Single Incision Laparoscopic Surgery in Treating Patients With Colorectal Disease

NCT01656746 | Completed DMC

• 2 other identifiers: OSU-09123NCI-2012-00604
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

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

Outcome Measures

Primary Outcomes (4)

• Operative time

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

  Up to 1 year

• Length of skin and fascial incisions

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

  Up to 1 year

• Estimated blood loss

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

  Up to 1 year

• 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

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

  Up to 1 year

Secondary Outcomes (11)

• Quality of life measured using the short form (SF)-12 health related quality of life scale (HQRL) scored using quality metric licensed software

  Baseline

• Quality of life measured using the SF-12 HQRL scored using quality metric licensed software

  2 weeks

• Quality of life measured using the SF-12 HQRL scored using quality metric licensed software

  3 months

• Quality of life measured using the SF-12 HQRL scored using quality metric licensed software

  6 months

• Visual analogue pain scale scored on the scale from 0 to 10 where 0 is no pain, and 10 is the maximum pain

  Baseline

Study Arms (1)

Treatment (single incision laparoscopic surgery)

EXPERIMENTAL

Patients undergo single incision laparoscopic surgery with GelPort® attachment.

Procedure: therapeutic laparoscopic surgery

Interventions

therapeutic laparoscopic surgery PROCEDURE

Undergo single incision laparoscopic surgery

Treatment (single incision laparoscopic surgery)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead

Study Sites (1)

Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

Related Links

• Jamesline

MeSH Terms

Conditions

Adenomatous Polyps; Crohn Disease; Adenomatous Polyposis Coli; Peutz-Jeghers Syndrome; Colonic Neoplasms

Condition Hierarchy (Ancestors)

Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplastic Syndromes, Hereditary; Colonic Diseases; Intestinal Polyposis; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Lentigo; Melanosis; Hyperpigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• David Renton, MD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2012
• First Posted: August 3, 2012
• Study Start: May 1, 2010
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: December 6, 2017

Record last verified: 2017-12

Locations

US (1)