Clinical trial

Reflux Disease After Gastric Bypass Versus Sleeve Gastrectomy in Morbid Obese Patients: an Italian Study

Opening soon · Not applicable · 0 countries · Registry ID NCT04763993

Opening soonNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 70 Years

SexAll

Healthy volunteersNot accepted

ConditionGastroesophageal Reflux Disease, Obesity

Full registry criteria

Inclusion Criteria: * 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; * Male and female; * ≥18 and ≤70 years old; * BMI ≥ 35 with obesity-related comorbidities; * BMI ≥ 40 with or without obesity-related comorbidities; * GERDQ score ≥ 3 points; * Use of proton pump inhibitor; * Mild and Moderate GERD (DMS ≥14.72 ≤100) * Incompetence of the Esophagogastric junction * Los Angeles grade A, B, C, D esophagitis. Exclusion criteria * 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; * Absence of GERD (DMS\<14.72); * Severe GERD (DMS\>100); * Hiatal hernia \> 5 cm; * Previous bariatric surgery or major general surgery; * Type 2 diabetes (T2D) for more than \> 5 years; * Necessity to explore stomach, the duodenum or the biliary tract; * Refuse of randomization; * Personal reasons.

Treatments and study arms

Roux-en-Y-Gastric bypass, Sleeve gastrectomy

Procedure

RYGBP 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

SG 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.

Primary outcomes

Change of the pre-existing Gastro-Esophageal Reflux Disease (GERD) from baseline in patients underwent SG and RYGBPChange from baseline DeMeester Score 24 months after surgery

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

Study locations

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No public site location was included in this record. Check the original registry for updates.