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OpenTrials
Completed

NCT Number: NCT05416645

Prevalence, Predictors and Management of Gastroesophageal Reflux After Laparoscopic Sleeve Gastrectomy

From January 2017 to January 2022, we looked at patients who had primary LSG and developed GERD. Before and after surgery, patients for LSG performed barium meal in Trendelenburg position and upper GIT endoscopy. Esophageal manometry and 24 h PH metery for patients who developed GERD.

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Key information

About this study

Patients with morbid obesity who had LSG between January 2017 to January 2022were included in the trial, which was a multicenter cohort study. Patients with morbid obesity, defined as a BMI of more than 40 or less than 35 with at least one comorbidity and ages ranging from 16 to 65, were patients' eligibility criteria for LSG. Patients under the age of 16 or over 65, as well as those with severe GERD, pregnancy, or inflammatory bowel disease, were excluded from the trial.

The data were recorded in a prospective manner in a computerized file, all patients signed the informed consent form after the description of the technique and possible postoperative morbidities.

Before and after surgery, patients for LSG performed barium meal in Trendelenburg position and upper GIT endoscopy. Esophageal manometry and 24 h PH metery for patients who developed GERD.

The study's purpose was to determine the prevalence of GERD symptoms, as well as potential predictors of GERD symptoms following LSG and how GERD symptoms were managed after LSG.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with morbid obesity defined as a BMI of more than 40 or
  • BMI less than 35 with at least one comorbidity and
  • ages ranging from 16 to 65, were patients'

Exclusion criteria

  • Patients under the age of 16 or over 65,
  • those with severe GERD,
  • pregnancy, or
  • inflammatory bowel disease,

Treatment and study plan

patients with GERD after LSG

Procedure

patients with GERD after LSG

Other names: GERD after LSG

Primary outcomes

  1. GERD-Health-Related Quality of Life (GERD-HRQL) questionnaire

    Time frame: one month

    GERD-Health-Related Quality of Life (GERD-HRQL) questionnaire including GERD symptoms easch one scaled from 1 to 5 the less score the better out come (1 the best and 5 is the worset)

Secondary outcomes

  1. Gastropexy

    Time frame: one month

    YES (WITH GASTROPEXY) OR NO (WITHOUT GASTROPEXY) .....RISK FACTORS AND PROTECTIVE FACTORS for GERD

  2. smoking

    Time frame: one month

    YES (WITH SMOKING) OR NO (WITHOUT SMOKING)......RISK FACTORS AND PROTECTIVE FACTORS for GERD

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

Prevalence, Predictors, and Management of Gastroesophageal Reflux After Laparoscopic Sleeve Gastrectomy Multicentric Cohort Study

Acronym: LSG-GERD

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Jun 13, 2022
Registry last updated
Jun 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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