Real-World Safety and Efficacy of Fluid-Filled Dual Intragastric Balloon for Weight Loss.

BACKGROUND & AIMS: Reshape Duo is a saline-filled dual, integrated intragastric balloon (IGB) approved by the Food and Drug Administration for weight loss in patients with obesity. In a prospective, randomized trial, obese patients who received the balloon had significantly greater percent excess weight loss (%EWL) compared with patients treated with diet and exercise alone. However, there are limited data on the real-world efficacy of the Reshape balloon. METHODS: We performed a retrospective study of data collected from 2 academic centers and 5 private practices in which all patients paid for the IGB and follow-up visits out of pocket. The IGB was removed after 6 months. We collected data (demographic, medical, and laboratory) from 202 adults (mean age 47.8 ± 10.8 years; 83% female) with a baseline mean body mass index of 36.8 + 8.4 kg/m2 who had IGB insertion for weight loss therapy, along with counselling on lifestyle modifications focused on diet and exercise. Primary outcomes were percent total body weight loss (%TBWL) and %EWL at 1, 3, 6, 9, and 12 months after the procedure. RESULTS: Mean %TBWL at 1, 3, 6, 9 and 12 months was 4.8 ± 2.4%, 8.8 ± 4.3%, 11.4 ± 6.7%, 13.3 ± 7.8%, and 14.7 ± 11.8%, respectively. Data were available from 101 patients at 6 months and 12 patients at 12 months; 60.4% of patients achieved more than 10% TBWL and 55.4% had more than 25% EWL. Seventeen patients (8.4%) had esophageal tears during balloon insertion, with no intervention required. Thirteen patients (6.4%) had their IGB removed before the end of the 6-month treatment period. Nausea, vomiting, and abdominal pain were the most common adverse effects, occurring in 149 (73.8%), 99 (49%), and 51 (25.2%) patients. In one patient, the IGB migrated distally leading to small intestinal obstruction requiring surgical removal. CONCLUSION: In a retrospective analysis of real-world patients who received the Reshape Duo IGB, we found it to be a safe and efficacious endoscopic method for producing weight loss, with most patients achieving greater than 10% TBWL at 6 months.

Effect of music on patients undergoing colonoscopy: a meta-analysis of randomized controlled trials.

PURPOSE: Music has been utilized as a therapeutic tool during colonoscopy, but various randomized controlled trials (RCTs) have been inconsistent. We conducted a meta-analysis to analyze the effect of music on patients undergoing colonoscopy. PATIENTS AND METHODS: Multiple medical databases were searched (12/06). Only RCTs on adult subjects that compared music versus no music during colonoscopy were included. Meta-analysis was analyzed for total procedure time, dose of sedative medications (midazolam and mepiridine), and patients' pain scores, experience, and willingness to repeat the same procedure in the future. RESULTS: Eight studies (N = 712) met the inclusion criteria. Patients' overall experience scores (P < 0.01) were significantly improved with music. No significant differences were noted for patients' pain scores (P = 0.09), mean doses of midazolam (P = 0.10), mean doses of meperidine (P = 0.23), procedure times (P = 0.06), and willingness to repeat the same procedure in future (P = 0.10). CONCLUSIONS: Music improves patients' overall experience with colonoscopy.

En bloc endoscopic submucosal dissection of a 14-cm laterally spreading adenoma of the rectum with involvement to the anal canal: expanding the frontiers of endoscopic surgery (with video).

BACKGROUND: Endoscopic submucosal dissection (ESD) was recently developed in Japan for en bloc removal of laterally spreading tumors (LSTs). Although initially used for gastric tumors, ESD has now been applied to lesions elsewhere in the gut. Recent reports from Japan included removal of colorectal lesions up to 10 cm. OBJECTIVE: To show the feasibility of ESD to remove en bloc, very large LSTs of the rectum, even when there is involvement to the dentate line. DESIGN: Case report. SETTING: The procedure was performed at an American GI unit. The patient was admitted to the hospital after the procedure for observation. PATIENTS: A 53-year-old patient, with a 14-cm tubulovillous adenoma of the rectum, which, at its maximal extent, involved two thirds of the circumference of the rectum. The tumor extended distally to the dentate line. INTERVENTIONS: En bloc submucosal dissection with a conventional needle-knife to remove the neoplasm. MAIN OUTCOME MEASUREMENTS: Completeness of en bloc removal of the tumor and subsequent follow-up endoscopy that showed no residual neoplasm. RESULTS: The tumor was able to be removed en bloc by ESD. The distal margin included squamous mucosa. At a 2.5-week endoscopic follow-up, a 3-mm focus of residual polyp was seen and removed. At the time of the last follow-up, there was complete healing of the wound and no residual neoplasm. LIMITATIONS: Single case. CONCLUSIONS: This case demonstrated the feasibility of using ESD to remove large laterally spreading rectal tumors, including when there was involvement to the dentate line (and the dissection line must include squamous mucosa of the anal canal). ESD is a promising alternative to conventional surgical techniques; however, additional published experience is needed.