Colon CancerNCT02253303
Evaluation of the Extraction-site, - Midline Incision vs Off-midline Incision-
A study testing midline incision or off-midline incision in people with Colon Cancer, run by Hiroki Yamaue.
Trial summary
The purpose of this study is to evaluate the midline extraction incision in patients with colon cancer. A prospective randomized controlled trial is conducted to compare midline extraction incision with off-midline extraction incision. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Colon Cancer
- What is being tested?
- midline incision or off-midline incision
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Oct 2014to Sep 2017
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Tumor size is less than 5cm
- No history of laparotomy
- No bowel obstruction by tumor
Who cannot join
- Patients who can't respond to medical question
- Patients who receive steroids or insulin therapy
- Uncontrolled DM
- Severe respiratory failure(HOT)
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Evaluation of the Extraction-site Location in Laparoscopic Colorectal Surgery - Midline Incision vs Off-midline Incision-
The purpose of this study is to evaluate the midline extraction incision in patients with colon cancer. A prospective randomized controlled trial is conducted to compare midline extraction incision with off-midline extraction incision.
Read the detailed description
Laparoscopic colon surgery is less invasive and more cosmetic than open surgery. But the extraction-site incision is 4 to 5 cm, and it is the largest and most painful incision in laparoscopic colon surgery. The purpose of this study is to evaluate the midline extraction incision in patients with colon cancer. A prospective randomized controlled trial is conducted to compare midline extraction incision with off-midline extraction incision. The investigators hypothesize that the use of the midline extraction incision in laparoscopic colon surgery will result in more cosmetic effect and better quality of life compared to the off-midline extraction incision.
- Conditions
- Colon Cancer
- Being tested
- midline incision or off-midline incision
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
midline incision or off-midline incisionOther
Eligible patients are randomized to midline incision or off-midline incision group in laparoscopic colectomy
| Study group | Role | What they receive |
|---|---|---|
| Midline incision | Experimental | The extraction-site incision in laparoscopic colectomy is middline Receives: Other: midline incision or off-midline incision |
| off-midline incision | Active comparator | The extraction-site incision in laparoscopic colectomy is off-middline Receives: Other: midline incision or off-midline incision |
What is being measured
The primary outcome is the main question the study is designed to answer.
cosmetic effect
Scar assessment score on the patient and observer scar assessment scale(POSAS)
Measured: 1 year
Secondary outcomes (1)
Quality of life
Questionnaire on the SF-36 v2 acute
Measured: 7 days, 14 days and 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionSep 2017 (estimated)
- Study completionSep 2017 (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 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hiroki Yamaue
- Sponsor type
- University, hospital or other
- Collaborators
- Katsunari Takifuji
- Responsible party
- Sponsor-investigator, Hiroki Yamaue, Wakayama Medical University
- Investigators
- HIroki Yamaue, Chief prof., Study director, Second Department of Surgery, Wakayama Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02253303
- Sponsor's protocol ID
- WMU1398
- Status last verified
- Sep 2014
- First submitted
- 24 Sep 2014
- Last updated
- 1 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Samia H, Lawrence J, Nobel T, Stein S, Champagne BJ, Delaney CP. Extraction site location and incisional hernias after laparoscopic colorectal surgery: should we be avoiding the midline? Am J Surg. 2013 Mar;205(3):264-7; discussion 268. doi: 10.1016/j.amjsurg.2013.01.006. Epub 2013 Jan 31.
PubMed 23375702Singh R, Omiccioli A, Hegge S, McKinley C. Does the extraction-site location in laparoscopic colorectal surgery have an impact on incisional hernia rates? Surg Endosc. 2008 Dec;22(12):2596-600. doi: 10.1007/s00464-008-9845-8. Epub 2008 Mar 18.
PubMed 18347858Lee L, Mappin-Kasirer B, Sender Liberman A, Stein B, Charlebois P, Vassiliou M, Fried GM, Feldman LS. High incidence of symptomatic incisional hernia after midline extraction in laparoscopic colon resection. Surg Endosc. 2012 Nov;26(11):3180-5. doi: 10.1007/s00464-012-2311-7. Epub 2012 May 12.
PubMed 22580878
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Extraction-site Location in Laparoscopic Colorectal Surgery - Midline Incision vs Off-midline Incision-
- ClinicalTrials.gov ID
- NCT02253303
- Acronym / sponsor ID
- WMU1398
- Conditions
- Colon Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hiroki YamaueUniversity, hospital or other
- Collaborators
- Katsunari Takifuji
- Study start
- Oct 2014
- Primary completion
- Sep 2017 (estimated)
- Study completion
- Sep 2017 (estimated)
- First posted
- 1 Oct 2014 (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.
The purpose of this study is to evaluate the midline extraction incision in patients with colon cancer. A prospective randomized controlled trial is conducted to compare midline extraction incision with off-midline extraction incision.
Detailed description
Laparoscopic colon surgery is less invasive and more cosmetic than open surgery. But the extraction-site incision is 4 to 5 cm, and it is the largest and most painful incision in laparoscopic colon surgery. The purpose of this study is to evaluate the midline extraction incision in patients with colon cancer. A prospective randomized controlled trial is conducted to compare midline extraction incision with off-midline extraction incision. The investigators hypothesize that the use of the midline extraction incision in laparoscopic colon surgery will result in more cosmetic effect and better quality of life compared to the off-midline extraction incision.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Midline incision | Experimental | Other: midline incision or off-midline incisionThe extraction-site incision in laparoscopic colectomy is middline |
| off-midline incision | Active comparator | Other: midline incision or off-midline incisionThe extraction-site incision in laparoscopic colectomy is off-middline |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Tumor size is less than 5cm
- No history of laparotomy
- No bowel obstruction by tumor
Key exclusion criteria (4 listed)
- Patients who can't respond to medical question
- Patients who receive steroids or insulin therapy
- Uncontrolled DM
- Severe respiratory failure(HOT)
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 |
|---|---|---|
| midline incision or off-midline incisionEligible patients are randomized to midline incision or off-midline incision group in laparoscopic colectomy | Other | Midline incision, off-midline incision |
Primary outcome
cosmetic effect
Time frame: 1 year
Scar assessment score on the patient and observer scar assessment scale(POSAS)
1 secondary outcome
Quality of life
Time frame: 7 days, 14 days and 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2014.
- Background: PubMed 23375702Samia H, Lawrence J, Nobel T, Stein S, Champagne BJ, Delaney CP. Extraction site location and incisional hernias after laparoscopic colorectal surgery: should we be avoiding the midline? Am J Surg. 2013 Mar;205(3):264-7; discussion 268. doi: 10.1016/j.amjsurg.2013.01.006. Epub 2013 Jan 31.
- Background: PubMed 18347858Singh R, Omiccioli A, Hegge S, McKinley C. Does the extraction-site location in laparoscopic colorectal surgery have an impact on incisional hernia rates? Surg Endosc. 2008 Dec;22(12):2596-600. doi: 10.1007/s00464-008-9845-8. Epub 2008 Mar 18.
- Background: PubMed 22580878Lee L, Mappin-Kasirer B, Sender Liberman A, Stein B, Charlebois P, Vassiliou M, Fried GM, Feldman LS. High incidence of symptomatic incisional hernia after midline extraction in laparoscopic colon resection. Surg Endosc. 2012 Nov;26(11):3180-5. doi: 10.1007/s00464-012-2311-7. Epub 2012 May 12.
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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.
HIroki Yamaue, Chief prof. study director
Second Department of Surgery, Wakayama Medical University
Questions about this trial
What is this clinical trial studying?
A study testing midline incision or off-midline incision in people with Colon Cancer, run by Hiroki Yamaue.
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: status not confirmed, as of the sponsor's last update on 1 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Katsunari Takifuji (073-447-2300 ext. 5112, takifuji@wakayama-med.ac.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cosmetic effect (time frame: 1 year). 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 NCT02253303, 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 1 Oct 2014.