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Silastic Ring Gastric Bypass Versus Sleeve Gastrectomy for Type 2 Diabetes Mellitus in Obese Patients

NCT01486680 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 106

Last updated 2021-09-28

No results posted yet for this study

Summary

Type 2 diabetes (T2DM) and obesity are becoming increasingly common in New Zealand (NZ) and worldwide. Both are associated with a risk of early mortality (death). Whilst weight loss surgery is known to be effective for weight loss, current research suggests that it may also be effective in resolving T2DM in around 60-80% of patients, with some no longer requiring their medication. The mechanism for this remains unclear.

Two main types of weight loss surgery are performed in NZ public hospitals, which include gastric bypass and sleeve gastrectomy. The gastric bypass is a more complex procedure compared to the sleeve gastrectomy. Whilst both appear to be effective for weight loss (with most patients losing more than 60% of their excess weight), it is still not known which one is better for treating T2DM.

This study will therefore compare which of these two surgical procedures is most effective at treating T2DM in obese patients, as well as comparing whether there are any differences in the amount of weight lost, side effects and quality of life.

Conditions

Interventions

PROCEDURE

Laparoscopic Silastic Ring Roux-en-Y Gastric Bypass

An isolated lesser curve-based gastric pouch will be created, with an antecolic antegastric Roux limb fashioned measuring 100 cm in length. The biliopancreatic limb will measure 50cm for all patients. A 6.5cm silastic ring will be placed above the gastrojejunostomy to prevent long term stomal dilatation.

PROCEDURE

Laparoscopic Sleeve gastrectomy

Resection of the greater curvature of the stomach from the distal antrum (2cm proximal to pylorus) to the angle of His, using a laparoscopic stapling device over a 36Fr bougie, will be performed to create a lesser curve gastric sleeve

Sponsors & Collaborators

  • North Shore Hospital, New Zealand

    lead OTHER

Principal Investigators

  • Michael Booth, MBA FRACS · North Shore Hospital, Auckland, NEW ZEALAND

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2014-10-31
Completion
2019-10-31

Countries

  • New Zealand

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01486680 on ClinicalTrials.gov