Safety Study of Totally Laparoscopic Resection With Natural Orifice Specimen Extraction (NOSE) for Rectosigmoid Cancer

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase: Enrolling; Phase 3

Conditions: Colorectal Cancer

Treatments: Procedure: Conventional laparoscopic surgery; Procedure: transrectal specimen extraction

Study type: Interventional

Funder types: Other

Identifiers

NCT02635503

NCC2015SF-04

Details and patient eligibility

About

The purpose of this study is to compare the safety and efficacy of laparoscopic resection with natural orifice specimen extraction versus conventional laparoscopic surgery for sigmoid colon or rectal cancer.

Full description

Further study details as provided by Chinese Academy of Medical Sciences.

Enrollment: 366 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 8- to 30-cm from the anal verge)
• Pathological rectosigmoid adenocarcinoma
• Preoperative T stage ranging from T1 to T4a according to the 7th Edition of American Joint Committee on Cancer (AJCC) Staging Manual
• Tumor size of 6 cm or less;
• Eastern Cooperative Oncology Group (ECOG) score is 0-1
• American Society of Anesthesiology (ASA) score 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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366 participants in 2 patient groups

transrectal specimen extraction

Experimental group

Description:

Laparoscopic colorectal resection with natural orifice specimen extraction will be performed for patients in this group.

Treatment:

Procedure: transrectal specimen extraction

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