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

Primary Purpose

Sigmoid Neoplasms

Status
Terminated
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
laparoscopic colonic resection
laparoscopic sigmoid resection
Sponsored by
University Hospital, Gentofte, Copenhagen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sigmoid Neoplasms focused on measuring nursing hours, length of hospital stay, reconvalescence, colorectal surgery, laparoscopic, sigmoid neoplasms

Eligibility Criteria

40 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital of Gentofte, gastroenterologic surgery

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

Intervention: Surgery: laparoscopic sigmoid resection without fast track postoperative care

Intervention: Surgery: conventional (open) sigmoid resection without fast track postoperative care

Outcomes

Primary Outcome Measures

primary: Length of stay

Secondary Outcome Measures

secondary: Nursing hours, pain and recovery

Full Information

First Posted
February 17, 2010
Last Updated
June 4, 2010
Sponsor
University Hospital, Gentofte, Copenhagen
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1. Study Identification

Unique Protocol Identification Number
NCT01127425
Brief Title
Length of Hospital Stay, Nursing Hours and Recovery After Laparoscopic Versus Open Colon Resection Without Fast Track
Official Title
Length of Hospital Stay, Nursing Hours and Recovery After Laparoscopic Versus Open Colon Resection Without Fast Track
Study Type
Interventional

2. Study Status

Record Verification Date
June 2006
Overall Recruitment Status
Terminated
Why Stopped
Due to reorganisation in the hospital structure
Study Start Date
July 2006 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospital, Gentofte, Copenhagen

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sigmoid Neoplasms
Keywords
nursing hours, length of hospital stay, reconvalescence, colorectal surgery, laparoscopic, sigmoid neoplasms

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Intervention: Surgery: laparoscopic sigmoid resection without fast track postoperative care
Arm Title
2
Arm Type
Active Comparator
Arm Description
Intervention: Surgery: conventional (open) sigmoid resection without fast track postoperative care
Intervention Type
Procedure
Intervention Name(s)
laparoscopic colonic resection
Intervention Description
Conventional surgery compared to laparoscopic sigmoid resection
Intervention Type
Procedure
Intervention Name(s)
laparoscopic sigmoid resection
Intervention Description
sigmoid resection by laparoscopic surgery
Primary Outcome Measure Information:
Title
primary: Length of stay
Time Frame
1 year
Secondary Outcome Measure Information:
Title
secondary: Nursing hours, pain and recovery
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Britta Kaltoft, doctor
Organizational Affiliation
University of Gentofte
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of Gentofte, gastroenterologic surgery
City
Hellerup
ZIP/Postal Code
2900
Country
Denmark

12. IPD Sharing Statement

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

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