Laparoscopic Single Incision -Vs- Multiple Incision Gastric Band Surgery (SIMIS)

King's College Hospital NHS Trust

Status: Completed

Conditions: Post-operative Pain; Surgery; Post-operative Recovery

Treatments: Procedure: Multiple Incision Gastric Band Insertion; Procedure: Single Incision Gastric Band Insertion

Study type: Interventional

Funder types: Other

Identifiers

NCT01844960

11/LO/1592

Details and patient eligibility

About

A double blinded randomised control trial comparing the differences between laparoscopic single incision versus multiple port bariatric surgery in morbidly obese patients (BMI>35). Single incision surgery is a new minimally invasive surgical technique requiring the surgeon to operate through one small single incision and is virtually scarless. The traditional laparoscopic approach to abdominal surgery is through multiple small incisions (4-7 ports) across the whole abdomen. This study seeks to identify the risks, benefits and costs of the adjustable gastric band insertion via single incision and multiple incision within the morbidly obese patient group.

Enrollment: 44 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Morbidly obese patients, BMI ≥35 kg/m2
• Undergoing gastric band surgery
• Undergone a pre-weight loss surgery risk assessment
• Fit for anaesthesia and surgery
• Fulfil day surgery criteria
• Full understanding of bariatric procedure, with informed consent of the risks and benefits of laparoscopic single incision and multiple incision surgery

Exclusion criteria

• Pregnancy
• History of portal hypertension
• Previous gastric surgery or large hiatus hernia
• Previous laparotomy or bariatric surgery
• Weight >150kg (day surgery limit)
• Unwilling to consider surgical treatment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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44 participants in 2 patient groups

Multiple Incision Gastric Band Insertion

Active Comparator group

Description:

Current standard surgical approach for laparoscopic gastric band insertion

Treatment:

Procedure: Multiple Incision Gastric Band Insertion

Single Incision Gastric Band Insertion

Experimental group

Description:

New surgical approach for gastric band insertion

Treatment:

Procedure: Single Incision Gastric Band Insertion