The Effect of Bowel Preparation on Perioperative Bleeding
Condition: Surgery
Study type: Interventional
Phase: Phase 1/Phase 2

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.
    

Detailed description: 
      The individuals evaluated in this study were those who have been admitted and undergone
      spiral surgery (Fusion and Instrumentation) with pedicular screw because of spinal column
      instability and canal stenosis.

      This study has been started and performed since Feb.2013 to June 2015 at the neurosurgery
      ward of Al.zahra hospital of Isfahan.

      The candidates chosen for the study were those who undergone the surgery procedure due to
      degenerative change of Lumbar spinal canal.

      The necessity of operation for each patient is diagnosed based on clinical finding, Imaging
      data and guidelines according to neurosurgery reference sources.(Richards Winn,Youmans
      Neurological Survey, Sixth Edition, Vol 3,Ch.303) During this prospective study, patients are
      randomly divided into two groups of Case and Control. The individuals attended these two
      groups are matched regarding age, sex and general medical condition. The age ranges in this
      study are 33 to 82 years old.

      Other than general surgery consent taken from both groups, patients in Case group are
      informed about the procedure of the program and probable side effects.

      Primarily, patients' weight, height, BMI, and Hemoglobin are recorded. In Case group,
      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, bowel is mechanically prepared for the procedure.
      Cefazolin 1 gram every 6hours for 2 days was taken in both groups.

      In both Case and Control groups, the time of surgery and the volume of bleeding (in CC) are
      precisely recorded by surgery and anesthesiology team. The need for blood transfusion during
      surgery is based on preoperation hemoglobin and the volume of bleeding during surgery and is
      calculated according to anesthesiology and surgical standards using the following formula:

      ( )/Hb ×0.6 BW kg×10022 Immediately at the end of surgery, the exact rate of bleeding during
      operation ( in CC), the length of operation and the length of the operation and the estimated
      transfusion rate are recorded.

      Also, after surgery the volume of bleeding in homovac drain in time intervals of 24 to
      48-hour are recorded.

      Also the patients' levels of Hb in 24 to 48-hour intervals are calculated. After improving
      general medical conditions of the patients and their walking abilities, they are ambulated
      and finally are discharged from hospital.
    

Intervention name(s): PEG; placebo; Cefazolin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): PEG solution (80gr/1Litr) each 8 hours for 24 hours; placebo each 8 hours for 24 hours; cefazolin 1gram, every 6hours for 2 days
Other intervention name(s): PEG solution; sham; Kefzol
Intervention MeSH terms: Cefazolin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Bowel preparation; perioperative bleeding; lumbar fusion