NCT05486169

Brief Summary

The planned research is to analyze the occurrence of gastroesophageal reflux disease (GERD) before and after sleeve gastrectomy (SG). The study includes patients with BMI above 40 kg / m2 without symptoms of GERD before surgery and any pathological changes in gastroscopy. The day before the surgery, patients will be tested with impedance pH measurement. Thereafter, patients will undergo SG according to standard technique. As part of the follow-up 6 months after the surgery, the pH-measurement test with impedance again will be performed again for evaluation of the occurrence of GERD after surgery. It was planned to include 50 people in the study. The main aim of the study is to assess the frequency and quality of GERD in patients after SG.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 30, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 3, 2022

Completed
29 days until next milestone

Study Start

First participant enrolled

September 1, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2023

Completed
Last Updated

January 3, 2024

Status Verified

January 1, 2024

Enrollment Period

11 months

First QC Date

July 30, 2022

Last Update Submit

January 1, 2024

Conditions

Gastroesophageal RefluxObesity

Keywords

Gastroesophageal Reflux DiseaseGERDObesity SurgerySleeve gastrectomy

Outcome Measures

Primary Outcomes (1)

  • gastroesophageal reflux after sleeve gastrectomy

    The main aim of the study is to assess the frequency and quality of gastroesophageal reflux disease in patients six months after sleeve gastrectomy. The reflux will be measured in each patient using 24-hour pH-impedance testing

    6 months

Secondary Outcomes (1)

  • outcomes of sleeve gastrectomy

    6 months

Interventions

Sleeve GastrectomyPROCEDURE

surgery of laparoscopic sleeve gastrectomy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI above 40kg/m2
  • positive qualification process for laparoscopic sleeve gastrectomy

You may not qualify if:

  • symptoms of gastroesophageal reflux disease before the surgery
  • pathological changes in gastroscopy before the surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UWM

Olsztyn, 10-045, Poland

Location

MeSH Terms

Conditions

Gastroesophageal RefluxObesity

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

July 30, 2022

First Posted

August 3, 2022

Study Start

September 1, 2022

Primary Completion

July 31, 2023

Study Completion

August 31, 2023

Last Updated

January 3, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

PL(1)