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
ConditionsColorectal Cancer
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.
Investigators
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)
Loading locations...
Similar Trials
Completed
Not Applicable
Efficacy of Laparoscopic Subtotal Gastrectomy With D2 Lymph Node Dissection for Locally Advanced Gastric CancerGastric CancerNCT01456598Ajou University School of Medicine1,050
Completed
Not Applicable
A randomised trial of open versus laparoscopic colposuspension for genuine stress incontinenceStress incontinenceUrological and Genital DiseasesISRCTN14969683Medical Research Council (MRC) (UK)290
Withdrawn
Phase 3
Evaluation of the Interest of the Instillation of Saline Intraperitoneally (INSI ) Versus Instillation of Naropin the Surgical Site Versus Lung Recruitment Maneuvers ( PVM ) in the Management of Pain After Laparoscopic Cholecystectomy in Ambulatory CareSurgeryPainNCT02819544Centre Hospitalier Universitaire, Amiens
Completed
Not Applicable
Open vs Laparoscopic Liver Surgery for Colorectal Liver MetastasesColorectal Liver MetastasisLaparoscopic Liver ResectionNCT02727179Hospital Universitario Virgen de la Arrixaca200
Active, not recruiting
Not Applicable
Oslo Randomized Laparoscopic Versus Open Liver Resection for Colorectal Metastases StudySecondary Malignant Neoplasm of LiverColorectal NeoplasmsNCT01516710Oslo University Hospital280