30-Days Post-Operative Complications in Bariatric Surgery

Bariatric Surgery Clinical Trial

— Bariatric  

Official title:

Comparison of Laparoscopic Sleeve Gastrectomy (LSG) With Laparoscopic Gastric Bypass (LRYGB) in Bariatric Surgery; 30-Days Post-Operative Complications in Bariatric Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04779723
• Other study ID #: MMDC-2018-023
• Status: Completed
• Phase: N/A
• Start date: June 13, 2018
• Est. completion date: October 12, 2019

Study information

• Verified date: February 2021
• Source: Multan Medical And Dental College
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Bariatric Surgery
• Postoperative Complications

Intervention

Procedure:
• Comparison of two Techniques of bariatric surgery
We compared the 30 days outcomes in patients who underwent LSG procedure with those who underwent LRYGB

Locations

Country	Name	City	State
Pakistan	Multan Medical and Dental College	Multan	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Multan Medical And Dental College

Country where clinical trial is conducted

Pakistan, 

References & Publications (7)

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

Outcome

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