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
- 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||198 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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,
- Operative outcomes [ Time Frame: intraoperative ]Operative time, estimated blood loss and incision length are recorded.
- Pathological outecomes [ Time Frame: 5 days ]Tumor size, length of proximal and distal margin and lymph nodes harvested are used to assess oncological resection.
- 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.
- 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.
- Cosmetic assessment [ Time Frame: 14 days ]Cosmetic assessment is perform using body image scale and cosmetic scale.
- 3-year disease free survival rate [ Time Frame: 36 months ]
- 5-year overall survival rate [ Time Frame: 60 months ]
- Inflammatory and immune response [ Time Frame: 7 days ]
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
|Contact: Guoxin Li, M.D., PH.D.||+firstname.lastname@example.org|
|Contact: Yanan Wang, M.D.||+email@example.com|
|Nanfang Hospital, Southern Medical University||Recruiting|
|Guangzhou, Guangdong, China, 510-515|
|Contact: Guoxin Li, M.D.,PH.D. +86-138-0277-1450 firstname.lastname@example.org|
|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.|
|Principal Investigator:||Guoxin Li, M.D., PH.D.||Nanfang Hospital, Southern Medical University, China|