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 |
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
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.
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
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