Clinical trial NCT04779723: 30-Days Post-Operative Complications in Bariatric Surgery
Official title: Comparison of Laparoscopic Sleeve Gastrectomy (LSG) With Laparoscopic Gastric Bypass (LRYGB) in Bariatric Surgery; 30-Days Post-Operative Complications in Bariatric Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bariatric Surgery
Keywords: Bariatric surgery
Laparoscopic Roux-en-Y gastric bypass
Laparoscopic sleeve gastrectomy
Lead sponsor: Multan Medical And Dental College
Sponsor class: OTHER
First posted: 2021-03-03
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: comparison of 30-days post-operative outcomes of laparoscopic sleeve gastrectomy (LSG) and laparoscopic Roux-en-Y gastric bypass (LRYGB)

Detailed description: Obesity is one of the most challenging chronic diseases in the western world as well as in Pakistan. Half of the people in this world consider themselves overweight or obese. Obesity is one of the most challenging chronic diseases in the western world as well as in Pakistan . Half of the people in this world consider themselves overweight or obese. Obesity is challenging to control by medical therapy and drug treatment. The most effective way to treat obesity is bariatric surgery. Laparoscopic Roux-en-Y gastric bypass (LRYGB) is a "gold standard" bariatric surgical procedure. Recently there is much attention gained by laparoscopic sleeve gastrectomy (LSG). Therefore, we decided to conduct this comparative study to compare the early post-op complications of LSG with LRYGB technique in patients undergoing bariatric surgery.

Eligibility criteria: 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

Primary outcomes:
measure: Frequency of Anastomotic Leakage in Each Study Arm
timeFrame: within the first 30 days after surgery
measure: Frequency of Bleeding in Each Study Arm
timeFrame: 24 hours after surgery
measure: Number of Infections in Each Study Arm
timeFrame: 30 days
measure: Mortality in Each Study Arm
timeFrame: 30 days
Secondary outcomes:
measure: Hospital Stay
timeFrame: 30 days
Other outcomes:
Locations:
city: Multan
country: Pakistan
facility: Multan Medical and Dental College
state: Punjab
Study officials:
References:
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.
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.
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
citation: 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. doi: 10.1001/2012.jama.11164.
citation: 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.
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.
citation: Peterli R, Borbely 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.