Colonic Stenting With Elective Surgery Versus Emergency Surgery in the Management of Acute Malign… (NCT01997684) | Clinical Trial Compass
UnknownNot Applicable
Colonic Stenting With Elective Surgery Versus Emergency Surgery in the Management of Acute Malignant Colonic Obstruction
China200 participantsStarted 2013-07
Plain-language summary
The use of colonic stenting with elective surgery has been suggested as an alternative management for acute malignant colonic obstruction, as emergency surgery has a high risk of morbidity and mortality.
However, the available body of literature addressing their benefit in this setting is contradictory.
The purpose of this study is to determine the efficacy and safety of colonic stenting with elective surgery versus emergency surgery in the management of acute malignant colonic obstruction.
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:
* Above 18 years of age.
* Symptoms of colonic obstruction, existing less than one week.
* Malignant obstruction in the colon.
* Signed informed consent.
Exclusion Criteria:
* Severe cardio-pulmonary disease or other serious disease leading to unacceptable surgical risk.
* Patients with signs of peritonitis, perforation, sepsis, or other serious complications demanding emergency surgery.
* Patients with distal rectal cancer less than 8 cm from the anal verge.
* Patients with suspected or proven metastatic adenocarcinoma.
* Patients with unresectable colorectal cancer, or planning for palliative treatment.
* Previous colonic surgery.
* Pregnancy or lactation women, or ready to pregnant women.
* Not capable of filling out questionnaires.
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
Rates of primary colorectal anastomosis
Timeframe: From date of randomization until the first follow-up ended, assessed up to 30 days
Trial details
NCT IDNCT01997684
SponsorNanfang Hospital, Southern Medical University