Uncut Roux-en-y Anastomosis Reduce Postoperative Complication and Improve Nutritional Status Afte… (NCT02763878) | Clinical Trial Compass
UnknownPhase 3
Uncut Roux-en-y Anastomosis Reduce Postoperative Complication and Improve Nutritional Status After Distal Gastrectomy
China832 participantsStarted 2016-09
Plain-language summary
The investigators intend to conduct multi-center randomized controlled study to find if Uncut Roux-en-Y anastomosis to the distal gastric cancer patients after radical D2 can reduce the long-term complications, affect the quality of life, and improve the prognosis, comparing to Billroth II anastomosis.
Who can participate
Age range
18 Years – 70 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
. pathological diagnosed as the gastric carcinoma, the possibility of removal by the surgeon and imaging physician assessment.
. no previous history of other malignancies combined.
. patients have signed informed consent;
. aged 18 to 80 years old, male or female patients;
. cardiopulmonary, liver and kidney function was normal, ECOG physical status score of 0 to 1 (see Appendix);
. the clinician determine the patient does not need emergency surgery;
Exclusion criteria
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
Number of participants with treatment-related gastrointestinal and gastroesophageal reflux as assessed by The Los Angeles and Savary-Miller systems for grading esophagitis
Timeframe: 0-5 years
Trial details
NCT IDNCT02763878
SponsorSixth Affiliated Hospital, Sun Yat-sen University
. suffering from other serious diseases, including cardiovascular, respiratory, kidney, or liver disease, poorly controlled hypertension merger, diabetes patients;
. or mental illness;
. 4 weeks prior to enrollment participated or are participating in other clinical trials of patients;
. had undergone surgery, and its influence has not been eliminated in the patient;