Comparison of NOSES and Conventional Laparoscopic Surgery in Colorectal Cancer
Primary Purpose
Colorectal Cancer
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Laparoscopic Surgery
Sponsored by

About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring Minimally invasive surgery, natural orififice specimen, radical resectiong of rectal cancer, laparoscopic surgery
Eligibility Criteria
Inclusion Criteria:
- The inclusion criteria were as follows: (1) patients aged between 18 and 80 years; (2) histopathology confirmed as colorectal adenocarcinoma; (3) preoperative imaging (CT and MR) assessments showed that colorectal cancer did not penetrate the serosa (≤T3); (4) tumor circumference <5 cm; (5) enhanced chest and abdominal pelvic CT scans before operation excluded liver metastasis, lung metastasis, and other distant organ metastases.
Exclusion Criteria:
- The preoperative exclusion criteria were as follows: (1) tumors could be resected by endoscopic submucosal dissection (ESD) and endoscopic mucosal resection (EMR); (2) body mass index (BMI) > 30 kg/m2; (3) patients with severe perforation, bleeding, or obstruction requiring emergency surgery; (4) recurrent cases; (5) patients undergoing neoadjuvant therapy or preoperative radiotherapy; (6) Anesthesiologists (ASA) score ≥ IV; (7) active period of infection; (8) blood neutrophils <3 × 109/L.
Sites / Locations
- Affiliated hospital of Zunyi Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Natural Orifice Specimen Extraction Surgery
Conventional laparoscopy
Arm Description
Outcomes
Primary Outcome Measures
Postoperative complications
pulmonary infection,Urinary tract infection,anal function,intestinal obstruction,Anastomotic bleeding,etc.
Secondary Outcome Measures
survival
3-year and 5-year Overall survival rate
Full Information
NCT ID
NCT04559087
First Posted
September 16, 2020
Last Updated
September 16, 2020
Sponsor
Zunyi Medical College
1. Study Identification
Unique Protocol Identification Number
NCT04559087
Brief Title
Comparison of NOSES and Conventional Laparoscopic Surgery in Colorectal Cancer
Official Title
Comparison of NOSES and Conventional Laparoscopic Surgery in Colorectal Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
April 2022 (Anticipated)
Study Completion Date
April 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zunyi Medical College
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Radical surgery for rectal cancer has evolved from the initial concept of total mesorctal excision (TME) to the wide application of laparoscopic surgery in the radical treatment of rectal cancer. After 30 years' rapid development, nowdays laparoscopic TME surgery for rectal cancer has become the first choice for those patients with rectal cancer. However, the auxiliary incision of the abdominal wall which is used to remove tumor specimens is contrary to the current concept of minimally invasive surgery. Avoiding abdominal wall incisions has become a common appeal of gastrointestinal surgeons and patients with rectal cancer. Natural orififice specimen extraction surgery (NOSES) can solve the problem of abdominal wall auxiliary incision, which complete rectal cancer radical resection and gastrointestinal reconstruction under the full laparoscopic. The specimens are taken out through the natural orifice (rectum or vagina) without an auxiliary incision, which is more in line with minimally invasive practice and easier to operate. Researching on the progress of laparoscopic radical resection of rectal cancer in NOSES aims to provide a certain reference for this operation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
Minimally invasive surgery, natural orififice specimen, radical resectiong of rectal cancer, laparoscopic surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Natural Orifice Specimen Extraction Surgery
Arm Type
Experimental
Arm Title
Conventional laparoscopy
Arm Type
Sham Comparator
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic Surgery
Other Intervention Name(s)
Conventional Laparoscopic Surgery
Intervention Description
NOSES:Natural orifice specimen extraction (NOSE) is the opening of a hollow viscus that already communicates with the outside world, such as the vagina or distal gastrointestinal tract, in order to remove a specimen. The premise of this technique is to reduce the trauma required to remove the specimen with the expectation that this may improve outcomes.
Conventional Laparoscopic Surgery:Surgical specimens were taken out through abdominal wall.
Primary Outcome Measure Information:
Title
Postoperative complications
Description
pulmonary infection,Urinary tract infection,anal function,intestinal obstruction,Anastomotic bleeding,etc.
Time Frame
One month after operation
Secondary Outcome Measure Information:
Title
survival
Description
3-year and 5-year Overall survival rate
Time Frame
3-year and 5-year after operation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
The inclusion criteria were as follows: (1) patients aged between 18 and 80 years; (2) histopathology confirmed as colorectal adenocarcinoma; (3) preoperative imaging (CT and MR) assessments showed that colorectal cancer did not penetrate the serosa (≤T3); (4) tumor circumference <5 cm; (5) enhanced chest and abdominal pelvic CT scans before operation excluded liver metastasis, lung metastasis, and other distant organ metastases.
Exclusion Criteria:
The preoperative exclusion criteria were as follows: (1) tumors could be resected by endoscopic submucosal dissection (ESD) and endoscopic mucosal resection (EMR); (2) body mass index (BMI) > 30 kg/m2; (3) patients with severe perforation, bleeding, or obstruction requiring emergency surgery; (4) recurrent cases; (5) patients undergoing neoadjuvant therapy or preoperative radiotherapy; (6) Anesthesiologists (ASA) score ≥ IV; (7) active period of infection; (8) blood neutrophils <3 × 109/L.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fujian Xu, Master
Phone
+8615895864837
Email
911583440@qq.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ming Xie, MD
Phone
+8615519202000
Email
2581303091@qq.com
Facility Information:
Facility Name
Affiliated hospital of Zunyi Medical University
City
Zunyi
State/Province
Guizhou
ZIP/Postal Code
563000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ming Xie, MD
Phone
+8615519202000
Email
2581303091@qq.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Comparison of NOSES and Conventional Laparoscopic Surgery in Colorectal Cancer
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