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The Clinical Research of Pull Through Conformal Resection for the Treatment of Ultra-Low Rectal Cancer

The Clinical Research of Pull Through Conformal Resection for the Treatment of Ultra-Low Rectal Cancer

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900026850
Enrollment
Unknown
Registered
2019-10-24
Start date
2019-10-24
Completion date
Unknown
Last updated
2019-10-28

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

Conditions

rectal cancer

Interventions

control group:Intersphincteric resection
experimental group:Pull Through Conformal Resection

Sponsors

Shanghai Ninth People's Hospital, School of Medicine, Shanghai Jiaotong University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1) The age is more than 18 years old, less than or equal to 80 years old; 2) The pathological report was highly or moderately differentiated cancer. 3) The distance between tumor and anal margin was less than or equal to 5cm and more than 3cm. 4) No distant metastasis (including pelvic cavity, peritoneum, liver, lung, brain, bone, distant lymph node metastasis, etc.) was detected by ultrasonography, CT, PET-CT, etc. 5) MRI, CT or B-ultrasound examination showed no infiltration of external sphincter, puborectalis and levator ani muscle or above CT2, which met the requirements after preoperative neoadjuvant radiotherapy and chemotherapy. 6) The peritumoral track of the tumor was less than 1 / 3 of the intestinal cavity, and the mass could be pushed by digital rectal examination. 7) The peritumoral track of the tumor was less than 1 / 3 of the intestinal cavity, and the mass could be pushed by digital rectal examination. 8) Preoperative imaging evaluation tn0m0 (T > 1 and < 3) 9) No other malignant tumor history; 10) Informed consent.

Exclusion criteria

Exclusion criteria: 1) MRI, CT or intracavitary B-ultrasonic examination showed lymph node metastasis or infiltration of external sphincter, puborectal muscle and levator ani muscle. 2) The mass in digital rectal examination could not be pushed; 3) The function of anal incontinence or defecation control decreased significantly before operation. 4) Emergency colorectal surgery due to acute intestinal obstruction, bleeding and perforation; 5) Multiple colorectal cancer; 6) Familial adenomatous polyposis (FAP), Lynch syndrome, inflammatory bowel disease; 7) Other cases requiring simultaneous colectomy; 8) ASA grade is higher than III; 9) Pregnancy and lactation; 10) Patients or family members could not understand the conditions and objectives of this study.

Design outcomes

Primary

MeasureTime frame
Wexner;

Secondary

MeasureTime frame
progression-free survival;

Countries

China

Contacts

Public ContactJiwei Yu

Shanghai Ninth People's Hospital, School of Medicine, Shanghai Jiaotong University

jenniferyu919@126.com+86 13651663559

Outcome results

None listed

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