30-Days Post-Operative Complications in Bariatric Surgery

NCT04779723 | Completed

• 1 other identifier: MMDC-2018-023
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Bariatric Surgery

Keywords

Bariatric surgery; Laparoscopic Roux-en-Y gastric bypass; Laparoscopic sleeve gastrectomy

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• Hospital Stay

  30 days

Study Arms (2)

LRYGB Procedure

ACTIVE COMPARATOR

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

LSG Procedure

ACTIVE COMPARATOR

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

Interventions

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

LRYGB Procedure; LSG Procedure

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients of age 18 to 65 years
• body mass index (BMI) \>35 kg/m2 (Morbidly obese)
• Patients with failed conservative treatment of weight control

You may not qualify if:

• Severe indicative gastroesophageal reflux disease (GERD)
• Conversion of another bariatric procedure
• Large hiatal hernia
• Patients with inflammatory bowel disease

Sponsors & Collaborators

• Multan Medical And Dental College: lead

Study Sites (1)

Multan Medical and Dental College

Multan, Punjab Province, 57000, Pakistan

Location

Related Publications (7)

• 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.

  PMID: 18775352 BACKGROUND

• 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.

  PMID: 30253139 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 22990271 BACKGROUND

• 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.

  PMID: 21772127 BACKGROUND

• 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.

  PMID: 24901132 BACKGROUND

• 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.

  PMID: 23989054 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant General and laparoscopic Surgeon

Study Record Dates

• First Submitted: February 7, 2021
• First Posted: March 3, 2021
• Study Start: June 13, 2018
• Primary Completion: February 12, 2019
• Study Completion: October 12, 2019
• Last Updated: March 3, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)