30-Days Post-Operative Complications in Bariatric Surgery (Bariatric)

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

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

Study Overview

• Status: Completed
• Conditions: Bariatric Surgery
• Intervention / Treatment: Procedure: Comparison of two Techniques of bariatric surgery

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.

• Study Type: Interventional
• Enrollment (Actual): 116
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab
    • Multan, Punjab, Pakistan, 57000
      • Multan Medical and Dental College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: LRYGB Procedure; LRYGB technique was performed by placing 4 to 6 trocars, a 150 cm ante-colic Roux-limb gastric pouch (30 to 50 ml) was created with linear stapled or circular stapled gastro-jejunostomy, a 50-cm long biliopancreatic limb was chosen. A passive drainage was kept near to the gastro-jejunostomy.	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
Active Comparator: LSG Procedure; 35 Fr bougie was used for the calibration of a gastric tube. 3 to 6 cm of longitudinal incision of the stomach was done at pylorus to the angle of His. Using of absorbable suture, the staple line was sewn.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Frequency of Bleeding in Each Study Arm	Patients were examined postoperative for the presence of bleeding	24 hours after surgery
Number of Infections in Each Study Arm	Patients were examined on postoperative 30 days for the presence of Wound infections	30 days
Mortality in Each Study Arm	Patients were followed for 30 days and number of mortalities was noted on each arm	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital Stay	Duration of hospitalization	30 days

Collaborators and Investigators

• Sponsor: Multan Medical And Dental College

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 13, 2018
• Primary Completion (Actual): February 12, 2019
• Study Completion (Actual): October 12, 2019

Study Registration Dates

• First Submitted: February 7, 2021
• First Submitted That Met QC Criteria: February 27, 2021
• First Posted (Actual): March 3, 2021

Study Record Updates

• Last Update Posted (Actual): March 3, 2021
• Last Update Submitted That Met QC Criteria: February 27, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Bariatric surgery; Laparoscopic sleeve gastrectomy; Laparoscopic Roux-en-Y gastric bypass
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications
• Other Study ID Numbers: MMDC-2018-023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No