Sleeve GastrectomyNCT07565038
A Comparative Study of Staple Line Reinforcement Techniques in Laparoscopic Sleeve Gastrectomy
A study testing laprascopic sleeve gastrectomy with omentopexy and suturing and titanium clips in people with Sleeve Gastrectomy and Reinforcement of Staple Line by Titanium Clips, run by Al-Kindy Teaching Hospital at 1 site in Iraq.
Trial summary
This prospective comparative cohort study was conducted in accordance with the Declaration of Helsinki and approved by the Ethical Committee of the Medical Research Institute. All consecutive patients undergoing laparoscopic sleeve gastrectomy (LSG) between January 2022 and June 2024 in Baghdad were screened for… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Sleeve Gastrectomy, Reinforcement of Staple Line by Titanium Clips, Reinforcement of Staple Line by Suturing, Omentopexy Over Staple Line
- What is being tested?
- laprascopic sleeve gastrectomy with omentopexy and suturing and titanium clips
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 290 participants
- Where
- 1 siteIraq
- Study dates
- 1 Jan 2022to 1 Jun 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
- BMI more than or equal to 40
- BMI equal or more than 35 with comorbidities
Who cannot join
- history of previous bariatric procedure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparative Study of Staple Line Reinforcement Techniques in Laparoscopic Sleeve Gastrectomy : Omentopexy With Plication Versus Titanium Clips
This prospective comparative cohort study was conducted in accordance with the Declaration of Helsinki and approved by the Ethical Committee of the Medical Research Institute. All consecutive patients undergoing laparoscopic sleeve gastrectomy (LSG) between January 2022 and June 2024 in Baghdad were screened for eligibility.
- Conditions
- Sleeve Gastrectomy, Reinforcement of Staple Line by Titanium Clips, Reinforcement of Staple Line by Suturing, Omentopexy Over Staple Line
- Being tested
- laprascopic sleeve gastrectomy with omentopexy and suturing, titanium clips
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laprascopic sleeve gastrectomy with omentopexy and suturingOther
reinforcement of staple line by invagination of staple line by seromuscular suturing and omentopexy
titanium clipsOther
titanium clips used for rienforcement and haemostais of staple line in laprascopic sleeve gastrectomy
| Study group | Role | What they receive |
|---|---|---|
| group A: omentopexy | Active comparator | complete staple line invagination using continuous seromuscular suturing with omentopexy Receives: Other: laprascopic sleeve gastrectomy with omentopexy and suturing |
| group B : Titanium clips | Active comparator | staple line reinforcement and homeostasis by using titanium clips Receives: Other: titanium clips |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of postoperative leakage
presence of clinical signs (fever , tachycardia ) or radiological evidence of contrast extravasation
Measured: up to 6 weeks postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2026
- Study start1 Jan 2022
- Primary completion1 Jun 2024
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleeve GastrectomyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- cohort
- Masking
- None (open label)
- Enrolment
- 290 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Kindy Teaching Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Safaa Hadi Abdulsattar Alshihmani, Al-Kindy Teaching Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07565038
- Sponsor's protocol ID
- Medical Research Institute
- Status last verified
- May 2026
- First submitted
- 27 Apr 2026
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study of Staple Line Reinforcement Techniques in Laparoscopic Sleeve Gastrectomy : Omentopexy With Plication Versus Titanium Clips
- ClinicalTrials.gov ID
- NCT07565038
- Acronym / sponsor ID
- Medical Research Institute
- Conditions
- Sleeve Gastrectomy, Reinforcement of Staple Line by Titanium Clips, Reinforcement of Staple Line by Suturing, Omentopexy Over Staple Line
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 290 participants (actual)
- Lead sponsor
- Al-Kindy Teaching HospitalUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 4 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 comparative cohort study was conducted in accordance with the Declaration of Helsinki and approved by the Ethical Committee of the Medical Research Institute. All consecutive patients undergoing laparoscopic sleeve gastrectomy (LSG) between January 2022 and June 2024 in Baghdad were screened for eligibility.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- cohort
| Arm | Type | Receives |
|---|---|---|
| group A: omentopexy | Active comparator | Other: laprascopic sleeve gastrectomy with omentopexy and suturingcomplete staple line invagination using continuous seromuscular suturing with omentopexy |
| group B : Titanium clips | Active comparator | Other: titanium clipsstaple line reinforcement and homeostasis by using titanium clips |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- BMI more than or equal to 40
- BMI equal or more than 35 with comorbidities
Key exclusion criteria (1 listed)
- history of previous bariatric procedure
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 |
|---|---|---|
| laprascopic sleeve gastrectomy with omentopexy and suturingreinforcement of staple line by invagination of staple line by seromuscular suturing and omentopexy | Other | group A: omentopexy |
| titanium clipstitanium clips used for rienforcement and haemostais of staple line in laprascopic sleeve gastrectomy | Other | group B : Titanium clips |
Primary outcome
incidence of postoperative leakage
Time frame: up to 6 weeks postoperatively
presence of clinical signs (fever , tachycardia ) or radiological evidence of contrast extravasation
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 7 May 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing laprascopic sleeve gastrectomy with omentopexy and suturing and titanium clips in people with Sleeve Gastrectomy and Reinforcement of Staple Line by Titanium Clips, run by Al-Kindy Teaching Hospital at 1 site in Iraq.
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 2 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 7 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 Iraq. 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 postoperative leakage (time frame: up to 6 weeks postoperatively). 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 7 May 2026.