Sleeve Gastrectomy as a Standard Bariatric Procedure

Postoperative Complications Clinical Trial

Official title:

Establishing Laparoscopic Sleeve Gastrectomy as a Standard Procedure at a Swedish Bariatric Center

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05336331
• Other study ID #: YCengiz
• Status: Active, not recruiting
• Start date: January 1, 2021
• Est. completion date: December 31, 2025

Study information

• Verified date: April 2022
• Source: Umeå University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study compared differences in weight loss, comorbidity resolution and complications and reoperations between a recently established sleeve gastrectomy (SG) and prior laparoscopic Rox-en-Y gastric bypass (RYGB).

Description:

This retrospective study with prospectively collected registry data presents results from establishment of SG as standard procedure for morbid obesity. Our first 368 patients operated with a SG were compared to 647 patients previously operated with a (RYGB. Perioperative data and results up to 2 years postoperatively regarding weight control, metabolic control as well as complications/reoperations necessary were registered.

In summary, a RYGB was associated with a longer operation time and higher rates of late complications and reoperations. Diabetes resolution was similar in both groups but patients with a RYGB had greater weight loss and significant improvement in hypertension and dyslipidemias.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1015
• Est. completion date: December 31, 2025
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Patients with either a BMI 35 or higher with comorbidity, or patients with a BMI of 40 or more without known comorbidity associated, undergoing a primary laparoscopic bariatric surgery in Sundsvall,Sweden 2010-01-01 to 2018-06-10.

Exclusion Criteria:

• All other patients undergoing a bariatric surgery during this time frame

Related Conditions & MeSH terms

• Postoperative Complications

Intervention

Procedure:
• SG or a RYGB
operation type differed between a partial gastrectomy (SG)or a combined restrictive/malabsorptive

Locations

Country	Name	City	State
Sweden	Sundsvall Hospital	Sundsvall

Sponsors (1)

Lead Sponsor	Collaborator
Umeå University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight loss	weight and height will be combined to report various measurements of BMI in kg/m^2	after 6 weeks
Primary	Weight loss	weight and height will be combined to report various measurements of BMI in kg/m^2	after 1 year
Primary	Weight loss	weight and height will be combined to report various measurements of BMI in kg/m^2	after 2 years
Primary	Changes in Diabetes	measured as fasting plasma glucose and/or Hemoglobin A1c	after 1 year
Primary	Changes in Diabetes	measured as fasting plasma glucose and/or Hemoglobin A1c	after 2 years
Primary	Changes in Hypertension	measured as Systolic- and Diastolic Blood Pressure	after 1 year
Primary	Changes in Hypertension	measured as Systolic- and Diastolic Blood Pressure	after 2 years
Primary	Changes in hypertriglyceridemia (plasma-level >1.7 mmol/l)	measured as hypertriglyceridaemia (plasma-level >1.7 mmol/l)	after 1 year
Primary	Changes in hypertriglyceridemia (plasma-level >1.7 mmol/l)	measured as hypertriglyceridaemia (plasma-level >1.7 mmol/l)	after 2 year
Primary	Changes in Hypercholesterolemia (LDL-C > 3.0 mmol/L and/or HDL-C < 1.0 mmol/L).	Measured as Hypercholesterolemia (Plasma concentration of LDL >3.0 mmol/L and/or of HDL < 1.0 mmol/L).	after 1 years
Primary	Changes in Hypercholesterolemia (LDL-C > 3.0 mmol/L and/or HDL-C < 1.0 mmol/L).	Measured as Hypercholesterolemia (Plasma concentration of LDL >3.0 mmol/L and/or of HDL < 1.0 mmol/L).	after 2 years
Primary	Duration of surgery	Operation time in minutes	From the start of the operation until completion, in average 62 minutes
Primary	Duration of hospital stay	Duration of hospital stay in days	From time of operation until discharge, in average 1.7 days
Primary	Early complications	Complications occurred until six weeks from operation	At six weeks
Primary	Early reoperations	Reoperations occurred until six weeks from operation	At six weeks
Primary	Late complications	Complications occurred from six weeks until 2 years from operation	From six weeks until 2 years from operation
Primary	Late reoperations	Reoperations occurred from six weeks until 2 years from operation	From six weeks until 2 years from operation