Clinical trial NCT02164136: Laparoscopic Versus Open PANP-TME for Male Mid-low Rectal Cancer Patients
Official title: Comparisons of Urinary and Sexual Function Protection and Long-term Outcomes Between Laparoscopy-assisted and Open Pelvic Autonomic Nerve Preservation Total Mesorectum Excision for Male Mid-low Rectal Cancer Patients: a Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rectum Neoplasms
Lead sponsor: Third Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2014-06-16
Enrollment: 172
Sex: MALE
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: 3-year disease free survival rate
timeFrame: 36 months
measure: Urinary function
timeFrame: 30 days
measure: Sexual function
timeFrame: 30 days
measure: 5-year disease free survival rate
timeFrame: 60 months
measure: Urinary function
timeFrame: 36 months
measure: Sexual function
timeFrame: 36 months
Secondary outcomes:
measure: Morbidity
timeFrame: 30 days
measure: 3-year overall survival rate
timeFrame: 36 months
measure: 3-year recurrence pattern
timeFrame: 36 months
measure: Mortality
timeFrame: 30 days
measure: Morbidity
timeFrame: 36 months
measure: Mortality
timeFrame: 36 months
measure: 5-year overall survival rate
timeFrame: 60 months
measure: 5-year recurrence pattern
timeFrame: 60 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The Third Affiliated Hospital of Sun Yat-sen University
state: Guangdong
Study officials:
References: