Rectal Cancer
Conditions
Keywords
Robotic, Intersphincteric Resection, rectal cancer, pelvic autonomic nerve anal function
Brief summary
This study compared robot-assisted total mesorectal excision to treat very low rectal cancer within 2 cm from the dentate line to avoid permanent colostomy. improves the quality of life with better defecation function, urinary function and sexual function.
Interventions
DEVICERobot-assisted surgery
robot-assisted intersphincteric resection for low location rectal cancer(T=1&2)
DEVICELaparoscopic surgery
laparoscopic intersphincteric resection for low location rectal cancer(T=1&2)
Sponsors
Southwest Hospital, China
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. 18 years \< age \< 80 years 2. Matching the diagnostic criteria; 3. tumor located 3 cm from anal verge 4. Clinically diagnosed cT1-3N0-2 M0 lesions 5. Tumor size of 4 cm or less 6. ASA 1-3 scores; 7. ECOG score is 0-1; 8. Adequate preoperative sphincter function
Exclusion criteria
1. Requiring a Mile's procedure 2. Fecal incontinence; 3. Previous abdominal surgery 4. Severe mental disease. 5. Intolerance of surgery for severe comorbidities 6. Emergency operation due to complication 7. Pregnant woman or lactating woman
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Female Sexual Function Index [FSFI] | 18 months | Alterations in FSFI from baseline up to 18 months postoperatively - 19-item self-report measure, each item ranges from 0-5, with full range from 2 to 36, with low score indicating sexual function disorder. |
| Change in urinary function | 6 months | The days of indwelling catheter after operation The overall efficiency of urination function |
| Change in International Index of Erectile Function [IIEF] score | 18 months | Alterations in IIEF scores from baseline up to 18 months postoperatively - 15 item questionnaire, each item range from 0 - 5, with total score to 30. lower score indicates more severe erectile dysfunction (ED) |
| Change in FIQL scores | 18 months | Alterations in Fecal Incontinence Quality of Life Instrument (FIQL) scores from baseline up to 18 months postoperatively - 29 items range from 1 (strongly agree) to 4 (strongly disagree); with a 1 indicating a lower functional status of quality of life. Scale scores are only calculated if at least half of the items have been answered |
Countries
China
Contacts
Primary ContactTang Bo, M.D
Backup ContactLi Chuan, M.D
Outcome results
None listed