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Completed

NCT Number: NCT01879605

Study About Effect of Preoperative Bowel Preparation Versus no Bowel Preparation Before Spinal Surgery

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

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Key information

Conditions

Constipation Digestive System Diseases Gastrointestinal Diseases Ileus Intestinal Diseases Intestinal Obstruction Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Surgery

Age range

15 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Oslo Universitetssykehus

Oslo, 0424, Norway

About this study

This was a randomised clinical trial with one control group and two treatment groups.

Forty-five elective spinal fusion patients were randomised into three groups who received preoperative treatment with either enema of sorbitol and docusat natrium, Bisacodyl suppository or no bowel preparation.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • Exclusion Criteria:
  • Constipation
  • Regularly use of enema

Treatment and study plan

Docusate natrium and sorbitol

Drug

Other names: Klyx

Bisacodyl

Drug

Other names: Dulcolax

Primary outcomes

  1. Defecation within 72 hours postoperatively

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

Secondary outcomes

  1. Postoperative constipation

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

Other outcomes

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

    Time frame: Nausea

  2. Pain

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

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Registry information

Official study title

Preoperative Bowel Preparation Versus no Preparation Before Spinal Surgery: a Randomised Clinical Trial

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Jun 18, 2013
Registry last updated
Jun 18, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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