Patient-reported outcomes, weight loss, and remission of type 2 diabetes 3 years after gastric bypass and sleeve gastrectomy (Oseberg); a single-centre, randomised controlled trial.

BACKGROUND: Little is known about the comparative effects of various bariatric procedures on patient-reported outcomes. We aimed to compare 3-year effects of gastric bypass and sleeve gastrectomy on patient-reported outcome measures in patients with obesity and type 2 diabetes. METHODS: The Oseberg trial was a single-centre, parallel-group, randomised trial at Vestfold Hospital Trust, a public tertiary obesity centre in Tønsberg, Norway. Eligible patients were aged 18 years or older with previously verified BMI 35·0 kg/m2 or greater. Diabetes was diagnosed if glycated haemoglobin was at least 6·5% (48 mmol/mol) or by their use of anti-diabetic medications with glycated haemoglobin at least 6·1% (43 mmol/mol). Eligible patients were randomly assigned (1:1) to gastric bypass or sleeve gastrectomy. All patients received identical preoperative and postoperative treatment. Randomisation was done with a computerised random number generator and a block size of ten. Study personnel, patients, and the primary outcome assessor were blinded to allocations for 1 year. The prespecified secondary outcomes reported here were 3-year changes in several clinically important patient-reported outcomes, weight loss, and diabetes remission. Analyses were done in the intention to treat population. This trial is ongoing, closed to recruitment and is registered with ClinicalTrials.gov, NCT01778738. FINDINGS: Between Oct 15, 2012 and Sept 1, 2017, 319 consecutive patients with type 2 diabetes scheduled for bariatric surgery were assessed for eligibility. 101 patients were not eligible (29 did not have type 2 diabetes according to inclusion criteria and 72 other exclusion criteria) and 93 declined to participate. 109 patients were enrolled and randomly assigned to sleeve gastrectomy (n=55) or gastric bypass (n=54). 72 (66%) of 109 patients were female and 37 (34%) were male. 104 (95%) of patients were White. 16 patients were lost to follow up and 93 (85%) patients completed the 3-year follow-up. Three additional patients were contacted by phone for registration of comorbidities Compared with sleeve gastrectomy, gastric bypass was associated with a greater improvement in weight-related quality of life (between group difference 9·4, 95% CI 3·3 to 15·5), less reflux symptoms (0·54, 0·17 to -0·90), greater total bodyweight loss (8% difference, 25% vs 17%), and a higher probability of diabetes remission (67% vs 33%, risk ratio 2·00; 95% CI 1·27 to 3·14). Five patients reported postprandial hypoglycaemia in the third year after gastric bypass versus none after sleeve-gastrectomy (p=0·059). Symptoms of abdominal pain, indigestion, diarrhoea, dumping syndrome, depression, binge eating, and appetitive drive did not differ between groups. INTERPRETATION: At 3 years, gastric bypass was superior to sleeve gastrectomy in patients with type 2 diabetes and obesity regarding weight related quality of life, reflux symptoms, weight loss, and remission of diabetes, while symptoms of abdominal pain, indigestion, diarrhoea, dumping, depression and binge eating did not differ between groups. This new patient-reported knowledge can be used in the shared decision-making process to inform patients about similarities and differences between expected outcomes after the two surgical procedures. FUNDING: Morbid Obesity Centre, Vestfold Hospital Trust. TRANSLATION: For the Norwegian translation of the abstract see Supplementary Materials section.

Colonoscopy quality improvement after initial training: A cross-sectional study of intensive short-term training.

Background and study aims High-quality is crucial for the effectiveness of colonoscopy and can be achieved by high-quality training and verified with assessment of key performance indicators (KPIs) for colonoscopy such as cecum intubation rate (CIR), adenoma detection rate (ADR) and adequate polyp resection. Typically, trainees achieve adequate CIR after 275 procedures, but little is known about learning curves for KPIs after initial training. Methods This cross-sectional study includes work-up colonoscopies after a positive screening test with fecal occult blood testing (FIT) or sigmoidoscopy, performed by either trainees after 300 training colonoscopies or by consultants. Outcome measures were KPIs. We assessed inter-endoscopist variation in trainees and learning curves for trainees as a group. We also compared KPIs for trainees and consultants as a group.  Results Data from 6,655 colonoscopies performed by 21 trainees and 921 colonoscopies performed by 17 consultants were included. Most trainees achieved target standards for main KPIs. With time, trainees shortened cecum intubation time and withdrawal time without decreasing their ADR, reduced the proportion of painful colonoscopies, and increased the adequate polyp resection rate (all P  < 0.01). Compared to consultants, trainees had higher CIR (97.7 % vs. 96.3 %, P  = 0.02), ADR after positive FIT (57.6 % vs. 50.3 %, P  < 0.01), and proximal ADR after sigmoidoscopy screening (41.1 % vs. 29.8 %; P  < 0.01), higher adequate polyp resection rate (94.9 % vs. 93.1 %, P  = 0.01) and fewer serious adverse events (0.65 % vs. 1.41 %, P  = 0.02). Conclusions Trainees performed high-quality colonoscopies and achieved international target standards. Several KPIs continuously improved after initial training. Trainees outperformed consultants on several KPIs.

The effect of train-the-colonoscopy-trainer course on colonoscopy quality indicators.

BACKGROUND: Systematic training in colonoscopy is highly recommended; however, we have limited knowledge of the effects of "training-the-colonoscopy-trainer" (TCT) courses. Using a national quality register on colonoscopy performance, we aimed to evaluate the effects of TCT participation on defined quality indicators. METHODS: This observational study compared quality indicators (pain, cecal intubation, and polyp detection) between centers participating versus not participating in a TCT course. Nonparticipating centers were assigned a pseudoparticipating year to match their participating counterparts. Results were compared between first year after and the year before TCT (pseudo)participation. Time trends up to 5 years after TCT (pseudo)participation were also compared. Generalized estimating equation models, adjusted for age, sex, and bowel cleansing, were used. RESULTS: 11 participating and 11 nonparticipating centers contributed 18 555 and 10 730 colonoscopies, respectively. In participating centers, there was a significant increase in detection of polyps ≥ 5 mm, from 26.4 % to 29.2 % (P = 0.035), and reduction in moderate/severe pain experienced by women, from 38.2 % to 33.6 % (P = 0.043); no significant changes were found in nonparticipating centers. Over 5 years, 20 participating and 18 nonparticipating centers contributed 85 691 and 41 569 colonoscopies, respectively. In participating centers, polyp detection rate increased linearly (P = 0.003), and pain decreased linearly in women (P = 0.004). Nonparticipating centers did not show any significant time trend during the study period. CONCLUSIONS: Participation in a TCT course improved polyp detection rates and reduced pain experienced by women. These effects were maintained during a 5-year follow-up.

Incomplete endoscopic resection of colorectal polyps: a prospective quality assurance study.

BACKGROUND: Endoscopic screening with polypectomy has been shown to reduce colorectal cancer incidence in randomized trials. Incomplete polyp removal and subsequent development of post-colonoscopy cancers may attenuate the effect of screening. This study aimed to quantify the extent of incomplete polyp removal. METHODS: We included patients aged 50-75 years with nonpedunculated polyps ≥ 5 mm removed during colonoscopy at four hospitals in Norway. To evaluate completeness of polyp removal, biopsies from the resection margins were obtained after polypectomy. Logistic regression models were fitted to identify factors explaining incomplete resection. RESULTS: 246 patients with 339 polyps underwent polypectomy between January 2015 and June 2017. A total of 12 polyps were excluded due to biopsy electrocautery damage, and 327 polyps in 246 patients (mean age 67 years [range 42-83]; 52 % male) were included in the analysis. Overall, 54 polyps (15.9 %) in 54 patients were incompletely resected. Histological diagnosis of the polyp (sessile serrated lesions vs. adenoma, odds ratio [OR] 10.9, 95 % confidence interval [CI] 3.9-30.1) and polyp location (proximal vs. distal colon, OR 2.8, 95 %CI 1.0-7.7) were independent risk factors for incomplete removal of polyps 5-19 mm. Board-certified endoscopists were not associated with lower rates of incomplete resection compared with trainees (14.0 % vs. 14.2 %), OR 1.0 (95 %CI 0.5-2.1). CONCLUSION: Incomplete polyp resection was frequent after polypectomy in routine clinical practice. Serrated histology and proximal location were independent risk factors for incomplete resection. The performance of board-certified gastroenterologists was not superior to that of trainees.

Erosive Esophagitis and Symptoms of Gastroesophageal Reflux Disease in Patients with Morbid Obesity with and without Type 2 Diabetes: a Cross-sectional Study.

BACKGROUND: Type 2 diabetes (T2DM) is associated with gastroesophageal reflux disease (GERD) in the general population, but the relationship between these conditions in candidates for bariatric surgery is uncertain. We compared the prevalence of GERD and the association between GERD symptoms and esophagitis among bariatric candidates with and without T2DM. METHODS: Cross-sectional study of baseline data from the Oseberg study in Norway. Both groups underwent gastroduodenoscopy and completed validated questionnaires: Gastrointestinal Symptom Rating Scale and Gastroesophageal Reflux Disease Questionnaire. Participants with T2DM underwent 24-h pH-metry. RESULTS: A total of 124 patients with T2DM, 81 women, mean (SD) age 48.6 (9.4) years and BMI 42.3 (5.5) kg/m2, and 64 patients without T2DM, 46 women, age 43.0 (11.0) years and BMI 43.0 (5.0) kg/m2, were included. The proportions of patients reporting GERD-symptoms were low (< 29%) and did not differ significantly between groups, while the proportions of patients with esophagitis were high both in the T2DM and non-T2DM group, 58% versus 47%, p = 0.16. The majority of patients with esophagitis did not have GERD-symptoms (68-80%). Further, 55% of the patients with T2DM had pathologic acid reflux. Among these, 71% also had erosive esophagitis, whereof 67% were asymptomatic. CONCLUSIONS: The prevalence of GERD was similar in bariatric patients with or without T2DM, and the proportion of patients with asymptomatic GERD was high independent of the presence or absence of T2DM. Accordingly, GERD may be underdiagnosed in patients not undergoing a preoperative endoscopy or acid reflux assessment. TRIAL REGISTRATION: Clinical Trials.gov number NCT01778738.

Single-centre, triple-blinded, randomised, 1-year, parallel-group, superiority study to compare the effects of Roux-en-Y gastric bypass and sleeve gastrectomy on remission of type 2 diabetes and ß-cell function in subjects with morbid obesity: a protocol for the Obesity surgery in Tønsberg (Oseberg) study.

INTRODUCTION: Bariatric surgery is increasingly recognised as an effective treatment option for subjects with type 2 diabetes and obesity; however, there is no conclusive evidence on the superiority of Roux-en-Y gastric bypass or sleeve gastrectomy. The Oseberg study was designed to compare the effects of gastric bypass and sleeve gastrectomy on remission of type 2 diabetes and ß-cell function. METHODS AND ANALYSIS: Single-centre, randomised, triple-blinded, two-armed superiority trial carried out at the Morbid Obesity Centre at Vestfold Hospital Trust in Norway. Eligible patients with type 2 diabetes and obesity were randomly allocated in a 1:1 ratio to either gastric bypass or sleeve gastrectomy. The primary outcome measures are (1) the proportion of participants with complete remission of type 2 diabetes (HbA1c≤6.0% in the absence of blood glucose-lowering pharmacologic therapy) and (2) ß-cell function expressed by the disposition index (calculated using the frequently sampled intravenous glucose tolerance test with minimal model analysis) 1 year after surgery. ETHICS AND DISSEMINATION: The protocol of the current study was reviewed and approved by the regional ethics committee on 12 September 2012 (ref: 2012/1427/REK sør-øst B). The results will be disseminated to academic and health professional audiences and the public via publications in international peer-reviewed journals and conferences. Participants will receive a summary of the main findings. TRIAL REGISTRATION NUMBER: NCT01778738;Pre-results.

Registration bias in a clinical quality register.

Background and aims The quality of medical quality registers is poorly defined and lack of trust in data due to low completeness may be a major barrier against their use in quality improvement interventions. The aim of the current observational study was to explore how selective reporting may influence adverse events registered in the Norwegian quality register for colonoscopy (Gastronet). Materials and methods Gastronet's database includes data provided by endoscopists, nurses and patients. All outpatient colonoscopies reported to Gastronet in 2015 were included and compared to the total number of colonoscopies performed in Norway as retrieved from the National Patient Registry. Hospitals were categorized into four groups according to reporting completeness < 50 %, 50 % to 69 %, 70 % to 89 % and ≥ 90 %. The number of recorded adverse events (AEs) and procedure time were analyzed. Multivariate logistic regression models were fitted to explore independent factors for selection bias. Results A total of 22,364 colonoscopies were reported to the National Patient Register of which 15,855 (71 %) were registered in Gastronet. Feedback was received from 11,079 patients (50 %). The frequency of AEs increased from 0.6 % in completeness group < 50 % to 1.6 % in completeness group ≥ 90 % ( P  < 0.001). Long colonoscopy procedure time was associated with low reporting completeness. Patient feedback was associated with older age, cecal intubation success and sedation-free colonoscopy. Conclusion Incomplete registration in a colonoscopy quality register is associated with underreporting of AEs. Longer procedure time, a surrogate marker for time constraint, is associated with low completeness.

Endoscopy assistants influence the quality of colonoscopy.

BACKGROUND: Colonoscopy performance varies between endoscopists, but little is known about the impact of endoscopy assistants on key performance indicators. We used a large prospective colonoscopy quality database to perform an exploratory study to evaluate differences in selected quality indicators between endoscopy assistants. METHODS: All colonoscopies reported to the Norwegian colonoscopy quality assurance register Gastronet can be used to trace individual endoscopy assistants. We analyzed key quality indicators (cecum intubation rate, polyp detection rate, colonoscopies rated as severely painful, colonoscopies with sedation or analgesia, and satisfaction with information) for colonoscopies performed between 1 January 2013 and 31 December 2014. Differences between individual assistants were analyzed by fitting multivariable logistic regression models, with the best performing assistant at each participating hospital as reference. All models were adjusted for the endoscopist. RESULTS: 63 endoscopy assistants from 12 hospitals assisted in 15 365 colonoscopies. Compared with their top performing peers from the same hospital, one assistant was associated with cecum intubation failure, four with poor polyp detection, nine with painful colonoscopy, 16 with administration of sedation or analgesics during colonoscopy, and three with patient dissatisfaction about information given relating to the colonoscopy. The number of procedures during the study period or lifetime experience as an endoscopy assistant were not associated with any quality indicator. CONCLUSION: In this exploratory study, there was little variation on important colonoscopy quality indicators between endoscopy assistants. However, there were differences among assistants that may be clinically important. Endoscopy assistants should be subject to quality surveillance similarly to endoscopists.

Performance measures for lower gastrointestinal endoscopy: a European Society of Gastrointestinal Endoscopy (ESGE) quality improvement initiative.

The European Society of Gastrointestinal Endoscopy and United European Gastroenterology present a short list of key performance measures for lower gastrointestinal endoscopy. We recommend that endoscopy services across Europe adopt the following seven key performance measures for lower gastrointestinal endoscopy for measurement and evaluation in daily practice at a center and endoscopist level: 1 rate of adequate bowel preparation (minimum standard 90%); 2 cecal intubation rate (minimum standard 90%); 3 adenoma detection rate (minimum standard 25%); 4 appropriate polypectomy technique (minimum standard 80%); 5 complication rate (minimum standard not set); 6 patient experience (minimum standard not set); 7 appropriate post-polypectomy surveillance recommendations (minimum standard not set). Other identified performance measures have been listed as less relevant based on an assessment of their importance, scientific acceptability, feasibility, usability, and comparison to competing measures.

Patient-reported adverse events after colonoscopy in Norway.

Background and aims Patient-reported outcome measures are increasingly important in healthcare. European guidelines have recommended inclusion of patient feedback to capture adverse events due to colonoscopy, but this is rarely implemented. Methods The Norwegian Quality Assurance network for endoscopy (Gastronet) collects patient-reported outcome for colonoscopies. Free-text comments on patient reports from January to December 2015 were characterized as positive or negative. All negative free-text comments were scrutinized for information that might suggest colonoscopy-related adverse events. We identified severe adverse events with and without admission to hospital. Results We included 16 552 outpatient colonoscopies performed at 21 hospitals. A total of 11 248 procedures (68 %) were accompanied by a patient feedback report, of which 2628 (23 %) had free-text comments (2196 [20 %] characterized as positive and 432 [3.8 %] as negative). These negative free texts on patient reports revealed 15 post-colonoscopy hospital admissions due to adverse events that had not been registered in the colonoscopy report. This increased the number of hospital admissions caused by adverse events from 3 (0.03 %) to 18 (0.16 %). In addition, there were 14 patient reports of severe events without hospital admission. Therefore, a total of 29 severe adverse events reported by patients were missed by conventional documentation in the colonoscopy form. Conclusion It is feasible to implement patient feedback as routine reporting to capture the full picture of colonoscopy-related adverse events. Some patients experience significant complications that are not recorded through any registries. Patient feedback forms should be tailored to capture adverse events after colonoscopy that are otherwise not easily disclosed.

Performance measures for lower gastrointestinal endoscopy: a European Society of Gastrointestinal Endoscopy (ESGE) Quality Improvement Initiative.

The European Society of Gastrointestinal Endoscopy and United European Gastroenterology present a short list of key performance measures for lower gastrointestinal endoscopy. We recommend that endoscopy services across Europe adopt the following seven key performance measures for lower gastrointestinal endoscopy for measurement and evaluation in daily practice at a center and endoscopist level: 1 Rate of adequate bowel preparation (minimum standard 90 %); 2 Cecal intubation rate (minimum standard 90 %); 3 Adenoma detection rate (minimum standard 25 %); 4 Appropriate polypectomy technique (minimum standard 80 %); 5 Complication rate (minimum standard not set); 6 Patient experience (minimum standard not set); 7 Appropriate post-polypectomy surveillance recommendations (minimum standard not set). Other identified performance measures have been listed as less relevant based on an assessment of their importance, scientific acceptability, feasibility, usability, and comparison to competing measures.

First quality score for referral letters in gastroenterology-a validation study.

OBJECTIVE: To create and validate an objective and reliable score to assess referral quality in gastroenterology. DESIGN: An observational multicentre study. SETTING AND PARTICIPANTS: 25 gastroenterologists participated in selecting variables for a Thirty Point Score (TPS) for quality assessment of referrals to gastroenterology specialist healthcare for 9 common indications. From May to September 2014, 7 hospitals from the South-Eastern Norway Regional Health Authority participated in collecting and scoring 327 referrals to a gastroenterologist. MAIN OUTCOME MEASURE: Correlation between the TPS and a visual analogue scale (VAS) for referral quality. RESULTS: The 327 referrals had an average TPS of 13.2 (range 1-25) and an average VAS of 4.7 (range 0.2-9.5). The reliability of the score was excellent, with an intra-rater intraclass correlation coefficient (ICC) of 0.87 and inter-rater ICC of 0.91. The overall correlation between the TPS and the VAS was moderate (r=0.42), and ranged from fair to substantial for the various indications. Mean agreement was good (ICC=0.47, 95% CI (0.34 to 0.57)), ranging from poor to good. CONCLUSIONS: The TPS is reliable, objective and shows good agreement with the subjective VAS. The score may be a useful tool for assessing referral quality in gastroenterology, particularly important when evaluating the effect of interventions to improve referral quality.

Time trends in quality indicators of colonoscopy.

BACKGROUND: There is considerable variation in the quality of colonoscopy performance. The Norwegian quality assurance programme Gastronet registers outpatient colonoscopies performed in Norwegian endoscopy centres. The aim of Gastronet is long-term improvement of endoscopist and centre performance by annual feedback of performance data. OBJECTIVE: The objective of this article is to perform an analysis of trends of quality indicators for colonoscopy in Gastronet. METHODS: This prospective cohort study included 73,522 outpatient colonoscopies from 73 endoscopists at 25 endoscopy centres from 2003 to 2012. We used multivariate logistic regression with adjustment for relevant variables to determine annual trends of three performance indicators: caecum intubation rate, pain during the procedure, and detection rate of polyps ≥5 mm. RESULTS: The proportion of severely painful colonoscopies decreased from 14.8% to 9.2% (relative risk reduction of 38%; OR = 0.92 per year in Gastronet; 95% CI 0.86-1.00; p = 0.045). Caecal intubation (OR = 0.99; 95% CI 0.94-1.04; p = 0.6) and polyp detection (OR = 1.03; 95% CI 0.99-1.07; p = 0.15) remained unchanged during the study period. CONCLUSIONS: Pain at colonoscopy showed a significant decrease during years of Gastronet participation while caecal intubation and polyp detection remained unchanged - independent of the use of sedation and/or analgesics and level of endoscopist experience. This may be due to the Gastronet audit, but effects of improved endoscopy technology cannot be excluded.

Risk stratification to predict pain during unsedated colonoscopy: results of a multicenter cohort study.

BACKGROUND AND STUDY AIMS: Colonoscopy without sedation has several advantages over sedated colonoscopy, but a considerable proportion of patients experience pain. The aim of this study was to develop a risk stratification model of pre-examination risk factors to enable targeted sedation during colonoscopy. PATIENTS AND METHODS: Between October 2011 and January 2012, consecutive outpatients who were willing to start colonoscopy without sedation at 11 Norwegian centers were prospectively recruited. Patients recorded pain on a validated 4-point scale (none, slight, moderate, or severe pain). Potential risk factors for a painful procedure (defined as moderate or severe pain) were evaluated using multivariate logistic regression analyses, and the area under the receiver operating characteristics curve (AUROC) was calculated to assess the discriminatory ability of the derived model. RESULTS: A total of 1198 patients (635 men and 563 women) were included. Seven independent, pre-procedural risk factors for patient pain were identified: female sex, age < 40 years, previous abdominal surgery, abdominal pain as indication for colonoscopy, anticipation of pain, previous painful colonoscopy, and a history of diverticulitis. In patients with 0, 1, 2, or ≥ 3 risk factors, a painful colonoscopy was experienced by 35 %, 43 %, 52 %, and 63 % of women and 18 %, 24 %, 35 %, and 63 % of men, respectively. The model showed modest discrimination abilities (AUROC = 0.69). CONCLUSION: Female sex was a strong risk factor for pain during colonoscopy, and sedation or analgesia should be considered for all women prior to colonoscopy. For male patients, the presence of multiple risk factors should encourage the endoscopist to offer sedation.

[Pain in connection with colonoscopy in Norway]. / Smerter ved koloskopi.

BACKGROUND: Colonoscopies are common examinations at Norwegian hospitals. In contrast to many other countries, the majority of colonoscopies in Norway are conducted without routine sedation or analgesia. We wanted to investigate whether current Norwegian practice offers adequate pain relief. MATERIAL AND METHOD: The material consists of prospectively recorded outpatient colonoscopies in the period January 2003-December 2011 performed at Norwegian hospitals in the quality assurance network for gastrointestinal endoscopy (Gastronet). We analysed demographic patient data and data from colonoscopies. Patients' experience of pain (none, slight, moderate or severe pain) in connection with the examination was established with the aid of a validated questionnaire. RESULTS: Data from 61,749 colonoscopies (55% on women) performed at 29 different hospitals were analysed. Colonoscopies were perceived as moderately or very painful by 33% of the patients (41% of the women, 24% of the men, p < 0.001). There were substantial differences between hospitals as to the percentage of colonoscopies that were perceived as moderately or very painful (from 9% to 43%, p < 0.001) and the use of sedatives and analgesics for the colonoscopies (from 1% to 92% of the examinations, p < 0.001). Only 23% of those who found the colonoscopy painful received analgesics. Pethidine was used in 95% of the cases in which analgesics were used during the examination. INTERPRETATION: Many patients find colonoscopies painful. Pain relief practice varies substantially between hospitals. Pethidine is an analgesic with a slow onset of action, and should perhaps be replaced with more rapidly acting opiates.