia/surgery , Postoperative Complications/epidemiology , Adult , Aged , Case-Control Studies , Cohort Studies , Female , Humans , Incidence , Male , Middle Aged , Treatment OutcomeABSTRACT
BACKGROUND AND AIMS: The recent development of EUS-guided gallbladder drainage (EGBD) with a lumen-apposing stent has made endoscopic assessment and advanced gallbladder interventions via the stent possible. The aim of this study was to assess the feasibility and safety of per-oral cholecystoscopy and the types of gallbladder interventions that can be performed. METHODS: This was a retrospective review conducted in the Prince of Wales Hospital from June 2012 to March 2016. All patients who had acute cholecystitis with EGBD were included. Cholecystoscopy was performed 1 to 3 months after stent insertion. Patients' demographic data, technical success, types of intervention, and adverse events were recorded. RESULTS: Twenty-nine cholecystoscopies were performed in 25 patients. Twenty-seven of 29 cholecystoscopies were successful (93.1%). Magnifying endoscopy was performed in 10 patients, confocal endomicroscopy and EUS in 1 patient, and endocytoscopy in another patient. Fourteen patients (56%) had spontaneous stone passage. Eleven patients (44%) had residual gallstones on cholecystoscopy, and removed in 8. Overall stone clearance rate was 88% after a mean (standard deviation) number of 1.25 (0.46) sessions of cholecystoscopy. CONCLUSIONS: Per-oral cholecystoscopy and advanced gallbladder interventions were feasible and safe. This opens up exciting possibilities for endoscopic treatment of gallbladder pathologies.
Subject(s)
Cholecystitis/surgery , Cholecystolithiasis/surgery , Cholecystostomy/methods , Drainage/methods , Endoscopy/methods , Gallbladder/surgery , Stents , Aged , Aged, 80 and over , Cholecystitis/diagnostic imaging , Cholecystolithiasis/diagnostic imaging , Endosonography , Feasibility Studies , Female , Gallbladder/diagnostic imaging , Humans , Intravital Microscopy , Male , Microscopy, Confocal , Natural Orifice Endoscopic Surgery , Retrospective Studies , Surgery, Computer-AssistedABSTRACT
BACKGROUND AND AIMS: Per-oral endoscopic myotomy (POEM) has shown promising safety and efficacy in short-term studies. However, long-term follow-up data are very limited. The aims of this study were to assess (1) clinical outcome of patients with a minimum post-POEM follow-up of 2 years and (2) factors associated with long-term clinical failure after POEM. METHODS: A retrospective chart review was performed that included all consecutive patients with achalasia who underwent POEM with a minimum follow-up of 2 years at 10 tertiary-care centers. Clinical response was defined by a decrease in Eckardt score to 3 or lower. RESULTS: A total of 205 patients (45.8% men; mean age, 49 years) were followed for a median of 31 months (interquartile range, 26-38 months). Of these, 81 patients (39.5%) had received previous treatment for achalasia before POEM. Clinical success was achieved in 98% (185/189), 98% (142/144), and 91% (187/205) of patients with follow-up within 6 months, at 12 months, and ≥24 months, respectively. Of 185 patients with clinical response at 6 months, 11 (6%) experienced recurrent symptoms at 2 years. History of previous pneumatic dilation was associated with long-term treatment failure (odds ratio, 3.41; 95% confidence interval, 1.25-9.23). Procedure-related adverse events occurred in 8.2% of patients and only 1 patient required surgical intervention. Abnormal esophageal acid exposure and reflux esophagitis were documented in 37.5% and 18% of patients, respectively. However, these rates are simply a reference number among a very selective group of patients. CONCLUSIONS: POEM is safe and provides high initial clinical success and excellent long-term outcomes. Among patients with confirmed clinical response within 6 months, 6% had recurrent symptoms by 2 years.
Subject(s)
Endoscopy, Digestive System/methods , Esophageal Achalasia/surgery , Esophageal Sphincter, Lower/surgery , Adult , Asia , Europe , Female , Follow-Up Studies , Humans , Male , Middle Aged , Natural Orifice Endoscopic Surgery , Postoperative Complications/epidemiology , Retrospective Studies , Treatment Outcome , United StatesABSTRACT
BACKGROUND: Pelvic floor muscles are subject to considerable stretching during vaginal birth. In 13-36% of women, stretching results in avulsion injury whereby the puborectalis muscle disconnects from its insertion points on the pubis bone. Until now, few studies have investigated the effect of this lesion on pelvic floor muscles in the early postpartum period. OBJECTIVE: The primary aim of this study was to compare pelvic floor muscle morphometry and function in primiparous women with and without puborectalis avulsion in the early postpartum period. Our secondary objective was to compare the 2 groups for pelvic floor disorders and impact on quality of life. STUDY DESIGN: In all, 52 primiparous women diagnosed with (n = 22) or without (n = 30) puborectalis avulsion injury were assessed at 3 months postpartum. Pelvic floor muscle morphometry was evaluated with 3-/4-dimensional transperineal ultrasound at rest, maximal contraction, and Valsalva maneuver. Different parameters were measured in the midsagittal and axial planes: bladder neck position, levator plate angle, anorectal angle, and levator hiatus dimensions. The dynamometric speculum was used to assess pelvic floor muscle function including: passive properties (passive forces and stiffness) during dynamic stretches, maximal strength, speed of contraction, and endurance. Pelvic floor disorder-related symptoms (eg, urinary incontinence, vaginal and bowel symptoms) and impact on quality of life were evaluated with the International Consultation on Incontinence Questionnaire and the Pelvic Floor Impact Questionnaire-Short Form. Pelvic Organ Prolapse Quantification was also assessed. RESULTS: In comparison to women without avulsion, women with avulsion presented an enlarged hiatus area at rest, maximal contraction, and Valsalva maneuver (P ≤ .013) and all other ultrasound parameters were found to be significantly altered during maximal contraction (P ≤ .014). They showed lower passive forces at maximal and 20-mm vaginal apertures as well as lower stiffness at 20-mm aperture (P ≤ .048). Significantly lower strength, speed of contraction, and endurance were also found in women with avulsion (P ≤ .005). They also presented more urinary incontinence symptoms (P = .040) whereas vaginal and bowel symptoms were found to be similar in the 2 groups. Pelvic Organ Prolapse Quantification revealed greater anterior compartment descent in women with avulsion (P ≤ .010). The impact of pelvic floor disorders on quality of life was found to be significantly higher in women with avulsion (P = .038). CONCLUSION: This study confirms that pelvic floor muscle morphometry and function are impaired in primiparous women with puborectalis avulsion in the early postpartum period. Moreover, it highlights specific muscle parameters that are altered such as passive properties, strength, speed of contraction, and endurance.
Subject(s)
Pelvic Floor Disorders/etiology , Pelvic Floor/pathology , Pelvic Floor/physiopathology , Adult , Female , Humans , Pelvic Floor/diagnostic imaging , Pelvic Floor/injuries , Postpartum Period , Time Factors , UltrasonographyABSTRACT
INTRODUCTION: The influence of levator-ani muscles on second-stage labor is poorly understood. The ability of these muscles to stretch without damage may affect birth outcomes, but little is known about material properties, effects of pregnancy and/or ethnicity on levator-ani stiffness. There are strong associations between muscle damage and subsequent pelvic floor disorders. This study aimed to quantify levator-ani muscle stiffness during the third trimester of pregnancy and postpartum in European and Polynesian women. Associations between stiffness, obstetric variables, and the risk of intrapartum levator-ani injury (avulsion) were investigated. MATERIAL AND METHODS: This was a prospective observational pilot study. A total of 167 (106 European and 61 Polynesian) nulliparous women were recruited antenatally; 129 returned postnatally. Participants were assessed between 36 and 38 weeks' gestation and three to five months postpartum. Assessments included pelvic floor ultrasound, elastometry testing, and validated questionnaires on pelvic floor function. Logistic regression, Student t-, Chi-square and Mann-Whitney tests were used as appropriate. RESULTS: There are significant differences between antenatal and postnatal muscle stiffness measurements (p < 0.01). Stiffness was significantly higher in the European cohort (p = 0.03). There were more avulsion injuries in European (20%) than in Polynesian (9%) women. There were no significant differences in antenatal stiffness between women with and without avulsion, but change in stiffness (antenatal to postnatal) was significantly less in the avulsion group. There were no associations between stiffness, and other obstetric variables, epidural anesthesia seemed protective (p = 0.03). CONCLUSIONS: Quantification of levator-ani muscle stiffness is feasible. Muscle stiffness is significantly different before and after birth.