Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Length of Hospital Stay, Nursing Hours and Recovery After Laparoscopic Versus Open Colon Resection Without Fast Track

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01127425
Recruitment Status : Terminated (Due to reorganisation in the hospital structure)
First Posted : May 20, 2010
Last Update Posted : June 7, 2010
Sponsor:
Information provided by:
University Hospital, Gentofte, Copenhagen

Brief Summary:
A blinded randomized trial. Length of hospital stay, nursing hours and recovery after laparoscopic versus open colonic resection without fast track.

Condition or disease Intervention/treatment Phase
Sigmoid Neoplasms Procedure: laparoscopic colonic resection Procedure: laparoscopic sigmoid resection Not Applicable

Detailed Description:

CONTEXT: Our preliminary experience (unpublished) indicate that less nursing hours are needed after laparoscopic colon resection without fast track. Length of hospital stay and recovery seems to be reduced as well.

OBJEKTIVE: To compare laparoscopic and open colonic resection concerning nursing hours, length of hospital stay and recovery.

DESIGN, SETTING AND PATIENTS: triple blinded study (Patient, nursing staff and data collector) including 2 x 12 patients needing sigmoid resection due to cancer. Nursing hours, length of hospital stay and recovery (postoperative pain, questionnaire, actigraph ect.)


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Length of Hospital Stay, Nursing Hours and Recovery After Laparoscopic Versus Open Colon Resection Without Fast Track
Study Start Date : July 2006
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 1
Intervention: Surgery: laparoscopic sigmoid resection without fast track postoperative care
Procedure: laparoscopic sigmoid resection
sigmoid resection by laparoscopic surgery

Active Comparator: 2
Intervention: Surgery: conventional (open) sigmoid resection without fast track postoperative care
Procedure: laparoscopic colonic resection
Conventional surgery compared to laparoscopic sigmoid resection




Primary Outcome Measures :
  1. primary: Length of stay [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. secondary: Nursing hours, pain and recovery [ Time Frame: 1 year ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   40 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • sigmoid resection without stoma
  • sigmoid neoplasms localized 20 cm from anus
  • age 40-90

Exclusion Criteria:

  • conversion from laparoscopic to open surgery
  • stoma
  • severe postoperative complications (anastomosis leak, intraabdominal abscess, reoperation, stay at intensive care unit, heart attack, pulmonary embolism)
  • no informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01127425


Locations
Layout table for location information
Denmark
University Hospital of Gentofte, gastroenterologic surgery
Hellerup, Denmark, 2900
Sponsors and Collaborators
University Hospital, Gentofte, Copenhagen
Investigators
Layout table for investigator information
Principal Investigator: Britta Kaltoft, doctor University of Gentofte

Layout table for additonal information
Responsible Party: Doctor Britta Kaltoft, Gentofte Hospital, Copenhagen
ClinicalTrials.gov Identifier: NCT01127425     History of Changes
Other Study ID Numbers: KA-20060067
First Posted: May 20, 2010    Key Record Dates
Last Update Posted: June 7, 2010
Last Verified: June 2006

Keywords provided by University Hospital, Gentofte, Copenhagen:
nursing hours
length of hospital stay
reconvalescence
colorectal surgery
laparoscopic
sigmoid neoplasms

Additional relevant MeSH terms:
Layout table for MeSH terms
Sigmoid Neoplasms
Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Sigmoid Diseases