A Prospective Randomized Controlled Trial Comparing Totally Laparoscopic Resection With Natural Orifice Specimen Extraction (NOSE) Versus Conventional Laparoscopic Surgery for Sigmoid Colon or Rectal Cancer
Who is this study for? Adult patients with Rectosigmoid Adenocarcinoma
What treatments are being studied? Transrectal Specimen Extraction
Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
China
Cancer Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College
RECRUITING
Beijing
Contact Information
Primary
Zhixiang Zhou, M.D.
Dr_zhouzx@163.com
+86-139-1123-2981
Backup
Jianwei Liang, M.D.
liangjw1976@126.com
+86-130-7119-7461
Time Frame
Start Date: 2015-11
Estimated Completion Date: 2025-12
Participants
Target number of participants: 366
Treatments
Experimental: transrectal specimen extraction
Laparoscopic colorectal resection with natural orifice specimen extraction will be performed for patients in this group.
Active_comparator: Conventional laparoscopic surgery
Conventional laparoscopic surgery for colorectal cancer will be performed for patients in this group.
Related Therapeutic Areas
Sponsors
Leads: Cancer Institute and Hospital, Chinese Academy of Medical Sciences