The Effect of Bowel Preparation on Perioperative Bleeding

NCT02493894 | Completed Phase 1 DMC

• 1 other identifier: Abbasi1
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

Now a days, due to the change in lifestyle, the extended lifespan and the increase in the rate of the road accidents, the need for surgical operation of spinal instrumentation has been increased. And these surgeries are the most crucial part of neurological surgery wards. The everyday improvements in the quality of equipment used and advancements in surgical methods lead to best performance of these procedures and finally the higher quality of patients' lives. The procedures of Laminectomy and pedicular screw instrumentation lead to pain relief and better performance and developments in the quality of patients' lives. In addition to the above mentioned improvements, you must consider the fact that these activities are still accompanied by complications during and after surgical operation. Nerve root injury, Thecal sac tearing, injury to the spinal cord and the inappropriate sagittal balance are the most significant side effects during spinal surgery. One of the most important complications during and after these surgeries is perioperative bleeding that causes problems both for the patients and the surgeon.

Conditions

Surgery

Keywords

Bowel preparation; perioperative bleeding; lumbar fusion

Outcome Measures

Primary Outcomes (1)

• The volume of bleeding was measured in milliliter

  up to 3 days

Study Arms (2)

PEG & Cefazolin

EXPERIMENTAL

patients firstly get liquid diet for 24 hours. After that they get PEG solution (80gr/1Litr) each 8 hours for 24 hours. After 48 hours, cefazolin 1gram, every 6hours for 2 days

Drug: PEG; Drug: Cefazolin

placebo & cefazolin

SHAM COMPARATOR

placebo for PEG and cefazolin 1gram, every 6hours for 2 days

Drug: placebo; Drug: Cefazolin

Interventions

PEG DRUG

PEG solution (80gr/1Litr) each 8 hours for 24 hours

Also known as: PEG solution

PEG & Cefazolin

placebo DRUG

placebo each 8 hours for 24 hours

Also known as: sham

placebo & cefazolin

Cefazolin DRUG

cefazolin 1gram, every 6hours for 2 days

Also known as: Kefzol

PEG & Cefazolin; placebo & cefazolin

Eligibility Criteria

• Age: 33 Years - 82 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who suffer from lumbar spine degenerative disease and need spine fusion surgery.

You may not qualify if:

• History of Trauma,
• History of Malignancy,
• previous spinal surgery,
• History of coagulation disorder,
• active infectious disease,
• gastrointestinal problems,
• severe movement disorders.

Sponsors & Collaborators

• Isfahan University of Medical Sciences: lead

Study Sites (1)

Alzahra Hospital

Isfahan, Isfahan, 81745319, Iran

Location

Related Publications (1)

• Zhang F, Wang K, Li FN, Huang X, Li Q, Chen Z, Tang YB, Shen HX, Song QX. Effectiveness of tranexamic acid in reducing blood loss in spinal surgery: a meta-analysis. BMC Musculoskelet Disord. 2014 Dec 22;15:448. doi: 10.1186/1471-2474-15-448.

  PMID: 25532706 RESULT

Related Links

• http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4326491/

MeSH Terms

Interventions

polyethylene glycol 3350; salicylhydroxamic acid; Cefazolin

Intervention Hierarchy (Ancestors)

Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Reza Abbasi, MD

  Alzahra University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Abbasi

Study Record Dates

• First Submitted: June 18, 2015
• First Posted: July 10, 2015
• Study Start: July 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: June 1, 2015
• Last Updated: July 10, 2015

Record last verified: 2015-07

Locations

IR (1)