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Single Incision Laparoscopic Surgery in Treating Patients With Colorectal Disease

NCT ID: NCT01656746

Last Updated: 2017-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2013-10-31

Brief Summary

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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

Detailed Description

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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.

Conditions

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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

Keywords

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Colorectal Disease SILS colorectal surgery

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment (single incision laparoscopic surgery)

Patients undergo single incision laparoscopic surgery with GelPort® attachment.

Group Type EXPERIMENTAL

therapeutic laparoscopic surgery

Intervention Type PROCEDURE

Undergo single incision laparoscopic surgery

Interventions

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therapeutic laparoscopic surgery

Undergo single incision laparoscopic surgery

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ohio State University Comprehensive Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David Renton, MD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

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Ohio State University Medical Center

Columbus, Ohio, United States

Site Status

Countries

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United States

Related Links

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http://cancer.osu.edu

Jamesline

Other Identifiers

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NCI-2012-00604

Identifier Type: REGISTRY

Identifier Source: secondary_id

OSU-09123

Identifier Type: -

Identifier Source: org_study_id