A Study to Reduce the Reflux After a Sleeve Gastrectomy in Obese Patients

March 22, 2022 updated by: Fabio Garofalo

A Monocentric Randomized Controlled Prospective Study to Evaluate the Antireflux Efficacy of Primary Crural Closure During Sleeve Gastrectomy for Obese Patients With Incompetents Oeso-gastric Valves

This is a monocentric randomized controlled prospective study. A total of 122 patients will be recruited and randomized 1: 1 in the experimental group - Laparoscopic Sleeve Gastrectomy and Diaphragmatic Pillar Closure - or in the control group - Laparoscopic Sleeve Gastrectomy.

At 6 months post surgery a gastroscopy, an oesophageal manometry and a PH-study will be perform to detect de novo GastroEsophageal Reflux Disease and hiatal hernia appearance.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Lugano, Switzerland, 6900
        • Ospedale Regionale di Lugano, Civico e Italiano

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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:

  • Age between 18-65 years
  • Patient with BMI between 35 and 50 Kg/m2 for whom laparoscopic sleeve gastrectomy indication was made
  • Patients with no preoperative gastroesophageal reflux disease symptoms
  • Hill 2-3 or 4 (with HH <2 cm) hypogastric valve diagnosed preoperatively

Exclusion Criteria:

  • Gastroesophageal reflux disease with daily symptoms or daily use of proton pump inhibitors drugs or daily use of anti-H2 drugs
  • Hiatal Hernia >2cm and/or esophagitis and/or Barrett metaplasia
  • Previous bariatric and/or gastric surgery
  • Normal gastroesophageal valve (Hill 1)
  • Motility disorders of the esophagus (documented on manometry)
  • PH-study positive for gastro-oesophageal reflux disease (DeMeester Score >14.1)
  • Contraindications to gastroscopy or manometry or ph-study
  • Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
  • Patient not legally competent
  • Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: LSG-DPC
Laparoscopic Sleeve Gastrectomy and Diaphragmatic Pillar Closure.
Procedure: DPC
The anterior fat pad is dissected until the left crura is visible, pars flaccida is open and the right crura exposed. Phreno-oesophageal ligament is sectioned starting from the right crura. Posterior and anterior vagal nerve are recognized before the oesophageal dissection. An intra-abdominal oesophagus lengths of 2 or 3 cm is obtained in order to reduce tension. Left and right crura are sutured with 2 or 3 non absorbable 2-0 stitches; an additional anterior stitch is posed if necessary to calibrate hiatus size without oesophageal deviation.
Procedure: LSG
After omental section close to gastric insertion, gastric stapling is realised with triple line endo stapler (normally 5 or 6 re-loads). The gastrectomy begins 5-6 cm from the pylorus; gastric fundus is totally resected keeping a distance of 5-10 mm from oesophagus. Any bleeding on staple line is controlled with surgical clips or coagulator.
ACTIVE_COMPARATOR: LSG
Laparoscopic Sleeve Gastrectomy
Procedure: LSG
After omental section close to gastric insertion, gastric stapling is realised with triple line endo stapler (normally 5 or 6 re-loads). The gastrectomy begins 5-6 cm from the pylorus; gastric fundus is totally resected keeping a distance of 5-10 mm from oesophagus. Any bleeding on staple line is controlled with surgical clips or coagulator.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
De novo GastroEsophageal Reflux Disease (GERD) onset
Time Frame: 6 months post surgery
At 6 months post surgery a gastroscopy, an oesophageal manometry and a PH-study will be perform to detect de novo GERD (GastroEsophageal Reflux Disease)
6 months post surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
hiatal hernia appearance
Time Frame: 6 months post surgery
At 6 months post surgery a gastroscopy, an oesophageal manometry and a PH-study will be perform to detect hiatal hernia appearance
6 months post surgery
change in patient-reported quality of life using Gastroparesis Cardinal Symptom Index (GCSI) questionnaire
Time Frame: baseline and 6 months post surgery

Evaluation of benefits in term of life quality by Gastroparesis Cardinal Symptom Index (GCSI) self-assessment of gastroparesis symptoms.

The Gastroparesis Cardinal Symptom Index (GCSI), is a questionnaire that assess severity of symptoms associated with gastroparesis. Symptoms are rated from 0 (no symptom) to 5 (very severe)
baseline and 6 months post surgery
change in patient-reported quality of life using GERD-Health Related Quality of Life Questionnaire (GERD-HRQL) questionnaire
Time Frame: baseline and 6 months post surgery

Evaluation of benefits in term of life quality and reduction of Protonic Pomp Inhibitors drugs by GERD-Health Related Quality of Life questionnaire.

Questionnaire (GERD-HRQL) for symptoms related to GERD. Symptoms are rated from 0 (no symptom) to 5 (Symptoms are incapacitating to do daily activities). The total Score is calculated by summing the individual scores to 15 questions.

  • Greatest possible score (worst symptoms) = 75
  • Lowest possible score (no symptoms) = 0
baseline and 6 months post surgery
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time Frame: 6 months post surgery
Evaluation of number of participants with treatment-related adverse events ( short and long term surgical complications)
6 months post surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fabio Garofalo

Investigators

  • Principal Investigator: Fabio Garofalo, EOC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 8, 2019

Primary Completion (ANTICIPATED)

October 31, 2022

Study Completion (ANTICIPATED)

October 31, 2022

Study Registration Dates

First Submitted

January 21, 2020

First Submitted That Met QC Criteria

February 26, 2020

First Posted (ACTUAL)

February 27, 2020

Study Record Updates

Last Update Posted (ACTUAL)

April 4, 2022

Last Update Submitted That Met QC Criteria

March 22, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ORL-CHIR-003

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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