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

18 Years
80 Years
Open (Enrolling)
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

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Trial Information

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


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

II. To standardize the SILS technique.


Patients undergo single incision laparoscopic surgery with GelPortĀ® 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

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Operative time

Outcome Description:

Summarized using descriptive statistics (i.e. means, standard deviations, 95% confidence intervals for continuous variables, and frequencies for discrete data).

Outcome Time Frame:

Up to 1 year

Safety Issue:


Principal Investigator

David Renton, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Ohio State University


United States: Institutional Review Board

Study ID:




Start Date:

May 2010

Completion Date:

Related Keywords:

  • 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
  • Colorectal Disease
  • SILS
  • colorectal surgery
  • Colonic Neoplasms
  • Crohn Disease
  • Adenomatous Polyposis Coli
  • Adenomatous Polyps
  • Intestinal Polyposis



Ohio State University Medical Center Columbus, Ohio  43210