Gastric CancerNCT04901585
Enterotomy Closure and Minimally Invasive Gastrectomy
An observational study of Gastric Cancer, run by Federico II University at 1 site in Italy.
Trial summary
All consecutive patients from January 2009 to december 2019 who underwent minimally invasive partial gastrectomy for gastric cancer at thirteen high volume institutions will be retrospective analysed to assess the better way to fashion a handsewn intracorporeal enterotomy closure after a stapled anastomosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- Totally intracorporeal distal gastrectomy
- Type of treatment
- Surgery or procedure
- How many people
- 600 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2009to 1 Apr 2021
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients who underwent laparoscopic or robotic partial gastrectomy for gastric cancer with Roux en Y or Billroth II reconstruction
Who may be able to join
- Age > 18 years
- laparoscopic or robotic partial gastrectomy for gastric cancer
- Roux en Y or Billroth II reconstruction
Who cannot join
- Age < 18 years
- open gastrectomy
- total gastrectomy
- Billroth I reconstruction
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Enterotomy Closure After Minimally Invasive Distal Gastrectomy With Intracorporeal Anastomosis.
All consecutive patients from January 2009 to december 2019 who underwent minimally invasive partial gastrectomy for gastric cancer at thirteen high volume institutions will be retrospective analysed to assess the better way to fashion a handsewn intracorporeal enterotomy closure after a stapled anastomosis.
Read the detailed description
Different ways to fashion intracorporeal anstomoses will be investigated: robotic vs laparoscopic approach; laparoscopic HD vs 3D vs 4K technologies; single layer vs double layer enterotomy closure. Additionally double layer enterotomies will be analysed layer by layer, comparing running vs interrupted suture, presence vs absence of deep corner suture and type of suture thread (barbed, braided, non braided suture)
- Conditions
- Gastric Cancer
- Being tested
- Totally intracorporeal distal gastrectomy
- Keywords
- intracorporeal gastrectomy, enterotomy closure
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Totally intracorporeal distal gastrectomyProcedure or surgery
Minimally invasive distal gastrectomy with intracorporeal anastomosis and handsewn enterotomy closure
| Study group | Role | What they receive |
|---|---|---|
| Totally intracorporeal distal gastrectomy | All patients who underwent minimally invasive distal gastrectomy with intracorporeal anastomosis for gastric cancer Receives: Procedure: Totally intracorporeal distal gastrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative complications
The better way to fashion enterotomy closure
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2021
- Study start1 Jan 2009
- Primary completion31 Dec 2019
- Study completion1 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by Federico II UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marco Milone, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04901585
- Sponsor's protocol ID
- intragastrectomy
- Status last verified
- May 2021
- First submitted
- 20 May 2021
- Last updated
- 25 May 2021
- 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 25 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enterotomy Closure After Minimally Invasive Distal Gastrectomy With Intracorporeal Anastomosis.
- ClinicalTrials.gov ID
- NCT04901585
- Acronym / sponsor ID
- intragastrectomy
- Conditions
- Gastric Cancer
- Keywords
- intracorporeal gastrectomy, enterotomy closure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- 1 Jan 2009 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 1 Apr 2021 (actual)
- First posted
- 25 May 2021 (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.
All consecutive patients from January 2009 to december 2019 who underwent minimally invasive partial gastrectomy for gastric cancer at thirteen high volume institutions will be retrospective analysed to assess the better way to fashion a handsewn intracorporeal enterotomy closure after a stapled anastomosis.
Detailed description
Different ways to fashion intracorporeal anstomoses will be investigated: robotic vs laparoscopic approach; laparoscopic HD vs 3D vs 4K technologies; single layer vs double layer enterotomy closure. Additionally double layer enterotomies will be analysed layer by layer, comparing running vs interrupted suture, presence vs absence of deep corner suture and type of suture thread (barbed, braided, non braided suture)
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Totally intracorporeal distal gastrectomy | – | Procedure: Totally intracorporeal distal gastrectomyAll patients who underwent minimally invasive distal gastrectomy with intracorporeal anastomosis for gastric cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients who underwent laparoscopic or robotic partial gastrectomy for gastric cancer with Roux en Y or Billroth II reconstruction
Key inclusion criteria (3 listed)
- Age > 18 years
- laparoscopic or robotic partial gastrectomy for gastric cancer
- Roux en Y or Billroth II reconstruction
Key exclusion criteria (4 listed)
- Age < 18 years
- open gastrectomy
- total gastrectomy
- Billroth I reconstruction
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 |
|---|---|---|
| Totally intracorporeal distal gastrectomyMinimally invasive distal gastrectomy with intracorporeal anastomosis and handsewn enterotomy closure | Procedure or surgery | Totally intracorporeal distal gastrectomy |
Primary outcome
Postoperative complications
Time frame: 1 month
The better way to fashion enterotomy closure
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 25 May 2021.
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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?
An observational study of Gastric Cancer, run by Federico II University 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 3 inclusion and 4 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 25 May 2021. 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?
Postoperative complications (time frame: 1 month). 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 25 May 2021.