An observational study in Hiatal Hernia, Gastroesophageal Reflux Disease and Obesity, sponsored by Kasr El Aini Hospital. Completed at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-29.
Sponsored by Kasr El Aini Hospital · Observational
Sleeve gastrectomy is the most commonly performed metabolic bariatric operation. After the operation, the upper part of the gastric sleeve can slide up through the opening in the diaphragm into the chest. This is called intrathoracic sleeve migration and is a form of sliding hiatal hernia. It may cause new reflux symptoms such as heartburn, regurgitation and vomiting, and may lead to further surgery. How often it happens is uncertain, because studies have used different definitions and tests.
This single-centre observational study included adults who had a laparoscopic sleeve gastrectomy at Cairo University Hospitals between July 2024 and August 2025 and were at least one year after surgery. Each patient had a CT scan of the chest and abdomen with oral contrast to look for migration of the sleeve above the diaphragm, and completed the GERD-Q reflux questionnaire. The study measured how often intrathoracic sleeve migration occurs one year or more after sleeve gastrectomy, whether it is associated with new (de novo) reflux disease, and which patient factors may be associated with it.
Background
Laparoscopic sleeve gastrectomy (LSG) is associated with de novo gastro-oesophageal reflux disease (GERD). One proposed mechanism is intrathoracic sleeve migration (ITSM): upward migration of the proximal sleeve, with its staple line, through the oesophageal hiatus after an operation in which the sleeve was entirely intra-abdominal. Reported rates range from about 5% to 45%, largely because of differing diagnostic definitions and imaging methods.
Design and setting
Single-centre observational cohort study in the Department of General Surgery, Cairo University Hospitals (Kasr Al-Ainy), Cairo, Egypt. Patients who underwent primary LSG between July 2024 and August 2025 were identified from the department's records and invited to a single study visit 12 months or more after surgery. Study visits (CT and GERD-Q) took place between April 2026 and September 2026. The protocol was approved by the Research Ethics Committee, Faculty of Medicine, Cairo University (code MS-620-2025) on 11 March 2026, before the first study visit. The study forms the basis of an MSc thesis in General Surgery (candidate: Dr. Dalia Moharam Hussein Mustafa).
Data collection
From the medical records: age, sex, preoperative body mass index (BMI), preoperative GERD status and operative details, to confirm that no hiatal hernia was found at operation and that no hiatal dissection, hiatal repair or sleeve fixation was performed. At the study visit: symptom history (heartburn, regurgitation, vomiting and others) and time of symptom onset after surgery, the GERD-Q questionnaire, and height, weight and BMI.
Imaging
CT of the thorax and abdomen (to the pubis) after oral water-soluble contrast, with 5 mm slices. Images were reconstructed and analysed by a single operator. The level of the oesophageal hiatus was identified along the staple line, and migration of the proximal end of the staple line above the hiatus was measured in millimetres.
Definitions
Statistical analysis
SPSS version 26. Normality is assessed with the Shapiro-Wilk test and histograms. Continuous data are summarised as mean and standard deviation or median and interquartile range, and compared between patients with and without ITSM using the Student t-test or the Mann-Whitney U test (paired t-test or Wilcoxon signed-rank test for paired observations). Categorical data are compared with the chi-square or Fisher exact test. A two-sided P value below 0.05 is considered significant.
87 studies on the registry are indexed under Hernia, Hiatal; 27 are open to participants now.
This study's enrollment of 61 is below the median of 151 across 29 observational studies indexed under Hernia, Hiatal.
Browse Hernia, Hiatal studies →Kasr El Aini Hospital is the lead sponsor of 287 studies on the registry; 34 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adults with obesity who underwent primary laparoscopic sleeve gastrectomy in the Department of General Surgery, Cairo University Hospitals (Kasr Al-Ainy), between July 2024 and August 2025, identified from the department's records and assessed 12 months or more after surgery.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Primary laparoscopic sleeve gastrectomy performed as part of routine care before enrolment. This is the exposure of interest; it was not assigned by the study.
Single CT examination at the study visit (5 mm slices) to detect and measure migration of the proximal sleeve staple line above the oesophageal hiatus.
Incidence of intrathoracic sleeve migration (ITSM)
Proportion of patients with ITSM on CT of the thorax and abdomen with oral water-soluble contrast, defined as the proximal end of the gastric sleeve staple line lying above the level of the oesophageal hiatus. The extent of migration above the hiatus is measured in millimetres.
Time frame: At a single study visit, 12 months or more after laparoscopic sleeve gastrectomy
Association between ITSM and de novo gastro-oesophageal reflux disease (GERD)
Proportion of patients with GERD, defined as a GERD-Q score of 8 or more (score range 0 to 18; higher scores indicate a higher likelihood of GERD), compared between patients with and without ITSM. Patients with GERD before surgery were excluded, so postoperative GERD is regarded as de novo. Reflux-related symptoms (heartburn, regurgitation, vomiting) and the time of symptom onset after surgery are also compared between the two groups.
Time frame: At a single study visit, 12 months or more after laparoscopic sleeve gastrectomy
Patient factors associated with ITSM
Age (years), sex, preoperative body mass index (kg/m²) and BMI reduction (preoperative minus postoperative BMI, kg/m²) compared between patients with and without ITSM.
Time frame: Preoperative (from medical records) and at a single study visit, 12 months or more after laparoscopic sleeve gastrectomy
Plan to share: No — Individual participant data will not be shared; aggregate results will be reported in the publication.
Ran from Apr 2026 to primary completion in Sep 2026, 5 months.
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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