Trial record 2 of 673 for:    "Colonic Neoplasms"

Right-sided Colon Tumor, Laparoscopic Versus Open Surgery, in an ERAS Protocol

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Danderyd Hospital
University Hospital Orebro
Ersta Hospital, Sweden
Information provided by (Responsible Party):
Ulf Gustafsson, Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT01831245
First received: February 25, 2013
Last updated: April 10, 2013
Last verified: April 2013
  Purpose

Register study. Patients who had been operated for right-sided colon tumor or benign adenoids between year 2011 to 2012. The study compare open surgery with laparoscopic surgery in an ERAS (Enhanced Recovery After Surgery) protocol.

Hypothesis:

Operation of right-sided colon tumor and large benign adenoids, a better selection of patients for open or laparoscopic surgery can improve short term results.


Condition
Colon Tumor

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: Right-sided Colon Tumor, Laparoscopic and Open Surgery, in an ERAS Protocol

Resource links provided by NLM:


Further study details as provided by Karolinska Institutet:

Primary Outcome Measures:
  • Pathological Anatomic diagnosis (PAD) on a tumor biopsy [ Time Frame: day of surgery ] [ Designated as safety issue: No ]

    After PAD result, malign or benign tumor, type of malign tumor,tumor growth, stage, lymphatic recharge.

    Right selection of patients to laparoscopic versus open surgery in relation to PAD result?



Secondary Outcome Measures:
  • Length of hospital stay, days [ Time Frame: 30 days after surgery ] [ Designated as safety issue: No ]
    Compare laparoscopic versus open surgery

  • C - reactive protein [ Time Frame: 1-7 days after surgery ] [ Designated as safety issue: No ]
    Inflammation answer laparoscopic versus open surgery


Other Outcome Measures:
  • Immobilizing patient after surgery [ Time Frame: 4 -10 hours after surgery ] [ Designated as safety issue: No ]
    After laparoscopic versus open surgery

  • Leakage of anastomosis [ Time Frame: 0 - 30 days after surgery ] [ Designated as safety issue: No ]
    Compare laparoscopic versus open surgery


Enrollment: 125
Study Start Date: January 2011
Estimated Study Completion Date: May 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Right sided colom tumor or large benign adenoids

Criteria

Inclusion Criteria:

  • right-sided colon tumor or large benign adenoids

Exclusion Criteria:

  • none
  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: NCT01831245

Locations
Sweden
Ersta Hospital
Stockholm, Sweden, 116 91
Danderyds Hospital
Stockholm, Sweden, 182 88
Örebro University Hospital
Örebro, Sweden, 701 85
Sponsors and Collaborators
Karolinska Institutet
Danderyd Hospital
University Hospital Orebro
Ersta Hospital, Sweden
Investigators
Principal Investigator: Ulf Gustafsson, MD, PhD Karolinska Institutet
  More Information

No publications provided

Responsible Party: Ulf Gustafsson, MD, PhD, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT01831245     History of Changes
Other Study ID Numbers: 2012/2105-31/2
Study First Received: February 25, 2013
Last Updated: April 10, 2013
Health Authority: Sweden: The National Board of Health and Welfare

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

ClinicalTrials.gov processed this record on July 26, 2014