Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200032, China
NCT Number: NCT01985698
In this study, the investigators assessed the difference in efficacy and safety among robotic-assisted versus laparoscopic abdominoperineal resection for patients with low rectal cancer.
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Notify Me18 year–75 year
All sexes
Interventional
Not applicable
Shanghai, Shanghai Municipality, 200032, China
Patients will be eligible for inclusion if their primary tumors is low rectal cancer.
Eligible patients will be randomly assigned to robotic-assisted (arm A) versus laparoscopic (arm B) abdominoperineal resection.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Robotic-assisted abdominoperineal resection.
Laparoscopic abdominoperineal resection
Time frame: 30 days post operatively
postoperative complications related to operation
Time frame: 30 days post operatively
death occurred 30 days after operation
Time frame: 3 years
disease-free survival rate at 3 years after operation
Time frame: 3 and 5 years
overall survival rate at 3 and 5 years after operation
Time frame: 3 and 5 years
local recurrence rate at 3 and 5 years after operation
Time frame: Day 1
Time from cutting the skin to suturing the incision during the surgery, recorded in minute
Time frame: Day 1
The rate of patients actually receiving open surgery in robotic or laparoscopic surgery groups.
Time frame: Day 1
Blood loss will be measured according to the suction and the weight of wet gauze, and then minus the irrigation.
Time frame: 10 days post operatively
The circumferential margin will be reported as "positive" or "negative" to define whether tumor is radically resected. It will be reported according to the post-operative pathology. Details are based on NCCN and Chinese guidelines for colorectal cancer.
Time frame: 10 days post operatively
The proximal/distal resection margin will be reported as "positive" or "negative" to define whether tumor is radically resected. It will be reported according to the post-operative pathology. Details are based on NCCN and Chinese guidelines for colorectal cancer.
Time frame: 10 days post operatively
It will be reported according to the post-operative pathology.
Time frame: 30 days post operatively
The postoperative hospital stay is defined as the number of date from the first day after operation to discharge.
Time frame: at postoperative 3, 6 and 1 2 months
This section is assessed using a self-rating scale "International prostate symptom score" (IPSS)
Time frame: at postoperative 3, 6 and 1 2 months
This section is assessed using a self-rating scale "International Index of Erectile Function" (IIEF-5).
Time frame: at postoperative 3, 6 and 1 2 months
This section is assessed using a self-rating scale "Female Sexual Function Index" (FSFI).
Fudan University
Other
A Single-centre, Prospective, Randomised, Controlled, Unblinded, Parallel-group Trial of Robotic-assisted Versus Laparoscopic Abdominoperineal Resection for the Curative Treatment of Low Rectal Cancer
Acronym: RLAPR
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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