Laparoscopic Hysterectomy Clinical Trial
Official title:
Clearance Rate of Peritoneal Fluid Assessed by Post-operative Ultrasound Decreases After Full Conditioning Pneumoperitoneum
Verified date | June 2013 |
Source | University Hospital, Gasthuisberg |
Contact | n/a |
Is FDA regulated | No |
Health authority | Belgium: Institutional Review Board |
Study type | Interventional |
Measurement of residual peritoneal fluid after laparoscopic surgery
Status | Completed |
Enrollment | 20 |
Est. completion date | September 2011 |
Est. primary completion date | September 2011 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - Women planned to undergo a total or subtotal laparoscopic hysterectomy and having signed the informed consent. - No limitation in body mass index or uterine size is made. Exclusion Criteria: - pregnancy - immunodeficiency - refuse or unable to sign informed consent - chronic disease (i.e. COPD, Crohn, cardiac…) - known allergy for Adept© |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Belgium | UZ Leuven, campus Gasthuisberg | Leuven |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Gasthuisberg |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | clearance rate of peritoneal fluid | We will estimate the residual volume of fluid in the abdominal cavity in a 30° anti-Trendelenburg position after 1 minute in this position. Measurements will be repeated daily until discharge. | 3 days after surgery | No |
Secondary | Pain and inflammation score | Postoperative pain will be assessed by the intake of ibuprofen or other pain killers and by Visual Analog Scale (VAS). Patients will be asked to locate their pain-symptoms (shoulder, subcostal, trocar wound and visceral pain) and score the severity. VAS will be collected 2-4 hours after surgery and every post-operative day until discharge. Daily routine blood samples will be obtained and CRP will be measured. Routinely time of first flatus or stools will be recorded |
3 days after surgery | No |
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