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


N/A
18 Years
80 Years
Open (Enrolling)
Both
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

Thank you

Trial Information

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


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

Type of Study:

Interventional

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:

No

Principal Investigator

David Renton, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Ohio State University

Authority:

United States: Institutional Review Board

Study ID:

OSU-09123

NCT ID:

NCT01656746

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

Name

Location
Ohio State University Medical Center Columbus, Ohio  43210