Obesity, MorbidNCT04488042
Stapler-less Burst Pressure in a Ex-vivo Human Gastric Tissue
A study testing Stapler-less gastrectomy and Suture in people with Obesity, Morbid and Suture, Complication, run by University of Campania Luigi Vanvitelli at 1 site in Italy.
Trial summary
Stapler-less laparoscopic sleeve gastrectomy (LSG) is emerging as a new potential affordable cost-effective alternative procedure. However, no pre-clinical data are currently available on human tissue. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Obesity, Morbid, Suture, Complication, Suture Rupture
- What is being tested?
- Stapler-less gastrectomy and Suture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2020to 30 Jun 2020
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Morbid obesity according to IFSO guidelines
Who cannot join
- Gastric specimen with injury and/or electrocoagulation signs at serosa
- Presence of comorbidities capable of affecting specimen tissue resistance (i.e. type II diabetes, gastric ulcer, connective tissue disease, systemic sclerosis, polymyositis)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Stapler-less Burst Pressure in a Ex-vivo Human Gastric Tissue: a Randomized Controlled Trial
Stapler-less laparoscopic sleeve gastrectomy (LSG) is emerging as a new potential affordable cost-effective alternative procedure. However, no pre-clinical data are currently available on human tissue. We aimed to evaluate whether traditionally suturing without the use of surgical stapling may produces a comparable bursting pressure on human gastric tissue.
Read the detailed description
Stapler-less laparoscopic sleeve gastrectomy (LSG) is emerging as a new potential affordable cost-effective alternative procedure. However, no pre-clinical data are currently available on human tissue. We aimed to evaluate whether traditionally suturing without the use of surgical stapling may produces a comparable bursting pressure on human gastric tissue.
A prospective cohort of consecutive patients underwent LSG was divided in two groups to compare a barbed extramucosal running suture (stapler-less) versus a standard stapler line. A burst pressure test was applied to the gastric specimen employing high-resolution manometric catheter. Type, location and features of the leak were described.
In human ex-vivo model, traditional surgical suture (i.e. running hand-sewn) produced an effective temporary closure, with superior resistance to increasing volume and pressure. How this may impact on clinical LSG outcomes needs further evaluations and was not the object of this study.
- Conditions
- Obesity, Morbid, Suture, Complication, Suture Rupture
- Being tested
- Stapler-less gastrectomy, Suture
- Keywords
- Sleeve gastrectomy, stapler-less, burst pressure, leaks
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stapler-less gastrectomyOther
After the LSG stapler line removal by electrothermal bipolar-activated device (LigaSure Atlas™, Valleylab, Boulder, CO, USA), a stapler-less hand-sewn reconstruction was adopted. A single extra-mucosal running barbed suture (3/0 V-Loc™ suture; Covidien, Mansfield, MA, USA), incorporating sero- and submucosal gastric layers, closed the gastric tube.
SutureOther
No reinforcement was performed, the stomach was re-sleeved along a 40F bougie with Echelon Flex Endopath 60-mm linear stapler (Ethicon Endo-Surgery, Cincinnati, OH, USA) to reproduce standard volume of remnant LSG stomach and/or eliminating zig-zag shape of suture-line.
| Study group | Role | What they receive |
|---|---|---|
| Stapler-less | Experimental | after the LSG stapler line removal by electrothermal bipolar-activated device (LigaSure Atlas™, Valleylab, Boulder, CO, USA), a stapler-less hand-sewn reconstruction was adopted. A single extra-mucosal running barbed suture (3/0 V-Loc™ suture; Covidien, Mansfield, MA, USA), incorporating sero- and submucosal gastric layers, closed the gastric tube. Receives: Other: Stapler-less gastrectomy |
| Conventional Stapler | Active comparator | no reinforcement was performed, the stomach was re-sleeved along a 40F bougie with Echelon Flex Endopath 60-mm linear stapler (Ethicon Endo-Surgery, Cincinnati, OH, USA) to reproduce standard volume of remnant LSG stomach and/or eliminating zig-zag shape of suture-line. Receives: Other: Suture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastric specimen tissue resistance
Evaluate the manometric burst pressure in the ex-vivo gastric specimen after hand-sewn running suture (group 1), and stapler suturing (group 2)
Measured: During procedure
Gastric specimen volume resistance
the saline volume needed to determine a gastric leak in the ex-vivo gastric specimen after hand-sewn running suture (group 1), and stapler suturing (group 2)
Measured: During procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2020
- Study start1 Jan 2020
- Primary completion30 Jun 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, MorbidStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- the gastric specimen were immediately randomly allocated to the two groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Campania Luigi Vanvitelli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claudio Gambardella, University of Campania Luigi Vanvitelli
- Investigators
- Gianmattia del Genio, Prof, Principal investigator, University of Campania Luigi Vanvitelli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04488042
- Sponsor's protocol ID
- Stapler-less sleeve
- Status last verified
- Jul 2020
- First submitted
- 22 Jul 2020
- Last updated
- 27 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stapler-less Burst Pressure in a Ex-vivo Human Gastric Tissue: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04488042
- Acronym / sponsor ID
- Stapler-less sleeve
- Conditions
- Obesity, Morbid, Suture, Complication, Suture Rupture
- Keywords
- Sleeve gastrectomy, stapler-less, burst pressure, leaks
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Campania Luigi VanvitelliUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 27 Jul 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.
Stapler-less laparoscopic sleeve gastrectomy (LSG) is emerging as a new potential affordable cost-effective alternative procedure. However, no pre-clinical data are currently available on human tissue. We aimed to evaluate whether traditionally suturing without the use of surgical stapling may produces a comparable bursting pressure on human gastric tissue.
Detailed description
Stapler-less laparoscopic sleeve gastrectomy (LSG) is emerging as a new potential affordable cost-effective alternative procedure. However, no pre-clinical data are currently available on human tissue. We aimed to evaluate whether traditionally suturing without the use of surgical stapling may produces a comparable bursting pressure on human gastric tissue.
A prospective cohort of consecutive patients underwent LSG was divided in two groups to compare a barbed extramucosal running suture (stapler-less) versus a standard stapler line. A burst pressure test was applied to the gastric specimen employing high-resolution manometric catheter. Type, location and features of the leak were described.
In human ex-vivo model, traditional surgical suture (i.e. running hand-sewn) produced an effective temporary closure, with superior resistance to increasing volume and pressure. How this may impact on clinical LSG outcomes needs further evaluations and was not the object of this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- the gastric specimen were immediately randomly allocated to the two groups
| Arm | Type | Receives |
|---|---|---|
| Stapler-less | Experimental | Other: Stapler-less gastrectomyafter the LSG stapler line removal by electrothermal bipolar-activated device (LigaSure Atlas™, Valleylab, Boulder, CO, USA), a stapler-less hand-sewn reconstruction was adopted. A single extra-mucosal running barbed suture (3/0 V-Loc™ suture; Covidien, Mansfield, MA, USA), incorporating sero- and submucosal gastric layers, closed the gastric tube. |
| Conventional Stapler | Active comparator | Other: Sutureno reinforcement was performed, the stomach was re-sleeved along a 40F bougie with Echelon Flex Endopath 60-mm linear stapler (Ethicon Endo-Surgery, Cincinnati, OH, USA) to reproduce standard volume of remnant LSG stomach and/or eliminating zig-zag shape of suture-line. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Morbid obesity according to IFSO guidelines
Key exclusion criteria (2 listed)
- Gastric specimen with injury and/or electrocoagulation signs at serosa
- Presence of comorbidities capable of affecting specimen tissue resistance (i.e. type II diabetes, gastric ulcer, connective tissue disease, systemic sclerosis, polymyositis)
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 |
|---|---|---|
| Stapler-less gastrectomyAfter the LSG stapler line removal by electrothermal bipolar-activated device (LigaSure Atlas™, Valleylab, Boulder, CO, USA), a stapler-less hand-sewn reconstruction was adopted. A single extra-mucosal running barbed suture (3/0 V-Loc™ suture; Covidien, Mansfield, MA, USA), incorporating sero- and submucosal gastric layers, closed the gastric tube. | Other | Stapler-less |
| SutureNo reinforcement was performed, the stomach was re-sleeved along a 40F bougie with Echelon Flex Endopath 60-mm linear stapler (Ethicon Endo-Surgery, Cincinnati, OH, USA) to reproduce standard volume of remnant LSG stomach and/or eliminating zig-zag shape of suture-line. | Other | Conventional Stapler |
Primary outcome
Gastric specimen tissue resistance
Time frame: During procedure
Evaluate the manometric burst pressure in the ex-vivo gastric specimen after hand-sewn running suture (group 1), and stapler suturing (group 2)
Gastric specimen volume resistance
Time frame: During procedure
the saline volume needed to determine a gastric leak in the ex-vivo gastric specimen after hand-sewn running suture (group 1), and stapler suturing (group 2)
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 27 Jul 2020.
- Individual participant dataSharing planned: No
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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.
Gianmattia del Genio, Prof principal investigator
University of Campania Luigi Vanvitelli
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stapler-less gastrectomy and Suture in people with Obesity, Morbid and Suture, Complication, run by University of Campania Luigi Vanvitelli at 1 site in Italy.
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 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: finished, as of the sponsor's last update on 27 Jul 2020. 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 Italy. 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?
Gastric specimen tissue resistance (time frame: During procedure). The study lists 2 primary outcomes in all. 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 27 Jul 2020.