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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Procedure: transrectal specimen extraction Procedure: Conventional laparoscopic surgery Phase 3

Detailed Description:
Further study details as provided by Chinese Academy of Medical Sciences.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 366 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : November 2015
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2025
Arms and Interventions
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Arm Intervention/treatment
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 Name: NOSE
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 Name: CLS


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Duration of the intervention [ Time Frame: 1 day ]
    Duration of surgery.

  2. 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.

  3. Pain score [ Time Frame: 14 days ]
    Recording of the needed analgesia guided by pain score

  4. 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. 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.

  6. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02635503


Contacts
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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

Locations
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China, Beijing
Cancer Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College Recruiting
Beijing, Beijing, China, 100021
Contact: Jianwei Liang, M.D.    +86-130-7119-7461    liangjw1976@126.com   
Contact: Zhixiang Zhou, M.D.    +86-139-1123-2981    Dr_zhouzx@163.com   
Principal Investigator: Zhixiang Zhou, M.D.         
Sponsors and Collaborators
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Investigators
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Principal Investigator: Zhixiang Zhou, M.D. Cancer Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College
More Information
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Responsible Party: Zhixiang Zhou, director of Colorectal surgical Department, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT02635503    
Other Study ID Numbers: NCC2015SF-04
First Posted: December 21, 2015    Key Record Dates
Last Update Posted: September 2, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Zhixiang Zhou, Cancer Institute and Hospital, Chinese Academy of Medical Sciences:
colorectal cancer
laparoscopic surgery
natural orifice specimen extraction
Inflammatory response
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases