Randomized Controlled Trial Between Laparoscopic and Open Surgery in Transverse and Descending Colon Cancer Patients
NCT ID: NCT01861691
Last Updated: 2013-11-26
Study Results
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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UNKNOWN
PHASE2
66 participants
INTERVENTIONAL
2008-08-31
2017-10-31
Brief Summary
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Detailed Description
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* This was a randomized controlled trial conducted at a single institute, which was Yokohama City University Medical Center (Japan).
* 80 patients who had transverse colon or descending colon cancer were randomly allocated to receive laparoscopic surgery or conventional open surgery.
Surgical procedures
* All surgical procedures were performed by one specialized colorectal treatment team. The laparoscopic surgeries were performed by a surgeon who passed the skill accreditation system for laparoscopic gastroenterological surgery was established by the Japanese Society for Endoscopic Surgery (JSES), and all open surgeries were performed under the supervision of these skillful surgeons.
* All operations were performed according to the standard radical cure procedure described in the seventh edition of the Japanese General Rules for Clinical and Pathological Studies on Cancer of the Colon, Rectum and Anus. That is, intestinal excision with lymph node dissection that separated the feeding blood vessel at its origin was performed in all surgical procedures. Patients who underwent palliative partial excision were not included.
* In the laparoscopic surgery, a medial-to-lateral approach was performed in all patients.
* In the conventional open surgery, the first procedure was done in lateral approach. The reconstruction techniques were the same as those used in laparoscopic surgery.
Randomization - To balance the operative backgrounds between the laparoscopic and the conventional open surgery groups, the patients were stratified by the tumor location (transverse colon, descending colon).
Adjuvant therapy
* When the pathological stage was diagnosed as stage 3 by histological examination of the resected specimen, adjuvant chemotherapy was done with oral fluoropyrimidine anti-cancer drug.
* Neither radiation therapy nor preoperative chemotherapy was given to any patient. Preoperative chemo-radiotherapy even for rectal cancer is not yet standard treatment in Japan.
Assessment parameters
* The preoperative parameters
* Operative assessment parameters
* Postoperative assessment parameters An early postoperative complication was defined as a complication that occurred between the finish of the operation and postoperative day 30. A late postoperative complication was defined as a complication that occurred after postoperative day 30. The terminologies of complications were classified according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, and grading was done by Classification of Surgical Complication.
* The pathological results were recorded according to the 7th edition of the Japanese General Rules for Clinical and Pathological Studies on Cancer of the Colon, Rectum and Anus and 7th edition of primary tumor, regional nodes, metastasis (TNM) classification. Circumferential margin involvement was defined as exposure of a cancer cell at the vertical dissection surface on histological examination.
* Quality of life (QOL) scores. 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.
Follow-up schedule
\- The follow-up schedule was as follows according to stage. Patients with stages 0 and I were followed up with outpatient examinations including tumor marker measurements, and chest, abdominal and pelvic computed tomography (CT) once a year for five years. Patients with stage 2 and 3a were examined by CT and tumor marker measurements every six months for the first two years. These examinations were done once a year from the third year to the fifth year. Patients with stage 3b and 3c were examined by CT and tumor marker measurements every four months for the first two years, and every six months from the third year to the fifth year.
Statistical analysis
* The primary endpoint was early complication rate.
* The secondary endpoints were 5-recurrence-free survival, 5-year overall survival, length of postoperative hospital stay, and HRQOL score. To evaluate whether a difference in the operative procedure influences survival including death due to another disease, a comparison of overall survival has meaning. Early complication rate, length of postoperative hospital stay and HRQOL score were added to the secondary endpoints because these parameters had a possibility of becoming grounds of selection of the operation method if there were no differences in overall survival and recurrence-free survival.
* A sample size of 74 patients was assured to achieve a power of more than 70% to detect a difference between the groups using a two-sided Chi-squared test with type I error rate equal to 0.2, when the true complication rates were 20% and 40% for the laparoscopic and open surgeries, respectively. The dropouts were considered and the number of accumulation targets was assumed to be 80 patients.
* For continuous variables, data are presented as means ± standard deviation (SD). For categorical variables, data are presented as frequencies and percentages (%). Comparison of the endpoints was based on intention-to-treat principle, that is, the patients who switched to another group during surgery were treated as members of the allocated group. The Chi-squared test was applied to evaluate the significance of differences in proportions, and t-test was used to evaluate the significance of differences in continuous variables. A p-value of less than 0.05 was considered to be statistically significant.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Open surgery
Open colectomy
Open surgery
Conventional technique
Laparoscopic surgery
Laparoscopic colectomy
Laparoscopic surgery
New minimum invasive technique
Interventions
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Open surgery
Conventional technique
Laparoscopic surgery
New minimum invasive technique
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
20 Years
ALL
No
Sponsors
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Shoichi Fujii, MD, PhD
OTHER
Responsible Party
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Shoichi Fujii, MD, PhD
Associate Professor
Principal Investigators
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Chikara Kunisaki, Professor
Role: STUDY_CHAIR
Yokohama City University, Gastroenterological Center
Locations
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Yokohama City University Medical Center
Yokohama, Kanagawa, Japan
Countries
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References
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Toritani K, Watanabe J, Nakagawa K, Suwa Y, Suwa H, Ishibe A, Ota M, Fujii S, Kunisaki C, Endo I. Randomized controlled trial to evaluate laparoscopic versus open surgery in transverse and descending colon cancer patients. Int J Colorectal Dis. 2019 Jul;34(7):1211-1220. doi: 10.1007/s00384-019-03305-2. Epub 2019 May 17.
Other Identifiers
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YokohamaCUMC33
Identifier Type: OTHER
Identifier Source: secondary_id
YCUMC-D1108014
Identifier Type: -
Identifier Source: org_study_id