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

Dong Yang1 site in 1 country158 target enrollmentMarch 20, 2018

ConditionsLaparoscopy-assisted Surgery Total Laparoscopic Surgery With no Incision (Natural Orifice Transluminal Endoscopic Surgery, NOSES)

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Laparoscopy-assisted Surgery
Sponsor: Dong Yang
Enrollment: 158
Locations: 1
Primary Endpoint: the incidence of complications
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 20, 2018

End Date

March 20, 2022

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Dong Yang

Responsible Party

Sponsor Investigator

Principal Investigator

Dong Yang

doctor

Jilin University

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

Outcomes

Primary Outcomes

the incidence of complications

Time Frame: one month after surgery

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 Outcomes

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-year disease-free survival(three years after operation)
The mean postoperative hospital stay(in the perioperative period)
cases converted to laparotomy(in the perioperative period)