Rhabdomyolysis and Robot-assisted Radical Prostatectomy

NCT02671604 | Completed

• 1 other identifier: GK9
• Study Type: observational
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

In patients undergoing robot-assisted radical prostatectomy (RARP), pneumoperitoneum, intraoperative fluid restriction and prolonged Trendelenburg position may cause rhabdomyolysis (RM) due to hypoperfusion in gluteal muscles and lower extremities. In this study, it was aimed to assess effects of BMI, comorbidities, intraoperative positioning, fluid restriction and length of surgery on development of RM in RARP patients during perioperative period.

Conditions

Rhabdomyolysis

Keywords

acute renal failure; prostatectomy; minimal invasive surgery

Outcome Measures

Primary Outcomes (1)

• Number of Participants With serumCreatine Phosphokinase Values greater than 5000IU/L

  Rhabdomyolysis was defined as postoperative serum Creatine Phosphokinase level exceeding 5000 IU/L.

  Change from Baseline Creatine Phosphokinase at 24 hours.

Secondary Outcomes (1)

• number of patients with abnormal laboratory values

  on the hours 0 (T9), 6 (T6), 12 (T12) and 24 (T24) after beginning of surgery.

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients scheduled for an elective Robot assisted radical prostatectomy were enrolled to the study.

You may qualify if:

• ASA I-II
• Aged 50-80 years,
• BMI \>25 kg/m2
• Patients scheduled for an elective RARP

You may not qualify if:

• Patients with ASA III-IV risk status,
• Patients with comorbid diseases that can cause increased muscular activity such as severe dystonia or status asthmaticus,
• Patients with renal or hepatic failure and patients on statin or steroid therapy were excluded.
• Patients converted to laparotomy during surgery.

Sponsors & Collaborators

• Umraniye Education and Research Hospital: lead

Study Sites (1)

gulsah Karaoren

Istanbul, Turkey (Türkiye)

Location

Related Publications (2)

• Kim TK, Yoon JR, Lee MH. Rhabdomyolysis after laparoscopic radical nephrectomy -A case report-. Korean J Anesthesiol. 2010 Dec;59 Suppl(Suppl):S41-4. doi: 10.4097/kjae.2010.59.S.S41. Epub 2010 Dec 31.

  PMID: 21286457 BACKGROUND

• Vijay MK, Vijay P, Kundu AK. Rhabdomyolysis and myogloginuric acute renal failure in the lithotomy/exaggerated lithotomy position of urogenital surgeries. Urol Ann. 2011 Sep;3(3):147-50. doi: 10.4103/0974-7796.84965.

  PMID: 21976928 RESULT

MeSH Terms

Conditions

Rhabdomyolysis; Acute Kidney Injury

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• eyup v kucuk, md

  Umraniye Education and Research Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Months
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 21, 2016
• First Posted: February 2, 2016
• Study Start: January 1, 2014
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: February 2, 2016

Record last verified: 2016-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)