ObesityNCT02272907
Leak Pressure After Reinforcement in Gastric Specimens
A study testing Injection of saline solution into specimen to test bursting pressure. in people with Obesity, run by Santa Barbara Cottage Hospital.
Trial summary
The investigators hypothesize that staple line reinforcement will result in a higher leak pressure than a non-reinforced staple line closure in the resected gastric specimens from laparoscopic sleeve gastrectomy. The primary endpoint of the study is leak pressure after various staple line treatments. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity
- What is being tested?
- Injection of saline solution into specimen to test bursting pressure.
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- May 2014to Mar 2017
- 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
- Undergoing laparoscopic sleeve gastrectomy
Who cannot join
- Undergoing a revisional procedure
- Subject whose specimens need clinical attention by pathology following resection (e.g. cancer biopsy)
- Steroid use
About this study
Official title: Comparison of Leak Pressure in the Resected Gastric Specimen From Sleeve Gastrectomy With Different Reinforcement Techniques
The investigators hypothesize that staple line reinforcement will result in a higher leak pressure than a non-reinforced staple line closure in the resected gastric specimens from laparoscopic sleeve gastrectomy. The primary endpoint of the study is leak pressure after various staple line treatments. The investigators will also analyze the most common site of specimen leak, association of stomach thickness to leak, association of stomach thickness to performance of the staple line techniques, and a cost analysis.
Read the detailed description
The purpose of this study is to evaluate the mechanical strength of various staple line reinforcement techniques using the resected portion of stomach in patients undergoing laparoscopic sleeve gastrectomy. The specimen will be collected at the time of surgery, the previous staple line will be excised, and a new staple line with one of the investigatory reinforcement procedures will be applied. The staple line techniques to be used in this study include non-buttressed and non-imbricated oversewing, non-buttressed and imbricated suture line, buttressed stapling, and no reinforcement (see protocol for description of each). The specimen will then be taken to the morgue where the experimental procedure will be performed within 6 hours of specimen procurement. The specimen will be attached to a catheter with a pressure monitor and blue dye will be instilled into the specimen until leakage is seen. The presence of leakage indicates failure of the staple line. Detailed measurements of all specimens will be performed as will leak pressure and location in the specimen where leak occurred. The specimen will then be turned over to pathology to undergo routine pathologic examination.
This experimental procedure has been used previously in published literature with animal samples, but never with human tissue. A possible reason for the lack of testing in the stomach staple line in patients after sleeve gastrectomy is that the technical aspects of bariatric surgery were developed using gastric bypass; a procedure where the stomach is divided but not excised.
The investigators hypothesize that the specimens treated with staple line buttressing material will fail at a higher pressure than those without reinforcement. The investigators will also explore the location of the failure to determine if there is a consistent site of weakness. Should this study yield consistent results, it would help determine a standard approach for staple line reinforcement after laparoscopic sleeve gastrectomy. Additionally, should the location of the leak be consistent, this information may help drive technical changes that could decrease leak rate, an infrequent but potentially devastating risk of this and other weight loss surgeries.
- Conditions
- Obesity
- Being tested
- Injection of saline solution into specimen to test bursting pressure.
- Keywords
- Bariatric Surgery, Laparoscopy, Weight Loss Surgery, Staple Line Reinforcement
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Injection of saline solution into specimen to test bursting pressure.Other
A 1 cm gastrotomy will be made with a purse-string suture placed around the defect. A fluid-instillation catheter will be inserted into the specimen via the gastrotomy. The purse-string suture will then be secured around the catheter. The catheter will be fenestrated with a flange to prevent leakage from the gastrotomy site. The catheter will be attached to a Biopac pressure-monitoring device to monitor pressure within the lumen of the specimen. The specimen will then be suspended in a water bath and methylene blue saline solution will be injected into the specimen to a pressure reading of 0. This will be time zero for our experiment. Methylene blue saline solution will then be injected steadily in incremental levels. During this process, the study team will observe for any obvious blue dye leaks at the staple line or drop in pressure on the monitor.
| Study group | Role | What they receive |
|---|---|---|
| Non-buttressed, non-imbricated oversewing | Experimental | Along the staple line, the surgical attending will oversew the length of the staple line using a 2-0 Vicryl suture in a continuous fashion. Receives: Other: Injection of saline solution into specimen to test bursting pressure. |
| Non-buttressed, imbricated suture line | Experimental | Along the staple line, the surgical attending will oversew the staple line using a 2-0 Vicryl suture in a continuous, imbricating fashion. Receives: Other: Injection of saline solution into specimen to test bursting pressure. |
| Buttressed stapling | Experimental | The specimen will be stapled utilizing the same stapling device, with Seamguard applied as a buttress. We will use the standard methodology to apply Seamguard as illustrated in the company's "Instructions for Use." Receives: Other: Injection of saline solution into specimen to test bursting pressure. |
| No reinforcement | Active comparator | Data will be collected on staple lines without any reinforcement as a baseline for leak pressure. Receives: Other: Injection of saline solution into specimen to test bursting pressure. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bursting pressure
The primary outcome will be assessed by inflating the resected stomach specimen (after staple line reinforcement and placement of pressure monitor within specimen) with a methylene blue saline solution until a leak is observed or drop in pressure on the monitor.
Measured: This will be measured within 6 hours of the specimen being resected from the patient.
Secondary outcomes (1)
Most common leak site
The site of leak will be documented. This outcome will be observed by the individual testing the leak pressure of the specimen.
Measured: This will be measured within 6 hours of the specimen being resected from the patient.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2014 (estimated)
- Study startMay 2014
- Primary completionMar 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Santa Barbara Cottage Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02272907
- Sponsor's protocol ID
- 14-27r
- Status last verified
- Jun 2018
- First submitted
- 15 Oct 2014
- Last updated
- 12 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Leak Pressure in the Resected Gastric Specimen From Sleeve Gastrectomy With Different Reinforcement Techniques
- ClinicalTrials.gov ID
- NCT02272907
- Acronym / sponsor ID
- 14-27r
- Conditions
- Obesity
- Keywords
- Bariatric Surgery, Laparoscopy, Weight Loss Surgery, Staple Line Reinforcement
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Santa Barbara Cottage HospitalUniversity, hospital or other
- Study start
- May 2014 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 23 Oct 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.
The investigators hypothesize that staple line reinforcement will result in a higher leak pressure than a non-reinforced staple line closure in the resected gastric specimens from laparoscopic sleeve gastrectomy. The primary endpoint of the study is leak pressure after various staple line treatments. The investigators will also analyze the most common site of specimen leak, association of stomach thickness to leak, association of stomach thickness to performance of the staple line techniques, and a cost analysis.
Detailed description
The purpose of this study is to evaluate the mechanical strength of various staple line reinforcement techniques using the resected portion of stomach in patients undergoing laparoscopic sleeve gastrectomy. The specimen will be collected at the time of surgery, the previous staple line will be excised, and a new staple line with one of the investigatory reinforcement procedures will be applied. The staple line techniques to be used in this study include non-buttressed and non-imbricated oversewing, non-buttressed and imbricated suture line, buttressed stapling, and no reinforcement (see protocol for description of each). The specimen will then be taken to the morgue where the experimental procedure will be performed within 6 hours of specimen procurement. The specimen will be attached to a catheter with a pressure monitor and blue dye will be instilled into the specimen until leakage is seen. The presence of leakage indicates failure of the staple line. Detailed measurements of all specimens will be performed as will leak pressure and location in the specimen where leak occurred. The specimen will then be turned over to pathology to undergo routine pathologic examination.
This experimental procedure has been used previously in published literature with animal samples, but never with human tissue. A possible reason for the lack of testing in the stomach staple line in patients after sleeve gastrectomy is that the technical aspects of bariatric surgery were developed using gastric bypass; a procedure where the stomach is divided but not excised.
The investigators hypothesize that the specimens treated with staple line buttressing material will fail at a higher pressure than those without reinforcement. The investigators will also explore the location of the failure to determine if there is a consistent site of weakness. Should this study yield consistent results, it would help determine a standard approach for staple line reinforcement after laparoscopic sleeve gastrectomy. Additionally, should the location of the leak be consistent, this information may help drive technical changes that could decrease leak rate, an infrequent but potentially devastating risk of this and other weight loss surgeries.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Non-buttressed, non-imbricated oversewing | Experimental | Other: Injection of saline solution into specimen to test bursting pressure.Along the staple line, the surgical attending will oversew the length of the staple line using a 2-0 Vicryl suture in a continuous fashion. |
| Non-buttressed, imbricated suture line | Experimental | Other: Injection of saline solution into specimen to test bursting pressure.Along the staple line, the surgical attending will oversew the staple line using a 2-0 Vicryl suture in a continuous, imbricating fashion. |
| Buttressed stapling | Experimental | Other: Injection of saline solution into specimen to test bursting pressure.The specimen will be stapled utilizing the same stapling device, with Seamguard applied as a buttress. We will use the standard methodology to apply Seamguard as illustrated in the company's "Instructions for Use." |
| No reinforcement | Active comparator | Other: Injection of saline solution into specimen to test bursting pressure.Data will be collected on staple lines without any reinforcement as a baseline for leak pressure. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Undergoing laparoscopic sleeve gastrectomy
Key exclusion criteria (3 listed)
- Undergoing a revisional procedure
- Subject whose specimens need clinical attention by pathology following resection (e.g. cancer biopsy)
- Steroid use
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 |
|---|---|---|
| Injection of saline solution into specimen to test bursting pressure.A 1 cm gastrotomy will be made with a purse-string suture placed around the defect. A fluid-instillation catheter will be inserted into the specimen via the gastrotomy. The purse-string suture will then be secured around the catheter. The catheter will be fenestrated with a flange to prevent leakage from the gastrotomy site. The catheter will be attached to a Biopac pressure-monitoring device to monitor pressure within the lumen of the specimen. The specimen will then be suspended in a water bath and methylene blue saline solution will be injected into the specimen to a pressure reading of 0. This will be time zero for our experiment. Methylene blue saline solution will then be injected steadily in incremental levels. During this process, the study team will observe for any obvious blue dye leaks at the staple line or drop in pressure on the monitor. | Other | Buttressed stapling, No reinforcement, Non-buttressed, imbricated suture line, Non-buttressed, non-imbricated oversewing |
Primary outcome
Bursting pressure
Time frame: This will be measured within 6 hours of the specimen being resected from the patient.
The primary outcome will be assessed by inflating the resected stomach specimen (after staple line reinforcement and placement of pressure monitor within specimen) with a methylene blue saline solution until a leak is observed or drop in pressure on the monitor.
1 secondary outcome
Most common leak site
Time frame: This will be measured within 6 hours of the specimen being resected from the patient.
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 12 Jun 2018.
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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 Injection of saline solution into specimen to test bursting pressure. in people with Obesity, run by Santa Barbara Cottage Hospital.
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 3 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 12 Jun 2018. 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?
Bursting pressure (time frame: This will be measured within 6 hours of the specimen being resected from the patient.). 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 12 Jun 2018.