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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Colorectal Cancer
• Intervention / Treatment: Procedure: transrectal specimen extraction; Procedure: Conventional laparoscopic surgery

Detailed Description

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

• Study Type: Interventional
• Enrollment (Anticipated): 366
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Zhixiang Zhou, M.D.; Phone Number: +86-139-1123-2981; Email: Dr_zhouzx@163.com
• Study Contact Backup: Name: Jianwei Liang, M.D.; Phone Number: +86-130-7119-7461; Email: liangjw1976@126.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100021
      • Recruiting
      • Cancer Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College
      • Principal Investigator: Zhixiang Zhou, M.D.
      • Contact: Zhixiang Zhou, M.D.; Phone Number: +86-139-1123-2981; Email: Dr_zhouzx@163.com
      • Contact: Jianwei Liang, M.D.; Phone Number: +86-130-7119-7461; Email: liangjw1976@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Conventional laparoscopic surgery; Conventional laparoscopic surgery for colorectal cancer will be performed for patients in this group.	Procedure: Conventional laparoscopic surgery; High ligation of inferior mesenteric vessel , mobilization of bowel, and dissection of lymph nodes were performed laparoscopically, and total mesorectal excision with nerve-sparing technique was followed for rectal cancer. Conventional laparoscopic-assisted surgery (CLS), a small incision with a 3-7cm length was made in hypogastrium, transection of rectum was completed through abdominal incision, then the specimen was removed and the bowel was prepared for anastomosis. The anastomosis for all rectal cancer and most of sigmoid colon cancer was performed by a double-stapling technique following open resection.; Other Names: CLS
Experimental: transrectal specimen extraction; Laparoscopic colorectal resection with natural orifice specimen extraction will be performed for patients in this group.	Procedure: transrectal specimen extraction; After mobilization of bowel and dissection of lymph nodes, a cross clamp was placed distal to the tumor. Distal rectum was transected after fully disinfecting rectal lumen by 10% povidone-iodine. An anvil head attached to circular stapling device was put into abdominal cavity through rectal stump, and put into colon lumen through a longitudinal incision, then the proximal colon was transected in close proximity to the upper pole of incision by a linear stapling device. During specimen extraction though the rectum, a disposable sterile protective cover was used to avoid cancer cell exfoliation and implantation. The rectal opening was reclosed by a linear stapler. End-to-end colorectal anastomosis was performed with a circular stapler using the double-stapling technique.; Other Names: NOSE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Early morbidity rate	The early morbidity rate is defined as the event observed during operation and within 30 days after surgery.	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of the intervention	Duration of surgery.	1 day
Peritoneal bacterial contamination	Peritoneal fluid samples were collected under sterile conditions at the end of the procedure and sent for gram stain as well as anaerobic, aerobic, and fungal cultures.We assess the contamination rate of peritoneal fluid in the two interventions.	1 day
Pain score	Recording of the needed analgesia guided by pain score	14 days
3-year disease free survival rate	A survival analysis will be performed using the Kaplan-Meier method, for which a comparison of the survival curve will also made using a Log-rank test.	3 years
5-year overall survival rate	A survival analysis will be performed using the Kaplan-Meier method, for which a comparison of the survival curve will also made using a Log-rank test.	5 years
Plasma levels of several cytokines after colorectal cancer surgery	We have measured and compared perioperative plasma levels of interleukin-2, interleukin-6, interleukin-8, C-reactive protein and procalcitonin in the two group sample.	7 days

Collaborators and Investigators

• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Investigators: Principal Investigator: Zhixiang Zhou, M.D., Cancer Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): December 1, 2025

Study Registration Dates

• First Submitted: November 30, 2015
• First Submitted That Met QC Criteria: December 16, 2015
• First Posted (Estimate): December 21, 2015

Study Record Updates

• Last Update Posted (Estimate): September 2, 2016
• Last Update Submitted That Met QC Criteria: September 1, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: colorectal cancer; laparoscopic surgery; Inflammatory response; natural orifice specimen extraction
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: NCC2015SF-04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO