Obesity & OverweightNCT07590206
Effect of Omentopexy on Incisura Angularis Morphology and Gastric Emptying After Laparoscopic Sleeve Gastrectomy
A study testing Laparoscopic Sleeve Gastrectomy With Omentopexy and Laparoscopic Sleeve Gastrectomy Without Omentopexy in people with Obesity & Overweight, run by Ankara University at 1 site in Turkey (Türkiye).
Trial summary
This prospective randomized study aimed to evaluate the effect of omentopexy performed during laparoscopic sleeve gastrectomy (LSG) on incisura angularis morphology, gastric emptying time, postoperative dyspeptic symptoms, and early weight loss outcomes. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity & Overweight
- What is being tested?
- Laparoscopic Sleeve Gastrectomy With Omentopexy and Laparoscopic Sleeve Gastrectomy Without Omentopexy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 26 Jun 2023to 27 Dec 2024
- Phase
- Interventional
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged between 18 and 65 years Patients scheduled for primary laparoscopic sleeve gastrectomy for obesity treatment Patients who provided written informed consent
Who cannot join
- Previous gastrointestinal surgery Hiatal hernia Peptic ulcer disease Esophagitis Pangastritis detected on preoperative endoscopy Inability to tolerate postoperative scintigraphic evaluation
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara University Faculty of Medicine
Ankara, Ankara, 06100
About this study
This prospective randomized study aimed to evaluate the effect of omentopexy performed during laparoscopic sleeve gastrectomy (LSG) on incisura angularis morphology, gastric emptying time, postoperative dyspeptic symptoms, and early weight loss outcomes. Patients undergoing primary LSG were randomized to either LSG with omentopexy or LSG without omentopexy. Gastric emptying was assessed using scintigraphic gastric emptying studies, and changes in incisura angularis angle were evaluated using intraoperative image analysis. Postoperative symptoms were assessed using the Short Form Leeds Dyspepsia Questionnaire.
Read the detailed description
Laparoscopic sleeve gastrectomy (LSG) is one of the most commonly performed bariatric surgical procedures worldwide. However, postoperative gastrointestinal symptoms, gastric torsion, and functional stenosis remain important concerns after surgery. Omentopexy has been proposed as a technical modification to stabilize the gastric tube and preserve anatomical alignment, but its clinical and functional effects remain controversial.
This prospective randomized controlled study was conducted to evaluate the effect of omentopexy performed during LSG on incisura angularis morphology, gastric emptying time, postoperative dyspeptic symptoms, and early weight loss outcomes. Eligible patients undergoing primary LSG were randomized into two groups: LSG with omentopexy and LSG without omentopexy.
The incisura angularis angle was evaluated using intraoperative image analysis. Gastric emptying time was assessed preoperatively and at the postoperative third month using scintigraphic gastric emptying studies (T½). Postoperative dyspeptic symptoms were evaluated using the Short Form Leeds Dyspepsia Questionnaire. Demographic, clinical, laboratory, and postoperative outcome data were prospectively recorded and compared between groups.
- Conditions
- Obesity & Overweight
- Being tested
- Laparoscopic Sleeve Gastrectomy With Omentopexy, Laparoscopic Sleeve Gastrectomy Without Omentopexy
- Keywords
- Obesity, Laparoscopic sleeve gastrectomy, Omentopexy, Dyspepsia
- Medical subject headings
- Obesity, Overweight, Dyspepsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic Sleeve Gastrectomy With OmentopexyProcedure or surgery
Laparoscopic sleeve gastrectomy was performed using a standard surgical technique. In addition, omentopexy was performed by fixation of the greater omentum to the gastric staple line in order to stabilize the gastric tube anatomy.
Laparoscopic Sleeve Gastrectomy Without OmentopexyProcedure or surgery
Standard laparoscopic sleeve gastrectomy was performed without omentopexy.
| Study group | Role | What they receive |
|---|---|---|
| LSG With Omentopexy | Experimental | Participants underwent laparoscopic sleeve gastrectomy with omentopexy. Omentopexy was performed by fixation of the greater omentum to the gastric staple line following sleeve gastrectomy. Receives: Procedure: Laparoscopic Sleeve Gastrectomy With Omentopexy |
| LSG Without Omentopexy | Active comparator | Participants underwent standard laparoscopic sleeve gastrectomy without omentopexy. Receives: Procedure: Laparoscopic Sleeve Gastrectomy Without Omentopexy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Incisura Angularis Angle
Changes in the incisura angularis angle were evaluated using vector-based measurements obtained from intraoperative images before and after laparoscopic sleeve gastrectomy.
Measured: Preoperative and postoperative 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2026
- Study start26 Jun 2023
- Primary completion27 Dec 2024
- Study completion27 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity & OverweightStudies of the same condition, open and under way.
- More trials run by Ankara UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomized in a 1:1 ratio into two parallel groups: laparoscopic sleeve gastrectomy with omentopexy and laparoscopic sleeve gastrectomy without omentopexy.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Volkan Genc, Ankara University
- Investigators
- Volkan Genç, MD, Principal investigator, Ankara University Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07590206
- Sponsor's protocol ID
- 2023000352-2
- Status last verified
- May 2026
- First submitted
- 11 May 2026
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Omentopexy on Incisura Angularis Morphology and Gastric Emptying After Laparoscopic Sleeve Gastrectomy
- ClinicalTrials.gov ID
- NCT07590206
- Acronym / sponsor ID
- 2023000352-2
- Conditions
- Obesity & Overweight
- Keywords
- Obesity, Laparoscopic sleeve gastrectomy, Omentopexy, Dyspepsia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- 26 Jun 2023 (actual)
- Primary completion
- 27 Dec 2024 (actual)
- Study completion
- 27 Dec 2024 (actual)
- First posted
- 15 May 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.
This prospective randomized study aimed to evaluate the effect of omentopexy performed during laparoscopic sleeve gastrectomy (LSG) on incisura angularis morphology, gastric emptying time, postoperative dyspeptic symptoms, and early weight loss outcomes. Patients undergoing primary LSG were randomized to either LSG with omentopexy or LSG without omentopexy. Gastric emptying was assessed using scintigraphic gastric emptying studies, and changes in incisura angularis angle were evaluated using intraoperative image analysis. Postoperative symptoms were assessed using the Short Form Leeds Dyspepsia Questionnaire.
Detailed description
Laparoscopic sleeve gastrectomy (LSG) is one of the most commonly performed bariatric surgical procedures worldwide. However, postoperative gastrointestinal symptoms, gastric torsion, and functional stenosis remain important concerns after surgery. Omentopexy has been proposed as a technical modification to stabilize the gastric tube and preserve anatomical alignment, but its clinical and functional effects remain controversial.
This prospective randomized controlled study was conducted to evaluate the effect of omentopexy performed during LSG on incisura angularis morphology, gastric emptying time, postoperative dyspeptic symptoms, and early weight loss outcomes. Eligible patients undergoing primary LSG were randomized into two groups: LSG with omentopexy and LSG without omentopexy.
The incisura angularis angle was evaluated using intraoperative image analysis. Gastric emptying time was assessed preoperatively and at the postoperative third month using scintigraphic gastric emptying studies (T½). Postoperative dyspeptic symptoms were evaluated using the Short Form Leeds Dyspepsia Questionnaire. Demographic, clinical, laboratory, and postoperative outcome data were prospectively recorded and compared between groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants were randomized in a 1:1 ratio into two parallel groups: laparoscopic sleeve gastrectomy with omentopexy and laparoscopic sleeve gastrectomy without omentopexy.
| Arm | Type | Receives |
|---|---|---|
| LSG With Omentopexy | Experimental | Procedure: Laparoscopic Sleeve Gastrectomy With OmentopexyParticipants underwent laparoscopic sleeve gastrectomy with omentopexy. Omentopexy was performed by fixation of the greater omentum to the gastric staple line following sleeve gastrectomy. |
| LSG Without Omentopexy | Active comparator | Procedure: Laparoscopic Sleeve Gastrectomy Without OmentopexyParticipants underwent standard laparoscopic sleeve gastrectomy without omentopexy. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients aged between 18 and 65 years Patients scheduled for primary laparoscopic sleeve gastrectomy for obesity treatment Patients who provided written informed consent
Key exclusion criteria (1 listed)
- Previous gastrointestinal surgery Hiatal hernia Peptic ulcer disease Esophagitis Pangastritis detected on preoperative endoscopy Inability to tolerate postoperative scintigraphic evaluation
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 Gastrectomy With OmentopexyLaparoscopic sleeve gastrectomy was performed using a standard surgical technique. In addition, omentopexy was performed by fixation of the greater omentum to the gastric staple line in order to stabilize the gastric tube anatomy. | Procedure or surgery | LSG With Omentopexy |
| Laparoscopic Sleeve Gastrectomy Without OmentopexyStandard laparoscopic sleeve gastrectomy was performed without omentopexy. | Procedure or surgery | LSG Without Omentopexy |
Primary outcome
Change in Incisura Angularis Angle
Time frame: Preoperative and postoperative 3 months
Changes in the incisura angularis angle were evaluated using vector-based measurements obtained from intraoperative images before and 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 18 May 2026.
- Individual participant dataSharing planned: Yes
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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.
Volkan Genç, MD principal investigator
Ankara University Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic Sleeve Gastrectomy With Omentopexy and Laparoscopic Sleeve Gastrectomy Without Omentopexy in people with Obesity & Overweight, run by Ankara University at 1 site in Turkey (Türkiye).
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 1 inclusion and 1 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 18 May 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 Turkey (Türkiye). 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?
Change in Incisura Angularis Angle (time frame: Preoperative and postoperative 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 May 2026.