Rectal Neoplasms
Conditions
Keywords
robot-assisted total mesorectal excision(RTME), laparoscopic total mesorectal excision(LTME), urinary function, sexual function, sphincter- preservation, low rectal cancer
Brief summary
This study compared robot-assisted total mesorectal excision (RTME) and laparoscopic total mesorectal excision (LTME) with regard to urinary function, sexual function and sphincter- preservation outcomes for low rectal cancer.
Detailed description
Urinary and sexual dysfunction are recognized complications of rectal cancer surgery in men. This study compared robot-assisted total mesorectal excision (RTME) and laparoscopic total mesorectal excision(LTME) with regard to these functional outcomes.Sphincter- preservation outcomes for low rectal cancer was observed as well.
Interventions
PROCEDURErobot-assisted total mesorectal excision
The Da Vinci Surgical System may help to protect subtle anatomical structure and provide more functional protection when compared to laparoscopic surgery. This study aimed to compare RTME and laparoscopic total mesorectal excision (LTME) for rectal cancer with regard to Urinary, sexual function and sphincter- preservation outcomes.
Traditional laparoscopic total mesorectal excision (LTME) for rectal cancer.
Sponsors
Southwest Hospital, China
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* 1\. Patients who are acceptable to two surgical procedures for the robot- assisted or laparoscopy-assisted rectal cancer, are willing to randomized trial; * 2\. Matching the diagnostic criteria; * 3\. Aged 18-70 years old; * 4\. Preoperative TNM staging (CT, laparoscopic exploration): cT1-3N0-3M0 (excluding M1, T4); * 5\. Preoperative ASA 3 scores; * 6\. There was no history of malignancy, no other malignant tumors by preoperative examination; * 7\. Without undergoing definitive treatment, such as radiotherapy, chemotherapy or immunotherapy preoperatively; * 8\. The informed consent form was signed by the patient himself(herself)or his principal agent; * 9\. In accordance with the international erectile function questionnaire (IIEF) urinary function scale, The urinary sexual function are normal.
Exclusion criteria
* 1\. Age less than 18 years old or more than 70 years old; * 2\. Previous psychiatric patients or patients refused to sign the informed consent; * 3\. Attending other related clinical studies on surgical treatment of rectal cancer; * 4\. The patient has a history of malignant tumor, or a combination of other malignant tumors; * 5\. Patients have been treated with definitive treatment: radiotherapy, chemotherapy or immunotherapy; * 6\. Patients had received otherper abdominal operations (except for laparoscopic cholecystectomy); * 7\. ASA \>3; * 8\. Laparoscopic surgical contraindications: such as severe heart lung disease; abdominal wall hernia; diaphragmatic hernia; coagulation disorder; portal hypertension; pregnancy, etc.; * 9\. Those who has been confirmed to be unable to do a radical resection (T4 stage) for local advanced tumor; * 10\. Those who have urination sexual dysfunction preoperatively.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of sexual and urinary dysfunction | One years after surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| disease-free survival(DFS ) | 3 years disease-free survival | DFS was defined as from the date of randomization to the date of tumor recurrence or death from any cause |
| Anus preservation rate | One years after surgery | — |
Outcome results
None listed