Rectal NeoplasmNCT00549276
Randomized Comparison of Curved Cutter Stapler and Linear Stapler
An observational study of Rectal Neoplasm and Surgical Stapler, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
This study aims to compare the safty and technical accessibility of linear stapler and curved cutter stapler during mid to low rectal cancer surgery. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Rectal Neoplasm, Surgical Stapler
- How many people
- Not given
- Where
- 1 siteSouth Korea
- Study dates
- May 2006to Nov 2006
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 60 patients were randomly assigned to either linear staplers or the CCS during low anterior resection for mid to low rectal cancers
Who may be able to join
- Biopsy proven adenocarcinoma of rectum.
- Preoperative stage I-III
- Patient who is expected to undergo low anterior resection at Samsung Medical Center.
- Age > 19 years old
Who cannot join
- Patient with complicated rectal cancers(obstruction, perforation, abscess)
- Patient who needs to undergo emergency operation.
- Patient who can not undergo general anesthesia.
- Patient who does not agree with the informed consent or does not have the ability to understand content of the trial .
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Samsung Medical Center Sungkyunkwan University School of Medicine,
Seoul, 135-710
About this study
This study aims to compare the safty and technical accessibility of linear stapler and curved cutter stapler during mid to low rectal cancer surgery.
- Conditions
- Rectal Neoplasm, Surgical Stapler
- Medical subject headings
- Rectal Neoplasms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2007 (estimated)
- Study startMay 2006
- Study completionNov 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal NeoplasmStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe 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
- Prospective
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Won-Suk Lee, M.D., Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00549276
- Sponsor's protocol ID
- Samsung Medical Center
- Status last verified
- May 2006
- First submitted
- 23 Oct 2007
- Last updated
- 25 Oct 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Comparison of Curved Cutter Stapler and Linear Stapler
- ClinicalTrials.gov ID
- NCT00549276
- Acronym / sponsor ID
- Samsung Medical Center
- Conditions
- Rectal Neoplasm, Surgical Stapler
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- May 2006
- Study completion
- Nov 2006 (actual)
- First posted
- 25 Oct 2007 (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.
This study aims to compare the safty and technical accessibility of linear stapler and curved cutter stapler during mid to low rectal cancer surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 60 patients were randomly assigned to either linear staplers or the CCS during low anterior resection for mid to low rectal cancers
Key inclusion criteria (4 listed)
- Biopsy proven adenocarcinoma of rectum.
- Preoperative stage I-III
- Patient who is expected to undergo low anterior resection at Samsung Medical Center.
- Age > 19 years old
Key exclusion criteria (4 listed)
- Patient with complicated rectal cancers(obstruction, perforation, abscess)
- Patient who needs to undergo emergency operation.
- Patient who can not undergo general anesthesia.
- Patient who does not agree with the informed consent or does not have the ability to understand content of the trial .
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
Not reported in the source record.
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 Oct 2007.
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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.
Won-Suk Lee, M.D. principal investigator
Samsung Medical Center
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 Neoplasm and Surgical Stapler, run by Samsung Medical Center at 1 site in South Korea.
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 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 Oct 2007. 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 South Korea. 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.
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 Oct 2007.