Trial record 20 of 223 for:    Open Studies | "Colonic Neoplasms"

The 'SILVERMAN1' Trial Single Incision Laparoscopic Versus Existing Resection (Minimal Access) for Neoplasia (SILVERMAN 1)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2012 by Irish Clinical Outcomes in Research and Education
Sponsor:
Collaborator:
The Cleveland Clinic
Information provided by (Responsible Party):
Irish Clinical Outcomes in Research and Education
ClinicalTrials.gov Identifier:
NCT01319890
First received: March 2, 2011
Last updated: March 31, 2012
Last verified: March 2012
  Purpose

Current evidence regarding the optimal surgical approach to potentially curable right colonic cancer is based on numerous, well designed randomised controlled clinical trials. Currently, eminence based opinion suggests that an alternative surgical technique, single incision laparoscopic surgery (SILS), may improve short and long term outcomes after minimally invasive right colonic resection. A true, prospective analysis comparing standard of care (laparoscopic right hemicolectomy) and this "new" therapy(SILS) has yet to be published. Having established the optimum treatment modality the minimally invasive approach to right colonic tumors the results will be communicated at national and international meetings.


Condition Intervention
Right Colon Tumors
Procedure: Patients will be divided in two groups- those having right colectomy by standard laparoscopy and those having Single Incision Laparoscopic Surgery (SILS)

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: The 'SILVERMAN1' Trial Single Incision Laparoscopic Versus Existing Resection (Minimal Access) for Neoplasia

Resource links provided by NLM:


Further study details as provided by Irish Clinical Outcomes in Research and Education:

Primary Outcome Measures:
  • operative time [ Time Frame: Within 3 months of surgery ] [ Designated as safety issue: No ]
    The length of time taken to complete each procedure will be recorded

  • pain scores (visual analog scale) [ Time Frame: Within 90 days of surgery ] [ Designated as safety issue: No ]
    Pain scores will be calculated on day 1,2 and 3 post-operatively and on first clinic visit

  • cosmesis satisfaction [ Time Frame: within 1 year of surgery ] [ Designated as safety issue: No ]
  • Peri-operative complications will be recorded within 3 months of the index operation [ Time Frame: within 3 months of surgery ] [ Designated as safety issue: No ]
    early morbidity- wound/respiratory / urinary sepsis, thromboembolic, cardiorespiratory, anastomotic leak, intra-abdominal abscess, reoperation

  • Intravenous narcotic/ oral analgesic requirements [ Time Frame: Within 3 months of surgery ] [ Designated as safety issue: No ]
    Patients analgesic requirements will be calculated both in-hospital and after discharge records will be detailed at clinic visit

  • Resumption of intestinal function/ diet - Duration to discharge home - Return to normal activity [ Time Frame: within 3 months of surgery ] [ Designated as safety issue: No ]
    Time to passage of flatus, bowel motion and dietary intake will be recorded while the patient is in hospital

  • Duration to discharge home [ Time Frame: within 3 months of date of surgery ] [ Designated as safety issue: No ]
    Time patient is in hospital will be recorded on discharge from the unit

  • Return to normal activity/work [ Time Frame: within 6 months of surgery ] [ Designated as safety issue: No ]
    The timeframe from surgery to resumption of normal activities of daily living and return to work will be determined at patients second clinic visit


Secondary Outcome Measures:
  • Lymph node yield [ Time Frame: within 3 months of surgery ] [ Designated as safety issue: No ]
    The pathology specimen detailing the lymph node count will be entered at first clinic visit post-operatively or within 3 months of surgery

  • Conversion rate [ Time Frame: Within 3 months of surgery ] [ Designated as safety issue: No ]
    The conversion from a laparoscopic to an open procedure will be known at time of operation and will be recorded prior to patient discharge or at the first clinic visit

  • 30 day mortality [ Time Frame: within 3 months of surgery ] [ Designated as safety issue: Yes ]
    Mortality rates within 30 days will be recorded during the hospitl stay or within 3 months of surgery

  • Cancer free survival [ Time Frame: 5 years following the date of surgery ] [ Designated as safety issue: Yes ]
    Cancer free survival will be determined at 5 years from the index surgery. Expected 5 years, disease free survival should be equivalent if the hypothesis is true.


Estimated Enrollment: 300
Study Start Date: July 2011
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Right Colectomy for colonic tumors
The group of patients enrolled will be patients with biopsy proven right colon tumors, both benign and malignant. These patients will then be subdivided into those having conventional laparoscopic right colectomy and SILS right colectomy
Procedure: Patients will be divided in two groups- those having right colectomy by standard laparoscopy and those having Single Incision Laparoscopic Surgery (SILS)
Patients will be divided into 2 arms- those with right colon tumors treated by conventional laparoscopic right colectomy and those having a Single Incision Laparoscopic Surgery (SILS)

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients with histologically proven right colon tumors, benign and malignant, aged 18-85 years will be included.

Criteria

Inclusion Criteria:

  1. Age 18-85 years
  2. Histologic confirmation of right colonic cancer
  3. Informed consent

Exclusion Criteria:

  1. Inability to give informed consent (e.g. dementia)
  2. Previous midline laparotomy incision
  3. T4 tumour diagnosed on pre-operative imaging or intra-operatively
  4. Previous pelvic irradiation
  5. FAP/ HNPCC
  6. Colonic carcinoma against a background of ulcerative colitis.
  7. Emergent surgery for perforated/obstructing right colonic cancer
  8. Pregnancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01319890

Contacts
Contact: Des Winter, M.D. F.R.C.S.I. winterd@indigo.ie

Locations
Ireland
St. Vincent's University Hospital Recruiting
Dublin, Ireland
Contact: Des Winter, M.D.F.R.C.S.I.       winterd@indigo.ie   
Contact: Sean Martin, M.D.F.R.C.S.I.         
Principal Investigator: Des Winter, M.D.F.R.C.S.I.         
Sponsors and Collaborators
Irish Clinical Outcomes in Research and Education
The Cleveland Clinic
Investigators
Principal Investigator: Des Winter, MD FRCSI St. Vincent's University Hospital, Dublin, Ireland
  More Information

Publications:

Responsible Party: Irish Clinical Outcomes in Research and Education
ClinicalTrials.gov Identifier: NCT01319890     History of Changes
Other Study ID Numbers: Silverman1
Study First Received: March 2, 2011
Last Updated: March 31, 2012
Health Authority: Ireland: Research Ethics Committee

Keywords provided by Irish Clinical Outcomes in Research and Education:
all histologic subtypes
benign
malignant

Additional relevant MeSH terms:
Colonic Neoplasms
Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on July 24, 2014