Evaluation of the Extraction-site, - Midline Incision vs Off-midline Incision-

Colon Cancer Clinical Trial

Official title:

Evaluation of the Extraction-site Location in Laparoscopic Colorectal Surgery - Midline Incision vs Off-midline Incision-

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02253303
• Other study ID #: WMU1398
• Status: Not yet recruiting
• Phase: N/A
• First received: September 24, 2014
• Last updated: September 26, 2014
• Start date: October 2014
• Est. completion date: September 2017

Study information

• Verified date: September 2014
• Source: Wakayama Medical University
• Contact: Katsunari Takifuji
• Phone: 073-447-2300
• Email: takifuji[@]wakayama-med.ac.jp
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Tumor size is less than 5cm

• No history of laparotomy

• No bowel obstruction by tumor

Exclusion Criteria:

• Patients who can't respond to medical question

• Patients who receive steroids or insulin therapy

• Uncontrolled DM

• Severe respiratory failure(HOT)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colon Cancer

Intervention

Other:
• midline incision or off-midline incision
Eligible patients are randomized to midline incision or off-midline incision group in laparoscopic colectomy

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Hiroki Yamaue	Katsunari Takifuji

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incisional hernia	Numbers of participants with incisional hernia	1 year	No
Primary	cosmetic effect	Scar assessment score on the patient and observer scar assessment scale(POSAS)	1 year	No
Secondary	Quality of life	Questionnaire on the SF-36 v2 acute	7 days, 14 days and 30 days	No