Single Incision Laparoscopic Surgery in Treating Patients With Colorectal Disease

Completed · Not applicable

Conditions studied: Adenomatous Polyp, Crohn Disease, Familial Adenomatous Polyposis, Hereditary Intestinal Polyposis Syndrome, Recurrent Colon Cancer, Stage I Colon Cancer, Stage IIA Colon Cancer, Stage IIB Colon Cancer, Stage IIC Colon Cancer, Stage IIIA Colon Cancer, Stage IIIB Colon Cancer, Stage IIIC Colon Cancer

In brief

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

Key facts

Study ID

NCT01656746

Run by

Ohio State University Comprehensive Cancer Center

People needed

10

Starts

2010-05-01

Expected to finish

2013-10-01

Last updated by the study team

2017-12-06

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Ohio State University Medical Center — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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