Prevention of Constipation: Systematic Nursing Interventi... | NCT00364169

Studies
Prevention of Constipation: Systematic Nursing Interventions to Reduce Postoperative Constipation After Thoracic Surgery

NCT00364169

Sponsor

Rigshospitalet, Denmark

Status

Completed

Last Update Posted

Jul 1, 2008Estimated

Enrollment

58Actual

Phase

Not Applicable

Conditions

Postoperative Constipation

Interventions

Degree of constipation

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2006

Primary Completion Date

Dec 2006Actual

Completion Date

Dec 2006Actual

First Submitted Date

Aug 11, 2006

First Submission Date that Met QC Criteria

Aug 11, 2006

First Posted Date

Aug 15, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 27, 2008

Last Update Posted Date

Jul 1, 2008Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Rigshospitalet, DenmarkOTHER

Collaborators

Name	Class
Institute of public health, department of nursing sciences, Århus University, Denmark	OTHER

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

58Actual

Name	Type	Description	Arm Group Labels	Other Names
Degree of constipation	Procedure

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Constipation incidence the first month after surgery

Secondary Outcomes

Measure	Description	Time Frame
Defecation pattern measured after The Bristol Stool scale.
ADL (after Sallings functional scale)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Cardiothoracic Surgery, The Heart Center, University hospital Rigshospitalet		Copenhagen		2100	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D003248	Constipation
D009369	Neoplasms

Ancestor Terms

ID	Term
D012817	Signs and Symptoms, Digestive
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided