Evaluation of the Extraction-site, - Midline Incision vs Off-midline Incision-
1 other identifier
interventional
100
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2014
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 24, 2014
CompletedFirst Posted
Study publicly available on registry
October 1, 2014
CompletedStudy Start
First participant enrolled
October 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2017
CompletedOctober 1, 2014
September 1, 2014
2.9 years
September 24, 2014
September 26, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
cosmetic effect
Scar assessment score on the patient and observer scar assessment scale(POSAS)
1 year
Secondary Outcomes (1)
Quality of life
7 days, 14 days and 30 days
Other Outcomes (1)
Incisional hernia
1 year
Study Arms (2)
Midline incision
EXPERIMENTALThe extraction-site incision in laparoscopic colectomy is middline
off-midline incision
ACTIVE COMPARATORThe extraction-site incision in laparoscopic colectomy is off-middline
Interventions
Eligible patients are randomized to midline incision or off-midline incision group in laparoscopic colectomy
Eligibility Criteria
You may qualify if:
- Tumor size is less than 5cm
- No history of laparotomy
- No bowel obstruction by tumor
You may not qualify if:
- Patients who can't respond to medical question
- Patients who receive steroids or insulin therapy
- Uncontrolled DM
- Severe respiratory failure(HOT)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hiroki Yamauelead
- Katsunari Takifujicollaborator
Related Publications (3)
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.
PMID: 23375702BACKGROUNDSingh 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.
PMID: 18347858BACKGROUNDLee 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.
PMID: 22580878BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
HIroki Yamaue, Chief prof.
Second Department of Surgery, Wakayama Medical University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Chief and professor of second department of surgery
Study Record Dates
First Submitted
September 24, 2014
First Posted
October 1, 2014
Study Start
October 1, 2014
Primary Completion
September 1, 2017
Study Completion
September 1, 2017
Last Updated
October 1, 2014
Record last verified: 2014-09