The Comparison Between Traditional Laparoscopy-assisted Surgery and NOSES in Radical Resection of Colorectal Cancer

Dong Yang

Status: Unknown

Conditions: Laparoscopy-assisted Surgery; Total Laparoscopic Surgery With no Incision (Natural Orifice Transluminal Endoscopic Surgery, NOSES)

Treatments: Procedure: total laparoscopic surgery with no incision (natural orifice transluminal endoscopic surgery, NOSES); Procedure: traditional laparoscopy-assisted surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT03470142

130001

Details and patient eligibility

About

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.

Enrollment: 158 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 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.
2. Eastern Cooperative Oncology Group (ECOG) scale 0-2
3. Heart, lung, liver, and kidney function can tolerate operation
4. Patients and their families are able to understand and be willing to participate in this clinical study and to sign informed consent.

Exclusion criteria

1. history of colorectal malignant disease
2. recent diagnosis of other malignant tumors (except for papillary carcinoma of the thyroid gland and basal cell carcinoma of the skin)
3. patients with intestinal obstruction, intestinal perforation, bleeding requiring emergency surgery
4. 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
5. combined colorectal multiple carcinomas
6. poor anal function before operation and incontinence of defecation
7. with a history of serious mental illness
8. pregnant or lactating women
9. The researchers believe that the patients are unsuitable to participate in the researchers with other cases. A patient or family refusal to join

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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158 participants in 2 patient groups

traditional laparoscopy-assisted surgery

Active Comparator group

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.

Treatment:

Procedure: traditional laparoscopy-assisted surgery

total laparoscopic surgery with no incision (NOSES)

Experimental group

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.

Treatment:

Procedure: total laparoscopic surgery with no incision (natural orifice transluminal endoscopic surgery, NOSES)