30-Days Post-Operative Complications in Bariatric Surgery

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

Detailed Description
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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.

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

Conditions
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Bariatric Surgery

Intervention / Treatment
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* Procedure: Comparison of two Techniques of bariatric surgery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: LRYGB Procedure<br>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<br>* We compared the 30 days outcomes in patients who underwent LSG procedure with those who underwent LRYGB<br>|
| Active Comparator: LSG Procedure<br>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<br>* We compared the 30 days outcomes in patients who underwent LSG procedure with those who underwent LRYGB<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bariatric surgery, Laparoscopic Roux-en-Y gastric bypass, Laparoscopic sleeve gastrectomy