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

Phase 2

• Conditions: Colorectal Cancer
• Interventions: Procedure: Conventional laparoscopic surgery; Procedure: Single incision laparoscopic surgery

• Registration Number: NCT02117557
• Lead Sponsor: Guoxin Li

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2014-04
• Study Start: 2014-04
• Study First Submitted: 2014-04-16
• Study First Submitted QC: 2014-04-17
• Last Update Submitted: 2014-04-17
• Study First Posted: 2014-04-21
• Last Update Posted: 2014-04-21
• Primary Completion: 2017-04
• Study Completion: 2022-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 198

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional laparoscopic surgery	Conventional laparoscopic surgery	Conventional laparoscopic surgery for colorectal cancer will be performed for patients in this group.
Single incision laparoscopic surgery	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Inflammatory and immune response	7 days
Operative outcomes	intraoperative	Operative time, estimated blood loss and incision length are recorded.
Pathological outecomes	5 days	Tumor size, length of proximal and distal margin and lymph nodes harvested are used to assess oncological resection.
Cosmetic assessment	14 days	Cosmetic assessment is perform using body image scale and cosmetic scale.
3-year disease free survival rate	36 months
Postoperative recovery course	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	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-year overall survival rate	60 months

Trial Locations

Locations (1)

Nanfang Hospital, Southern Medical University; 🇨🇳 Guangzhou, Guangdong, China