Single Incision Laparoscopic Surgery in Treating Patients With Colorectal Disease

The Ohio State University

Status: Completed

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

Treatments: Procedure: therapeutic laparoscopic surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT01656746

NCI-2012-00604 (Registry Identifier)

OSU-09123

Details and patient eligibility

About

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

Full description

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.

Enrollment: 10 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Treatment (single incision laparoscopic surgery)

Experimental group

Description:

Patients undergo single incision laparoscopic surgery with GelPort® attachment.

Treatment:

Procedure: therapeutic laparoscopic surgery