Multicenter Study on Laparoscopic Versus Open PANP-TME for Male Mid-low Rectal Cancer Patients
NCT ID: NCT02165800
Last Updated: 2018-04-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
667 participants
INTERVENTIONAL
2014-01-31
2023-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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 multiple-center 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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Laparoscopic Versus Open PANP-TME for Male Mid-low Rectal Cancer Patients
NCT02164136
Multicenter Study on Preservation Versus Excision of Denonvilliers Fascia in L-PANP Surgery
NCT02435758
Preservation Versus Excision of Denonvilliers Fascia in L-PANP Surgery
NCT02311803
Transanal Total Mesorectal Excision Versus Laparoscopic TME for Rectal Cancer
NCT02252250
Low or High Ligation of the IMA With Apical Lymph Node Dissection in Rectal Cancer Laparoscopic Surgery
NCT03013153
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
O-PANP-TME
Open pelvic autonomic nerve preservation total mesorectum excision for male mid-low rectal cancer patients
O-PANP-TME
L-PANP-TME
Laparoscopy-assisted pelvic autonomic nerve preservation total mesorectum excision for male mid-low rectal cancer patients
L-PANP-TME
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
L-PANP-TME
O-PANP-TME
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
20 Years
60 Years
MALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
First Affiliated Hospital, Sun Yat-Sen University
OTHER
Sixth Affiliated Hospital, Sun Yat-sen University
OTHER
Nanfang Hospital, Southern Medical University
OTHER
Southern Medical University, China
OTHER
Third Affiliated Hospital, Sun Yat-Sen University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Hongbo Wei
Chief of surgery
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Hongbo Wei, M.D., Ph.D.
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CUSTOMER-001
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.