Hiatal HerniaNCT07902895
Intrathoracic Sleeve Migration (Sliding Hiatal Hernia) One Year or More After Laparoscopic Sleeve Gastrectomy
An observational study of Hiatal Hernia and Gastroesophageal Reflux Disease, run by Kasr El Aini Hospital at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hiatal Hernia, Gastroesophageal Reflux Disease, Obesity
- What is being tested?
- Laparoscopic sleeve gastrectomy and CT of the thorax and abdomen with oral water-soluble contrast
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 61 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2026to 30 Sep 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- Adults (18 years or older) with a preoperative body mass index above 35 kg/m²
- Primary laparoscopic sleeve gastrectomy between July 2024 and August 2025
- 12 months or more after surgery
Who cannot join
- Roux-en-Y gastric bypass or one-anastomosis (mini) gastric bypass
- Revisional bariatric surgery
- Hiatal hernia or gastro-oesophageal reflux disease diagnosed before surgery
- Hiatal hernia found at operation
- Hiatal dissection, hiatal hernia repair or sleeve fixation performed at the index operation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Incidence of Intra-thoracic Sleeve Migration (Sliding Hiatus Hernia) One Year Post Laparoscopic Sleeve Gastrectomy
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.
Read the detailed description
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
- ITSM: proximal end of the sleeve staple line above the level of the oesophageal hiatus on CT.
- GERD: GERD-Q score of 8 or more.
- Because patients with GERD or hiatal hernia before surgery were excluded, postoperative GERD is regarded as de novo.
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.
- Being tested
- Laparoscopic sleeve gastrectomy, CT of the thorax and abdomen with oral water-soluble contrast
- Keywords
- Laparoscopic sleeve gastrectomy, Intrathoracic sleeve migration, Sliding hiatal hernia, De novo GERD, GERD-Q, Computed tomography, Metabolic bariatric surgery
- Medical subject headings
- Hernia, Hiatal, Gastroesophageal Reflux, Obesity, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic sleeve gastrectomyProcedure or surgery
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.
CT of the thorax and abdomen with oral water-soluble contrastDiagnostic test
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At a single study visit, 12 months or more after laparoscopic sleeve gastrectomy
Secondary outcomes (2)
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.
Measured: 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.
Measured: Preoperative (from medical records) and at a single study visit, 12 months or more after laparoscopic sleeve gastrectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2026
- Study start1 Apr 2026
- Primary completion30 Sep 2026
- Study completion30 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hiatal HerniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Abdelsalam M, Kasr El Aini Hospital
- Investigators
- Ahmed Abdelsalam, MD, Principal investigator, Cairo UniversityMohamed Hassan Ali Fahmy, MD, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07902895
- Sponsor's protocol ID
- MS-620-2025-ITSM
- Status last verified
- Oct 2026
- First submitted
- 21 Oct 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared; aggregate results will be reported in the publication.
Publications
Saber AA, Shoar S, Khoursheed M. Intra-thoracic Sleeve Migration (ITSM): an Underreported Phenomenon After Laparoscopic Sleeve Gastrectomy. Obes Surg. 2017 Aug;27(8):1917-1923. doi: 10.1007/s11695-017-2589-6.
PubMed 28233265Sarhan MD, Aboueisha HA, Fathy E, AbdelSalam MN, Abdelsalam A. Intra-thoracic Gastric Pouch Migration Following Laparoscopic Sleeve Gastrectomy - Short Term Study. Surg Gastroenterol Oncol. 2024;29(2 Suppl):S24-S29.
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Intra-thoracic Sleeve Migration (Sliding Hiatus Hernia) One Year Post Laparoscopic Sleeve Gastrectomy
- ClinicalTrials.gov ID
- NCT07902895
- Acronym / sponsor ID
- MS-620-2025-ITSM
- Keywords
- Laparoscopic sleeve gastrectomy, Intrathoracic sleeve migration, Sliding hiatal hernia, De novo GERD, GERD-Q, Computed tomography, Metabolic bariatric surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 30 Sep 2026 (actual)
- Study completion
- 30 Sep 2026 (actual)
- First posted
- 29 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
- ITSM: proximal end of the sleeve staple line above the level of the oesophageal hiatus on CT.
- GERD: GERD-Q score of 8 or more.
- Because patients with GERD or hiatal hernia before surgery were excluded, postoperative GERD is regarded as de novo.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (3 listed)
- Adults (18 years or older) with a preoperative body mass index above 35 kg/m²
- Primary laparoscopic sleeve gastrectomy between July 2024 and August 2025
- 12 months or more after surgery
Key exclusion criteria (5 listed)
- Roux-en-Y gastric bypass or one-anastomosis (mini) gastric bypass
- Revisional bariatric surgery
- Hiatal hernia or gastro-oesophageal reflux disease diagnosed before surgery
- Hiatal hernia found at operation
- Hiatal dissection, hiatal hernia repair or sleeve fixation performed at the index operation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laparoscopic sleeve gastrectomyPrimary laparoscopic sleeve gastrectomy performed as part of routine care before enrolment. This is the exposure of interest; it was not assigned by the study. | Procedure or surgery | – |
| CT of the thorax and abdomen with oral water-soluble contrastSingle CT examination at the study visit (5 mm slices) to detect and measure migration of the proximal sleeve staple line above the oesophageal hiatus. | Diagnostic test | – |
Primary outcome
Incidence of intrathoracic sleeve migration (ITSM)
Time frame: At a single study visit, 12 months or more after laparoscopic sleeve gastrectomy
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.
2 secondary outcomes
Association between ITSM and de novo gastro-oesophageal reflux disease (GERD)
Time frame: At a single study visit, 12 months or more after laparoscopic sleeve gastrectomy
Patient factors associated with ITSM
Time frame: Preoperative (from medical records) and at a single study visit, 12 months or more after laparoscopic sleeve gastrectomy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Background: PubMed 28233265Saber AA, Shoar S, Khoursheed M. Intra-thoracic Sleeve Migration (ITSM): an Underreported Phenomenon After Laparoscopic Sleeve Gastrectomy. Obes Surg. 2017 Aug;27(8):1917-1923. doi: 10.1007/s11695-017-2589-6.
- BackgroundSarhan MD, Aboueisha HA, Fathy E, AbdelSalam MN, Abdelsalam A. Intra-thoracic Gastric Pouch Migration Following Laparoscopic Sleeve Gastrectomy - Short Term Study. Surg Gastroenterol Oncol. 2024;29(2 Suppl):S24-S29.
- Individual participant dataSharing planned: No. Individual participant data will not be shared; aggregate results will be reported in the publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed Abdelsalam, MD principal investigator
Cairo University
Mohamed Hassan Ali Fahmy, MD study chair
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hiatal Hernia and Gastroesophageal Reflux Disease, run by Kasr El Aini Hospital at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of intrathoracic sleeve migration (ITSM) (time frame: At a single study visit, 12 months or more after laparoscopic sleeve gastrectomy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07902895, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.