Colon NeoplasmsSIMPLENCT01480128
Multicenter Single-port Colectomy RCT
A study testing Single-port and Multi-port in people with Colon Neoplasms, run by The Catholic University of Korea at 1 site in South Korea.
Trial summary
This clinical trial is going to compare the single-port and multi-port laparoscopic colectomy for colon cancer treatment, in terms of safety, efficacy, and cost. The investigators hypothesize that the single-port laparoscopic colectomy is not inferior to multiport laparoscopic colectomy. Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Colon Neoplasms
- What is being tested?
- Single-port and Multi-port
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 1 siteSouth Korea
- Study dates
- Start not givento not given
- Phase
- Expanded access
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- colon adenocarcinoma
- curative resection
- age : 20 ~ 85
Who cannot join
- distal transverse colon cancer
- splenic flexure colon cancer
- descending colon cancer
- emergency operation
- obstruction
- perforation
Show all 13Show fewer
- ASA 3 or 4
- pregnant woman
- tumor associated with FAP, HNPCC, or IBD
- distant metastasis
- adjacent organ invasion
- synchronous colorectal cancer
- other malignancy within last five years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter Prospective Randomized Clinical Trail on the Efficacy of the Single Port Laparoscopic Surgery Compared With Multiport Laparoscopic Surgery
This clinical trial is going to compare the single-port and multi-port laparoscopic colectomy for colon cancer treatment, in terms of safety, efficacy, and cost.
The investigators hypothesize that the single-port laparoscopic colectomy is not inferior to multiport laparoscopic colectomy.
Read the detailed description
This clinical trial is a multicenter prospective randomized trial to compare the single-port and multi-port laparoscopic colectomy for colon cancer treatment.
- Conditions
- Colon Neoplasms
- Being tested
- Single-port, Multi-port
- Keywords
- Single-port, Laparoscopy, colectomy, Single port, colon cancer, minimally invasive 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-portProcedure or surgery
Also called Single-incision, SILS, Octoport
Single-port laparoscopic colon resection
Multi-portProcedure or surgery
Also called laparoscopy
Multi-port laparoscopic colon resection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Colon NeoplasmsStudies 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
- Expanded access
Sponsor and investigators
- Lead sponsor
- The Catholic University of Korea
- Sponsor type
- University, hospital or other
- Collaborators
- Kyunghee University, Chonnam National University
- Responsible party
- Principal investigator, Hyung-Jin Kim, The Catholic University of Korea
- Investigators
- Jun-Gi Kim, MD, Principal investigator, The Catholic University of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01480128
- Sponsor's protocol ID
- SPA-2011
- Acronym
- SIMPLE
- Status last verified
- Jun 2020
- First submitted
- 23 Nov 2011
- Last updated
- 19 Jun 2020
- Results posted
- No
Publications
Kang BM, Lee YS, Kim JH, Kim HJ, Lee SC, Kim CW, Lim SW, Kim JG, Lee SH. Quality of life and patient satisfaction after single- and multiport laparoscopic surgery in colon cancer: a multicentre randomised controlled trial (SIMPLE Trial). Surg Endosc. 2021 Nov;35(11):6278-6290. doi: 10.1007/s00464-020-08128-9. Epub 2020 Nov 3.
PubMed 33141277Lee YS, Kim JH, Kim HJ, Lee SC, Kang BM, Kim CW, Lim SW, Lee SH, Kim JG. Short-term Outcomes of Single-port Versus Multiport Laparoscopic Surgery for Colon Cancer: The SIMPLE Multicenter Randomized Clinical Trial. Ann Surg. 2021 Feb 1;273(2):217-223. doi: 10.1097/SLA.0000000000003882.
PubMed 32209897Kang BM, Kim HJ, Kye BH, Lee SC, Lee KY, Park SJ, Lee SH, Lim SW, Lee YS, Kim JH, Lee J, Kim MK, Kim JG. Multicenter, randomized single-port versus multiport laparoscopic surgery (SIMPLE) trial in colon cancer: an interim analysis. Surg Endosc. 2018 Mar;32(3):1540-1549. doi: 10.1007/s00464-017-5842-0. Epub 2017 Sep 15.
PubMed 28916955
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Prospective Randomized Clinical Trail on the Efficacy of the Single Port Laparoscopic Surgery Compared With Multiport Laparoscopic Surgery
- ClinicalTrials.gov ID
- NCT01480128
- Acronym / sponsor ID
- SIMPLE / SPA-2011
- Conditions
- Colon Neoplasms
- Keywords
- Single-port, Laparoscopy, colectomy, Single port, colon cancer, minimally invasive surgery
- Study type
- Expanded access
- Recruitment status
- Approved For Marketing
- Lead sponsor
- The Catholic University of KoreaUniversity, hospital or other
- Collaborators
- Kyunghee University, Chonnam National University
- First posted
- 28 Nov 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.
This clinical trial is going to compare the single-port and multi-port laparoscopic colectomy for colon cancer treatment, in terms of safety, efficacy, and cost.
The investigators hypothesize that the single-port laparoscopic colectomy is not inferior to multiport laparoscopic colectomy.
Detailed description
This clinical trial is a multicenter prospective randomized trial to compare the single-port and multi-port laparoscopic colectomy for colon cancer treatment.
Study design
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- colon adenocarcinoma
- curative resection
- age : 20 ~ 85
Key exclusion criteria (13 listed)
- distal transverse colon cancer
- splenic flexure colon cancer
- descending colon cancer
- emergency operation
- obstruction
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-portAlso: Single-incision, SILS, OctoportSingle-port laparoscopic colon resection | Procedure or surgery | – |
| Multi-portAlso: laparoscopyMulti-port laparoscopic colon resection | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2020.
- Derived from this study: PubMed 33141277Kang BM, Lee YS, Kim JH, Kim HJ, Lee SC, Kim CW, Lim SW, Kim JG, Lee SH. Quality of life and patient satisfaction after single- and multiport laparoscopic surgery in colon cancer: a multicentre randomised controlled trial (SIMPLE Trial). Surg Endosc. 2021 Nov;35(11):6278-6290. doi: 10.1007/s00464-020-08128-9. Epub 2020 Nov 3.
- Derived from this study: PubMed 32209897Lee YS, Kim JH, Kim HJ, Lee SC, Kang BM, Kim CW, Lim SW, Lee SH, Kim JG. Short-term Outcomes of Single-port Versus Multiport Laparoscopic Surgery for Colon Cancer: The SIMPLE Multicenter Randomized Clinical Trial. Ann Surg. 2021 Feb 1;273(2):217-223. doi: 10.1097/SLA.0000000000003882.
- Derived from this study: PubMed 28916955Kang BM, Kim HJ, Kye BH, Lee SC, Lee KY, Park SJ, Lee SH, Lim SW, Lee YS, Kim JH, Lee J, Kim MK, Kim JG. Multicenter, randomized single-port versus multiport laparoscopic surgery (SIMPLE) trial in colon cancer: an interim analysis. Surg Endosc. 2018 Mar;32(3):1540-1549. doi: 10.1007/s00464-017-5842-0. Epub 2017 Sep 15.
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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.
Jun-Gi Kim, MD principal investigator
The Catholic University of Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single-port and Multi-port in people with Colon Neoplasms, run by The Catholic University of 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 3 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: status not confirmed, as of the sponsor's last update on 19 Jun 2020. 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?
Results are not available in the source record.
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?
On the ClinicalTrials.gov record for NCT01480128, which also lists 3 linked publications.
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 19 Jun 2020.