The Comparison Between Traditional Laparoscopy-assisted Surgery and NOSES in Radical Resection of Colorectal Cancer
1 other identifier
interventional
158
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2018
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 4, 2018
CompletedFirst Posted
Study publicly available on registry
March 19, 2018
CompletedStudy Start
First participant enrolled
March 20, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 20, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 20, 2022
CompletedSeptember 24, 2019
September 1, 2019
2 years
March 4, 2018
September 23, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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)
one month after surgery
Secondary Outcomes (8)
the operation time
in the perioperative period
the blood loss during the operation
in the perioperative period
Postoperative recovery of intestinal peristalsis
in the perioperative period
Visual Analogue Scale/Score
in the perioperative period
the functional outcome of defecation, if there is incontinence
Three months after operation
- +3 more secondary outcomes
Study Arms (2)
traditional laparoscopy-assisted surgery
ACTIVE COMPARATORThe 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.
total laparoscopic surgery with no incision (NOSES)
EXPERIMENTALThe 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.
Interventions
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.
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).
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Dong Yanglead
Study Sites (1)
the First Hospital of Jilin University
Ch’ang-ch’un, Jilin, 130021, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Dong-Hui Sun, Doctor
The First Hospital of Jilin University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- doctor
Study Record Dates
First Submitted
March 4, 2018
First Posted
March 19, 2018
Study Start
March 20, 2018
Primary Completion
March 20, 2020
Study Completion
March 20, 2022
Last Updated
September 24, 2019
Record last verified: 2019-09
Data Sharing
- IPD Sharing
- Will not share
There is no plan to make individual participant data (IPD) available to other researchers.