Sleeve Gastrectomy as a Standard Bariatric Procedure

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

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Postoperative Complications
• Intervention / Treatment: Procedure: SG or a RYGB

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 1015

Contacts and Locations

Study Locations

• Sweden
  • Sundsvall, Sweden
    • Sundsvall Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Morbid obesity patients found suitable for a SG or RYGB

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
laparoscopic sleeve gastrectomy (SG); Patients operated on with a SG	Procedure: SG or a RYGB; operation type differed between a partial gastrectomy (SG)or a combined restrictive/malabsorptive
laparoscopic Roux-en-Y gastric bypass (RYGB); patients operated on with aRYGB	Procedure: SG or a RYGB; operation type differed between a partial gastrectomy (SG)or a combined restrictive/malabsorptive

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Umeå University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Actual): January 1, 2022
• Study Completion (Anticipated): December 31, 2025

Study Registration Dates

• First Submitted: February 14, 2022
• First Submitted That Met QC Criteria: April 12, 2022
• First Posted (Actual): April 20, 2022

Study Record Updates

• Last Update Posted (Actual): April 20, 2022
• Last Update Submitted That Met QC Criteria: April 12, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Metabolic syndrome; bariatric surgery; Weight loss; Morbid obesity; laparoscopic sleeve gastrectomy; Metabolic control; laparoscopic Roux-en-Y gastric bypass; Complication risk
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications
• Other Study ID Numbers: YCengiz

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No