Effects of Modified Precision Functional Sphincter-Preserving Surgery (PPS) on Ultralow Rectal Ca… (NCT05245565) | Clinical Trial Compass
UnknownNot Applicable
Effects of Modified Precision Functional Sphincter-Preserving Surgery (PPS) on Ultralow Rectal Cancer
China120 participantsStarted 2021-05-01
Plain-language summary
RATIONALE: Colorectal cancer is one of the most common cancers. However, approaches to minimize surgical trauma, preserve anal function, avoid abdominal stoma, and improve quality of life for patients with ultralow rectal cancers were limited. Thus, new technologies are urgently needed to improve the anal preservation rate, reduce the incidence of anastomotic leakage and improve postoperative anal function in patients with ultralow rectal cancer.
PURPOSE: This one-arm multicenter prospective cohort study aims to collect the data of patients with ultralow rectal cancer who undergo sphincter-preserving surgeries, including modified PPS and conventional surgeries, then compare the effects of different operations on clinical outcomes and to see the efficacy and safety of modified PPS surgery when compared with conventional procedures in the treatment of ultralow rectal cancer.
Who can participate
Age range
18 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
. Histological proof of newly diagnosed primary adenocarcinoma of the rectum
. The lower edge of tumor \< 3 cm from the dentate line
. Clinical T stage ≤ T3
Exclusion criteria
. The lower edge of tumor \< 1 cm from the dentate line
. Locally advanced stage of tumor
. Presence of metastatic disease or recurrent rectal tumor
. Concomitant malignancies
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
Rate of temporary defunctioning stoma
Timeframe: Within 30 days after operation
2
The percentage of patients who develop anastomotic leakage
Timeframe: Within 30 days after operation
3
Postoperative anal function assessed by Wexner scale
Timeframe: 2 years since the start of treatment
4
Postoperative anal function assessed by Vaizey scale