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
1 other identifier
interventional
366
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 colorectal-cancer
Started Nov 2015
Longer than P75 for phase_3 colorectal-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2015
CompletedFirst Submitted
Initial submission to the registry
November 30, 2015
CompletedFirst Posted
Study publicly available on registry
December 21, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2025
CompletedSeptember 2, 2016
September 1, 2016
5.1 years
November 30, 2015
September 1, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Early morbidity rate
The early morbidity rate is defined as the event observed during operation and within 30 days after surgery.
30 days
Secondary Outcomes (6)
Duration of the intervention
1 day
Peritoneal bacterial contamination
1 day
Pain score
14 days
3-year disease free survival rate
3 years
5-year overall survival rate
5 years
- +1 more secondary outcomes
Study Arms (2)
transrectal specimen extraction
EXPERIMENTALLaparoscopic colorectal resection with natural orifice specimen extraction will be performed for patients in this group.
Conventional laparoscopic surgery
ACTIVE COMPARATORConventional laparoscopic surgery for colorectal cancer will be performed for patients in this group.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cancer Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College
Beijing, Beijing Municipality, 100021, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Zhixiang Zhou, M.D.
Cancer Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- director of Colorectal surgical Department
Study Record Dates
First Submitted
November 30, 2015
First Posted
December 21, 2015
Study Start
November 1, 2015
Primary Completion
December 1, 2020
Study Completion
December 1, 2025
Last Updated
September 2, 2016
Record last verified: 2016-09
Data Sharing
- IPD Sharing
- Will not share