Clinical trial NCT05336331: Sleeve Gastrectomy as a Standard Bariatric Procedure
Official title: Establishing Laparoscopic Sleeve Gastrectomy as a Standard Procedure at a Swedish Bariatric Center
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Postoperative Complications
Keywords: bariatric surgery
laparoscopic Roux-en-Y gastric bypass
laparoscopic sleeve gastrectomy
Morbid obesity
Weight loss
Metabolic control
Metabolic syndrome
Complication risk
Lead sponsor: Umeå University
Sponsor class: OTHER
First posted: 2022-04-20
Enrollment: 1015
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Morbid obesity patients found suitable for a SG or RYGB

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.

Eligibility criteria: 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

Primary outcomes:
measure: Weight loss
timeFrame: after 6 weeks
measure: Weight loss
timeFrame: after 1 year
measure: Weight loss
timeFrame: after 2 years
measure: Changes in Diabetes
timeFrame: after 1 year
measure: Changes in Diabetes
timeFrame: after 2 years
measure: Changes in Hypertension
timeFrame: after 1 year
measure: Changes in Hypertension
timeFrame: after 2 years
measure: Changes in hypertriglyceridemia (plasma-level >1.7 mmol/l)
timeFrame: after 1 year
measure: Changes in hypertriglyceridemia (plasma-level >1.7 mmol/l)
timeFrame: after 2 year
measure: Changes in Hypercholesterolemia (LDL-C > 3.0 mmol/L and/or HDL-C < 1.0 mmol/L).
timeFrame: after 1 years
measure: Changes in Hypercholesterolemia (LDL-C > 3.0 mmol/L and/or HDL-C < 1.0 mmol/L).
timeFrame: after 2 years
measure: Duration of surgery
timeFrame: From the start of the operation until completion, in average 62 minutes
measure: Duration of hospital stay
timeFrame: From time of operation until discharge, in average 1.7 days
measure: Early complications
timeFrame: At six weeks
measure: Early reoperations
timeFrame: At six weeks
measure: Late complications
timeFrame: From six weeks until 2 years from operation
measure: Late reoperations
timeFrame: From six weeks until 2 years from operation
Secondary outcomes:
Other outcomes:
Locations:
city: Sundsvall
country: Sweden
facility: Sundsvall Hospital
Study officials:
References: