Clinical trial NCT00567125: Comparison of Systemic Response After Laparoscopies Performed With Standard and Low-Pressure Pneumoperitoneum
Official title: A Comparative Study of Angiogenic and Cytokine Responses After Laparoscopic Cholecystectomy Performed With Standard-Pressure and Low-Pressure Pneumoperitoneum
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Laparoscopy.
Keywords: low-pressure pneumoperitoneum
laparoscopy
cytokines
VEGF-A
endostatin
Lead sponsor: Medical University of Lublin
Sponsor class: OTHER
First posted: 2007-12-04
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with cholelithiasis and indications for surgical treatment; the median age of the patients included in the study was 48,5 and ranged from 18 to 70 years. The ratio of female to male patients was identical within each group and amounted 7:3.

Brief summary: The purpose of the study was the comparative assessment of the influence of low and standard pressure CO2 pneumoperitoneum on the systemic inflammatory and angiogenic responses during the postoperative period after laparoscopic management of cholelithiasis.

Detailed description: Objective: The purpose of the study was to access the influence of low pressure CO2 pneumoperitoneum on the inflammatory and angiogenic responses during the postoperative period after laparoscopy. Summary background data: Surgical procedures enhance production of pro- and anti-inflammatory cytokines and angiogenic factors that play a pivotal role in the immunological response to surgical trauma and take part in the pathogenesis of tumor growth and adhesions formation. Methods: Study group consisted of 40 patients, operated on due to cholelithiasis using standard- (n=20) and low-pressure (n=20) CO2 pneumoperitoneum. Serum concentration of IL-6, IL-8, IL-10, VEGF-A and endostatin were measured before the surgeries and thereafter at 6, 24 and 48h with commercially available ELISA assays. Results: Concentrations of IL-6 increased significantly after the operations in both groups. No differences were observed between the groups in regards to IL-6, IL-8 and IL-10 levels. Concentrations of VEGF-A measured at 6 and 48h were significantly lower in patients who underwent laparoscopies performed with low pressure pneumoperitoneum. No significant variations were observed in endostatin serum concentration. Concentrations of the studied parameters were not influenced by the duration of surgeries, age, gender, or BMI of the patients. Conclusions: The results obtained in our study do not show any significant differences between studied operative procedures with regards to systemic inflammatory response. Changes in the concentrations of VEGF-A and endostatin observed in the studied population may suggest this technique to be more favorable with regards to angiogenesis process intensity, along with all its consequences and implications.

Eligibility criteria: Inclusion Criteria:

* cholelithiasis

Exclusion Criteria:

* symptoms of acute cholecystitis, diabetes, body mass indx above 36 kg/m2 and autoimmunological diseases.

Primary outcomes:
measure: IL-6, IL-8, IL-10, VEGF-A, Endostatin serum levels before the laparoscopies and 6, 24, and 48 h afterwards
timeFrame: January 2006 - March 2006
Secondary outcomes:
Other outcomes:
Locations:
city: Lublin
country: Poland
facility: Medical University of Lublin
Study officials:
affiliation: Medical University of Lublin
name: Ryszard Maciejewski, Md, PhD
role: STUDY_CHAIR
References: