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Clinical Trials/NCT02117557
NCT02117557
Unknown
Phase 2

A Prospective Randomized Controlled Trial Comparing Transumbilical Single Incision Versus Conventional Laparoscopic Surgery for Colorectal Cancer

Guoxin Li1 site in 1 country198 target enrollmentApril 2014

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Colorectal Cancer
Sponsor
Guoxin Li
Enrollment
198
Locations
1
Primary Endpoint
Early morbidity rate
Last Updated
12 years ago

Overview

Brief Summary

  • Compared with traditional open colectomy, laparoscopic surgery is associated with less pain, earlier recovery, and better cosmetic outcome, and its short- and long-term oncologic outcomes have been demonstrated.
  • In experienced surgeons' hands, single incision laparoscopic surgery is increasingly performed for colorectal disease, and even for malignant lesion because of its reduced incision-associated morbidity and scarring.
  • However, the safety and efficacy of single incision laparoscopic surgery for colorectal cancer has not yet been evaluated. Thus, the prospective randomized trial comparing single incision versus conventional laparoscopic surgery for colorectal cancer is needed.
Registry
clinicaltrials.gov
Start Date
April 2014
End Date
April 2022
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Guoxin Li
Responsible Party
Sponsor Investigator
Principal Investigator

Guoxin Li

M.D., Ph.D.

Nanfang Hospital, Southern Medical University

Eligibility Criteria

Inclusion Criteria

  • 18 years \< age \< 80 years
  • Tumor located in rectosigmoid (defined as 10- to 30-cm from the anal verge)
  • Pathological rectosigmoid carcinoma
  • Preoperative T stage ranging from T1 to T4a according to the 7th Edition of AJCC Cancer Staging Manual
  • Tumor size of 5 cm or less; 6) ECOG score is 0-1
  • ASA socre is Ⅰ-Ⅲ
  • Informed consent

Exclusion Criteria

  • Body mass index (BMI) \>30 kg/m2
  • Pregnant woman or lactating woman
  • Severe mental disease
  • Previous abdominal surgery
  • Emergency operation due to complication (bleeding, perforation or obstruction) caused by colorectal cancer
  • Requirement of simultaneous surgery for other disease

Outcomes

Primary Outcomes

Early morbidity rate

Time Frame: 30 days

The early morbidity rate is defined as the event observed during operation and within 30 days after surgery,

Secondary Outcomes

  • Operative outcomes(intraoperative)
  • Pathological outecomes(5 days)
  • Postoperative recovery course(14 days)
  • Pain score(14 days)
  • Cosmetic assessment(14 days)
  • 3-year disease free survival rate(36 months)
  • 5-year overall survival rate(60 months)
  • Inflammatory and immune response(7 days)

Study Sites (1)

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