Clinical trial NCT01656746: Single Incision Laparoscopic Surgery in Treating Patients With Colorectal Disease
Official title: Single Incision Laparoscopic Surgery (SILS) for Colorectal Disease - A Novel Approach
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: 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: Colorectal Disease
SILS
colorectal surgery
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2012-08-03
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Operative time
timeFrame: Up to 1 year
measure: Length of skin and fascial incisions
timeFrame: Up to 1 year
measure: Estimated blood loss
timeFrame: Up to 1 year
measure: Oncologic sample including size of specimen removed, number of lymph nodes (LN) removed, pathological type and staging, lymph node, vessel or perineural invasion, and status of margins
timeFrame: Up to 1 year
Secondary outcomes:
measure: Quality of life measured using the short form (SF)-12 health related quality of life scale (HQRL) scored using quality metric licensed software
timeFrame: Baseline
measure: Quality of life measured using the SF-12 HQRL scored using quality metric licensed software
timeFrame: 2 weeks
measure: Quality of life measured using the SF-12 HQRL scored using quality metric licensed software
timeFrame: 3 months
measure: Quality of life measured using the SF-12 HQRL scored using quality metric licensed software
timeFrame: 6 months
measure: Visual analogue pain scale scored on the scale from 0 to 10 where 0 is no pain, and 10 is the maximum pain
timeFrame: Baseline
measure: Visual analogue pain scale scored on the scale from 0 to 10 where 0 is no pain, and 10 is the maximum pain
timeFrame: 2 weeks
measure: Visual analogue pain scale scored on the scale from 0 to 10 where 0 is no pain, and 10 is the maximum pain
timeFrame: 3 months
measure: Visual analogue pain scale scored on the scale from 0 to 10 where 0 is no pain, and 10 is the maximum pain
timeFrame: 6 months
measure: Visual analogue cosmesis scale scored on the scale from 0 to 10 where 0 is "worst scar", and 10 is the "best scar"
timeFrame: 2 weeks
measure: Visual analogue cosmesis scale scored on the scale from 0 to 10 where 0 is "worst scar", and 10 is the "best scar"
timeFrame: 3 months
measure: Visual analogue cosmesis scale scored on the scale from 0 to 10 where 0 is "worst scar", and 10 is the "best scar"
timeFrame: 6 months
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Ohio State University Medical Center
state: Ohio
Study officials:
affiliation: Ohio State University
name: David Renton, MD
role: PRINCIPAL_INVESTIGATOR
References: