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

NCT04763993 | Not Yet Recruiting

• 1 other identifier: ReBvSS
• Study Type: interventional
• Target: 128
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Gastroesophageal Reflux Disease; Obesity

Keywords

Gastroesophageal Reflux Disease; Obesity; Sleeve gastrectomy; Gastric bypass; DeMeester score; pH-monitoring

Outcome Measures

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

  Change from baseline DeMeester Score 24 months after surgery

Secondary Outcomes (6)

• Postoperative Gastroesophageal Reflux Disease (GERD) from baseline

  Change from baseline DeMeester Score 12 months after surgery

• Postoperative reflux symptoms

  Baseline and 12 and 24 months from the surgery

• Quality of life Questionnaire

  month 12 and 24 after surgery

• Trend of the obesity-related diseases (Arterial hypertension, Type 2 Diabetes, continuous positive airway pressure (CPAP) use

  month 12 and 24 after surgery

• Demographic

  Enrollment

Study Arms (2)

RYGBP

ACTIVE COMPARATOR

RYGBP: Roun-en-Y Gastric Bypass

Procedure: Roux-en-Y-Gastric bypass, Sleeve gastrectomy; Procedure: SG

SG

EXPERIMENTAL

SG: Sleeve Gastrectomy

Procedure: Roux-en-Y-Gastric bypass, Sleeve gastrectomy; Procedure: SG

Interventions

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.

RYGBP; SG

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.

RYGBP; SG

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Niguarda Hospital: lead

MeSH Terms

Conditions

Gastroesophageal Reflux; Obesity

Interventions

Gastric Bypass

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Bariatric Surgery; Bariatrics; Obesity Management; Therapeutics; Gastroenterostomy; Anastomosis, Surgical; Surgical Procedures, Operative; Digestive System Surgical Procedures

Central Study Contacts

Gisella Barone, MD

CONTACT

+39 026444; gisella.barone89@gmail.com

Valerio Girardi, MD

CONTACT

+39 026444; valerio.girardi@ospedaleniguarda.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2021
• First Posted: February 21, 2021
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2030
• Last Updated: April 16, 2026

Record last verified: 2026-04