The Application Value of da Vinci Linear Cutting Stapler SureForm in Robotic Anus Preserving Surg… (NCT05667181) | Clinical Trial Compass
CompletedNot Applicable
The Application Value of da Vinci Linear Cutting Stapler SureForm in Robotic Anus Preserving Surgery for Rectal Cancer
China276 participantsStarted 2022-12-29
Plain-language summary
Anastomotic complications are serious complications after anus preserving surgery for rectal cancer,the instrument anastomosis technology are one of the factors that influence the occurrence of anastomotic complications after surgery,the laparoscopic linear cutting closure device used in robotic rectal cancer may increase the occurrence of anastomotic complications,but the robot linear cutting stapler (SureForm) may reduce the incidence of postoperative anastomotic complications due to the technical advantages,therefore,the aim of this study is to evaluate the impact of robotic linear cutting stapler SureForm and laparoscopic linear cutting stapler on the incidence of anastomotic complications after robotic rectal cancer anus preserving surgery.
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
. The age is more than 18 years old and less than or equal to 80 years old
. Pathological diagnosis of rectal adenocarcinoma by colonoscopy biopsy
. The distance between the tumor and the anal margin diagnosed by colonoscopy and pelvic MRI before operation is less than or equal to 15cm
. No distant metastasis (including pelvic cavity, peritoneum, liver, lung, brain, bone, distant lymph node metastasis, etc.) is judged by ultrasound, CT, PET-CT, etc
. No local complications before operation (no obstruction, incomplete obstruction, no massive active bleeding, no perforation, abscess formation, no local invasion)
. Robot surgery
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.
. Voluntary participation and signing of informed consent
Exclusion criteria
. Previous history of malignant colorectal tumors
. Simultaneous diagnosis of multiple primary colorectal tumors
. Those who have performed abdominal and pelvic surgery for many times or have extensive abdominal adhesions
. Patients with familial adenomatous polyposis, Lynch syndrome associated rectal cancer, and inflammatory bowel disease at active stage
. Diagnosis of other malignant tumors in recent 5 years
. ASA grade ≥ IV and/or ECOG physical status score ≥ 2
. Patients with severe liver and kidney function, heart and lung function, blood coagulation dysfunction or combined with severe basic diseases can not tolerate surgery