Bariatric Surgery Clinical Trial
— BariatricOfficial title:
Comparison of Laparoscopic Sleeve Gastrectomy (LSG) With Laparoscopic Gastric Bypass (LRYGB) in Bariatric Surgery; 30-Days Post-Operative Complications in Bariatric Surgery
Verified date | February 2021 |
Source | Multan Medical And Dental College |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
comparison of 30-days post-operative outcomes of laparoscopic sleeve gastrectomy (LSG) and laparoscopic Roux-en-Y gastric bypass (LRYGB)
Status | Completed |
Enrollment | 116 |
Est. completion date | October 12, 2019 |
Est. primary completion date | February 12, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - patients of age 18 to 65 years - body mass index (BMI) >35 kg/m2 (Morbidly obese) - Patients with failed conservative treatment of weight control Exclusion Criteria: - Severe indicative gastroesophageal reflux disease (GERD) - Conversion of another bariatric procedure - Large hiatal hernia - Patients with inflammatory bowel disease |
Country | Name | City | State |
---|---|---|---|
Pakistan | Multan Medical and Dental College | Multan | Punjab |
Lead Sponsor | Collaborator |
---|---|
Multan Medical And Dental College |
Pakistan,
Adams TD, Davidson LE, Litwin SE, Kolotkin RL, LaMonte MJ, Pendleton RC, Strong MB, Vinik R, Wanner NA, Hopkins PN, Gress RE, Walker JM, Cloward TV, Nuttall RT, Hammoud A, Greenwood JL, Crosby RD, McKinlay R, Simper SC, Smith SC, Hunt SC. Health benefits of gastric bypass surgery after 6 years. JAMA. 2012 Sep 19;308(11):1122-31. — View Citation
Chooi YC, Ding C, Magkos F. The epidemiology of obesity. Metabolism. 2019 Mar;92:6-10. doi: 10.1016/j.metabol.2018.09.005. Epub 2018 Sep 22. Review. — View Citation
Gallagher EJ, LeRoith D, Karnieli E. The metabolic syndrome--from insulin resistance to obesity and diabetes. Endocrinol Metab Clin North Am. 2008 Sep;37(3):559-79, vii. doi: 10.1016/j.ecl.2008.05.002. Review. — View Citation
Li K, Gao F, Xue H, Jiang Q, Wang Y, Shen Q, Tian Y, Yang Y. Comparative study on laparoscopic sleeve gastrectomy and laparoscopic gastric bypass for treatment of morbid obesity patients. Hepatogastroenterology. 2014 Mar-Apr;61(130):319-22. — View Citation
Peterli R, Borbély Y, Kern B, Gass M, Peters T, Thurnheer M, Schultes B, Laederach K, Bueter M, Schiesser M. Early results of the Swiss Multicentre Bypass or Sleeve Study (SM-BOSS): a prospective randomized trial comparing laparoscopic sleeve gastrectomy and Roux-en-Y gastric bypass. Ann Surg. 2013 Nov;258(5):690-4; discussion 695. doi: 10.1097/SLA.0b013e3182a67426. — View Citation
Siddiqui M, Hameed R, Nadeem M, Mohammad T, Simbak N, Latif A, et al. Obesity in Pakistan; current and future perceptions. J Curr Trends Biomed Eng Biosci. 2018;17:001-004
Suter M, Donadini A, Romy S, Demartines N, Giusti V. Laparoscopic Roux-en-Y gastric bypass: significant long-term weight loss, improvement of obesity-related comorbidities and quality of life. Ann Surg. 2011 Aug;254(2):267-73. doi: 10.1097/SLA.0b013e3182263b66. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Frequency of Anastomotic Leakage in Each Study Arm | Patients were examined on postoperative 30 days for the presence of Anastomotic leakage | within the first 30 days after surgery | |
Primary | Frequency of Bleeding in Each Study Arm | Patients were examined postoperative for the presence of bleeding | 24 hours after surgery | |
Primary | Number of Infections in Each Study Arm | Patients were examined on postoperative 30 days for the presence of Wound infections | 30 days | |
Primary | Mortality in Each Study Arm | Patients were followed for 30 days and number of mortalities was noted on each arm | 30 days | |
Secondary | Hospital Stay | Duration of hospitalization | 30 days |
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