Laparoscopic Single Incision -Vs- Multiple Incision Gastric Band Surgery

A Prospective Double Blinded Randomised Control Trial Comparing Laparoscopic Single Incision Versus Multiple Incision Adjustable Gastric Band Surgery in Patients With Morbid Obesity

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01844960

Acronym

SIMIS

Enrollment

Registered

2013-05-03

Start date

2011-11-30

Completion date

2013-10-31

Last updated

2015-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-operative Pain, Post-operative Recovery, Surgery

Keywords

Single Incision Surgery, SILS, Laparoscopic Gastric Band, Morbid Obesity, Bariatric Surgery

Brief summary

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.

Interventions

PROCEDURESingle Incision Gastric Band Insertion

Insertion of gastric band though single abdominal incision

PROCEDUREMultiple Incision Gastric Band Insertion

Insertion of gastric band though multiple abdominal incisions

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Pain	first 10 days post-operatively

Secondary

Measure	Time frame
Time to Discharge	Post-operative ward stay (estimated 2-8 hours)

Other

Measure	Time frame
Conversion to laparoscopic or open surgery	Intra-operatively
Intraoperative and post-operative complications	During surgery (intraoperative) and first 30 days (post-operative)
Operative time	Skin incision to skin closure (estimated 45 -75 minutes)
Cosmesis	6 weeks to 6 months post-operatively

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026