Laparoscopic Sleeve GastrectomyNCT04323696
Comparison of Staple Line Suturing in Laparoscopic Sleeve Gastrectomy
A study testing Staple line suturing reinforcement methods - Plication and Over-sewing in people with Laparoscopic Sleeve Gastrectomy, run by Universiti Putra Malaysia.
Trial summary
Sleeve gastrectomy (SG) involves the creation of small gastric reservoir based on lesser curvature of the stomach, which is fashioned by a longitudinal gastrectomy that preserves the antrum and pylorus together with its vagal innervation. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Laparoscopic Sleeve Gastrectomy
- What is being tested?
- Staple line suturing reinforcement methods - Plication and Over-sewing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2023to 30 Jun 2025
- 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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients at our Bariatric Clinic fulfilling NIH criteria for bariatric surgery and planned operation of laparoscopic sleeve gastrectomy as primary bariatric procedure will be evaluated for possible inclusion
Who cannot join
- Age < 18 or > 65
- BMI < 35 and > 60 kg/m2
- American Society of Anesthesiologists (ASA) score > 3
- Concurrent surgical procedure including:
- ventral hernia repair
- cholecystectomy
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- hiatal hernia repair with posterior cruroplasty
- extensive lysis of adhesions
- other procedures that mandate addition of 'trocar(s)' or 'feeding tube'
About this study
Official title: Comparison of Staple Line Suturing Reinforcement Methods in Laparoscopic Sleeve Gastrectomy
Sleeve gastrectomy (SG) involves the creation of small gastric reservoir based on lesser curvature of the stomach, which is fashioned by a longitudinal gastrectomy that preserves the antrum and pylorus together with its vagal innervation. Recently SG is viewed as a multi-purpose bariatric procedure that restricts the stomach size to induce satiety and resects fundal ghrelin-producing cells to decrease appetite. However, the risk of staple line leak and bleeding remains one of its challenging complications. Despite the fact that there are a large number of studies assessing various methods of making the staple line secure, there is to date, no consensus on which technique is best for reducing the risk of stapler line bleeding and leak. Hence, this study aims to compare staple line suturing reinforcement methods in sleeve gastrectomy using plication and over-sewing techniques.
- Conditions
- Laparoscopic Sleeve Gastrectomy
- Being tested
- Staple line suturing reinforcement methods - Plication and Over-sewing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Staple line suturing reinforcement methods - Plication and Over-sewingProcedure or surgery
Sleeve gastrectomy procedure will be performed laparoscopically. The greater curvature of the stomach will be mobilised, and stomach will be sleeved using 39F calibration tube as the stent using 5-6 60 mm-stapler reloads depending on the length and thickness of the stomach. The staple-line is then reinforced using 3/0 absorbable sutures continuously throughout the staple-line. The two staple-line suturing methods in this study include over-sewing (through and through) and plication (Lembert).
| Study group | Role | What they receive |
|---|---|---|
| Over-sewing | Other | Patients under over-sewing arm are subjected to staple line reinforcement using over-sewing method Receives: Procedure: Staple line suturing reinforcement methods - Plication and Over-sewing |
| Plication | Other | Patients under over-sewing arm are subjected to staple line reinforcement using plication method Receives: Procedure: Staple line suturing reinforcement methods - Plication and Over-sewing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immediate and early post-operative complication
Staple line bleeding
Measured: 0-30 days
Secondary outcomes (2)
Immediate and early post-operative complication
Staple line leak
Measured: 0-30 days
Immediate and early post-operative complication
Re-admission and re-operation
Measured: 0-30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2020
- Study start1 Jul 2023 (estimated)
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Why it stopped: Study was not initiated due to operational and feasibility constraints; no participants were enrolled.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopic 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- All patients who underwent laparoscopic sleeve gastrectomy from March 2020 till February 2021 will be included
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universiti Putra Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zubaidah Nor hanipah, Universiti Putra Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04323696
- Sponsor's protocol ID
- 53293
- Status last verified
- Sep 2026
- First submitted
- 24 Mar 2020
- Last updated
- 24 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Staple Line Suturing Reinforcement Methods in Laparoscopic Sleeve Gastrectomy
- ClinicalTrials.gov ID
- NCT04323696
- Acronym / sponsor ID
- 53293
- Conditions
- Laparoscopic Sleeve Gastrectomy
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was not initiated due to operational and feasibility constraints; no participants were enrolled.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Universiti Putra MalaysiaUniversity, hospital or other
- Study start
- 1 Jul 2023 (estimated)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 26 Mar 2020 (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 (SG) involves the creation of small gastric reservoir based on lesser curvature of the stomach, which is fashioned by a longitudinal gastrectomy that preserves the antrum and pylorus together with its vagal innervation. Recently SG is viewed as a multi-purpose bariatric procedure that restricts the stomach size to induce satiety and resects fundal ghrelin-producing cells to decrease appetite. However, the risk of staple line leak and bleeding remains one of its challenging complications. Despite the fact that there are a large number of studies assessing various methods of making the staple line secure, there is to date, no consensus on which technique is best for reducing the risk of stapler line bleeding and leak. Hence, this study aims to compare staple line suturing reinforcement methods in sleeve gastrectomy using plication and over-sewing techniques.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- All patients who underwent laparoscopic sleeve gastrectomy from March 2020 till February 2021 will be included
| Arm | Type | Receives |
|---|---|---|
| Over-sewing | Other | Procedure: Staple line suturing reinforcement methods - Plication and Over-sewingPatients under over-sewing arm are subjected to staple line reinforcement using over-sewing method |
| Plication | Other | Procedure: Staple line suturing reinforcement methods - Plication and Over-sewingPatients under over-sewing arm are subjected to staple line reinforcement using plication method |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients at our Bariatric Clinic fulfilling NIH criteria for bariatric surgery and planned operation of laparoscopic sleeve gastrectomy as primary bariatric procedure will be evaluated for possible inclusion
Key exclusion criteria (9 listed)
- Age < 18 or > 65
- BMI < 35 and > 60 kg/m2
- American Society of Anesthesiologists (ASA) score > 3
- Concurrent surgical procedure including:
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 |
|---|---|---|
| Staple line suturing reinforcement methods - Plication and Over-sewingSleeve gastrectomy procedure will be performed laparoscopically. The greater curvature of the stomach will be mobilised, and stomach will be sleeved using 39F calibration tube as the stent using 5-6 60 mm-stapler reloads depending on the length and thickness of the stomach. The staple-line is then reinforced using 3/0 absorbable sutures continuously throughout the staple-line. The two staple-line suturing methods in this study include over-sewing (through and through) and plication (Lembert). | Procedure or surgery | Over-sewing, Plication |
Primary outcome
Immediate and early post-operative complication
Time frame: 0-30 days
Staple line bleeding
2 secondary outcomes
Immediate and early post-operative complication
Time frame: 0-30 days
Immediate and early post-operative complication
Time frame: 0-30 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Staple line suturing reinforcement methods - Plication and Over-sewing in people with Laparoscopic Sleeve Gastrectomy, run by Universiti Putra Malaysia.
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 9 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: withdrawn, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Immediate and early post-operative complication (time frame: 0-30 days). 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 24 Sep 2026.