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

Hiroki Yamaue

Status: Unknown

Conditions: Colon Cancer

Treatments: Other: midline incision or off-midline incision

Study type: Interventional

Funder types: Other

Identifiers

NCT02253303

WMU1398

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

100 participants in 2 patient groups

Midline incision

Experimental group

Description:

The extraction-site incision in laparoscopic colectomy is middline

Treatment:

Other: midline incision or off-midline incision

off-midline incision

Active Comparator group

Description:

The extraction-site incision in laparoscopic colectomy is off-middline

Treatment:

Other: midline incision or off-midline incision