Single Incision Laparoscopic Surgery in Treating Patients With Colorectal Disease (NCT01656746) | Clinical Trial Compass
CompletedNot Applicable
Single Incision Laparoscopic Surgery in Treating Patients With Colorectal Disease
United States10 participantsStarted 2010-05
Plain-language summary
This study is being done to evaluate single incision laparoscopic surgery (SILS) for colorectal diseases, compared to multi-port laparoscopic surgery. This study is also intended to standardize the SILS technique for colorectal diseases
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:
* Patients who are willing to give consent and comply with the evaluation and the treatment schedule
* Patients with disease processes limited to the right colon; this will include Crohn's disease, polyp disease, and cancers of the right colon
* American Society of Anesthesiologists (ASA) =\< 3
Exclusion Criteria:
* Inability to obtain informed consent
* Previous right colon surgery
* Previous extensive abdominal surgery that would limit the laparoscopic approach
* Stage IV disease at surgery
* Metastatic disease diagnosed by computed tomography (CT), magnetic resonance imaging (MRI), or nuclear imaging
* Patient enrolled in other interventional study
* ASA score greater than 3
* Any condition which precludes compliance with the study (Investigator discretion)
* Co-morbid condition(s) that could limit the subject's ability to participate in the study or to comply with follow-up requirements, or that could impact the scientific integrity of the trial
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
Operative time
Timeframe: Up to 1 year
2
Length of skin and fascial incisions
Timeframe: Up to 1 year
3
Estimated blood loss
Timeframe: Up to 1 year
4
Oncologic sample including size of specimen removed, number of lymph nodes (LN) removed, pathological type and staging, lymph node, vessel or perineural invasion, and status of margins
Timeframe: Up to 1 year
Trial details
NCT IDNCT01656746
SponsorOhio State University Comprehensive Cancer Center