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OpenTrials
Completed

NCT Number: NCT04779723

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)

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Key information

Conditions

Bariatric Surgery

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Multan Medical and Dental College

Multan, Punjab Province, 57000, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Comparison of two Techniques of bariatric surgery

Procedure

We compared the 30 days outcomes in patients who underwent LSG procedure with those who underwent LRYGB

Primary outcomes

  1. Frequency of Anastomotic Leakage in Each Study Arm

    Time frame: within the first 30 days after surgery

    Patients were examined on postoperative 30 days for the presence of Anastomotic leakage

  2. Frequency of Bleeding in Each Study Arm

    Time frame: 24 hours after surgery

    Patients were examined postoperative for the presence of bleeding

  3. Number of Infections in Each Study Arm

    Time frame: 30 days

    Patients were examined on postoperative 30 days for the presence of Wound infections

  4. Mortality in Each Study Arm

    Time frame: 30 days

    Patients were followed for 30 days and number of mortalities was noted on each arm

Secondary outcomes

  1. Hospital Stay

    Time frame: 30 days

    Duration of hospitalization

Sponsors and collaborators

Lead sponsor

Multan Medical And Dental College

Other

Registry information

Official study title

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

Acronym: Bariatric

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Mar 3, 2021
Registry last updated
Mar 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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