NCT00364169

Brief Summary

The purpose of the study is to reduce the incidence of postoperative constipation by systematic nurse assessment, interventions and evaluation, in the first month after thoracic surgery.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2006

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 11, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 15, 2006

Completed
17 days until next milestone

Study Start

First participant enrolled

September 1, 2006

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

July 1, 2008

Status Verified

June 1, 2008

Enrollment Period

3 months

First QC Date

August 11, 2006

Last Update Submit

June 27, 2008

Conditions

Postoperative Constipation

Keywords

constipationcancersurgeryinterventionnursingpostoperative

Outcome Measures

Primary Outcomes (1)

  • Constipation incidence the first month after surgery

Secondary Outcomes (2)

  • Defecation pattern measured after The Bristol Stool scale.

  • ADL (after Sallings functional scale)

Interventions

Degree of constipationPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients admitted for planned lung surgery
  • Patients are capable
  • Able to talk and understand Danish

You may not qualify if:

  • Patients with colostomy and / or ileostomy
  • Neurological or abdominal diseases
  • Feed through a tube

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Cardiothoracic Surgery, The Heart Center, University hospital Rigshospitalet

Copenhagen, 2100, Denmark

Location

MeSH Terms

Conditions

ConstipationNeoplasms

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Lene S. Rasmussen, RN,Stud.-MPH

    Department of Cardiothoracic Surgery, The Heart Center, University hospital, Rigshospitalet, Copenhagen, Denmark

    PRINCIPAL INVESTIGATOR

  • Lene S. Rasmussen, RN,Stud.-MPH

    Department of Cardiothoracic Surgery, The Heart Center, University hospital Rigshospitalet, Copenhagen, Denmark

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 11, 2006

First Posted

August 15, 2006

Study Start

September 1, 2006

Primary Completion

December 1, 2006

Study Completion

December 1, 2006

Last Updated

July 1, 2008

Record last verified: 2008-06

Locations

DK(1)