Sleeve Gastrectomy as a Standard Bariatric Procedure

Active, not recruiting

• Conditions: Postoperative Complications
• Interventions: Procedure: SG or a RYGB

• Registration Number: NCT05336331
• Lead Sponsor: Umeå University

Brief 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).

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 Timeline

• Study Start: 2021-01-01
• Primary Completion: 2022-01-01
• Study First Submitted: 2022-02-14
• Status Verified: 2022-04
• Study First Submitted QC: 2022-04-12
• Last Update Submitted: 2022-04-12
• Study First Posted: 2022-04-20
• Last Update Posted: 2022-04-20
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 1015

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
laparoscopic Roux-en-Y gastric bypass (RYGB)	SG or a RYGB	patients operated on with aRYGB
laparoscopic sleeve gastrectomy (SG)	SG or a RYGB	Patients operated on with a SG

Primary Outcome Measures

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

Trial Locations

Locations (1)

Sundsvall Hospital; 🇸🇪 Sundsvall, Sweden