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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
Sponsor:
Information provided by (Responsible Party):
Shoichi Fujii, MD, PhD, Yokohama City University Medical Center

Brief Summary:
The long-term results of several large-scale prospective randomized trials that compared laparoscopic-assisted and open colectomy for colon cancer were published in the past decade. The oncologic outcomes were nearly similar in patients who underwent laparoscopic or open surgery. In Japan, the Japan Clinical Oncology Group (JCOG) conducted a randomized trial to compare oncological outcomes between patients who underwent laparoscopic or open surgery for advanced colon cancer and recto-sigmoid cancer. However, the exclusion criterion were concerning tumor site in transverse and descending colon. The reason of exclusion was that laparoscopic procedure was difficult in transverse and descending colon cancers. However, laparoscopic surgery for transverse and descending colon cancer was performed clinically. We conducted a randomized trial that compared laparoscopic surgery and conventional open surgery in in transverse and descending colon cancer. The purpose of the present study was to clarify the safety and feasibility of laparoscopic surgery on in transverse and descending colon cancer patients.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Arm Intervention/treatment
Active Comparator: Open surgery
Open colectomy
Procedure: Open surgery
Conventional technique
Other Name: Open colectomy

Experimental: Laparoscopic surgery
Laparoscopic colectomy
Procedure: Laparoscopic surgery
New minimum invasive technique
Other Name: Laparoscopic colectomy




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Recurrence-free survival [ Time Frame: 5 years ]
    All death and recurrence of colon cancer is defined as an event of recurrence-free survival.

  2. Overall survival [ Time Frame: 5 years ]
    All death is defined as an event of overall survival.

  3. 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.

  4. 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.



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age of 20 years old or over
  • Histologically proven adenocarcinoma
  • Clinical tumor penetrates visceral peritoneum (T4a), no metastasis (M0) or lower T factor
  • Elective operation
  • Tolerable surgery under general anesthesia
  • No bulky tumor larger than 8cm in diameter
  • No history of laparotomy for colorectal resection except appendectomy
  • Provided written informed consent

Exclusion Criteria:

  • Synchronous or metachronous (within 5 years) malignancy in another organ except carcinoma in situ
  • Multiple colorectal cancer that needs reconstruction two or more times
  • Acute intestinal obstruction or perforation due to colorectal cancer
  • Lower rectal cancer that required pelvic side wall lymphadenectomy
  • Pregnant or lactating women

Information from the National Library of Medicine

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


Locations
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Japan
Yokohama City University Medical Center
Yokohama, Kanagawa-ken, Japan, 232-0024
Sponsors and Collaborators
Shoichi Fujii, MD, PhD
Investigators
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Study Chair: Chikara Kunisaki, Professor Yokohama City University, Gastroenterological Center

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Shoichi Fujii, MD, PhD, Associate Professor, Yokohama City University Medical Center
ClinicalTrials.gov Identifier: NCT01861691     History of Changes
Other Study ID Numbers: YCUMC-D1108014
YokohamaCUMC33 ( Other Identifier: YokohamaCUMC )
First Posted: May 23, 2013    Key Record Dates
Last Update Posted: November 26, 2013
Last Verified: November 2013
Keywords provided by Shoichi Fujii, MD, PhD, Yokohama City University Medical Center:
Transverse colon cancer
Descending colon cancer
Laparoscopic surgery
Randomized controlled trial
Additional relevant MeSH terms:
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Colonic Neoplasms
Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases