| 1. |
- Hedberg, Jakob, et al.
(författare)
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Randomized controlled trial of nasogastric tube use after esophagectomy : study protocol for the kinetic trial
- 2024
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Ingår i: Diseases of the esophagus. - : John Wiley & Sons. - 1120-8694 .- 1442-2050. ; 37:6
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Tidskriftsartikel (refereegranskat)abstract
- Esophagectomy is a complex and complication laden procedure. Despite centralization, variations in perioparative strategies reflect a paucity of evidence regarding optimal routines. The use of nasogastric (NG) tubes post esophagectomy is typically associated with significant discomfort for the patients. We hypothesize that immediate postoperative removal of the NG tube is non-inferior to current routines. All Nordic Upper Gastrointestinal Cancer centers were invited to participate in this open-label pragmatic randomized controlled trial (RCT). Inclusion criteria include resection for locally advanced esophageal cancer with gastric tube reconstruction. A pretrial survey was undertaken and was the foundation for a consensus process resulting in the Kinetic trial, an RCT allocating patients to either no use of a NG tube (intervention) or 5 days of postoperative NG tube use (control) with anastomotic leakage as primary endpoint. Secondary endpoints include pulmonary complications, overall complications, length of stay, health related quality of life. A sample size of 450 patients is planned (Kinetic trial: https://www.isrctn.com/ISRCTN39935085). Thirteen Nordic centers with a combined catchment area of 17 million inhabitants have entered the trial and ethical approval was granted in Sweden, Norway, Finland, and Denmark. All centers routinely use NG tube and all but one center use total or hybrid minimally invasive-surgical approach. Inclusion began in January 2022 and the first annual safety board assessment has deemed the trial safe and recommended continuation. We have launched the first adequately powered multi-center pragmatic controlled randomized clinical trial regarding NG tube use after esophagectomy with gastric conduit reconstruction.
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| 2. |
- Raoof, Mustafa, 1966-, et al.
(författare)
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Health-Related Quality-of-Life (HRQoL) on an Average of 12 Years After Gastric Bypass Surgery
- 2015
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Ingår i: Obesity Surgery. - : Springer Science and Business Media LLC. - 0960-8923 .- 1708-0428. ; 25:7, s. 1119-1127
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Tidskriftsartikel (refereegranskat)abstract
- It is evident that morbidly obese patients have a low health-related quality-of-life (HRQoL), and this low HRQoL has become a common reason for them to seek bariatric surgery. Several HRQoL studies demonstrate a dramatic postoperative improvement, but most of these have had a short follow-up period.An observational, cross-sectional study for HRQoL was conducted to study 486 patients (average age of 50.7 +/- 10.0 years, with 84 % of them being female) operated with gastric bypass (GBP) in the period 1993 to 2003 at the University Hospitals of A-rebro and Uppsala. Mean follow-up after gastric bypass was 11.5 +/- 2.7 years (range 7-17). Two HRQoL instruments were used, SF-36 and the Obesity-related Problems scale (OP). The study group was compared with two control groups, both matched for age and gender, one from the general population and one containing morbidly obese patients evaluated and awaiting bariatric surgery.The study group scored better in the SF-36 domains (all four physical domains and the vitality subscore) and OP scale compared to obese controls, but their HRQoL scores were lower than those of the general population. HRQoL was better among younger patients and in the following subgroups: men, patients with satisfactory weight loss, satisfied with the procedure, free from co-morbidities and gastrointestinal symptoms, employment, good oral status and those not hospitalised or regularly followed up for non-bariatric reasons.Long-term follow-up after GBP for morbid obesity showed better scores in most aspects of HRQoL compared to obese controls but did not achieve the levels of the general population. Patients with better medical outcome after gastric bypass operation had better HRQoL.
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| 3. |
- Sellberg, Fanny, et al.
(författare)
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A dissonance-based intervention for women post roux-en-Y gastric bypass surgery aiming at improving quality of life and physical activity 24 months after surgery : study protocol for a randomized controlled trial
- 2018
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Ingår i: BMC Surgery. - : BioMed Central. - 1471-2482. ; 18:1
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Tidskriftsartikel (refereegranskat)abstract
- BACKGROUND: Roux-en-Y gastric bypass (RYGB) surgery is the most common bariatric procedure in Sweden and results in substantial weight loss. Approximately one year post-surgery weight regain for these patient are common, followed by a decrease in health related quality of life (HRQoL) and physical activity (PA). Our aim is to investigate the effects of a dissonance-based intervention on HRQoL, PA and other health-related behaviors in female RYGB patients 24 months after surgery. We are not aware of any previous RCT that has investigated the effects of a similar intervention targeting health behaviors after RYGB.METHODS: The ongoing RCT, the "WELL-GBP"-trial (wellbeing after gastric bypass), is a dissonance-based intervention for female RYGB patients conducted at five hospitals in Sweden. The participants are randomized to either control group receiving usual follow-up care, or to receive an intervention consisting of four group sessions three months post-surgery during which a modified version of the Stice dissonance-based intervention model is used. The sessions are held at the hospitals, and topics discussed are PA, eating behavior, social and intimate relationships. All participants are asked to complete questionnaires measuring HRQoL and other health-related behaviors and wear an accelerometer for seven days before surgery and at six months, one year and two years after surgery. The intention to treat and per protocol analysis will focus on differences between the intervention and control group from pre-surgery assessments to follow-up assessments at 24 months after RYGB. Patients' baseline characteristics are presented in this protocol paper.DISCUSSION: A total of 259 RYGB female patients has been enrolled in the "WELL-GBP"-trial, of which 156 women have been randomized to receive the intervention and 103 women to control group. The trial is conducted within a Swedish health care setting where female RYGB patients from diverse geographical areas are represented. Our results may, therefore, be representative for female RYGB patients in the country as a whole. If the intervention is effective, implementation within the Swedish health care system is possible within the near future.TRIAL REGISTRATION: The trial was registered on February 23th 2015 with registration number ISRCTN16417174.
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| 4. |
- Stenberg, Erik, 1979-, et al.
(författare)
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Early complications after laparoscopic gastric bypass surgery : results from the Scandinavian Obesity Surgery Registry
- 2014
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Ingår i: Annals of Surgery. - : Lippincott Williams & Wilkins. - 0003-4932 .- 1528-1140. ; 260:6, s. 1040-1047
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Tidskriftsartikel (refereegranskat)abstract
- OBJECTIVE: To identify risk factors for serious and specific early complications of laparoscopic gastric bypass surgery using a large national cohort of patients.BACKGROUND: Bariatric procedures are among the most common surgical procedures today. There is, however, still a need to identify preoperative and intraoperative risk factors for serious complications.METHODS: From the Scandinavian Obesity Surgery Registry database, we identified 26,173 patients undergoing primary laparoscopic gastric bypass operation for morbid obesity between May 1, 2007, and September 30, 2012. Follow-up on day 30 was 95.7%. Preoperative data and data from the operation were analyzed against serious postoperative complications and specific complications.RESULTS: The overall risk of serious postoperative complications was 3.4%. Age (adjusted P = 0.028), other additional operation [odds ratio (OR) = 1.50; confidence interval (CI): 1.04-2.18], intraoperative adverse event (OR = 2.63; 1.89-3.66), and conversion to open surgery (OR = 4.12; CI: 2.47-6.89) were all risk factors for serious postoperative complications. Annual hospital volume affected the rate of serious postoperative complications. If the hospital was in a learning curve at the time of the operation, the risk for serious postoperative complications was higher (OR = 1.45; CI: 1.22-1.71). The 90-day mortality rate was 0.04%.CONCLUSIONS: Intraoperative adverse events and conversion to open surgery are the strongest risk factors for serious complications after laparoscopic gastric bypass surgery. Annual operative volume and total institutional experience are important for the outcome. Patient related factors, in particular age, also increased the risk but to a lesser extent.
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| 5. |
- Stenberg, Erik, 1979-, et al.
(författare)
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The association between socioeconomic factors and weight loss 5 years after gastric bypass surgery
- 2020
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Ingår i: International Journal of Obesity. - : Nature Publishing Group. - 0307-0565 .- 1476-5497. ; 44:11, s. 2279-2290
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Tidskriftsartikel (refereegranskat)abstract
- Introduction: Patients with low socioeconomic status have been reported to have poorer outcome than those with a high socioeconomic status after several types of surgery. The influence of socioeconomic factors on weight loss after bariatric surgery remains unclear. The aim of the present study was to evaluate the association between socioeconomic factors and postoperative weight loss.Materials and methods: This was a retrospective, nationwide cohort study with 5-year follow-up data for 13,275 patients operated with primary gastric bypass in Sweden between January 2007 and December 2012 (n = 13,275), linking data from the Scandinavian Obesity Surgery Registry, Statistics Sweden, the Swedish National Patient Register, and the Swedish Prescribed Drugs Register. The assessed socioeconomic variables were education, profession, disposable income, place of residence, marital status, financial aid and heritage. The main outcome was weight loss 5 years after surgery, measured as total weight loss (TWL). Linear regression models, adjusted for age, preoperative body mass index (BMI), sex and comorbid diseases were constructed.Results: The mean TWL 5 years after surgery was 28.3 +/- 9.86%. In the adjusted model, first-generation immigrants (%TWL, B -2.4 [95% CI -2.9 to -1.9],p < 0.0001) lost significantly less weight than the mean, while residents in medium-sized (B 0.8 [95% CI 0.4-1.2],p = 0.0001) or small towns (B 0.8 [95% CI 0.4-1.2],p < 0.0001) lost significantly more weight.Conclusions: All socioeconomic groups experienced improvements in weight after bariatric surgery. However, as first-generation immigrants and patients residing in larger towns (>200,000 inhabitants) tend to have inferior weight loss compared to other groups, increased support in the pre- and postoperative setting for these two groups could be of value. The remaining socioeconomic factors appear to have a weaker association with postoperative weight loss.
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| 6. |
- Stenberg, Erik, 1979-, et al.
(författare)
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The impact of socioeconomic factors on the early postoperative complication rate after laparoscopic gastric bypass surgery : A register-based cohort study
- 2019
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Ingår i: Surgery for Obesity and Related Diseases. - : Elsevier. - 1550-7289 .- 1878-7533. ; 15:4, s. 575-581
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Tidskriftsartikel (refereegranskat)abstract
- Background: Socioeconomic factors may influence the outcome of certain surgical procedures, but it is not known whether such factors influence the risk for postoperative complication after bariatric surgery.Objectives: Determining whether different socioeconomic factors influence the risk for postoperative complication after laparoscopic gastric bypass surgery.Setting: Nationwide in Sweden.Methods: Retrospective register-based cohort study that includes all primary laparoscopic gastric bypass procedures in Sweden between 2010 and 2016, using data from the Scandinavian Obesity Surgery Registry, Statistics Sweden, and the Swedish Population Register. Main outcome measures were occurrence and severity of early postoperative complications.Results: Included in this study were 41,537 patients with 30-day follow-up percentage of 96.7%. Study groups with increased risk for postoperative complication (age, sex, body mass index, and co-morbidity adjusted odds ratio with 95% confidence intervals) were as follows: being divorced, a widow, or a widower (1.14 [1.03-1.23]); receiving disability pension (1.37 [1.23-1.53]) or social assistance (1.22 [1.07-1.401); and being first- (1.22 [1.04-1.44]) or second-generation (1.20 [1.09-1.32]) immigrant. In contrast, being single (.90 [.83.991), having higher disposable income (50th-80th percentile:.84 [.76.93]; >80th percentile:.84 [72.98]), and living in a medium (.90 [.83.98]) or small (.84 [.76.92]) town were associated with lower risk. Increased risk for severe postoperative complication was seen for divorced, widowm, or widower (1.30 [1.12-1.521) and those receiving disability pension (1.37 [1.16-1.611) or social assistance (1.32 [1.08-1.62]), while higher disposable income (50th-80th percentile:.79 [.68.92]; >80th percentile .57 [.46.72]) was associated with lower risk.Conclusion: Socioeconomic factors influence the risk for early postoperative complication after laparoscopic gastric bypass surgery. The impact is not enough to exclude patients from surgery, but they must be taken into account in preoperative risk assessment.
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