Safety and Efficacy of Reduced-port Laparoscopic Surgery for Patients Of Colon and Upper Rectal C… (NCT05953662) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Safety and Efficacy of Reduced-port Laparoscopic Surgery for Patients Of Colon and Upper Rectal Cancer
China500 participantsStarted 2023-09-01
Plain-language summary
Colorectal cancer is the third most common malignant tumor. Radical resection is the mainstay of treatments for non-metastatic colorectal cancer. In case of traditional laparoscopic surgery, inexperienced assistants are likely to cause side injuries and interfere surgeon due to limited operating space. Reduced-port laparoscopic surgery has only 3 ports for surgeon and observer, and the surgeon completes the surgery independently, which increases the difficulty of the operation. However, reduced-port laparoscopy has some potential advantages and applications. Reduced-port laparoscopic surgery avoids the prolongation of the operation time and parainjury caused by inexperienced assistant. Reduced-port laparoscopy reduces some surgical incisions, resulting in less pain and faster recovery. Reduced-port laparoscopy also reduces the consumables, human resources and medical expenses. This study aims to evaluate the curative effect and safety of reduced-port laparoscopic surgery versus conventional laparoscopic surgery for resectable colorectal cancer.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age 18-80 years old;
. Pathological diagnosis of colorectal adenocarcinoma (including high, medium and low-differentiated adenocarcinoma, excluded: mucinous adenocarcinoma, signet ring cell carcinoma);
. Eastern Cooperative Oncology Group (ECOG) is 0-1 points;
. Chest, whole abdomen, pelvic enhanced CT confirm colon or upper rectal cancer, without distant metastasis;
. No other multiple primary tumors;
. No organ dysfunction;
. The patient and his/her family are able to understand the study protocol and are willing to participate in the study and sign informed consent.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
DFS rate
Timeframe: 1 year
Trial details
NCT IDNCT05953662
SponsorSixth Affiliated Hospital, Sun Yat-sen University