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

Primary Purpose

Bariatric Surgery

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Comparison of two Techniques of bariatric surgery
Sponsored by
Multan Medical And Dental College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bariatric Surgery focused on measuring Bariatric surgery, Laparoscopic Roux-en-Y gastric bypass, Laparoscopic sleeve gastrectomy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Multan Medical and Dental College

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

LRYGB Procedure

LSG Procedure

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Frequency of Anastomotic Leakage in Each Study Arm
Patients were examined on postoperative 30 days for the presence of Anastomotic leakage
Frequency of Bleeding in Each Study Arm
Patients were examined postoperative for the presence of bleeding
Number of Infections in Each Study Arm
Patients were examined on postoperative 30 days for the presence of Wound infections
Mortality in Each Study Arm
Patients were followed for 30 days and number of mortalities was noted on each arm

Secondary Outcome Measures

Hospital Stay
Duration of hospitalization

Full Information

First Posted
February 7, 2021
Last Updated
February 27, 2021
Sponsor
Multan Medical And Dental College
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1. Study Identification

Unique Protocol Identification Number
NCT04779723
Brief Title
30-Days Post-Operative Complications in Bariatric Surgery
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
June 13, 2018 (Actual)
Primary Completion Date
February 12, 2019 (Actual)
Study Completion Date
October 12, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Multan Medical And Dental College

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bariatric Surgery
Keywords
Bariatric surgery, Laparoscopic Roux-en-Y gastric bypass, Laparoscopic sleeve gastrectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
116 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LRYGB Procedure
Arm Type
Active Comparator
Arm Description
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.
Arm Title
LSG Procedure
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Comparison of two Techniques of bariatric surgery
Intervention Description
We compared the 30 days outcomes in patients who underwent LSG procedure with those who underwent LRYGB
Primary Outcome Measure Information:
Title
Frequency of Anastomotic Leakage in Each Study Arm
Description
Patients were examined on postoperative 30 days for the presence of Anastomotic leakage
Time Frame
within the first 30 days after surgery
Title
Frequency of Bleeding in Each Study Arm
Description
Patients were examined postoperative for the presence of bleeding
Time Frame
24 hours after surgery
Title
Number of Infections in Each Study Arm
Description
Patients were examined on postoperative 30 days for the presence of Wound infections
Time Frame
30 days
Title
Mortality in Each Study Arm
Description
Patients were followed for 30 days and number of mortalities was noted on each arm
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Hospital Stay
Description
Duration of hospitalization
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Multan Medical and Dental College
City
Multan
State/Province
Punjab
ZIP/Postal Code
57000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
18775352
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.
Results Reference
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PubMed Identifier
30253139
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.
Results Reference
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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
Results Reference
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PubMed Identifier
22990271
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.
Results Reference
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PubMed Identifier
21772127
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.
Results Reference
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PubMed Identifier
24901132
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.
Results Reference
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PubMed Identifier
23989054
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.
Results Reference
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30-Days Post-Operative Complications in Bariatric Surgery

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