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NCT Number: NCT01656746

Single Incision Laparoscopic Surgery in Treating Patients With Colorectal Disease

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

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Key information

Conditions

Adenomatous Polyp Adenoma Adenomatous Polyposis Coli Adenomatous Polyps Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Congenital, Hereditary, and Neonatal Diseases and Abnormalities Crohn Disease Digestive System Diseases Digestive System Neoplasms Familial Adenomatous Polyposis Gastroenteritis Gastrointestinal Diseases Gastrointestinal Neoplasms Genetic Diseases, Inborn Hereditary Intestinal Polyposis Syndrome Hyperpigmentation Inflammatory Bowel Diseases Intestinal Diseases Intestinal Neoplasms Intestinal Polyposis Lentigo Melanosis Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neoplastic Syndromes, Hereditary Peutz-Jeghers Syndrome Pigmentation Disorders Recurrent Colon Cancer Skin Diseases Skin and Connective Tissue Diseases 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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ohio State University Medical Center

Columbus, Ohio, 43210, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

therapeutic laparoscopic surgery

Procedure

Undergo single incision laparoscopic surgery

Primary outcomes

  1. Operative time

    Time frame: Up to 1 year

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

  2. Length of skin and fascial incisions

    Time frame: Up to 1 year

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

  3. Estimated blood loss

    Time frame: Up to 1 year

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

  4. 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

    Time frame: Up to 1 year

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

Secondary outcomes

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

    Time frame: Baseline

    Linear mixed model will be applied with repeated measures considering the observations from the same patient are correlated.

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

    Time frame: 2 weeks

    Linear mixed model will be applied with repeated measures considering the observations from the same patient are correlated.

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

    Time frame: 3 months

    Linear mixed model will be applied with repeated measures considering the observations from the same patient are correlated.

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

    Time frame: 6 months

    Linear mixed model will be applied with repeated measures considering the observations from the same patient are correlated.

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

    Time frame: Baseline

    Linear mixed model will be applied with repeated measures considering the observations from the same patient are correlated.

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

    Time frame: 2 weeks

    Linear mixed model will be applied with repeated measures considering the observations from the same patient are correlated.

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

    Time frame: 3 months

    Linear mixed model will be applied with repeated measures considering the observations from the same patient are correlated.

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

    Time frame: 6 months

    Linear mixed model will be applied with repeated measures considering the observations from the same patient are correlated.

  9. Visual analogue cosmesis scale scored on the scale from 0 to 10 where 0 is "worst scar", and 10 is the "best scar"

    Time frame: 2 weeks

    Linear mixed model will be applied with repeated measures considering the observations from the same patient are correlated.

  10. Visual analogue cosmesis scale scored on the scale from 0 to 10 where 0 is "worst scar", and 10 is the "best scar"

    Time frame: 3 months

    Linear mixed model will be applied with repeated measures considering the observations from the same patient are correlated.

  11. Visual analogue cosmesis scale scored on the scale from 0 to 10 where 0 is "worst scar", and 10 is the "best scar"

    Time frame: 6 months

    Linear mixed model will be applied with repeated measures considering the observations from the same patient are correlated.

Sponsors and collaborators

Lead sponsor

Ohio State University Comprehensive Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Aug 3, 2012
Registry last updated
Dec 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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