Single Incision Laparoscopic Surgery in Treating Patients With Colorectal Disease



Status:Completed
Conditions:Colorectal Cancer, Cancer, Gastrointestinal, Crohns Disease
Therapuetic Areas:Gastroenterology, Oncology
Healthy:No
Age Range:18 - 80
Updated:12/8/2017
Start Date:May 2010
End Date:October 2013

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Single Incision Laparoscopic Surgery (SILS) for Colorectal Disease - A Novel Approach

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

PRIMARY OBJECTIVES:

I. To report the experience of SILS procedure in the treatment of colorectal disease.

II. To standardize the SILS technique.

OUTLINE:

Patients undergo single incision laparoscopic surgery with GelPort® attachment.

After completion of study treatment, patients are followed up at 2 weeks, 3 and 6 months, and
at 1 year.

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
We found this trial at
1
site
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mi
from
Columbus, OH
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