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Laparoscopy-assisted natural orifice specimen extraction without incision to treat cancer of the sigmoid colon and rectum: a multicenter prospective randomized controlled trial

Laparoscopy-assisted natural orifice specimen extraction without incision to treat cancer of the sigmoid colon and rectum: a multicenter prospective randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800017757
Enrollment
Unknown
Registered
2018-08-13
Start date
2018-10-30
Completion date
Unknown
Last updated
2018-08-20

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

Conditions

cancer of the sigmoid colon and rectum

Interventions

NOSE group:natural orifice specimen extraction
Conventional laparoscopic surgery group:conventional specimen extraction through abdomen incision

Sponsors

Tenth People's Hospital of Shanghai, School of Medicine, Tongji University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 80 years; 2. Pathological rectosigmoid carcinoma located in 8-30cm from the anal verge; 3. preoperative stage with CT and MR for sigmoid cancer is T1-T3, for rectal tumor is T1-T2, both without synchronous, distant metastasis; 4. Tumor size of 4 cm or less; 5. Informed consent.

Exclusion criteria

Exclusion criteria: 1. BMI=30; 2. Pregnant woman or lactating woman; 3. Severe mental disease; 4. Previous sever pelvic surgery; 5. mergency operation due to complication (bleeding, perforation or obstruction) caused by colorectal cancer; 6. Requirement of simultaneous surgery for other disease.

Design outcomes

Primary

MeasureTime frame
postoperative morbidity rate;time to first flatus;time to take liquid diet;3-year disease free survival rate;5-year overall survival rate;

Secondary

MeasureTime frame
Duration time of surgery;postoperative pain score;time of hospital stay;Peritoneal bacterial contamination status;Rate of R0 resection;number of lymph nodes harvested;Distal resection margin;

Countries

China

Contacts

Public ContactLu Yin

Tenth people's hospital of Shanghai, School of Medicine, Tongji University

Yinluipad@icloud.com+86 13818602344

Outcome results

None listed

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