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

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ClinicalTrials.gov Identifier: NCT02635503
Recruitment Status : Recruiting
First Posted : December 21, 2015
Last Update Posted : September 2, 2016
Sponsor:
Information provided by (Responsible Party):
Zhixiang Zhou, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Tracking Information
First Submitted Date  ICMJE November 30, 2015
First Posted Date  ICMJE December 21, 2015
Last Update Posted Date September 2, 2016
Study Start Date  ICMJE November 2015
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 16, 2015)		 Early morbidity rate [ Time Frame: 30 days ]
The early morbidity rate is defined as the event observed during operation and within 30 days after surgery.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 16, 2015)
  • Duration of the intervention [ Time Frame: 1 day ]
    Duration of surgery.
  • Peritoneal bacterial contamination [ Time Frame: 1 day ]
    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.
  • Pain score [ Time Frame: 14 days ]
    Recording of the needed analgesia guided by pain score
  • 3-year disease free survival rate [ Time Frame: 3 years ]
    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-year overall survival rate [ Time Frame: 5 years ]
    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.
  • Plasma levels of several cytokines after colorectal cancer surgery [ Time Frame: 7 days ]
    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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety Study of Totally Laparoscopic Resection With Natural Orifice Specimen Extraction (NOSE) for Rectosigmoid Cancer
Official Title  ICMJE 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
Brief 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.
Detailed Description Further study details as provided by Chinese Academy of Medical Sciences.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Colorectal Cancer
Intervention  ICMJE
  • 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 Name: NOSE
  • 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 Name: CLS
Study Arms  ICMJE
  • Experimental: transrectal specimen extraction
    Laparoscopic colorectal resection with natural orifice specimen extraction will be performed for patients in this group.
    Intervention: Procedure: transrectal specimen extraction
  • Active Comparator: Conventional laparoscopic surgery
    Conventional laparoscopic surgery for colorectal cancer will be performed for patients in this group.
    Intervention: Procedure: Conventional laparoscopic surgery
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 16, 2015)		 366
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2025
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Zhixiang Zhou, M.D. +86-139-1123-2981 Dr_zhouzx@163.com
Contact: Jianwei Liang, M.D. +86-130-7119-7461 liangjw1976@126.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02635503
Other Study ID Numbers  ICMJE NCC2015SF-04
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Zhixiang Zhou, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Zhixiang Zhou, M.D. Cancer Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College
PRS Account Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Verification Date September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP