Rectum Neoplasms
Conditions
Brief summary
TME (Total mesorectum excision) is the golden standard of radical resection for mid-low rectal cancer. However, the damage of pelvic autonomic nerve following with TME principle will lead to high incidence of urinary and sexual function disorder. Open PANP (pelvic autonomic nerve preservation) TME surgery played a role in decreasing incidence of urinary and sexual function disorder. However, 32%-44% patients still suffered from urinary and sexual function disorder when underwent Open PANP TME surgery (O-PANP-TME). Laparoscopy-assisted TME surgery (L-TME) is applied wildly nowadays. In the early stage of work, we performed laparoscopy-assisted PANP TME surgery (L-PANP-TME) to discuss the protection of urinary and sexual function of male mid-low rectal cancer patients. The results showed that L-PANP-TME significantly decreased incidence of urinary and sexual function disorder. In order to further confirm our early work, we design a randomized controlled clinical trial to compare differences in urinary and sexual function protection and long-term outcomes between L-PANP-TME and O-PANP-TME.
Interventions
PROCEDUREL-PANP-TME
PROCEDUREO-PANP-TME
Sponsors
Third Affiliated Hospital, Sun Yat-Sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
20 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Age from over 20 to under 60 years; * Primary rectal adenocarcinoma confirmed pathologically by endoscopic biopsy; * Mid-low rectal cancer (distance from anal edge≤12cm); * cT1-3, N0-3, M0 at preoperative evaluation according to the AJCC Cancer Staging Manual Seventh Edition; * Expected curative resection through both L-PANP-TME and O-PANP-TME; * Performance status of 0 or 1 on ECOG (Eastern Cooperative Oncology Group) scale; * ASA (American Society of Anesthesiology) score class I, II, or III; * Written informed consent; * Urinary and sexual function normal preoperatively
Exclusion criteria
* Women during pregnancy or breast-feeding; * Severe mental disorder; * History of previous pelvic surgery; * Enlarged or bulky regional lymph node diameter over 3cm by preoperative imaging; * History of other malignant disease within past five years; * History of unstable angina or myocardial infarction within past six months; * History of cerebrovascular accident within past six months; * History of continuous systematic administration of corticosteroids within one month; * Contraindication of heart, brain, lung, etc dysfunction; * Requirement of simultaneous surgery for other disease; * Emergency surgery due to complication (bleeding, obstruction or perforation) caused by rectal cancer; * Rectal cancer invades surrounding tissues; * Existence of genuine incontinence or severe stress incontinence preoperatively
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 3-year disease free survival rate | 36 months | — |
| Urinary function | 30 days | Urodynamic study and IPSS (International prostate symptom score) are used to assess urinary function |
| Sexual function | 30 days | IIEF-5 (International questionnaire of erectile function-5) and Ejaculation function classification are used to assess sexual function |
| 5-year disease free survival rate | 60 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 5-year overall survival rate | 60 months |
| Morbidity | 30 days |
| 5-year recurrence pattern | 60 months |
| 3-year overall survival rate | 36 months |
| 3-year recurrence pattern | 36 months |
| Mortality | 30 days |
Countries
China
Contacts
Primary ContactHongbo Wei, M.D. Ph.D.
Outcome results
None listed