Clinical Trial: Omega Loop Gastric Bypass With And Without Anti-Reflux Sutures

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Prospective, Randomized, Controlled Trial of Omega Loop Gastric Bypass With and Without Anti-reflux Sutures - a Pilot Study

Brief Summary:

This proposed trial is designed to answer the following questions: First, is biliary reflux to the distal esophagus present before OLGB and does it increase after the procedure? Second, does performing an OLGB with or without anti-reflux sutures make a difference in (biliary) reflux exposures of the distal esophagus? To answer these questions the investigators plan to perform a randomized, controlled trial involving two groups. Group A will undergo an OLGB without anti-reflux sutures and consists of 50 patients. Group B will receive an OLGB with anti-reflux sutures and also consists of 50 patients.

Gastroscopic evaluation for inflammation and reflux will be performed before and one year after the operation utilizing multilevel intraluminal impedance pH-monitoring (MII-pH) and intragastric Bilitec 2000™. Furthermore, the study will be blinded to the patient. Long-term weight loss, the resolution of comorbidities and the incidence of surgical complications will serve as secondary endpoints. Follow-ups will be performed at 3, 6, and 12 months postoperatively to assess all primary and secondary goals.


Detailed Summary:

Obesity, and especially its comorbidities, has unarguably become the number one threat to human health in the modern world. Western lifestyle leads to an increased prevalence and thus to a higher mortality (i.e. due to cardiovascular diseases).

The positive effects of gastric bypass surgery on excess weight loss and comorbidity resolution are well-known. In contrast to the standard laparoscopic Roux-en-Y Gastric Bypass (RYGB), a newer method, the laparoscopic Omega Loop Gastric Bypass (OLGB), has emerged over the past years. It is believed to be the simpler method involving only one anastomosis (instead of two) and therefore potentially reducing morbidity and mortality whilst maintaining comparable excess weight loss. However, since this new type of gastric bypass is similar to the former Billroth II resection (BII), the carcinoma risk is a concern. The OLGB is different from the BII resection in many ways. For instance, it involves creating an approximately 10 cm long narrow gastric pouch which could prevent the suspected underlying pathogenetic mechanism: biliary reflux to the gastric tube and subsequently to the esophagus. Biliary reflux is suspected to stimulate squamous esophageal cells and Barrett's epithelial cells to produce inflammatory mediators and therefore cause oxidative stress, DNA damage and apoptosis which might lead to adenocarcinoma.

Worldwide, there are currently two different ways to perform an OLGB: with or without anti-reflux sutures, which involve sewing the biliopancreatic limb to the staple line of the pouch using V-Loc (non-absorbable) moving upwards as far as easily possible without creating any tension.

This proposed trial is designed to answer the following questions: First, is biliary reflux to the distal esophagus present before OLGB and does
Sponsor: Medical University of Vienna

Current Primary Outcome:

  • Bile Reflux [ Time Frame: 1 year ]
    The primary goal of this study is to assess, whether the choice of method (OLGB with or without anti-reflux sutures) affects the occurrence or severity of biliary reflux to the gastric pouch. Biliary exposure will therefore be assessed before and 12 months after the operation utilizing multilevel intraluminal impedance pH-monitoring (MII-pH) and intragastric Bilitec 2000™.
  • Bile Reflux [ Time Frame: 1 year ]
    The primary goal of this study is to assess, whether the choice of method (OLGB with or without anti-reflux sutures) affects the occurrence or severity of biliary reflux to the gastric pouch. Extensive biopsies of the gastric pouch and gastroesophageal junction will be taken to prove histological changes due to biliary reflux.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Inflammation [ Time Frame: 1 year ]
    Assessing inflammation before and 12 months after surgery using gastroscopy with biopsy.
  • Weight loss [ Time Frame: 1 year ]
    Measuring excess weight loss (EWL), to reveal any changes in patients' weight
  • BMI loss [ Time Frame: 1 year ]
    Excess BMI loss (EBMIL), to reveal any changes in patients' BMI
  • Complications by point in time/stage [ Time Frame: 1 year ]
    Early postoperative complications (occurring within 30 days) Late postoperative complications (occurring after 30 days)
  • Complications by severity [ Time Frame: 1 year ]
    Moderate complications (not requiring additional surgical intervention) Severe complications (requiring surgical intervention)
  • Resolution of hyperlipidemia [ Time Frame: 1 year ]
    Collecting evidence for the resolution of hyperlipidemia
  • Resolution of hypertension [ Time Frame: 1 year ]
    Collecting evidence for the resolution of hypertension
  • Resolution of diabetes [ Time Frame: 1 year ]
    Collecting evidence for the resolution of diabetes
  • Resolution of sleep apnea [ Time Frame: 1 year ]
    Collecting evidence for the resolution of sleep apnea


Original Secondary Outcome: Same as current

Information By: Medical University of Vienna

Dates:
Date Received: March 21, 2017
Date Started: July 1, 2017
Date Completion: July 1, 2019
Last Updated: March 25, 2017
Last Verified: March 2017