Reflux Disease After Gastric Bypass Versus Sleeve Gastrectomy in Morbid Obese Patients: an Italian Study
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorNiguarda Hospital
About this trial
The study aims to clarify if GERD, defined by results of 24 hours potential of hydrogen (pH) monitoring and abnormal DeMeester Score (DMS), in obese patients could worsen after Sleeve Gastrectomy (SG) more than after RYGBP. To demonstrate this hypothesis, the investigators will study the obese population suspected for GERD with 24 hours monitoring and High-Resolution Esophageal Manometry (HRM). DMS is calculated pre-operatively and, once GERD is confirmed, the patients are enrolled for randomization to SG or RYGBP. The suspicion of GERD is investigated with the GERDQ score and EGDS, that all obese patients have pre-operatory.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Acceptance of randomization to surgery;
Participant is willing and able to give informed consent for participation in the trial;
Written informed consent;
Compliance to follow-up;
Disqualifiers
Medical or psychiatric conditions that compromises the patient's ability to give informed consent or comply with the study protocol;
Barrett's esophagus (BE);
Spastic motor disorders and esophageal hypomotility;
Peptic strictures;
Trial design
Design model
Parallel
Treatments tested in this trial
Roux-en-Y-Gastric bypass, Sleeve gastrectomy
Procedure/SurgeryRYGBP consists in creating a small gastric pouch along the little curvature of the stomach, followed by the section of the small bowel. The restoration of the gastro-intestinal tract is achieved by performing a gastro-jejunal and a jejuno-jejunal anastomosis, giving this procedure the characteristic aspect of a Y. Also, for RYGBP the laparoscopic approach requires the placement of 5 trocars in the upper part of the abdomen.
SG
Procedure/SurgerySG consists in removing the fundus and the body of the stomach, along the greater curvature. To perform it with a laparoscopic approach, we create the pneumoperitoneum with Veress needle and place 5 trocars in the upper part of the abdomen. The first step is the dissection of the greater curvature of the stomach, that starts at 6 centimetres from pylorus and it's conducted up to the angle of His, freeing the fundus and exposing the left pillar. A 38 Fr bougie is placed inside the stomach to calibrate its section. After it is carried out, the specimen is removed from the greater trocar site.
Treatment groups
128 Participants
are divided into 2 treatment groupsGroup A: RYGBPActive comparator 2 interventions
Group B: SGExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Change of the pre-existing Gastro-Esophageal Reflux Disease (GERD) from baseline in patients underwent SG and RYGBP
GERD will be evaluated performing 24-h pH monitoring before the surgery. The presence and the degree of GERD will be quantified calculating the DeMeester Score (DMS): * DMS \< 14.72 there is no evidence of GERD; * DMS 14.72 - 50 mild GERD; * DMS 50 - 100 moderate GERD; * DMS \> 100 severe GERD An upgrading in DMS class will determine a worsening in GERD
Time frame
Change from baseline DeMeester Score 24 months after surgerySecondary outcomes
1
Postoperative Gastroesophageal Reflux Disease (GERD) from baseline
The degree of GERD will be quantified calculating the DeMeester Score (DMS): * DMS \< 14.72 there is no evidence of GERD; * DMS 14.72 - 50 mild GERD; * DMS 50 - 100 moderate GERD; * DMS \> 100 severe GERD An upgrading in DMS class will determine a worsening in GERD
Time frame
Change from baseline DeMeester Score 12 months after surgery2
Postoperative reflux symptoms
Expressed by Gastroesophageal Reflux Disease Questionnaire (GERDQ) Scoring How many times per week do each of the following symptoms occur per week Score 0: Occurs on 0 days Score 1: Occurs on 1 day Score 2: Occurs on 2-3 days Score 3: Occurs on 4-7 days Questions (Score 0-3 for each based on above) Burning feeling behind the Breastbone (Heartburn)? Stomach contents moving up to the throat or mouth (regurgitation)? Pain in the middle of the upper Stomach area? Nausea? Trouble getting a good night's sleep because of Heartburn or regurgitation? Need for over-the-counter medicine for Heartburn or regurgitation? Examples: Tums, Rolaids, Maalox, or other Antacids) In addition to the medicine your doctor prescribed Interpretation Total score of 0-2 points Likelihood of GERD: 0 percent Total score of 3-7 points Likelihood of GERD: 50 percent Total score of 8-10 points Likelihood of GERD: 79 percent Total score of 11-18 points Likelihood of GERD: 89 percent
Time frame
Baseline and 12 and 24 months from the surgery3
Quality of life Questionnaire
Expressed by Bariatric Analysis and Reporting Outcome System (BAROS) Score, calculated after 12 and 24 months from the surgery. The scoring key is assessed as follows: Failure ≤1 point; Fair \> 1 to 3 points; Good \> 3 to 5 points; Very Good \> 5 to 7 points; Excellent \> 7 to 9 points
Time frame
month 12 and 24 after surgery4
Trend of the obesity-related diseases (Arterial hypertension, Type 2 Diabetes, continuous positive airway pressure (CPAP) use
Anti-hypertensive drugs (AH) taken before surgery:stability=no change in AH,resolution= no AH,improvement=decrease in AH,worsening=increase in AH In no hypertension pts before surgery;new onset=introduction of AH Oral anti-glycemic (AG) medication taken before surgery:Stability=no change in number of oral AG.Resolution=defined as no oral AG,Improvement=decrease in number of oral AG,Worsening=increase in number of oral AG or switch to insulin-dependence In pts with insulin dependence before surgery:Stability=no change in number of insulin units,Resolution=no anti-diabetic therapy,Improvement=decrease in number of insulin units or oral AG,Worsening=increase in number of insulin units In pts not affected by type 2 diabetes before surgery:new onset=introduction of anti-diabetic therapy In pts using CPAP before surgery:Stability=continued use of CPAP,Resolution=discontinued use of CPAP In pts not affected by obstructive sleep apnea syndrome (OSAS) before surgery:new onset=use of CPAP
Time frame
month 12 and 24 after surgeryLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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