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

NCT ID: NCT02253303

Last Updated: 2014-10-01

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2017-09-30

Brief Summary

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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

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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.

Conditions

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Colon Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Midline incision

The extraction-site incision in laparoscopic colectomy is middline

Group Type EXPERIMENTAL

midline incision or off-midline incision

Intervention Type OTHER

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

Group Type ACTIVE_COMPARATOR

midline incision or off-midline incision

Intervention Type OTHER

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

Intervention Type OTHER

Eligibility Criteria

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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)
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Katsunari Takifuji

UNKNOWN

Sponsor Role collaborator

Hiroki Yamaue

OTHER

Sponsor Role lead

Responsible Party

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Hiroki Yamaue

Chief and professor of second department of surgery

Responsibility Role SPONSOR_INVESTIGATOR

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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Katsunari Takifuji

Role: CONTACT

073-447-2300 ext. 5112

Tsukasa Hotta

Role: CONTACT

073-447-2300 ext. 5112

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.

Reference Type BACKGROUND
PMID: 23375702 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18347858 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22580878 (View on PubMed)

Other Identifiers

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WMU1398

Identifier Type: -

Identifier Source: org_study_id

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