Randomized Controlled Trial Between Laparoscopic and Open Surgery in Transverse and Descending Colon Cancer Patients
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|ClinicalTrials.gov Identifier: NCT01861691|
Recruitment Status : Unknown
Verified November 2013 by Shoichi Fujii, MD, PhD, Yokohama City University Medical Center.
Recruitment status was: Active, not recruiting
First Posted : May 23, 2013
Last Update Posted : November 26, 2013
|Condition or disease||Intervention/treatment||Phase|
|Malignant Neoplasm of Transverse Colon Malignant Neoplasm of Descending Colon||Procedure: Open surgery Procedure: Laparoscopic surgery||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||66 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Randomized Controlled Trial to Evaluate Laparoscopic Versus Open Surgery in Transverse and Descending Colon Cancer Patients|
|Study Start Date :||August 2008|
|Actual Primary Completion Date :||October 2012|
|Estimated Study Completion Date :||October 2017|
Active Comparator: Open surgery
Procedure: Open surgery
Other Name: Open colectomy
Experimental: Laparoscopic surgery
Procedure: Laparoscopic surgery
New minimum invasive technique
Other Name: Laparoscopic colectomy
- Early complication rate [ Time Frame: within the first 30 days after surgery ]Early complication is defined as a complication that occured between the finish of the surgery and postoperative day 30.
- Recurrence-free survival [ Time Frame: 5 years ]All death and recurrence of colon cancer is defined as an event of recurrence-free survival.
- Overall survival [ Time Frame: 5 years ]All death is defined as an event of overall survival.
- Length of postoperative hospital stay [ Time Frame: 10 days ]Length of postoperative hospital stay is defined as a duration between surgery and first discharge. An expected average is 10 days.
- Health-related QOL score [ Time Frame: 1 year after surgery ]The QOL score was measured using the 36-item Short Form Health Survey (SF-36) version 2.0. It is a tool that measures health-related QOL (HRQOL) according to an inclusive standard and not a disease-specific standard. The SF-36 is composed of 36 questions. The score is expressed numerically by the provided scoring algorithm. SF-36 questionnaires were sent to the patients at one month, 6 months and one year after the surgery by postal mail. A return envelope was enclosed with the SF-36 questionnaire, and the patient sent it back to the research secretariat by postal mail. A questionnaire on the defecation situation and wound pain besides the SF-36 was added all three times. The question of when complete rehabilitation occurred was added in the questionnaire at one year.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01861691
|Yokohama City University Medical Center|
|Yokohama, Kanagawa-ken, Japan, 232-0024|
|Study Chair:||Chikara Kunisaki, Professor||Yokohama City University, Gastroenterological Center|