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Completed

NCT Number: NCT01844960

Laparoscopic Single Incision -Vs- Multiple Incision Gastric Band Surgery

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.

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Key information

Conditions

Surgery Body Weight Neurologic Manifestations Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity, Morbid Overnutrition Overweight Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Post-operative Pain Post-operative Recovery Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

King's College Hospital NHS Foundation Trust

London, Greater London, SE5 9RS, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Single Incision Gastric Band Insertion

Procedure

Insertion of gastric band though single abdominal incision

Multiple Incision Gastric Band Insertion

Procedure

Insertion of gastric band though multiple abdominal incisions

Primary outcomes

  1. Pain

    Time frame: first 10 days post-operatively

Secondary outcomes

  1. Time to Discharge

    Time frame: Post-operative ward stay (estimated 2-8 hours)

Other outcomes

  1. Conversion to laparoscopic or open surgery

    Time frame: Intra-operatively

  2. Intraoperative and post-operative complications

    Time frame: During surgery (intraoperative) and first 30 days (post-operative)

  3. Operative time

    Time frame: Skin incision to skin closure (estimated 45 -75 minutes)

  4. Cosmesis

    Time frame: 6 weeks to 6 months post-operatively

Sponsors and collaborators

Lead sponsor

King's College Hospital NHS Trust

Other

Registry information

Official study title

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

Acronym: SIMIS

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
May 3, 2013
Registry last updated
Sep 2, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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