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A study on the safety and validity of the laparoscopic-assisted resection of colorectal cancer with NOSES techniques

A study on the safety and validity of the laparoscopic-assisted resection of colorectal cancer with NOSES techniques

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000037118
Enrollment
Unknown
Registered
2020-08-27
Start date
2020-10-01
Completion date
Unknown
Last updated
2020-10-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal cancer

Interventions

experimental group:laparoscopic-assisted resection of colorectal cancer with NOSES techniques
control group:laparoscopic-assisted resection of colorectal cancer

Sponsors

Shanghai First People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Patients with age > 18 years and <= 80 years old; 2. Patients with primary colorectal adenocarcinoma diagnosed by colonoscopy; 3. Patients whose preoperative imaging examination such as CT, MRI or endoscopic ultrasonography showed that the tumor did not invade adjacent structures and had no distant metastasis; 4. Patients with tumor invasion depth T2-T3 whose tumor diameter is less than 5 cm and whose lower edge is 5 cm-30 cm away from Anal edge; 5. Patients with BMI <= 30 kg / m2; 6. Patients whose heart, lung, liver and kidney functions can tolerate surgery; 7. Patients and their families can understand and be willing to participate in the clinical study and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with mesenteric hypertrophy; 2. Patients with perianal diseases or anal stenosis are not recommended for colorectal noses; 3. Women with acute gynecological infection, vaginal malformation or unmarried child-bearing and married women planning to have another child; 4. Patients with intestinal obstruction, intestinal perforation and intestinal bleeding who need emergency operation; 5. Patients with tumor involving adjacent organs and requiring combined organ resection; 6. Patients with tumor recurrence; 7. Patients with multiple primary colorectal cancer; 8. Patients with a history of inflammatory bowel disease or familial adenomatous polyposis; 9. American Society of anesthesiologists (ASA) grade > III patients; 10. Physical status: Karnofsky score is greater than or equal to 60 points, or ECoG score is greater than or equal to 2 points; 11. In patients with liver dysfunction, MELD score was higher than 12; 12. Patients considered by the researchers to be combined with other conditions and not suitable for the study.

Design outcomes

Primary

MeasureTime frame
overall survival;disease free survival;local recurrence rate;

Secondary

MeasureTime frame
postoperative complications;conversion rate;dissected lymph node number;positive circumferential margin rate;

Countries

China

Contacts

Public ContactZhengjun Qiu

Shanghai First People's Hospital

qiuzjdoctor@sina.com+86 13386259665

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026