A Multi-Center Randomised Controlled Study to Evaluate Laparoscopic Versus Open Surgery for Colorectal Cancer

Colorectal Cancer Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00788281
• Other study ID #: BJLS01
• Status: Recruiting
• Phase: Phase 2
• First received: November 7, 2008
• Last updated: November 12, 2008
• Start date: April 2008
• Est. completion date: April 2016

Study information

• Verified date: November 2008
• Source: Beijing Friendship Hospital
• Contact: jin wang, doctor
• Phone: 86-10-63138712
• Email: zhangzht[@]medmail.com.cn
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Laparoscopic surgery has been widely accepted for its minimal invasion and safety. However, whether it has the same survival benefit as the traditional open surgery in Chinese population is still unknown. So we designed this study to evaluate the 3 year disease free survival rate in the laparoscopic group versus the open surgery group.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: April 2016
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Informed consent

• Pathologically confirmed adenocarcinoma

• Pre-surgery image staging as (CT/MRI):T2-3,N0-2,M0,(TNM stage,AJCC,version of 2003)

• Single tumor locating at cecum, ascending colon, descending colon, sigmoid colon, rectosigmoid junction, rectum(distance from anal verge more than 7cm)

• Tumor diameter less than 6cm

• Age 18-75 year

• ECOG 0-2

• Predicted survival longer than 6 months

• Normal liver, renal, bone marrow function: (GPT less than 2 ULN,total bilirubin less than 1.5mg/dl,Cr less than 1.5 ULN,WBC more than 4×109/L,PLT more than 100×109/L)

• No previous history of gastrointestinal surgery

• No previous history of chemotherapy or radiotherapy

Exclusion criteria

• Severe and uncontrolled medical disease including unstable angina pectoris, cardiac infarction and cerebral attack in 6 months

• Could not tolerant general anesthesia or surgery for other organ dis-function

• Allergy to chemotherapeutical agents in the protocol

• History of other malignant tumor within 5 years

• Severe mental disorder

• Continued systematic steroid therapy

• Woman during pregnancy or lactation

• Under study of other clinical trial

• No compliance of the protocol

• Discovery of distant metastasis during surgery

• Postsurgery stage of I or IV tumors

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Procedure:
• laparoscopic surgery
surgery would be performed by laparoscope
• open surgery
surgery would be performed by traditional surgery.

Locations

Country	Name	City	State
China	Beijing Friendship Hospital, Department of General Surgery	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Friendship Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	disease free survival rate		3 year	No
Primary	tumor residual rate of LRM and CRM		1 week	No
Primary	operation mortality		2 months	Yes
Secondary	survival rate		3 year	No
Secondary	survival rate		5 year	No
Secondary	local recurrence rate		5 year	No
Secondary	operation time		at the end of operation	No
Secondary	blood lost		during operation	Yes
Secondary	analgesic dosage		1,2 and 3 days post surgery	No
Secondary	evacuating time		post surgery	No
Secondary	operation morbidity		2 months	Yes
Secondary	transfer to open surgery		during operation	No
Secondary	fee		peri-operation	No