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Study on quality control of taTME operation guided by digital pelvic diameter measurement

Study on quality control of taTME operation guided by digital pelvic diameter measurement

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000036498
Enrollment
Unknown
Registered
2020-08-23
Start date
2020-10-01
Completion date
Unknown
Last updated
2020-09-14

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:transanal total mesorectal excision

Sponsors

The First Affiliated Hospital of Naval Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Aged 18-80 years old; 2) Colonoscopy examines the lower edge of the tumor within 2-8 cm from the dentinal line, and biopsy pathology confirms rectal adenocarcinoma; 3) No distant transfer; 4) No other multiple primary cancers; 5) Preoperative CT or MRI or B-ultrasound in the rectal below T3 (not including T3), the tumor can be removed; 6) Possess sufficient organ function; 7) Patients or family members who can understand the research plan and are willing to participate in the research, and sign written informed consent.

Exclusion criteria

Exclusion criteria: 1. Malignant tumors at the same time or at different times (within 5 years); 2. Patients with intestinal obstruction, intestinal perforation, intestinal bleeding, etc. who need emergency surgical resection; 3. Past history of colorectal surgery, which may affect patients with this digestive tract reconstruction; 4. It is expected that more than 2 organs will be removed together; 5. ASA IV or V level; 6. Pregnant or lactating women; (1) Women of childbearing age have a positive pregnancy test at baseline or have not received a pregnancy test. Postmenopausal women must be at least 12 months after menopause; (2) Men or women who are sexually active (childbearing age) are unwilling to use contraception during the trial. 8. Severe mental illness; 9. Severe emphysema, interstitial pneumonia or ischemic heart disease who cannot tolerate surgery; 10. Continuous systemic steroid therapy within 1 month; 11. The patient has contraindications to laparoscopic surgery; 12. Past trauma or operation history of pelvic fracture; 13. Allergy to the contrast agent iopromide; 14. History of pelvic radiotherapy, or preoperative staging assessment requiring neoadjuvant therapy; 15. Patients or family members cannot understand the conditions and goals of this study.

Design outcomes

Primary

MeasureTime frame
Overall survival rate;

Secondary

MeasureTime frame
Local recurrence rate;Complication rate after surgery;

Countries

China

Contacts

Public ContactXiaohui Shi

The First Affiliated Hospital of Naval Medical University

drshixh@sina.com+86 13585799364

Outcome results

None listed

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