Rectal CancerNCT05498506
Multiple Firings in Double-stapled Colorectal Anastomosis
An observational study of Rectal Cancer, run by Shanghai Minimally Invasive Surgery Center at 1 site in China.
Trial summary
Multiple linear stapler firings during double stapling technique (DST) is associated with anastomotic leakage (AL) after laparoscopic low anterior resection (LAR). We aim to investigate the risk factors and then to develop a deep learning model to predict the usage of ≥3 linear stapler cartridges during DST… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Rectal Cancer
- How many people
- 350 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2022to 31 Jan 2023
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients who underwent Laparoscopic anterior resection for mid-low rectal cancer at Ruijin Hospital, Shanghai, People's Republic of China, between 2016 and 2021.
Who may be able to join
- 1) carcinoma of rectum confirmed by histopathological evaluation;
- 2) tumor located in the mid-low rectum (less than 10cm from the anal verge);
- 3) performance of DST anastomosis;
- 4) pelvic MRI obtained within 14 days before surgery.
Who cannot join
- 1) other anastomotic techniques (e.g., trans-anal rectal excision);
- 2) Hartmann's operation or other procedures without anastomosis;
- 3) the number of linear stapler cartridges was not traceable in the operative report.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Risk Factors for the Usage of ≥3 Linear Stapler Cartridges During Double Stapling Anastomosis in Laparoscopic Low Anterior Resection of Rectal Cancer
Multiple linear stapler firings during double stapling technique (DST) is associated with anastomotic leakage (AL) after laparoscopic low anterior resection (LAR). We aim to investigate the risk factors and then to develop a deep learning model to predict the usage of ≥3 linear stapler cartridges during DST anastomosis.
- Conditions
- Rectal Cancer
- Medical subject headings
- Rectal Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
the number of linear stapler cartridges
the number of linear stapler cartridges used during DST anastomosis
Measured: during surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2022
- Study start1 Dec 2022
- Primary completion31 Dec 2022
- Study completion31 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Minimally Invasive Surgery Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cai Zhenghao, Shanghai Minimally Invasive Surgery Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05498506
- Sponsor's protocol ID
- MISC-DST
- Status last verified
- Feb 2024
- First submitted
- 10 Aug 2022
- Last updated
- 26 Feb 2024
- 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 26 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors for the Usage of ≥3 Linear Stapler Cartridges During Double Stapling Anastomosis in Laparoscopic Low Anterior Resection of Rectal Cancer
- ClinicalTrials.gov ID
- NCT05498506
- Acronym / sponsor ID
- MISC-DST
- Conditions
- Rectal Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- Shanghai Minimally Invasive Surgery CenterUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Jan 2023 (actual)
- First posted
- 12 Aug 2022 (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.
Multiple linear stapler firings during double stapling technique (DST) is associated with anastomotic leakage (AL) after laparoscopic low anterior resection (LAR). We aim to investigate the risk factors and then to develop a deep learning model to predict the usage of ≥3 linear stapler cartridges during DST anastomosis.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients who underwent Laparoscopic anterior resection for mid-low rectal cancer at Ruijin Hospital, Shanghai, People's Republic of China, between 2016 and 2021.
Key inclusion criteria (4 listed)
- 1) carcinoma of rectum confirmed by histopathological evaluation;
- 2) tumor located in the mid-low rectum (less than 10cm from the anal verge);
- 3) performance of DST anastomosis;
- 4) pelvic MRI obtained within 14 days before surgery.
Key exclusion criteria (3 listed)
- 1) other anastomotic techniques (e.g., trans-anal rectal excision);
- 2) Hartmann's operation or other procedures without anastomosis;
- 3) the number of linear stapler cartridges was not traceable in the operative report.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
the number of linear stapler cartridges
Time frame: during surgery
the number of linear stapler cartridges used during DST anastomosis
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 26 Feb 2024.
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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 Rectal Cancer, run by Shanghai Minimally Invasive Surgery Center at 1 site in China.
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 4 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: finished, as of the sponsor's last update on 26 Feb 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 China. 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?
the number of linear stapler cartridges (time frame: during surgery). 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 26 Feb 2024.