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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02253303

Enrollment

100

Registered

2014-10-01

Start date

2014-10-31

Completion date

2017-09-30

Last updated

2014-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colon Cancer

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.

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.

Interventions

OTHERmidline incision or off-midline incision

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

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)

Design outcomes

Primary

Measure	Time frame	Description
cosmetic effect	1 year	Scar assessment score on the patient and observer scar assessment scale(POSAS)

Secondary

Measure	Time frame	Description
Quality of life	7 days, 14 days and 30 days	Questionnaire on the SF-36 v2 acute

Other

Measure	Time frame	Description
Incisional hernia	1 year	Numbers of participants with incisional hernia

Contacts

Primary ContactKatsunari Takifuji

takifuji@wakayama-med.ac.jp073-447-2300

Backup ContactTsukasa Hotta

hotta@wakayama-med.ac.jp073-447-2300

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026