Laparoscopic Sleeve Gastrectomy
Conditions
Brief summary
Sleeve gastrectomy (SG) involves the creation of small gastric reservoir based on lesser curvature of the stomach, which is fashioned by a longitudinal gastrectomy that preserves the antrum and pylorus together with its vagal innervation. Recently SG is viewed as a multi-purpose bariatric procedure that restricts the stomach size to induce satiety and resects fundal ghrelin-producing cells to decrease appetite. However, the risk of staple line leak and bleeding remains one of its challenging complications. Despite the fact that there are a large number of studies assessing various methods of making the staple line secure, there is to date, no consensus on which technique is best for reducing the risk of stapler line bleeding and leak. Hence, this study aims to compare staple line suturing reinforcement methods in sleeve gastrectomy using plication and over-sewing techniques.
Interventions
PROCEDUREStaple line suturing reinforcement methods - Plication and Over-sewing
Sleeve gastrectomy procedure will be performed laparoscopically. The greater curvature of the stomach will be mobilised, and stomach will be sleeved using 39F calibration tube as the stent using 5-6 60 mm-stapler reloads depending on the length and thickness of the stomach. The staple-line is then reinforced using 3/0 absorbable sutures continuously throughout the staple-line. The two staple-line suturing methods in this study include over-sewing (through and through) and plication (Lembert).
Sponsors
Universiti Putra Malaysia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Masking description
This is a single blinded randomisation whereby the patient is not aware on the staple-line suturing reinforcement used. Suturing reinforcement of the staple-line is our standard of care in all laparoscopic sleeve gastrectomy patients
Intervention model description
All patients who underwent laparoscopic sleeve gastrectomy from March 2020 till February 2021 will be included
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
\- Patients at our Bariatric Clinic fulfilling NIH criteria for bariatric surgery and planned operation of laparoscopic sleeve gastrectomy as primary bariatric procedure will be evaluated for possible inclusion
Exclusion criteria
1. Age \< 18 or \> 65 2. BMI \< 35 and \> 60 kg/m2 3. American Society of Anesthesiologists (ASA) score \> 3 4. Concurrent surgical procedure including: 1. ventral hernia repair 2. cholecystectomy 3. hiatal hernia repair with posterior cruroplasty 4. extensive lysis of adhesions 5. other procedures that mandate addition of 'trocar(s)' or 'feeding tube'
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Immediate and early post-operative complication | 0-30 days | Staple line bleeding |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Immediate and early post-operative complication | 0-30 days | Staple line leak |
Outcome results
None listed