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The feasibility and safety of no-scar transanal total mesorectal excision(TME) for rectal cancer

The feasibility and safety of no-scar transanal total mesorectal excision(TME) for rectal cancer

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-ONC-14005103
Enrollment
Unknown
Registered
2014-09-21
Start date
2014-09-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

Rectal cancer

Interventions

transanal surgery:radical surgery for rectal cancer

Sponsors

Department of colorectal surgery, The Sixth Affiliated Hospital of Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Male or female; 2. subjects 18 - 70 of age; BMI less than 3030kg/m2; 3. biopsy-proven adenocarcinoma of the rectum; 4. no previous abdominal surgery, no distant metastasis or synchronous colon cancer; 5. clinical staging (T1 or T2 or T3) with N1-2M0; 6. distance from tumor to anal verge should greater than 3cm; 7. the diameter of primary tumor should smaller than 5cm; 8. Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; 9. American Society of Anesthesiology (ASA) class I to III lesions; 10. after the evaluation of Multi-disciplinary team (MDT), whether receive neoadjuvant chemoradiotherapy or not; 11. written informed consent.

Exclusion criteria

Exclusion criteria: 1. obstructing, perforated or hemorrhagic rectal cancer require for emergent surgery; 2. T4 tumor that invade the external sphincter or levator ani muscle or neighbor organs that should undergo multivisceral resection; 3. pregnant or breast-feeding women; 4. fecal incontinence; 5. mental disorder or disease; 6. history of inflammatory bowel disease; 7. other malignancies diagnosed within the previous year; 8. severe impaired renal and hepatic function, coagulopathy or other severe comorbidities that cannot tolerate surgery; 9. any evidence of active infection; 10. cannot reach written informed consent.

Design outcomes

Secondary

MeasureTime frame
recovery outcome;postoperative pain evaluation;defecation, urinary and sexual function;Quality of life;3 year disease free survival;3 year overall surviva;

Primary

MeasureTime frame
Operative time;Estimated blood loss;intraoperative complications;conver to Hybrid NOTES with assistance of conventional laparoscopic surgery;conver to open surgery;postoperative complication;pathological outcome;cost of hospitalization;

Countries

China

Contacts

Public ContactJianping Wang
wangjpgz@126.com+86 13808874808

Outcome results

None listed

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