Colon CancerPhase 1NCT01203969
Safety and Efficacy of Single Port Laparoscopic Surgery in Colon Cancer
A Phase 1 study testing Single port laparoscopic surgery and Conventional laparoscopic surgery in people with Colon Cancer, run by Kyunghee University Medical Center at 1 site in South Korea.
Trial summary
This randomized trial is designed to identify the safety and efficacy of single port laparoscopic surgery in colon cancer compared with conventional laparoscopic surgery. Read more about this study
- Who is it for?
- Ages Up to 85 years
- Conditions the study is for
- Colon Cancer
- What is being tested?
- Single port laparoscopic surgery and Conventional laparoscopic surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2010to Apr 2012
- Phase
- Phase 1
- 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 Up to 85 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- pathologic proven colon cancer
Who cannot join
- Tumor located in distal transverse colon, splenic flexure, and descending colon
- distant metastasis
- acute obstruction and/or perforation
- associated with FAP or HNPCC
- synchronous malignancy
- ASA score 3 or 4
- pregnancy
- no consent
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Kyung Hee University School of Medicine, Neo Medical Center
Seoul, 134-727
About this study
This randomized trial is designed to identify the safety and efficacy of single port laparoscopic surgery in colon cancer compared with conventional laparoscopic surgery.
- Conditions
- Colon Cancer
- Being tested
- Single port laparoscopic surgery, Conventional laparoscopic surgery
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single port laparoscopic surgeryProcedure or surgery
laparoscopic surgery in which all the instrument was entered into the abdominal cavity through the single port in the umbilicus
Conventional laparoscopic surgeryProcedure or surgery
laparoscopic surgery in which each of the instrument were entered into the abdominal cavity through the multiple port in multiple quadrants of abdomen
| Study group | Role | What they receive |
|---|---|---|
| Single port laparoscopic surgery | Experimental | Not described Receives: Procedure: Single port laparoscopic surgery |
| Conventional laparoscopic surgery | Active comparator | Not described Receives: Procedure: Conventional laparoscopic surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of intraoperative complication
Measured: 1 day
rate of 30 day morbidity and mortality
Measured: 1 month
Secondary outcomes (5)
operation time
operative time
Measured: 1 day
degree of postoperative pain
postoperative pain score using visual analog scale (VAS)
Measured: 5 days
amount of postoperative analgesics usage
Measured: 5 days
postoperative functional recovery
time to first passage of flatus time to start diet
Measured: 7 days
Duration of postoperative hospital stay
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2010 (estimated)
- Study startJun 2010
- Primary completionApr 2011
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colon 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyunghee University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Byung Mo Kang, Kyunghee University Medical Center
- Investigators
- Suk Hwan Lee, MD. PhD, Principal investigator, Kyung Hee University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01203969
- Sponsor's protocol ID
- KHNMC IRB 2010-007
- Status last verified
- Feb 2016
- First submitted
- 15 Sep 2010
- Last updated
- 3 Feb 2016
- Results posted
- No
Publications
Kang BM, Park SJ, Lee KY, Lee SH. Single-Port Laparoscopic Surgery Can Be Performed Safely and Appropriately for Colon Cancer: Short-Term Results of a Pilot Randomized Controlled Trial. J Laparoendosc Adv Surg Tech A. 2017 May;27(5):501-509. doi: 10.1089/lap.2016.0467. Epub 2017 Jan 6.
PubMed 28061037
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Single Port Laparoscopic Surgery in Colon Cancer
- ClinicalTrials.gov ID
- NCT01203969
- Acronym / sponsor ID
- KHNMC IRB 2010-007
- Conditions
- Colon Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Kyunghee University Medical CenterUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 17 Sep 2010 (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 randomized trial is designed to identify the safety and efficacy of single port laparoscopic surgery in colon cancer compared with conventional laparoscopic surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single port laparoscopic surgery | Experimental | Procedure: Single port laparoscopic surgery |
| Conventional laparoscopic surgery | Active comparator | Procedure: Conventional laparoscopic surgery |
Who may qualify
- Ages
- Up to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- pathologic proven colon cancer
Key exclusion criteria (8 listed)
- Tumor located in distal transverse colon, splenic flexure, and descending colon
- distant metastasis
- acute obstruction and/or perforation
- associated with FAP or HNPCC
- synchronous malignancy
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 |
|---|---|---|
| Single port laparoscopic surgerylaparoscopic surgery in which all the instrument was entered into the abdominal cavity through the single port in the umbilicus | Procedure or surgery | Single port laparoscopic surgery |
| Conventional laparoscopic surgerylaparoscopic surgery in which each of the instrument were entered into the abdominal cavity through the multiple port in multiple quadrants of abdomen | Procedure or surgery | Conventional laparoscopic surgery |
Primary outcome
rate of intraoperative complication
Time frame: 1 day
rate of 30 day morbidity and mortality
Time frame: 1 month
5 secondary outcomes
operation time
Time frame: 1 day
degree of postoperative pain
Time frame: 5 days
amount of postoperative analgesics usage
Time frame: 5 days
postoperative functional recovery
Time frame: 7 days
Duration of postoperative hospital stay
Time frame: 7 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 3 Feb 2016.
- Derived from this study: PubMed 28061037Kang BM, Park SJ, Lee KY, Lee SH. Single-Port Laparoscopic Surgery Can Be Performed Safely and Appropriately for Colon Cancer: Short-Term Results of a Pilot Randomized Controlled Trial. J Laparoendosc Adv Surg Tech A. 2017 May;27(5):501-509. doi: 10.1089/lap.2016.0467. Epub 2017 Jan 6.
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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.
Suk Hwan Lee, MD. PhD principal investigator
Kyung Hee University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Single port laparoscopic surgery and Conventional laparoscopic surgery in people with Colon Cancer, run by Kyunghee University 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 1 inclusion and 8 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 3 Feb 2016. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
rate of intraoperative complication (time frame: 1 day). 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?
On the ClinicalTrials.gov record for NCT01203969, which also lists 1 linked publication.
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 3 Feb 2016.