Bleeding of the Staple LineNCT02069626
The Effect of Compression Time for Secure Stapling With a Linear Stapler in Laparoscopic Gastric Bypass Surgery
A study testing compression time of the laparoscopic linear stapler in people with Bleeding of the Staple Line, run by Inonu University at 1 site in Turkey (Türkiye).
Trial summary
Bleeding from the staple line is a complication of linear stapling. After clamping, a short period after firing of the laparoscopic linear stapler is recommended. That is, the clinician should continue to press the tissue between the prongs of the device to achieve adequate hemostasis at the staple line. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bleeding of the Staple Line
- What is being tested?
- compression time of the laparoscopic linear stapler
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Start not givento Dec 2014
- 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
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of morbid obesity
- Must be laparoscopic surgery
Who cannot join
- Usage of anti-coagulant
- Presence of impaired blood clotting
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Turgut Özal medical center
Malatya, Malatya, 44000
About this study
Bleeding from the staple line is a complication of linear stapling. After clamping, a short period after firing of the laparoscopic linear stapler is recommended. That is, the clinician should continue to press the tissue between the prongs of the device to achieve adequate hemostasis at the staple line. The significance of the waiting period for hemostasis at the staple line has not been empirically clarified in humans. In this study, the investigators compared the number of bleeding points use of the laparoscopic linear stapler. Consequently, the investigators assessed the effects of time after the firing of linear stapling in patients who underwent laparoscopic gastric bypass.
- Conditions
- Bleeding of the Staple Line
- Being tested
- compression time of the laparoscopic linear stapler
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
compression time of the laparoscopic linear staplerProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| No wait | Active comparator | Usage of linear stapler without waiting of compression time Receives: Procedure: compression time of the laparoscopic linear stapler |
| 20 second wait | Active comparator | Usage of linear stapler with 20 second compression time Receives: Procedure: compression time of the laparoscopic linear stapler |
| 60 second wait | Active comparator | Usage of linear stapler with 60 second compression time Receives: Procedure: compression time of the laparoscopic linear stapler |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of the bleeding points at the staple line
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2014 (estimated)
- Primary completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bleeding of the Staple LineStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mehmet ali yagci, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02069626
- Sponsor's protocol ID
- 2013/214
- Status last verified
- Feb 2014
- First submitted
- 18 Feb 2014
- Last updated
- 24 Feb 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Compression Time for Secure Stapling With a Linear Stapler in Laparoscopic Gastric Bypass Surgery
- ClinicalTrials.gov ID
- NCT02069626
- Acronym / sponsor ID
- 2013/214
- Conditions
- Bleeding of the Staple Line
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Primary completion
- Dec 2014 (estimated)
- First posted
- 24 Feb 2014 (estimated)
- 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.
Bleeding from the staple line is a complication of linear stapling. After clamping, a short period after firing of the laparoscopic linear stapler is recommended. That is, the clinician should continue to press the tissue between the prongs of the device to achieve adequate hemostasis at the staple line. The significance of the waiting period for hemostasis at the staple line has not been empirically clarified in humans. In this study, the investigators compared the number of bleeding points use of the laparoscopic linear stapler. Consequently, the investigators assessed the effects of time after the firing of linear stapling in patients who underwent laparoscopic gastric bypass.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| No wait | Active comparator | Procedure: compression time of the laparoscopic linear staplerUsage of linear stapler without waiting of compression time |
| 20 second wait | Active comparator | Procedure: compression time of the laparoscopic linear staplerUsage of linear stapler with 20 second compression time |
| 60 second wait | Active comparator | Procedure: compression time of the laparoscopic linear staplerUsage of linear stapler with 60 second compression time |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of morbid obesity
- Must be laparoscopic surgery
Key exclusion criteria (2 listed)
- Usage of anti-coagulant
- Presence of impaired blood clotting
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 |
|---|---|---|
| compression time of the laparoscopic linear stapler | Procedure or surgery | 20 second wait, 60 second wait, No wait |
Primary outcome
Number of the bleeding points at the staple line
Time frame: intraoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2014.
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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 compression time of the laparoscopic linear stapler in people with Bleeding of the Staple Line, run by Inonu 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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 24 Feb 2014. 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?
Results are not available in the source record.
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?
Number of the bleeding points at the staple line (time frame: intraoperative). 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 Feb 2014.