ImmunityNCT00744159
Prospective Comparison of Immunological Benefit of Laparoscopic Colectomy
An observational study of Immunity, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
This study aimed to clarify existence of immunological benefit of laparoscopic colon cancer surgery compared to open colon surgery. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Immunity
- How many people
- 84 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2006to Nov 2007
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: hospital based cohort
Who may be able to join
- Biopsy proven of colon cancer
- Preoperatively suspected as clinical stage III colon cancer
- Lesion located Descending colon, sigmoid colon and upper rectal cancer
Who cannot join
- Could not perform curative resection
- Intestinal obstruction, perforation, intra-abdominal abscess
- Severe medical illness
- Immunopathy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Comparative Study of Immunological Benefit Between Laparoscopic Colectomy and Open Colectomy
This study aimed to clarify existence of immunological benefit of laparoscopic colon cancer surgery compared to open colon surgery.
Read the detailed description
Patients with clinical stage Ⅲ left colon and upper rectal cancer were prospectively assigned to undergo LC (n=35) or OC (n=39). Factors related to cellular immunity of host (total lymphocyte count, CD4 lymphocyte, CD8 lymphocyte, CD4/CD8 ratio, HLA-DR expression on monocyte (mHLA-DR)) were examined preoperatively, on the 1st day of operation (POD1) and the 5th day of operation (POD5).
- Conditions
- Immunity
- Keywords
- colon cancer, laparoscopic colorectal surgery, cellular immunity, HLA-DR expression on monocyte
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| OC | Open colorectal resection | |
| LC | Laparoscopic colorectal resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immune factors
Measured: post OP 5th day
Secondary outcomes (1)
Post-operative complications
Measured: POD 7th days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2008 (estimated)
- Study startJan 2006
- Primary completionNov 2007
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ImmunityStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Woo Yong Lee, MD,PhD, Study chair, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00744159
- Sponsor's protocol ID
- IRB 2005-08-041
- Other IDs
- #CRS-106-14-1
- Status last verified
- Aug 2008
- First submitted
- 27 Aug 2008
- Last updated
- 29 Aug 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Comparative Study of Immunological Benefit Between Laparoscopic Colectomy and Open Colectomy
- ClinicalTrials.gov ID
- NCT00744159
- Acronym / sponsor ID
- IRB 2005-08-041
- Conditions
- Immunity
- Keywords
- colon cancer, laparoscopic colorectal surgery, cellular immunity, HLA-DR expression on monocyte
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Nov 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 29 Aug 2008 (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 aimed to clarify existence of immunological benefit of laparoscopic colon cancer surgery compared to open colon surgery.
Detailed description
Patients with clinical stage Ⅲ left colon and upper rectal cancer were prospectively assigned to undergo LC (n=35) or OC (n=39). Factors related to cellular immunity of host (total lymphocyte count, CD4 lymphocyte, CD8 lymphocyte, CD4/CD8 ratio, HLA-DR expression on monocyte (mHLA-DR)) were examined preoperatively, on the 1st day of operation (POD1) and the 5th day of operation (POD5).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OC | – | –Open colorectal resection |
| LC | – | –Laparoscopic colorectal resection |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- hospital based cohort
Key inclusion criteria (3 listed)
- Biopsy proven of colon cancer
- Preoperatively suspected as clinical stage III colon cancer
- Lesion located Descending colon, sigmoid colon and upper rectal cancer
Key exclusion criteria (4 listed)
- Could not perform curative resection
- Intestinal obstruction, perforation, intra-abdominal abscess
- Severe medical illness
- Immunopathy
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
Immune factors
Time frame: post OP 5th day
1 secondary outcome
Post-operative complications
Time frame: POD 7th days
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 29 Aug 2008.
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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.
Woo Yong Lee, MD,PhD study chair
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 Immunity, 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 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 29 Aug 2008. 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.
What does the primary outcome measure?
Immune factors (time frame: post OP 5th day). 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 29 Aug 2008.