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Safety Study of Transumbilical Single Incision Versus Conventional Laparoscopic Surgery for Colorectal Cancer

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ClinicalTrials.gov Identifier: NCT02117557
Recruitment Status : Recruiting
First Posted : April 21, 2014
Last Update Posted : April 21, 2014
Sponsor:
Information provided by (Responsible Party):
Guoxin Li, Nanfang Hospital of Southern Medical University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Procedure: Single incision laparoscopic surgery Procedure: Conventional laparoscopic surgery Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 198 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Randomized Controlled Trial Comparing Transumbilical Single Incision Versus Conventional Laparoscopic Surgery for Colorectal Cancer
Study Start Date : April 2014
Estimated Primary Completion Date : April 2017
Estimated Study Completion Date : April 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Single incision laparoscopic surgery
Transumbilical single incision laparoscopic surgery will be performed for patients in this group.And addition of only one trocar through the stoma for drainage tube is allowed.
 Procedure: Single incision laparoscopic surgery
Other Name: SILS
Active Comparator: Conventional laparoscopic surgery
Conventional laparoscopic surgery for colorectal cancer will be performed for patients in this group.
 Procedure: Conventional laparoscopic surgery
Other Name: CLS


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Operative outcomes [ Time Frame: intraoperative ]
    Operative time, estimated blood loss and incision length are recorded.

  2. Pathological outecomes [ Time Frame: 5 days ]
    Tumor size, length of proximal and distal margin and lymph nodes harvested are used to assess oncological resection.

  3. Postoperative recovery course [ Time Frame: 14 days ]
    Time to first ambulation, flatus, liquid diet, soft diet, and duration of hospital stay are used to assess the postoperative recoverty course.

  4. Pain score [ Time Frame: 14 days ]
    Postoperative pain is recorded using the visual analog scale (VAS) pain score tool on postoperative day 1, 2, 3 and the day of discharge.

  5. Cosmetic assessment [ Time Frame: 14 days ]
    Cosmetic assessment is perform using body image scale and cosmetic scale.

  6. 3-year disease free survival rate [ Time Frame: 36 months ]
  7. 5-year overall survival rate [ Time Frame: 60 months ]
  8. Inflammatory and immune response [ Time Frame: 7 days ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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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): NCT02117557


Contacts
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Contact: Guoxin Li, M.D., PH.D. +86-138-0277-1450 gzliguoxin@163.com
Contact: Yanan Wang, M.D. +86-150-1875-3181 wyn8116@163.com

Locations
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China, Guangdong
Nanfang Hospital, Southern Medical University Recruiting
Guangzhou, Guangdong, China, 510-515
Contact: Guoxin Li, M.D.,PH.D.    +86-138-0277-1450    gzliguoxin@163.com   
Principal Investigator: Guoxin Li, M.D.,PH.D.         
Sub-Investigator: Yanan Wang, M.D.         
Sub-Investigator: Haijun Deng, M.D.,PH.D.         
Sub-Investigator: Qi Xue, M.D.         
Sponsors and Collaborators
Guoxin Li
Investigators
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Principal Investigator: Guoxin Li, M.D., PH.D. Nanfang Hospital, Southern Medical University, China
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Guoxin Li, M.D., Ph.D., Nanfang Hospital of Southern Medical University
ClinicalTrials.gov Identifier: NCT02117557    
Other Study ID Numbers: NFGS-SILS-01
First Posted: April 21, 2014    Key Record Dates
Last Update Posted: April 21, 2014
Last Verified: April 2014
Keywords provided by Guoxin Li, Nanfang Hospital of Southern Medical University:
Single-incision
Laparoscopy
Colorectal Cancer
Additional relevant MeSH terms:
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Colorectal Neoplasms
Surgical Wound
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Wounds and Injuries