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

Guoxin Li

Status and phase: Unknown; Phase 2

Conditions: Colorectal Cancer

Treatments: Procedure: Single incision laparoscopic surgery; Procedure: Conventional laparoscopic surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT02117557

NFGS-SILS-01

Details and patient eligibility

About

• 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.

Enrollment: 198 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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198 participants in 2 patient groups

Single incision laparoscopic surgery

Experimental group

Description:

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.

Treatment:

Procedure: Single incision laparoscopic surgery

Conventional laparoscopic surgery

Active Comparator group

Description:

Conventional laparoscopic surgery for colorectal cancer will be performed for patients in this group.

Treatment:

Procedure: Conventional laparoscopic surgery