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

Laparoscopic Roux-en-Y Gastric Bypass Versus Laparoscopic Mini Gastric Bypass: A Randomized Controlled Trial

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.

Study Overview

• Status: Unknown
• Conditions: Obesity; Bypass Complications
• Intervention / Treatment: Procedure: Mini Gastric Bypass; Procedure: Roux-en-Y Gastric Bypass

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
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marko Kraljevic, MD; Phone Number: +41 79 942 50 10; Email: marko.kraljevic@gmail.com
• Study Contact Backup: Name: Tarik Delko, MD; Phone Number: +41 78 910 30 21; Email: tarik.delko@gmail.com

Study Locations

• Switzerland
  • Zürich
    • Schlieren, Zürich, Switzerland, 8952
      • Recruiting
      • Spital Limmattal
      • Contact: Marko Kraljevic, MD; Email: marko.kraljevic@gmail.com
      • Contact: Urs Zingg, MD; Email: urs.zingg@spital-limmattal.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• BMI > 35
• age > 18

Exclusion Criteria:

• malignancy
• lack of compliance
• BMI > 50

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Excess Weight Loss	1 year postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Early surgical complications		≤ 30 days
Early non-surgical complications		≤ 30 days
Operation time	Operation time measured in minutes for the primary procedure (e.g. LRYGB or LMGB)	intraoperative
Length of stay	Length of stay after the primary operation (e.g. LRYGB or LMGB)	up to 24 weeks
Subjective perception of the appetite and saturation	measured by questionnaires	6 weeks, 1 and 3 years
Hormonal assay (Ghrelin)	measured in pg/ml	preoperative, 6 weeks, 1 and 3 years
Hormonal assay (GLP-1)	measured in pg/ml	preoperative, 6 weeks, 1 and 3 years
Hormonal assay (PYY)	measured in pg/ml	preoperative, 6 weeks, 1 and 3 years
Glucose homeostasis		preoperative, 6 weeks, 1 and 3 years
Lipid profile	LDL (mg/dl), HDL (mg/dl), triglycerides (mg/dl), total cholesterol (mg/dl)	preoperative, 6 weeks, 1 and 3 years

Collaborators and Investigators

• Sponsor: Spital Limmattal Schlieren
• Investigators: Principal Investigator: Urs Zingg, MD, Spital Limmattal Schlieren

Publications and helpful links

General Publications

• Lee WJ, Yu PJ, Wang W, Chen TC, Wei PL, Huang MT. Laparoscopic Roux-en-Y versus mini-gastric bypass for the treatment of morbid obesity: a prospective randomized controlled clinical trial. Ann Surg. 2005 Jul;242(1):20-8. doi: 10.1097/01.sla.0000167762.46568.98.
• Sjostrom L, Narbro K, Sjostrom CD, Karason K, Larsson B, Wedel H, Lystig T, Sullivan M, Bouchard C, Carlsson B, Bengtsson C, Dahlgren S, Gummesson A, Jacobson P, Karlsson J, Lindroos AK, Lonroth H, Naslund I, Olbers T, Stenlof K, Torgerson J, Agren G, Carlsson LM; Swedish Obese Subjects Study. Effects of bariatric surgery on mortality in Swedish obese subjects. N Engl J Med. 2007 Aug 23;357(8):741-52. doi: 10.1056/NEJMoa066254.
• Christou NV, Look D, Maclean LD. Weight gain after short- and long-limb gastric bypass in patients followed for longer than 10 years. Ann Surg. 2006 Nov;244(5):734-40. doi: 10.1097/01.sla.0000217592.04061.d5.
• Adams TD, Gress RE, Smith SC, Halverson RC, Simper SC, Rosamond WD, Lamonte MJ, Stroup AM, Hunt SC. Long-term mortality after gastric bypass surgery. N Engl J Med. 2007 Aug 23;357(8):753-61. doi: 10.1056/NEJMoa066603.
• Colquitt JL, Pickett K, Loveman E, Frampton GK. Surgery for weight loss in adults. Cochrane Database Syst Rev. 2014 Aug 8;2014(8):CD003641. doi: 10.1002/14651858.CD003641.pub4.
• Rutledge R. The mini-gastric bypass: experience with the first 1,274 cases. Obes Surg. 2001 Jun;11(3):276-80. doi: 10.1381/096089201321336584.
• Rutledge R, Walsh TR. Continued excellent results with the mini-gastric bypass: six-year study in 2,410 patients. Obes Surg. 2005 Oct;15(9):1304-8. doi: 10.1381/096089205774512663.
• Lee WJ, Ser KH, Lee YC, Tsou JJ, Chen SC, Chen JC. Laparoscopic Roux-en-Y vs. mini-gastric bypass for the treatment of morbid obesity: a 10-year experience. Obes Surg. 2012 Dec;22(12):1827-34. doi: 10.1007/s11695-012-0726-9.
• Wittgrove AC, Clark GW. Laparoscopic gastric bypass, Roux-en-Y- 500 patients: technique and results, with 3-60 month follow-up. Obes Surg. 2000 Jun;10(3):233-9. doi: 10.1381/096089200321643511.
• Rutledge R. Similarity of Magenstrasse-and-Mill and Mini-Gastric bypass. Obes Surg. 2003 Apr;13(2):318. doi: 10.1381/096089203764467315. No abstract available.
• Kraljevic M, Delko T, Kostler T, Osto E, Lutz T, Thommen S, Droeser RA, Rothwell L, Oertli D, Zingg U. Laparoscopic Roux-en-Y gastric bypass versus laparoscopic mini gastric bypass in the treatment of obesity: study protocol for a randomized controlled trial. Trials. 2017 May 22;18(1):226. doi: 10.1186/s13063-017-1957-9.

Study record dates

Study Major Dates

• Study Start: October 1, 2016
• Primary Completion (Anticipated): November 1, 2017
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: September 28, 2015
• First Submitted That Met QC Criteria: November 7, 2015
• First Posted (Estimate): November 10, 2015

Study Record Updates

• Last Update Posted (Actual): February 27, 2017
• Last Update Submitted That Met QC Criteria: February 23, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: RCT; Roux-en-Y Gastric Bypass; Mini Gastric Bypass
• Other Study ID Numbers: SLS-002