Bariatric Surgery Candidate Clinical Trial
Official title:
The Role of Extended Antral Resection on Weight Loss and Metabolic Response After Sleeve Gastrectomy
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.
Following approval of the ethical committee patients who underwent LSG between January 2016
and June 2018 are retrospectively analyzed. Patients with BMI > 40 were included. 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.
The patients were grouped according to the distance of gastric division as AP group (6cm from
pylorus) and AR group (2cm prom pylorus). The first 68 patients underwent AP, and the
following 43 patients underwent AR.
Patient characteristics and demographic data, including age, gender, BMI, co-morbid diseases
(hypertension (HT), Type II diabetes, dyslipidemia), biochemical parameters (glucose, HbA1c,
C-peptide, insulin, , cholesterol, triglyceride, HDL, LDL, and VLDL was extracted from a
prospectively prepared patient's chart. The 30-day outcomes including postoperative morbidity
and mortality are taken from patient's folder.
Weight loss alteration at the end of first, 6th and 12 months are calculated as %EWL and
%TBWL. The %EWL is calculated as [(preoperative weight - follow up weight) / (preoperative
weight-ideal weight)] x100, with ideal weight based on a BMI of 25kg/m2. The total body
weight loss percentile (%TBWL) is calculated as [(preoperative weight - follow up weight) /
(preoperative body weight)] x100.
Resolution of co-morbidities was defined as reduction of co-morbidity related symptom and
signs with change of specific biochemical blood tests to normal ranges.
The Clavien-Dindo classification scale was used to define the severity of complications:
Grade I; no requirement of specific intervention, Grade II; antibiotic treatment, total
parenteral nutrition, and/or blood transfusion is mandatory, Grade III; invasive
interventions such as endoscopy, percutaneous drainage, or surgery is needed, Grade IV;
intensive care management for organ dysfunction, and Grade V; as death, respectively [10].
2.1. Surgical Technique The LSGs were performed by two surgeons. Patients were placed in
supine position. Antibiotic prophylaxis was started before anesthesia induction by using 2g
first-generation cephalosporin for patients <120kg, and 3g for patients ≥120 kg. The liver is
retracted by using Nathanson Hook. 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. The gastric specimen is removed
through the 12mm trocar. The procedure is completed by placing an abdominal drain just next
to the staple line.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05650307 -
CV Imaging of Metabolic Interventions
|
||
Not yet recruiting |
NCT05536466 -
The Influence of Having Bariatric Surgery on the Pharmacokinetics, Safety and Efficacy of the Novel Non-nucleoside Reverse Transcriptase Inhibitor Doravirine
|
N/A | |
Active, not recruiting |
NCT04583683 -
Effects of Very Low Calorie Diet vs Metabolic Surgery on Weight Loss and Obesity Comorbidities
|
N/A | |
Completed |
NCT04099654 -
The Effect of Core Stabilization Exercise Program in Obese Subjects Awaiting Bariatric Surgery
|
N/A | |
Completed |
NCT03809182 -
Effect of Dexmedetomidine on Postoperative Glucose and Insulin Levels.
|
Phase 4 | |
Completed |
NCT03638843 -
Endoscopic Gastric Mucosal Devitalization (GMD) as a Primary Obesity Therapy - Part 2
|
N/A | |
Withdrawn |
NCT05845359 -
Intraoperative Methadone for Postoperative Pain Control
|
Phase 4 | |
Not yet recruiting |
NCT04343040 -
Perioperative Evaluation of Glucose Profile Using Continuous Glucose Monitoring System in Glucose Intolerant Patients
|
N/A | |
Withdrawn |
NCT03095404 -
Intravenous Lidocaine for Post-Operative Pain Control in Patients Undergoing Bariatric Bowel Surgery
|
Early Phase 1 | |
Recruiting |
NCT03100292 -
Korean OBEsity Surgical Treatment Study
|
N/A | |
Active, not recruiting |
NCT04357119 -
Common Limb Length in One-anastomosis Gastric Bypass
|
N/A | |
Completed |
NCT04883268 -
Focusing on Body Functionality After Bariatric Surgery
|
N/A | |
Completed |
NCT03210207 -
Gastric Plication in Mexican Patients
|
N/A | |
Completed |
NCT02300168 -
Neuromuscular Blockade: Outcome and Recovery for Laparoscopic Bariatric Surgery
|
N/A | |
Unknown status |
NCT01264120 -
The Impact of a Bariatric Rehabilitation Service on Patient Outcomes
|
N/A | |
Recruiting |
NCT03972319 -
Omega-3 Supplementation for LIver VolumE Reduction Study (OLIVER) Study
|
Early Phase 1 | |
Terminated |
NCT04626232 -
Comparison of the Sleeve Gastrectomy Technique With a Nissen Fundoplication Added to the Conventional Sleeve Gastrectomy Technique in Morbidly Obese Patients
|
N/A | |
Completed |
NCT03643783 -
Impact of Plasma Soluble Prorenin Receptor in Obese and Type 2 Diabetic Patients
|
||
Completed |
NCT04219852 -
Contraception and Bariatric Surgery: Evaluation of Contraception and Contraceptive Knowledge of Women Undergoing Bariatric Surgery at the University Hospital of Reims
|
||
Recruiting |
NCT05570474 -
Effect of Protein Supplementation on Fat Free Mass Preservation After Bariatric Surgery
|
N/A |