Colorectal CancerPhase 2NCT01269060
Efficacy of Single Incision (Embryonic NOTES) Laparoscopic Colorectal Surgery
A Phase 2 study testing Single Incision Laparoscopic Surgery in people with Colorectal Cancer, run by National Cancer Center, Korea at 1 site in South Korea.
Trial summary
Laparoscopic colon surgery has been performed widely. As a minimal invasive approach, single incision (Embryonic NOTES) colon surgery has been attempted. However, there are not sufficient evidences for single incision colon surgery in colon cancer. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Single Incision Laparoscopic Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2011to Aug 2011
- Phase
- Phase 2
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients should sign a written informed consent
- Age between 18-80
- Patients have sigmoid colon cancer that was proved by pathology
- Adequate bone marrow function Hb ≥ 10g/dl (after treatment for simple iron deficiency anemia) WBC ≥ 3,000/mm3 PLT ≥ 100,000/mm3
- Adequate kidney function Creatinine ≤ 1.5 mg/dl
- No remarkable evidence of heart dysfunction and lung dysfunction
Who cannot join
- Distant metastasis
- Tumor diameter > 5 cm
- Other organ invasion
- Intestinal obstruction and stent insertion status
- Patient was used steroid
- Patients undergo emergency surgery with multiple symptoms
Show all 13Show fewer
- Other organ cancer history (except who had radical excision for skin cancer)
- Presence of other serious disease
- Mentally ill patients
- Legally unable to participate in clinical trial
- Lactating or pregnant women
- Patients who will obviously fail to regular follow-up visit or will be off study voluntarily
- Not eligible to participate for other reasons by doctor's decision
Trial locations and contacts
1 site in 1 country.
South Korea1 site
National Cancer Center Hospital
Goyang-si, Gyeonggi-do, 410-769
About this study
Official title: Phase 2 Study of Efficacy of Single Incision (Embryonic NOTES) Laparoscopic Colorectal Surgery
Laparoscopic colon surgery has been performed widely. As a minimal invasive approach, single incision (Embryonic NOTES) colon surgery has been attempted.
However, there are not sufficient evidences for single incision colon surgery in colon cancer.
The investigators are researching the efficacy and safety of single incision laparoscopic sigmoidectomy in sigmoid colon cancer.
Read the detailed description
After several randomized clinical trials, laparoscopic colon surgery has been performed widely. As a minimal invasive approach, single Incision (Embryonic NOTES) colon surgery has been attempted. Several studies reported the feasibility of single incision colon surgery.However, there are not sufficient evidences for single incision colon surgery, especially in colon cancer.
The investigators are researching the efficacy and safety of single incision laparoscopic sigmoidectomy in sigmoid colon cancer. Harvested numbers of lymph node will be assessed for the efficacy and postoperative morbidity and mortality will be assess for the safety.
- Conditions
- Colorectal Cancer
- Being tested
- Single Incision Laparoscopic Surgery
- Keywords
- Colorectal Cancer, laparoscopic surgery
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single Incision Laparoscopic SurgeryProcedure or surgery
Also called Embryonic NOTES Sigmoidectomy
Single Incision Laparoscopic Sigmoidectomy
| Study group | Role | What they receive |
|---|---|---|
| Single incision sigmoidectomy | Experimental | Single incision laparoscopic sigmoidectomy for sigmoid colon cancer Receives: Procedure: Single Incision Laparoscopic Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Harvested numbers of lymph node
Measured: Within the first 7 days (plus or minus 3 days) after surgery
Secondary outcomes (1)
Postoperative mortality, morbidity
Measured: Within 30 days after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Center, Korea
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ji Won Park, National Cancer Center, Korea
- Investigators
- Jae Hwan Oh, Dr. PhD., Study chair, Center for Colorectal Cancer, National Cancer Center Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01269060
- Sponsor's protocol ID
- NCCCTS-484
- Status last verified
- Aug 2012
- First submitted
- 3 Jan 2011
- Last updated
- 6 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study of Efficacy of Single Incision (Embryonic NOTES) Laparoscopic Colorectal Surgery
- ClinicalTrials.gov ID
- NCT01269060
- Acronym / sponsor ID
- NCCCTS-484
- Conditions
- Colorectal Cancer
- Keywords
- Colorectal Cancer, laparoscopic surgery
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- National Cancer Center, KoreaOther government
- Study start
- Jan 2011
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 4 Jan 2011 (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.
Laparoscopic colon surgery has been performed widely. As a minimal invasive approach, single incision (Embryonic NOTES) colon surgery has been attempted.
However, there are not sufficient evidences for single incision colon surgery in colon cancer.
The investigators are researching the efficacy and safety of single incision laparoscopic sigmoidectomy in sigmoid colon cancer.
Detailed description
After several randomized clinical trials, laparoscopic colon surgery has been performed widely. As a minimal invasive approach, single Incision (Embryonic NOTES) colon surgery has been attempted. Several studies reported the feasibility of single incision colon surgery.However, there are not sufficient evidences for single incision colon surgery, especially in colon cancer.
The investigators are researching the efficacy and safety of single incision laparoscopic sigmoidectomy in sigmoid colon cancer. Harvested numbers of lymph node will be assessed for the efficacy and postoperative morbidity and mortality will be assess for the safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single incision sigmoidectomy | Experimental | Procedure: Single Incision Laparoscopic SurgerySingle incision laparoscopic sigmoidectomy for sigmoid colon cancer |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients should sign a written informed consent
- Age between 18-80
- Patients have sigmoid colon cancer that was proved by pathology
- Adequate bone marrow function Hb ≥ 10g/dl (after treatment for simple iron deficiency anemia) WBC ≥ 3,000/mm3 PLT ≥ 100,000/mm3
- Adequate kidney function Creatinine ≤ 1.5 mg/dl
Key exclusion criteria (13 listed)
- Distant metastasis
- Tumor diameter > 5 cm
- Other organ invasion
- Intestinal obstruction and stent insertion status
- Patient was used steroid
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 Incision Laparoscopic SurgeryAlso: Embryonic NOTES SigmoidectomySingle Incision Laparoscopic Sigmoidectomy | Procedure or surgery | Single incision sigmoidectomy |
Primary outcome
Harvested numbers of lymph node
Time frame: Within the first 7 days (plus or minus 3 days) after surgery
1 secondary outcome
Postoperative mortality, morbidity
Time frame: Within 30 days after operation
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 6 Aug 2012.
Related trials for Colorectal Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
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.
Jae Hwan Oh, Dr. PhD. study chair
Center for Colorectal Cancer, National Cancer Center Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Single Incision Laparoscopic Surgery in people with Colorectal Cancer, run by National Cancer Center, Korea 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 6 inclusion and 13 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 6 Aug 2012. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Harvested numbers of lymph node (time frame: Within the first 7 days (plus or minus 3 days) after 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 6 Aug 2012.