Back to resultsThe Comparison Between Traditional Laparoscopy-assisted Surgery and NOSES in Radical Resection of Colorectal Cancer
Primary Purpose
Laparoscopy-assisted Surgery, Total Laparoscopic Surgery With no Incision (Natural Orifice Transluminal Endoscopic Surgery, NOSES)
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
traditional laparoscopy-assisted surgery
total laparoscopic surgery with no incision (natural orifice transluminal endoscopic surgery, NOSES)
Sponsored by
About this trial
This is an interventional treatment trial for Laparoscopy-assisted Surgery focused on measuring laparoscopy-assisted surgery, NOSES
Eligibility Criteria
Inclusion Criteria:
- All cases should be diagnosed as rectal or sigmoid colon cancer by histology or cytology. The tumor is 5-20cm from the pectinate line. The clinical stage is T1-2, N0, M0 for rectal cancer and T1-T3, N0-2, M0 for sigmoid colon cancer.
- Eastern Cooperative Oncology Group (ECOG) scale 0-2
- Heart, lung, liver, and kidney function can tolerate operation
- Patients and their families are able to understand and be willing to participate in this clinical study and to sign informed consent.
Exclusion Criteria:
- history of colorectal malignant disease
- recent diagnosis of other malignant tumors (except for papillary carcinoma of the thyroid gland and basal cell carcinoma of the skin)
- patients with intestinal obstruction, intestinal perforation, bleeding requiring emergency surgery
- a history of abdominal surgery (which makes it difficult to perform laparoscopic procedures), severe systemic disease such as diabetes, severe chronic lung disease, cirrhosis, other malignant diseases
- combined colorectal multiple carcinomas
- poor anal function before operation and incontinence of defecation
- with a history of serious mental illness
- pregnant or lactating women
- The researchers believe that the patients are unsuitable to participate in the researchers with other cases. A patient or family refusal to join
Sites / Locations
- the First Hospital of Jilin UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
traditional laparoscopy-assisted surgery
total laparoscopic surgery with no incision (NOSES)
Arm Description
The traditional laparoscopic operation undergo and then a small incision(5cm) is made in the middle of the lower abdominal wall to trim the mesangial membrane and remove the specimen. At last the anastomosis operation undergo by the laparoscopic operation.
The whole procedures undergo by total laparoscopic surgery with no incision in the abdominal wall. The specimen then will be removed through natural orifice such as anal.
Outcomes
Primary Outcome Measures
the incidence of complications
All postoperative complications in the perioperative period will be classified by the Clavien-Dindo classification.The classification mainly focuses on the medical perspective, with major emphasis on the risk and invasiveness of the therapy used to correct a complication. From light to heavy, it consists of five grades (Ⅰ to Ⅴ)
Secondary Outcome Measures
the operation time
The descriptive name of unit would be minute (min).
the blood loss during the operation
The descriptive name of unit would be millilitre (ml).
Postoperative recovery of intestinal peristalsis
The descriptive name of unit would be hour (h).
Visual Analogue Scale/Score
A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured.It is often used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms.For example, the amount of pain that a patient feels ranges across a continuum from none to an extreme amount of pain ( from 0 to 10).
the functional outcome of defecation, if there is incontinence
Anal incontinence was evaluated using the Wexner Continence Grading Scale , the score being calculated after the patients' completion of a daily defecatory questionnaire. Range is from 0 (normal continence) to 20 (maximum incontinence with maximum disturbance of lifestyle).
3-year disease-free survival
cases converted to laparotomy
The procedure for cases who underwent laparoscopy-assisted surgery or NOSES can not go successfully, and then it will be converted to laparotomy. The number of all those cases should be recorded.
The mean postoperative hospital stay
The descriptive name of unit would be day (d).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03470142
Brief Title
The Comparison Between Traditional Laparoscopy-assisted Surgery and NOSES in Radical Resection of Colorectal Cancer
Official Title
The Comparison Between Traditional Laparoscopy-assisted Surgery and Total Laparoscopic Surgery With no Incision (Natural Orifice Transluminal Endoscopic Surgery，NOSES) in Radical Resection of Colorectal Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 20, 2018 (Actual)
Primary Completion Date
March 20, 2020 (Anticipated)
Study Completion Date
March 20, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dong Yang
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This study is to compare the short-term and long-term outcomes of traditional laparoscopy-assisted surgery and total laparoscopic surgery with no incision (natural orifice transluminal endoscopic surgery, NOSES) for colorectal cancer and to find a better surgical method for patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Laparoscopy-assisted Surgery, Total Laparoscopic Surgery With no Incision (Natural Orifice Transluminal Endoscopic Surgery, NOSES)
Keywords
laparoscopy-assisted surgery, NOSES
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
158 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
traditional laparoscopy-assisted surgery
Arm Type
Active Comparator
Arm Description
The traditional laparoscopic operation undergo and then a small incision(5cm) is made in the middle of the lower abdominal wall to trim the mesangial membrane and remove the specimen. At last the anastomosis operation undergo by the laparoscopic operation.
Arm Title
total laparoscopic surgery with no incision (NOSES)
Arm Type
Experimental
Arm Description
The whole procedures undergo by total laparoscopic surgery with no incision in the abdominal wall. The specimen then will be removed through natural orifice such as anal.
Intervention Type
Procedure
Intervention Name(s)
traditional laparoscopy-assisted surgery
Intervention Description
All surgical procedures will be performed by the surgery team ,which is leaded by professor Sun Dong-Hui and Wang Quan. The traditional laparoscopic operation undergo and then a small incision(5cm) is made in the middle of the lower abdominal wall to trim the mesangial membrane and remove the specimen. At last the anastomosis operation undergo by the laparoscopic operation.
Intervention Type
Procedure
Intervention Name(s)
total laparoscopic surgery with no incision (natural orifice transluminal endoscopic surgery, NOSES)
Intervention Description
All surgical procedures will be performed by the surgery team ,which is leaded by professor Sun Dong-Hui and Wang Quan. The whole procedures undergo by total laparoscopic surgery with no incision in the abdominal wall. The specimen then will be removed through natural orifice (anal).
Primary Outcome Measure Information:
Title
the incidence of complications
Description
All postoperative complications in the perioperative period will be classified by the Clavien-Dindo classification.The classification mainly focuses on the medical perspective, with major emphasis on the risk and invasiveness of the therapy used to correct a complication. From light to heavy, it consists of five grades (Ⅰ to Ⅴ)
Time Frame
one month after surgery
Secondary Outcome Measure Information:
Title
the operation time
Description
The descriptive name of unit would be minute (min).
Time Frame
in the perioperative period
Title
the blood loss during the operation
Description
The descriptive name of unit would be millilitre (ml).
Time Frame
in the perioperative period
Title
Postoperative recovery of intestinal peristalsis
Description
The descriptive name of unit would be hour (h).
Time Frame
in the perioperative period
Title
Visual Analogue Scale/Score
Description
A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured.It is often used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms.For example, the amount of pain that a patient feels ranges across a continuum from none to an extreme amount of pain ( from 0 to 10).
Time Frame
in the perioperative period
Title
the functional outcome of defecation, if there is incontinence
Description
Anal incontinence was evaluated using the Wexner Continence Grading Scale , the score being calculated after the patients' completion of a daily defecatory questionnaire. Range is from 0 (normal continence) to 20 (maximum incontinence with maximum disturbance of lifestyle).
Time Frame
Three months after operation
Title
3-year disease-free survival
Time Frame
three years after operation
Title
cases converted to laparotomy
Description
The procedure for cases who underwent laparoscopy-assisted surgery or NOSES can not go successfully, and then it will be converted to laparotomy. The number of all those cases should be recorded.
Time Frame
in the perioperative period
Title
The mean postoperative hospital stay
Description
The descriptive name of unit would be day (d).
Time Frame
in the perioperative period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All cases should be diagnosed as rectal or sigmoid colon cancer by histology or cytology. The tumor is 5-20cm from the pectinate line. The clinical stage is T1-2, N0, M0 for rectal cancer and T1-T3, N0-2, M0 for sigmoid colon cancer.
Eastern Cooperative Oncology Group (ECOG) scale 0-2
Heart, lung, liver, and kidney function can tolerate operation
Patients and their families are able to understand and be willing to participate in this clinical study and to sign informed consent.
Exclusion Criteria:
history of colorectal malignant disease
recent diagnosis of other malignant tumors (except for papillary carcinoma of the thyroid gland and basal cell carcinoma of the skin)
patients with intestinal obstruction, intestinal perforation, bleeding requiring emergency surgery
a history of abdominal surgery (which makes it difficult to perform laparoscopic procedures), severe systemic disease such as diabetes, severe chronic lung disease, cirrhosis, other malignant diseases
combined colorectal multiple carcinomas
poor anal function before operation and incontinence of defecation
with a history of serious mental illness
pregnant or lactating women
The researchers believe that the patients are unsuitable to participate in the researchers with other cases. A patient or family refusal to join
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dong Yang, Master
Email
714488468@qq.com
First Name & Middle Initial & Last Name or Official Title & Degree
Quan Wang, Doctor
Phone
043181875602
Email
wangquanjdyy@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dong-Hui Sun, Doctor
Organizational Affiliation
The First Hospital of Jilin University
Official's Role
Study Director
Facility Information:
Facility Name
the First Hospital of Jilin University
City
Ch'ang-ch'un
State/Province
JI Lin
ZIP/Postal Code
130021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Quan Wang, Professor
Email
18844097668@163.com
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to make individual participant data (IPD) available to other researchers.
Learn more about this trial
The Comparison Between Traditional Laparoscopy-assisted Surgery and NOSES in Radical Resection of Colorectal Cancer
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