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Quality of life (QoL) and efficacy of laparoscopic- ultimate sphincter-preserving procedures (uSPP) versus extralevator abdominoperineal excision (ELAPE) in patients with extremely low rectal cancer following long-course neoadjuvant radiotherapy: a prospective clinical controlled study

Quality of life (QoL) and efficacy of laparoscopic- ultimate sphincter-preserving procedures (uSPP) versus extralevator abdominoperineal excision (ELAPE) in patients with extremely low rectal cancer following long-course neoadjuvant radiotherapy: a prospective clinical controlled study

Status
Active, not recruiting
Phases
Phase 3
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2200058417
Enrollment
Unknown
Registered
2022-04-09
Start date
2022-04-30
Completion date
Unknown
Last updated
2024-01-08

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

Conditions

Rectal Cancer

Interventions

uSPP group:Ultimate sphincter-preserving procedures
ELAPE group:Extralevator abdominoperineal excision

Sponsors

West China Hospital of Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 75 years old; 2. Pathologically confirmed adenocarcinoma of the rectum; 3. The lower edge of the tumor is <=5 cm from the anus; 4. Rectal MRI staging of cT1-2N1-2M0 or cT3N0-2M0 before radiotherapy; 5. 6-12 weeks after receiving long course neoadjuvant radiotherapy (50Gy/25f); 6. Understand the study protocol and volunteer to participate.

Exclusion criteria

Exclusion criteria: 1. Emergency surgery; 2. Combined with other primary tumors or with distant metastases; 3. ASA>=IV; 4. PS>2; 5. Pregnant or breastfeeding women; 6. Severe cardiopulmonary complications cannot tolerate surgery; 7. Continuous systemic steroid therapy for 1 month; 8. Contraindication to laparoscopic surgery or MRI; 9. Tumor invasion or suspected invasion of the vagina, prostate, sacrococcyx, and lateral pelvic wall (T4b); 10. Those who can only undergo non-anal preservation surgery after preoperative evaluation.

Design outcomes

Primary

MeasureTime frame
socre of Quality of Life Questionaire - Cancer 30 (QLQ-C30);

Secondary

MeasureTime frame
score of Quality of Life Questionnaire - Colorectal 29 (QLQ-CR29);score of Low Anterior Resection Syndrome (LARS);Score of Wexner Incontinence Score (WIS);Score of International Prostate Symptom Scale (IPSS);Score of International Index of Erectile Function-5 (IIEF-5);Score of Female Sexual Function Index (FSFI);Health Economics indexes;

Countries

China

Contacts

Public ContactLie Yang

West China Hospital of Sichuan University

lie_222@163.com+86 18980602267

Outcome results

None listed

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