Sleeve Gastrectomy and Cholecystectomy Are Safe in Obese Patients With Asymptomatic Cholelithiasis

NCT04878640 | Completed

• 1 other identifier: Sleeve Gastrectomy
• Study Type: interventional
• Target: 222
• Locations: 0 countries
• Sites: N/A

Brief Summary

Introduction: Obesity is an increasingly serious public health problem on a global level. Gallstones may become symptomatic after sleeve gastrectomy surgery. There is a debate regarding concomitant cholecystectomy during bariatric surgery. Aim of the study: This study analyzed outcomes of laparoscopic sleeve gastrectomy (LSG) with and without concomitant laparoscopic cholecystectomy in morbid obese patients with gall bladder stones. Patients and methods: We conducted randomized clinical study on 222 patients. These patients were categorized into two equal groups (111 in each group) .Group A: underwent SG and concomitant laparoscopic cholecystectomy in morbid obese patient with evidence of gall bladder stone, Group B: SG only without concomitant LC inspite of evidence of gall bladder stone. This study was performed at single institution from January 1, 2016 to January 1, 2019.

Conditions

Bariatric Surgery Candidate

Keywords

obesity; bariatric surgery; concomitant, cholecystectomy

Outcome Measures

Primary Outcomes (2)

• time of operation

  time of operation in minutes

  2 years

• hospital length of stay

  hospital length of stay i days

  2 years

Secondary Outcomes (1)

• body mass loss

  2 years

Other Outcomes (1)

• timing in which gallstones symptomatize

  2 years

Study Arms (2)

Group A

ACTIVE COMPARATOR

patients with morbid obesity and gall bladder stone underwent concomitant laparoscopic cholecystectomy in the same setting during laparoscopic sleeve gastrectomy

Procedure: patients with morbid obesity and gall bladder stone underwent concomitant laparoscopic cholecystectomy in the same setting during laparoscopic sleeve gastrectomy

Group B

ACTIVE COMPARATOR

patients with morbid obesity and gall bladder stone underwent laparoscopic sleeve gastrectomy without concomitant laparoscopic cholecystectomy

Procedure: patients with morbid obesity and gall bladder stone underwent laparoscopic sleeve gastrectomy without concomitant laparoscopic cholecystectomy

Interventions

patients with morbid obesity and gall bladder stone underwent concomitant laparoscopic cholecystectomy in the same setting during laparoscopic sleeve gastrectomy PROCEDURE

patients with morbid obesity and gall bladder stone underwent concomitant laparoscopic cholecystectomy in the same setting during laparoscopic sleeve gastrectomy

Group A

patients with morbid obesity and gall bladder stone underwent laparoscopic sleeve gastrectomy without concomitant laparoscopic cholecystectomy PROCEDURE

patients with morbid obesity and gall bladder stone underwent laparoscopic sleeve gastrectomy without concomitant laparoscopic cholecystectomy

Group B

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and Non pregnant female, \>20 years old, All patients were contender for bariatric surgery in conformity with National Institutes of Health consensus criteria for the management of morbid obesity (BMI ≥ 40 kg/m² or BMI ≥ 35 kg/m² with compelling co-morbidities linked to obesity),, had pre-operative ultrasound patients who completed at least two-years follow up

You may not qualify if:

• younger than 20 years, History of cholecystectomy, No pre-operative imaging available within 6 months, dearth of interest. Subjective mess and cognitive vulnerability that halt the patient from considering the operation, Drug or alcohol junkie, Patients unsuitable for general anesthesia, preceding bariatric operation, Patients with calcular obstructive jaundice underwent ERCP with stenting and Cases with arduous displaying of right upper quadrant or liver cirrhosis found at surgery.

Sponsors & Collaborators

• Zagazig University: lead

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professour of general and laparoscopic surgery

Study Record Dates

• First Submitted: May 1, 2021
• First Posted: May 7, 2021
• Study Start: January 1, 2016
• Primary Completion: January 1, 2019
• Study Completion: January 1, 2021
• Last Updated: December 20, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share