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A single-center, prospective, randomized controlled clinical trial comparing robotic-assisted and laparoscopic-assisted ISR in the treatment of low rectal cancer

A single-center, prospective, randomized controlled clinical trial comparing robotic-assisted and laparoscopic-assisted ISR in the treatment of low rectal cancer

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100053539
Enrollment
Unknown
Registered
2021-11-24
Start date
2021-12-01
Completion date
Unknown
Last updated
2022-10-04

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

Conditions

rectal cancer

Interventions

experimental group:Robot-assisted ISR
control group:Laparoscopic ISR

Sponsors

Nanjing Drum Tower Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. High-moderately differentiated rectal adenocarcinoma confirmed by electronic colonoscopy and histopathological examination before operation; 2. Aged 18-75 years; 3. The size of the tumor < 1/3 the circumference of the bowel; 4. The cancer is located in the lower 1/3 of the rectum (2-5cm from the anal verge); 5. Preoperative pelvic rectal sequence MRI examination, the tumor is in T1-T2 stage, and it is not suitable for local resection through anus; 6. No distant metastasis in preoperative examination; 7. No history of gastrointestinal surgery; 8. Anal function is normal; 9. The enrolled patients underwent robotic-assisted or laparoscopic-assisted radical rectal resection (ISR); 10. The patient has good compliance and signed the informed consent.

Exclusion criteria

Exclusion criteria: 1. Poor tumor differentiation; 2. Received neoadjuvant therapy before surgery, including radiotherapy and chemotherapy; 3. Patients with acute abdomen such as acute intestinal obstruction and intestinal perforation; 4. History of rectal or anal surgery in the past; 5. Patients with tumors in other parts; 6. Combined with severe cardiopulmonary diseases, etc., unable to tolerate anesthesia and surgery; 7. Patients with combined mental illness; 8. Combined pregnancy patients; 9. Other patients deemed unsuitable for inclusion by the investigator.

Design outcomes

Primary

MeasureTime frame
Kelly Scale;QLQ-C30 Quality of Life Score;

Countries

China

Contacts

Public ContactChen Gang
331812195@qq.com+86 13770705070

Outcome results

None listed

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