An interventional study of Sleeve gastrectomy and Roux-en-Y gastric bypass in Obesity, Morbid, Overnutrition and Nutrition Disorders, sponsored by Inha University Hospital. Status unknown at 1 site in Korea, Republic of. Open to participants aged 20 Years to 65 Years. Per ClinicalTrials.gov, last updated 2020-10-08.
Sponsored by Inha University Hospital · Not applicable, Interventional, and Treatment
Prospective, double-arm, multi-center cohort study on obese patients, for laparoscopic sleeve gastrectomy versus Roux-en Y gastric bypass
This is prospective cohort study. Total 400 obese patients will be enrolled(Sleeve gastrectomy 200 patients, Roux-en-Y gastric bypass 200)
The principal investigator or another clinical investigator in charge will individually inform the patients about the study, before operation at out patient clinic. At that time patient is selected to either sleeve gastrectomy group or Roux-en-Y gastric bypass group. All investigator report to clinical research center about patients BMI and operation method.
About 30-35 obesity patients will be enrolled according to their BMI status. Patients' BMI status is classified into several parts by 2.5 gap started from 27.5.
All patients will undergo periodically anthropometry, laboratory tests, bioelectrical impedance analysis, gastrofiberscopy, polysomnography and abdomen CT before and after surgery.
Patients with hypertension will undergo echocardiography. Patients with polycystic ovary syndrome will be checked hormonal study. Patients with type 2 diabetes mellitus will be performed 75g oral glucose tolerance test test.
Surgical complication include wound morbidities, gastrointestinal leakage or fistula, postoperative bleeding, intra-abdominal abscess, stricture , adhesive ileus, reflux esophagitis, marginal ulceration, dumping syndrome and internal hernia.
Systemic complication which is not associated with the operation field include ling morbidities, heart morbidities, urinary morbidities and others.
Hospital mortality is defined as postoperative death form any cause within 30 days after operation.
All patients will be followed up post operative 1 month, 3 month, 6 month, 12 month, 18 month, 24 month.
All patients' liver tissue, visceral fat and subcutaneous fat will be harvested during operation.
All patients' blood sample will be collected at out patient clinic visit. All patients' urine and face will be collected at out patient clinic visit and will be analyzed to evaluate microbial change throughout pre and post operation period.
941 studies on the registry are indexed under Obesity, Morbid; 163 are open to participants now.
This study's planned enrollment of 400 is above the median of 62 across 602 interventional studies indexed under Obesity, Morbid.
Browse Obesity, Morbid studies →Inha University Hospital is the lead sponsor of 37 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
200 obesity patients who undergo laparoscopic sleeve gastrectomy
Procedure: Sleeve gastrectomy
200 obesity patients who undergo laparoscopic Roux-en-Y gastric bypass
Procedure: Roux-en-Y gastric bypass
Bariatric operation will be done by laparoscopic sleeve gastrectomy procedure.
Bariatric operation will be done by laparoscopic Roux-en-Y gastric bypass procedure.
Obesity Cure Success Rate
Proportion of patients who reach BMI bellow 25
Time frame: Postoperative 1 year
Body weight change rate
Decreased body weight proportion compare to preoperative body weight
Time frame: Postoperative 1 year
Waist circumference change rate
Decreased waist circumference change proportion compare to preoperative waist circumference
Time frame: Postoperative 1 year
Rate of morbid disease remission or partial remission
Remission rate or partial remission rate of morbid disease related to obesity such as hypertension, type 2 diabetes mellitus, hyperlipidemia after surgery
Time frame: Postoperative 1 year, 2 year
Postoperative complication rate and mortality rate
Number of participants surgical complications associate with the surgical technique or the operation field Number of participants mortality after operation associated with surgical complication or underlying disease
Time frame: Within postoperative 30 days
Micronutrient deficiency
Incidence of micronutrient deficiency rate such as vitamine, calcium, iron
Time frame: Postoperative 1 year, 2 year
Quality of life improvement rate and degree-1
Patients rate and quantitative analysis of the improved life quality using several survey EQ-5D-3L(EuroQol-5D) consists of 5 dimensions(mobility, self-care, usual activities, pain/discomfort and anxiety/depression). Each of which is scored as no/some/extreme problems. The dimension scores are converted into health utility scores ranging form 0(death) to 1(perfect health)
Time frame: Postoperative 1 year, 2 year
Quality of life improvement rate and degree-2
EQ-VAS(EuroQol-Visual Analogue scale) is a question scale ranging form 0 to 100. 0 indicated the worst and 100 indicated the best condition. EQ-VAS provides important, complementary information on patient's view about their own health.
Time frame: Postoperative 1 year, 2 year
Quality of life improvement rate and degree-3
Impact of Weight on QoL(IWQoL) has 5 dimensions and each dimension has several items. * physical function : 11 items * self-esteem : 7 items * sexual life : 4 items * public distress : 5 items * work : 4 items Score range from 0 to 100 and 100 represents the best quality of life.
Time frame: Postoperative 1 year, 2 year
Quality of life improvement rate and degree-4
Moore-head-Ardelt QoL questionnaire II(MA-II) has 6 items(general self-esteem, physical activity, social contacts, satisfaction concerning work, pleasure related to sexuality and focus on eating behavior). All items are scored according to 10-level Likert scale(-0.5 to 0.5) and all have the same weight.
Time frame: Postoperative 1 year, 2 year
Quality of life improvement rate and degree-5
Obesity-related Psychosocial Problem scale(OP scale) consists of 8 items that measure the bothersome impact of body weight on given situations. (private gatherings in their own home, private gatherings at their friend or relative's home and going to restaurant)
Time frame: Postoperative 1 year, 2 year
Started Sep 2020 (actual). Primary completion is estimated for Aug 2022, 23 months after the start.
Of 274 non-industry interventional studies with no phase under Obesity, Morbid, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 48. This study's planned 23 months is close to that.
Counting every sponsor, half of 286 studies reached it within 25 months; a quarter within 11 and three quarters within 48.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.
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Inha University Hospital