NCT01879605

Brief Summary

This study investigated the effect of preoperative bowel preparations for patients undergoing spinal fusion surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Dec 2007

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

Study Start

First participant enrolled

December 1, 2007

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

June 13, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 18, 2013

Completed
Last Updated

June 18, 2013

Status Verified

June 1, 2013

Enrollment Period

2 years

First QC Date

June 13, 2013

Last Update Submit

June 17, 2013

Conditions

ConstipationIleusSurgery

Keywords

Spinal surgeryBowel preparationIleusConstipationWell-being

Outcome Measures

Primary Outcomes (1)

  • Defecation within 72 hours postoperatively

    The study's outcome measures were recorded every evening between 17.00 and 21.00 hours

Secondary Outcomes (1)

  • Postoperative constipation

    The study's outcome measures were recorded every evening between 17.00 and 21.00 hours

Other Outcomes (2)

  • The study's outcome measures were recorded every evening between 17.00 and 21.00 hours

    Nausea

  • Pain

    The study's outcome measures were recorded every evening between 17.00 and 21.00 hours

Study Arms (3)

Enema

EXPERIMENTAL

Docusate natrium and sorbitol, 240 ml enema, the evening before surgery

Drug: Docusate natrium and sorbitol

Suppository

ACTIVE COMPARATOR

Bisacodyl, suppository 10 mg, the evening before surgery.

Drug: Bisacodyl

Control grup

NO INTERVENTION

No intervention

Interventions

Docusate natrium and sorbitolDRUG
Also known as: Klyx
Enema
BisacodylDRUG
Also known as: Dulcolax
Suppository

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing spinal fusion surgery
  • Age 15 years or older
  • The patients had to understand oral and written Norwegian.
  • Postoperative pain management via epidural catheter should have been planned.

You may not qualify if:

  • Constipation
  • Regularly use of enema

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oslo Universitetssykehus

Oslo, Oslo County, 0424, Norway

Location

MeSH Terms

Conditions

ConstipationIleus

Interventions

SorbitolBisacodyl

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsIntestinal ObstructionIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Sugar AlcoholsAlcoholsOrganic ChemicalsCarbohydratesCresolsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Study Officials

  • Ida T Bjork, MNSc, PhD,

    University of Oslo, Institute of Health and society

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 13, 2013

First Posted

June 18, 2013

Study Start

December 1, 2007

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

June 18, 2013

Record last verified: 2013-06

Locations

NO(1)