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A controlled study on the efficacy and quality of life of laparoscopic Intersphincteric resection (ISR) and extralevator abdominoperineal resection (ELAPE) in the treatment of extremely low rectal cancer

A controlled study on the efficacy and quality of life of laparoscopic Intersphincteric resection (ISR) and extralevator abdominoperineal resection (ELAPE) in the treatment of extremely low rectal cancer

Status
Active, not recruiting
Phases
Phase 2
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1800017512
Enrollment
Unknown
Registered
2018-08-02
Start date
2018-09-01
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

Rectal Cancer

Interventions

ISR group:Receive Laparoscopic ISR surgery
ELAPE group:Receive Laparoscopic ELAPE surgery

Sponsors

Department of Gastrointestinal Surgery,West China Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: (1) Aged 18-70; Pathological diagnosis of colorectal cancer; (2) Tumor lower margin is less than 5cm from the anus; (3) Preoperative tumor stage: ct1-2n1-2m0, ct3-4n0-2m0; (4) patients receiving long-term neoadjuvant chemoradiotherapy (2x25gy)

Exclusion criteria

Exclusion criteria: (1) distant metastasis; (2) not sensitivity after neoadjuvant therapy; (3) external sphincter and levator ANI of the anus were invaded; (4) Unable to radical resection; (5) pregnant women; (6) severe cardiopulmonary complications.

Design outcomes

Primary

MeasureTime frame
socre of QLQ-C30;score of QLQ-CR29;

Secondary

MeasureTime frame
Intraoperative blood loss;First bowel exhaust time;postoperative mortality in 30 days;Incidence of urinary retention;3 years local recurrence rate;Disease-free survival in 3 years;Overall survival in 3 years;

Countries

China

Contacts

Public ContactLie Yang

Department of Gastrointestinal Surgery, West China Hospital

lie_222@163.com+86 18980602267

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 18, 2026