Comparison of Systemic Response After Laparoscopies Performed With Standard and Low-Pressure Pneumoperitoneum

Laparoscopy. Clinical Trial

Official title:

A Comparative Study of Angiogenic and Cytokine Responses After Laparoscopic Cholecystectomy Performed With Standard-Pressure and Low-Pressure Pneumoperitoneum

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00567125
• Other study ID #: PW 205
• Secondary ID: PW 205/07
• Status: Completed
• Phase: N/A
• First received: December 1, 2007
• Last updated: December 3, 2007
• Start date: January 2006
• Est. completion date: March 2006

Study information

• Verified date: December 2007
• Source: Medical University of Lublin
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• cholelithiasis

Exclusion Criteria:

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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Laparoscopy.
• Pneumoperitoneum

Locations

Country	Name	City	State
Poland	Medical University of Lublin	Lublin

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Lublin

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IL-6, IL-8, IL-10, VEGF-A, Endostatin serum levels before the laparoscopies and 6, 24, and 48 h afterwards		January 2006 - March 2006	No