Evaluation of the Extraction-site, - Midline Incision vs Off-midline Incision-
NCT ID: NCT02253303
Last Updated: 2014-10-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
100 participants
INTERVENTIONAL
2014-10-31
2017-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Midline incision
The extraction-site incision in laparoscopic colectomy is middline
midline incision or off-midline incision
Eligible patients are randomized to midline incision or off-midline incision group in laparoscopic colectomy
off-midline incision
The extraction-site incision in laparoscopic colectomy is off-middline
midline incision or off-midline incision
Eligible patients are randomized to midline incision or off-midline incision group in laparoscopic colectomy
Interventions
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midline incision or off-midline incision
Eligible patients are randomized to midline incision or off-midline incision group in laparoscopic colectomy
Eligibility Criteria
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Inclusion Criteria
* No history of laparotomy
* No bowel obstruction by tumor
Exclusion Criteria
* Patients who receive steroids or insulin therapy
* Uncontrolled DM
* Severe respiratory failure(HOT)
ALL
No
Sponsors
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Katsunari Takifuji
UNKNOWN
Hiroki Yamaue
OTHER
Responsible Party
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Hiroki Yamaue
Chief and professor of second department of surgery
Principal Investigators
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HIroki Yamaue, Chief prof.
Role: STUDY_DIRECTOR
Second Department of Surgery, Wakayama Medical University
Central Contacts
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References
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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.
Singh 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.
Lee 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.
Other Identifiers
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WMU1398
Identifier Type: -
Identifier Source: org_study_id
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