Comparison of Staple Line Suturing in Laparoscopic Sleeve Gastrectomy

University of Putra Malaysia (UPM)

Status: Unknown

Conditions: Laparoscopic Sleeve Gastrectomy

Treatments: Procedure: Staple line suturing reinforcement methods - Plication and Over-sewing

Study type: Interventional

Funder types: Other

Identifiers

NCT04323696

53293

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

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'

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

Over-sewing

Other group

Description:

Patients under over-sewing arm are subjected to staple line reinforcement using over-sewing method

Treatment:

Procedure: Staple line suturing reinforcement methods - Plication and Over-sewing

Plication

Other group

Description:

Patients under over-sewing arm are subjected to staple line reinforcement using plication method

Treatment:

Procedure: Staple line suturing reinforcement methods - Plication and Over-sewing