Staple MisfireNCT05703035
Waiting for Stapler Firing in Laparoscopic Sleeve Gastrectomy
A study testing standby while firing staple in people with Staple Misfire, run by Medeni Şermet at 1 site in Turkey (Türkiye).
Trial summary
Complications will be evaluated by waiting 30 seconds after firing 30 seconds during stapler compression while performing sleeve gastrectomy. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Staple Misfire
- What is being tested?
- standby while firing staple
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2022to 20 Apr 2023
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Among the patients between the ages of 18-65 who will undergo morbid obesity operation;
- Body mass index (BMI): 35.0-39.9 and those with at least one obesity-related comorbidity
- Patients with BMI: 40.0-49.9
Who cannot join
- a-Applicants for revision surgery, b- Patients with a history of thromboembolism, c- Patients with known coagulation disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Waiting 1 Minute During Stapling During Laparoscopic Sleeve Gastrectomy on
Complications will be evaluated by waiting 30 seconds after firing 30 seconds during stapler compression while performing sleeve gastrectomy.
Read the detailed description
Those with a BMI between 35.0 and 39.90 and those with an obesity-related comorbidity, and all morbid obesity patients with a BMI of 40.0 and above, were previously adequate for at least 6 (six) months with non-surgical (diet, medication, exercise, etc.) methods. Patients with morbid obesity who could not lose weight and who were unsuccessful will be included in the study by signing an informed consent form for the operation and study, after being evaluated by the "obesity council" consisting of endocrinology, psychiatry, anesthesiology, dietitian and general surgery, and approved for bariatric surgery. Waiting will be made for patients whose patient file number has an odd number in the last digit, and no waiting will be made for patients whose last digit is an even number. At the time of the operation, the patients will be put on thromboembolic stockings and the reverse trendelenburg position will be given and the operation will be started with the laparoscopic method. After the stomach is mobilized from the adjacent organs and structures, the 38F gastric tube will be advanced to the stomach, the tissue will be closed with a 60 mm laparoscopic stapler, waited for 30 seconds, and then ignition will be performed. After the stapler is fired, a waiting period of 30 seconds will be waited and it will be removed from the tissue. In this first case, whether there is bleeding or not, at how many points, whether additional intervention is required or not will be recorded. At the end of the operation, the gastric tube will be withdrawn, and the stomach will be filled with 120 cc saline colored with methylene blue to check if there is any leakage. If there is no leakage, a gastric drainage drain will be placed and the operation will be completed. Postoperative 24 - 48 . After discharge, the patient will be called for routine control on the 1st week, 15th day and 30th day after discharge.
- Conditions
- Staple Misfire
- Being tested
- standby while firing staple
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standby while firing stapleProcedure or surgery
VOLUNTEER PATIENTS WHO ACCEPT THE SURGERY WILL HAVE TISSUE CLOSURE AND CUTTING WITH STAPLER IN AVERAGE 30 MINUTES DURING THE SURGERY AND THE PATIENT WILL BE FOLLOWED FOR 30 DAYS.
| Study group | Role | What they receive |
|---|---|---|
| waiting group during staple firing | Active comparator | In this group, the amount of bleeding, bleeding points, postoperative drain amount and laboratory values will be monitored during the operation. Receives: Procedure: standby while firing staple |
| staple firing group without waiting for a certain time | Active comparator | In this group, no further intervention will be made, and the same treatment will be given as the 1st group and comparison will be made. Receives: Procedure: standby while firing staple |
What is being measured
The primary outcome is the main question the study is designed to answer.
to measure that waiting a certain time before and after firing the stapler can reduce complications.
There will be a waiting period of 30 seconds during stapler compression and 30 seconds after ignition. Thus, complications such as postoperative bleeding and leakage can be reduced.
Measured: the period from the 1st day to the 1st month postoperatively will be taken as a basis.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2023
- Study start1 Jan 2022
- Primary completion1 Feb 2023
- Study completion20 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Staple MisfireStudies 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
- Model description
- Two equal groups with equal comorbid conditions will be compared
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medeni Şermet
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Medeni Şermet, Goztepe Prof Dr Suleyman Yalcın City Hospital
- Investigators
- medeni sermet, 1, Study director, goztepe prof. dr. suleyman yacin city hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05703035
- Sponsor's protocol ID
- 2021/0530
- Status last verified
- Apr 2024
- First submitted
- 9 Jan 2023
- Last updated
- 16 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sermet M. Compression pre-stapler firing and post-ignition wait during sleeve gastrectomy: a prospective randomized trial. Sao Paulo Med J. 2023 Dec 15;142(3):e2023163. doi: 10.1590/1516-3180.2023.0163.140823. eCollection 2023.
PubMed 38126605
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Waiting 1 Minute During Stapling During Laparoscopic Sleeve Gastrectomy on
- ClinicalTrials.gov ID
- NCT05703035
- Acronym / sponsor ID
- 2021/0530
- Conditions
- Staple Misfire
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Medeni ŞermetUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 20 Apr 2023 (actual)
- First posted
- 27 Jan 2023 (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.
Complications will be evaluated by waiting 30 seconds after firing 30 seconds during stapler compression while performing sleeve gastrectomy.
Detailed description
Those with a BMI between 35.0 and 39.90 and those with an obesity-related comorbidity, and all morbid obesity patients with a BMI of 40.0 and above, were previously adequate for at least 6 (six) months with non-surgical (diet, medication, exercise, etc.) methods. Patients with morbid obesity who could not lose weight and who were unsuccessful will be included in the study by signing an informed consent form for the operation and study, after being evaluated by the "obesity council" consisting of endocrinology, psychiatry, anesthesiology, dietitian and general surgery, and approved for bariatric surgery. Waiting will be made for patients whose patient file number has an odd number in the last digit, and no waiting will be made for patients whose last digit is an even number. At the time of the operation, the patients will be put on thromboembolic stockings and the reverse trendelenburg position will be given and the operation will be started with the laparoscopic method. After the stomach is mobilized from the adjacent organs and structures, the 38F gastric tube will be advanced to the stomach, the tissue will be closed with a 60 mm laparoscopic stapler, waited for 30 seconds, and then ignition will be performed. After the stapler is fired, a waiting period of 30 seconds will be waited and it will be removed from the tissue. In this first case, whether there is bleeding or not, at how many points, whether additional intervention is required or not will be recorded. At the end of the operation, the gastric tube will be withdrawn, and the stomach will be filled with 120 cc saline colored with methylene blue to check if there is any leakage. If there is no leakage, a gastric drainage drain will be placed and the operation will be completed. Postoperative 24 - 48 . After discharge, the patient will be called for routine control on the 1st week, 15th day and 30th day after discharge.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Two equal groups with equal comorbid conditions will be compared
| Arm | Type | Receives |
|---|---|---|
| waiting group during staple firing | Active comparator | Procedure: standby while firing stapleIn this group, the amount of bleeding, bleeding points, postoperative drain amount and laboratory values will be monitored during the operation. |
| staple firing group without waiting for a certain time | Active comparator | Procedure: standby while firing stapleIn this group, no further intervention will be made, and the same treatment will be given as the 1st group and comparison will be made. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Among the patients between the ages of 18-65 who will undergo morbid obesity operation;
Key exclusion criteria (1 listed)
- a-Applicants for revision surgery, b- Patients with a history of thromboembolism, c- Patients with known coagulation disorders
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 |
|---|---|---|
| standby while firing stapleVOLUNTEER PATIENTS WHO ACCEPT THE SURGERY WILL HAVE TISSUE CLOSURE AND CUTTING WITH STAPLER IN AVERAGE 30 MINUTES DURING THE SURGERY AND THE PATIENT WILL BE FOLLOWED FOR 30 DAYS. | Procedure or surgery | staple firing group without waiting for a certain time, waiting group during staple firing |
Primary outcome
to measure that waiting a certain time before and after firing the stapler can reduce complications.
Time frame: the period from the 1st day to the 1st month postoperatively will be taken as a basis.
There will be a waiting period of 30 seconds during stapler compression and 30 seconds after ignition. Thus, complications such as postoperative bleeding and leakage can be reduced.
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 16 Apr 2024.
- Derived from this study: PubMed 38126605Sermet M. Compression pre-stapler firing and post-ignition wait during sleeve gastrectomy: a prospective randomized trial. Sao Paulo Med J. 2023 Dec 15;142(3):e2023163. doi: 10.1590/1516-3180.2023.0163.140823. eCollection 2023.
- Individual participant dataSharing planned: No
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.
medeni sermet, 1 study director
goztepe prof. dr. suleyman yacin city hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing standby while firing staple in people with Staple Misfire, run by Medeni Şermet 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 3 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 16 Apr 2024. 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?
to measure that waiting a certain time before and after firing the stapler can reduce complications. (time frame: the period from the 1st day to the 1st month postoperatively will be taken as a basis.). 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 NCT05703035, which also lists 1 linked publication.
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 16 Apr 2024.