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Preoperative factors and 3-year weight change in the Longitudinal Assessment of Bariatric Surgery (LABS) consortium.
Courcoulas, AP, Christian, NJ, O'Rourke, RW, Dakin, G, Patchen Dellinger, E, Flum, DR, Melissa Kalarchian, PD, Mitchell, JE, Patterson, E, Pomp, A, et al
Surgery for obesity and related diseases : official journal of the American Society for Bariatric Surgery. 2015;(5):1109-18
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Abstract
BACKGROUND Limited data guide the prediction of weight loss success or failure after bariatric surgery according to presurgery factors. There is significant variation in weight change after bariatric surgery and much interest in identifying preoperative factors that may contribute to these differences. This report evaluates the associations of a comprehensive set of baseline factors and 3-year weight change. SETTING Ten hospitals in 6 geographically diverse clinical centers in the United States. METHODS Adults undergoing a first bariatric surgical procedure as part of clinical care by participating surgeons were recruited between 2006 and 2009. Participants completed research assessments utilizing standardized and detailed data collection on over 100 preoperative and operative parameters for individuals undergoing Roux-en-Y gastric bypass (RYGB) and laparoscopic adjustable gastric banding (LAGB). Weight was measured 3 years after surgery. Percent weight change for RYGB or LAGB from baseline to 3 years was analyzed as both a continuous and dichotomous outcome with cut points at 25% for RYGB and 10% for LAGB. Multivariable linear and logistic regression models were used to identify independent baseline predictors of the continuous and categorical outcomes, respectively. RESULTS The median weight loss 3 years after surgery for RYGB (n = 1513) participants was 31.5% (IQR: 24.6%-38.4%; range, 59.2% loss to .9% gain) of baseline weight and 16.0% (IQR: 8.1%-23.1%; range, 56.1% loss to 12.5% gain) for LAGB (n = 509) participants. The median age was 46 years for RYGB and 48 years for LAGB; 80% of RYGB participants and 75% of LAGB participants were female; and the median baseline body mass index (BMI) was 46 kg/m(2) for RYGB and 44 kg/m(2) for LAGB. For RYGB, black participants lost 2.7% less weight compared with whites and participants with diabetes at baseline had 3.7% less weight loss at year 3 than those without diabetes at baseline. There were small but statistically significant differences in weight change for RYGB in those with abnormal kidney function and current or recent smoking. For LAGB participants, those with a large band circumference had 75% greater odds of experiencing less than 10% weight loss after adjusting for BMI and sex. CONCLUSIONS Few baseline variables were associated with 3-year weight change and the effects were small. These results indicate that baseline variables have limited predictive value for an individual's chance of a successful weight loss outcome after bariatric surgery. TRIAL REGISTRATION NCT00465829, ClinicalTrials.gov.
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Laparoscopic versus open adhesiolysis for small bowel obstruction - a multicenter, prospective, randomized, controlled trial.
Sallinen, V, Wikström, H, Victorzon, M, Salminen, P, Koivukangas, V, Haukijärvi, E, Enholm, B, Leppäniemi, A, Mentula, P
BMC surgery. 2014;:77
Abstract
BACKGROUND Laparoscopic adhesiolysis is emerging as an alternative for open surgery in adhesive small bowel obstruction. Retrospective studies suggest that laparoscopic approach shortens hospital stay and reduces complications in these patients. However, no prospective, randomized, controlled trials comparing laparoscopy to open surgery have been published. METHODS/DESIGN This is a multicenter, prospective, open label, randomized, controlled trial comparing laparoscopic adhesiolysis to open surgery in patients with computed-tomography diagnosed adhesive small bowel obstruction that is not resolving with conservative management. The primary study endpoint is the length of postoperative hospital stay in days.Sample size was estimated based on preliminary retrospective cohort, which suggested that 102 patients would provide 80% power to detect a difference of 2.5 days in the length of postoperative hospital stay with significance level of 0.05. Secondary endpoints include passage of stool, commencement of enteral nutrition, 30-day mortality, complications, postoperative pain, and the length of sick leave. Tertiary endpoints consist of the rate of ventral hernia and the recurrence of small bowel obstruction during long-term follow-up. Long-term follow-up by letter or telephone interview will take place at 1, 5, and 10 years. DISCUSSION To the best of our knowledge, this trial is the first one aiming to provide level Ib evidence to assess the use of laparoscopy in the treatment of adhesive small bowel obstruction. TRIAL REGISTRATION ClinicalTrials.gov identifier: NCT01867528. Date of registration May 26th 2013.
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Patient factors associated with undergoing laparoscopic adjustable gastric banding vs Roux-en-Y gastric bypass for weight loss.
Apovian, CM, Huskey, KW, Chiodi, S, Hess, DT, Schneider, BE, Blackburn, GL, Jones, DB, Wee, CC
Journal of the American College of Surgeons. 2013;(6):1118-25
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Abstract
BACKGROUND Roux-en-Y gastric bypass and laparoscopic adjustable gastric banding are 2 commonly performed bariatric procedures in the US with different profiles for risk and effectiveness. Little is known about factors that might lead patients to proceed with one procedure over the other. STUDY DESIGN We recruited and interviewed patients seeking bariatric surgery from 2 academic centers in Boston (response rate 70%). We conducted multivariable analyses to identify patient perceptions and clinical and behavioral characteristics that correlated with undergoing gastric banding (n = 239) vs gastric bypass (n = 297). RESULTS After adjustment for socio-demographic and clinical factors, we found that older patients (odds ratio [OR] 1.03; 95% CI 1.00 to 1.05) and those with higher quality of life scores and higher levels of uncontrolled eating were more likely to undergo gastric banding as opposed to gastric bypass. In contrast, patients with type 2 diabetes (OR 0.46; 95% CI 0.28 to 0.77), those who desired greater weight loss, and those who were willing to assume higher mortality risk to achieve their ideal weight were less likely to proceed with gastric banding. After initial adjustment, male sex and lower body mass index were associated with a likelihood of undergoing gastric banding; however, these factors were no longer significant after adjustment for other significant correlates such as patients' perceived ideal weight, predilection to assume risk to lose weight, and eating behavior. CONCLUSIONS Patients' diabetes status, quality of life, eating behavior, ideal weight loss, and willingness to assume mortality risk to lose weight were associated with whether patients proceeded with gastric banding as opposed to gastric bypass. Other clinical factors were less important.
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Fast track multi-discipline treatment (FTMDT trial) versus conventional treatment in colorectal cancer--the design of a prospective randomized controlled study.
Zhou, JJ, Li, J, Ying, XJ, Song, YM, Chen, R, Chen, G, Yan, M, Ding, KF
BMC cancer. 2011;:494
Abstract
BACKGROUND Laparoscopy-assisted surgery, fast-track perioperative treatment are both increasingly used in colorectal cancer treatment, for their short-time benefits of enhanced recovery and short hospital stays. However, the benefits of the integration of the Laparoscopy-assisted surgery, fast-track perioperative treatment, and even with the Xelox chemotherapy, are still unknown. In this study, the three treatments integration is defined as "Fast Track Multi-Discipline Treatment Model" for colorectal cancer and this model extends the benefits to the whole treatment process of colorectal cancer. The main purpose of the study is to explore the feasibility of "Fast Track Multi-Discipline Treatment" model in treatment of colorectal cancer. METHODS The trial is a prospective randomized controlled study with 2 × 2 balanced factorial design. Patients eligible for the study will be randomized to 4 groups: (I) Laparoscopic surgery with fast track perioperative treatment and Xelox chemotherapy; (II) Open surgery with fast track perioperative treatment and Xelox chemotherapy; (III) Laparoscopic surgery with conventional perioperative treatment and mFolfox6 chemotherapy; (IV) Open surgery with conventional perioperative treatment and mFolfox6 chemotherapy. The primary endpoint of this study is the hospital stays. The secondary endpoints are the quality of life, chemotherapy related adverse events, surgical complications and hospitalization costs. Totally, 340 patients will be enrolled with 85 patients in each group. CONCLUSIONS The study initiates a new treatment model "Fast Track Multi-Discipline Treatment" for colorectal cancer, and will provide feasibility evidence on the new model "Fast Track Multi-Discipline Treatment" for patients with colorectal cancer. TRIAL REGISTRATION ClinicalTrials.gov: NCT01080547.