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Laparoscopic Roux-en-Y Gastric Bypass Versus Laparoscopic Mini Gastric Bypass (MGB)

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ClinicalTrials.gov Identifier: NCT02601092
Recruitment Status : Recruiting
First Posted : November 10, 2015
Last Update Posted : February 27, 2017
Sponsor:
Information provided by (Responsible Party):
Marko Kraljevic, MD, Spital Limmattal Schlieren

Brief Summary:
Several retrospective studies have shown same efficiency in regard to weight loss, with a lower rate of complications for the laparoscopic mini gastric bypass (LMGB) compared to Roux-en-Y gastric bypass (LRYGB). The aim of this double-blinded randomized controlled trial is to compare the two procedures in respect of excess weight loss, complications, operation time, length of stay and the metabolic impact on the hormonal brain-gut-axis.

Condition or disease Intervention/treatment Phase
Obesity Bypass Complications Procedure: Mini Gastric Bypass Procedure: Roux-en-Y Gastric Bypass Not Applicable

Detailed Description:

Bariatric surgery, the only effective treatment for morbid obesity, has shown effective long term weight loss and good control of obesity related comorbidities in randomized controlled trials.

Obesity related diseases, such as hypertension, type 2 diabetes, dyslipidemia, osteoarthritis and various tumours, have a significant socio-economic impact, since the cost of the obesity epidemic is 5.7 billion Swiss francs yearly.

According to the current Swiss National Guidelines defined by the Swiss Group for Morbid Obesity surgical therapy is indicated in cases of BMI 35 kg/m2 or higher, showing better weight reduction and control of comorbidties than conservative therapy alone. Obesity reduces quality of life and life expectancy dramatically. Furthermore it has a significant impact on our economy. Bariatric surgery is likely to improve all of these negative impacts on society.

The most commonly performed procedures at present are laparoscopic adjustable gastric banding, laparoscopic Roux-en-Y gastric bypass (LRYGB) and laparoscopic sleeve gastrectomy (LSG).

LRYGB is considered the golden standard in bariatric surgery, although little evidence is available to justify this standpoint. In fact, the choice of the surgical procedure depends more on patient factors such as present comorbidities and operative risk. Therefore, surgeons consult after a work up within a multidisciplinary team of caretakers such as nutritionists, endocrinologists and psychiatrists and chose a patient tailored approach. Recently, the laparoscopic mini gastric bypass (LMGB) has gained worldwide popularity in addition to the standard available procedures for the treatment of morbid obesity. Therefore, it has been added by the Swiss Group for Morbid Obesity as a surgical option, which has to be evaluated in clinical trials.

Robert Rutledge, the pioneer of the LMGB, published in 2001 results of 1274 patients, who received surgical treatment with LMGB. After two years the patients showed an excess weight loss (EWL) of 77%. The rate of anastomotic leakage in the gastroenterostomy amounted 1.6%. The rate of mortality was 0.08%. Subsequently, Rutledge published in 2005 the results of 2410 patients with a follow up of 38.7 months. These cohort reached/achieved an EWL of 80% after a year and even after 5 years 5% of all these patients showed a weight rebound of maximum 10 kg. In fact, those results seemed superior to outcomes of the other standard bariatric procedures.

The rate of anastomotic leakage was 1.08%, mortality 0.08%. Long-term complications were ulcer disease (4%) and iron deficiency (5%). Both complications are also known in LRYGB with similar rates.

The first and only randomized controlled trial comparing the LRYGB to LMGB was carried out by Lee in 2005. With a group of 40 patients the effectiveness of LMGB was compared to the LRYGB. The authors found an EWL of 64.9% after one and 64.4% after two years, respectively, in patients having a LMGB accompanied by less complications and a shorter hospitalization time than in LRYGB. Patients with LRYGB had an EWL of 58.7% and 60%, respectively.

These results showed similar benefits of the LMGB compared to LRYGB. This is in accordance with the already mentioned observational studies.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Laparoscopic Roux-en-Y Gastric Bypass Versus Laparoscopic Mini Gastric Bypass: A Randomized Controlled Trial
Study Start Date : October 2016
Estimated Primary Completion Date : November 2017
Estimated Study Completion Date : December 2020

Arm Intervention/treatment
Experimental: Mini Gastric Bypass

The mini gastric bypass procedure was first developed by Dr Robert Rutledge from the USA in 1997, as a modification of the standard Billroth II procedure. A mini gastric bypass creates a long narrow tube of the stomach along its right border (the lesser curvature). A loop of the small gut is brought up and hooked to this tube at about 180 cm from the start of the intestine.

No drugs or devices will be used.

Procedure: Mini Gastric Bypass

The mini gastric bypass procedure was first developed by Dr Robert Rutledge from the USA in 1997, as a modification of the standard Billroth II procedure. A mini gastric bypass creates a long narrow tube of the stomach along its right border (the lesser curvature). A loop of the small gut is brought up and hooked to this tube at about 180 cm from the start of the intestine.

No drugs or devices will be used.


Active Comparator: Roux-en-Y Gastric Bypass

This variant is the most commonly employed gastric bypass technique, and is by far the most commonly performed bariatric procedure in the United States. The small intestine is divided approximately 45 cm (18 in) below the lower stomach outlet and is re-arranged into a Y-configuration, enabling outflow of food from the small upper stomach pouch via a "Roux limb". In the proximal version, the Y-intersection is formed near the upper (proximal) end of the small intestine. The Roux limb is constructed using 80-150 cm (31-59 in) of the small intestine, preserving the rest (and the majority) of it for absorbing nutrients.

No drugs or devices will be used.

Procedure: Roux-en-Y Gastric Bypass

This variant is the most commonly employed gastric bypass technique, and is by far the most commonly performed bariatric procedure in the United States. The small intestine is divided approximately 45 cm (18 in) below the lower stomach outlet and is re-arranged into a Y-configuration, enabling outflow of food from the small upper stomach pouch via a "Roux limb". In the proximal version, the Y-intersection is formed near the upper (proximal) end of the small intestine. The Roux limb is constructed using 80-150 cm (31-59 in) of the small intestine, preserving the rest (and the majority) of it for absorbing nutrients.

No drugs or devices will be used.





Primary Outcome Measures :
  1. Excess Weight Loss [ Time Frame: 1 year postoperative ]

Secondary Outcome Measures :
  1. Early surgical complications [ Time Frame: ≤ 30 days ]
  2. Early non-surgical complications [ Time Frame: ≤ 30 days ]
  3. Operation time [ Time Frame: intraoperative ]
    Operation time measured in minutes for the primary procedure (e.g. LRYGB or LMGB)

  4. Length of stay [ Time Frame: up to 24 weeks ]
    Length of stay after the primary operation (e.g. LRYGB or LMGB)

  5. Subjective perception of the appetite and saturation [ Time Frame: 6 weeks, 1 and 3 years ]
    measured by questionnaires

  6. Hormonal assay (Ghrelin) [ Time Frame: preoperative, 6 weeks, 1 and 3 years ]
    measured in pg/ml

  7. Hormonal assay (GLP-1) [ Time Frame: preoperative, 6 weeks, 1 and 3 years ]
    measured in pg/ml

  8. Hormonal assay (PYY) [ Time Frame: preoperative, 6 weeks, 1 and 3 years ]
    measured in pg/ml

  9. Glucose homeostasis [ Time Frame: preoperative, 6 weeks, 1 and 3 years ]
  10. Lipid profile [ Time Frame: preoperative, 6 weeks, 1 and 3 years ]
    LDL (mg/dl), HDL (mg/dl), triglycerides (mg/dl), total cholesterol (mg/dl)



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • BMI > 35
  • age > 18

Exclusion Criteria:

  • malignancy
  • lack of compliance
  • BMI > 50

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02601092


Contacts
Contact: Marko Kraljevic, MD +41 79 942 50 10 marko.kraljevic@gmail.com
Contact: Tarik Delko, MD +41 78 910 30 21 tarik.delko@gmail.com

Locations
Switzerland
Spital Limmattal Recruiting
Schlieren, Zürich, Switzerland, 8952
Contact: Marko Kraljevic, MD       marko.kraljevic@gmail.com   
Contact: Urs Zingg, MD       urs.zingg@spital-limmattal.ch   
Sponsors and Collaborators
Spital Limmattal Schlieren
Investigators
Principal Investigator: Urs Zingg, MD Spital Limmattal Schlieren

Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Marko Kraljevic, MD, MD, Spital Limmattal Schlieren
ClinicalTrials.gov Identifier: NCT02601092     History of Changes
Other Study ID Numbers: SLS-002
First Posted: November 10, 2015    Key Record Dates
Last Update Posted: February 27, 2017
Last Verified: February 2017

Keywords provided by Marko Kraljevic, MD, Spital Limmattal Schlieren:
Mini Gastric Bypass
Roux-en-Y Gastric Bypass
RCT