The Role of Extended Antral Resection on Weight Loss and Metabolic Response After Sleeve Gastrectomy

NCT04109664 | Completed DMC

• 1 other identifier: 2019-69
• Study Type: observational
• Target: 111
• Locations: 1 country
• Sites: 1

Brief Summary

Aim: The impact of extended antral resection (AR) after laparoscopic sleeve gastrectomy (LSG) on weight loss changes and metabolic response is still not clearly elucidated with conflicting results. The investigator's retrospective cohort study aimed to determine whether AR is superior to antral preservation (AP) regarding weight loss and resolution of co-morbidities. Methods: Patients were divided into two groups according to the distance of gastric division as AR group (2cm from pylorus) and AP group (6cm from pylorus). Postoperative excess weight loss percentile (%EWL) and total body weight loss percentiles (%TBWL) at the end of first, 6th and 12 months were compared. Secondly, metabolic parameters and complications were compared.

Conditions

Bariatric Surgery Candidate; Obesity, Morbid

Keywords

antral resection; sleeve gastrectomy; excess weight loss; total body weight loss

Outcome Measures

Primary Outcomes (12)

• Glucose(mg/dl) change

  Preoperative fasting glucose (mg/dl) values compared with fasting glucose (mg/dl) values at 12 months.

  0, 12. month

• Glycated hemoglobin(Hb A1c) (mmol/mol) change

  Preoperative glycated hemoglobin(Hb A1c) (mmol/mol) values compared with glycated hemoglobin(Hb A1c) (mmol/mol) values at 12 months.

  0, 12. month

• C-Peptide(ng/ml) change

  Preoperative C-peptide (ngl/ml) values compared with C-peptide (ngl/ml) values at 12 months.

  0, 12. month

• Insulin (mg/dl) change

  Preoperative Insulin (mg/dl) values compared with Insulin (mg/dl) values at 12 months.

  0, 12. month

• Cholesterol (mg/dl) levels change

  Preoperative Cholesterol (mg/dl) values compared with Cholesterol (mg/dl) values at 12 months.

  0, 12. month

• Triglyceride(mg/dl) levels change

  Preoperative Triglyceride(mg/dl) values compared with Triglyceride(mg/dl) values at 12 months.

  0, 12. month

• HDL (mg/dl) levels change

  Preoperative HDL(mg/dl) values compared with HDL(mg/dl) values at 12 months.

  0, 12. month

• LDL (mg/dl) levels change

  Preoperative LDL(mg/dl) values compared with LDL(mg/dl) values at 12 months.

  0, 12. month

• VLDL (mg/dl) levels change

  Preoperative VLDL(mg/dl) values compared with VLDL(mg/dl) values at 12 months.

  0, 12. month

• Resolution of co-morbidities

  Resolution of co-morbidities (hypertension, hyperlipidemia, diabetes type 2) was defined as reduction of co-morbidity related symptom and signs with change of specific biochemical blood tests to normal ranges. Preoperative status will be compared with 12.months status.

  0,12. month

• Excess Weight Loss change

  The %Excess Weight Loss is calculated as \[(preoperative weight - follow up(1,6,12 month weight) / (preoperative weight-ideal weight)\] x100, with ideal weight based on a BMI of 25kg/m2.

  0,1,6, 12. month

• The total body weight loss percentile change

  The total body weight loss percentile (%TBWL) is calculated as \[(preoperative weight - follow up(1,6,12. month weight) / (preoperative body weight)\] x100. ideal weight based on a BMI of 25kg/m2

  0,1,6, 12. month

Secondary Outcomes (1)

• complication

  1 year

Study Arms (2)

antral preservation

The patients were grouped according to the distance of gastric division as Antral preservation group (6cm from pylorus)

Procedure: laparoscopic sleeve gastrectomy

Antral resection

The patients were grouped according to the distance of gastric division as Antral preservation group (2 cm from pylorus)

Procedure: laparoscopic sleeve gastrectomy

Interventions

laparoscopic sleeve gastrectomy PROCEDURE

The greater omentum is carefully dissected from the stomach at a distance of 2cm for the patients with AR, and 6cm for patients with AP. The omental dissection was performed using 5mm-abdominal ligature (Ligasure®, Metronic-Covidien, Minneapolis, USA), from the antrum towards the angle of His. Transection from the omentum is continued until the left crus has been identified. All sleeves are transected using 36 French orogastric tubes. Green cartridges (4.8 mm staple height) are used for the first firing and blue cartridges (3.5 mm) for the rest. Neither oversewing sutures to the staple line nor staple line reinforcement products are used. Homeostatic metallic clips are used for bleeding at the staple line. If bleeding persists and cannot be controlled, an interrupted suture is performed at the point of bleeding. A leak test with methylene blue is performed to the gastric remnant to assess the integrity of the suture line.

Antral resection; antral preservation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who underwent Laparoscopic Sleeve Gastrectomy between January 2016 and June 2018 are retrospectively analyzed.

You may qualify if:

• Patients with Body Mass Index \> 40 were included

You may not qualify if:

• Patients with a history of previous bariatric surgery and patients who did not attend regular follow-up visits (first, 6th and 12 months) are excluded

Sponsors & Collaborators

• Kocaeli Derince Education and Research Hospital: lead

Study Sites (1)

Kocaeli Derince Training and research Hospital

Kocasinan, Derince, 41900, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Obesity, Morbid

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D. Department of Gastroenterological surgery,Principal Investigator

Study Record Dates

• First Submitted: September 25, 2019
• First Posted: September 30, 2019
• Study Start: January 1, 2016
• Primary Completion: June 1, 2018
• Study Completion: July 1, 2018
• Last Updated: September 30, 2019

Record last verified: 2019-09

Locations

TU (1)