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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00567125
First Posted: December 4, 2007
Last Update Posted: December 4, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Medical University of Lublin
  Purpose
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.

Condition
Laparoscopy.

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: A Comparative Study of Angiogenic and Cytokine Responses After Laparoscopic Cholecystectomy Performed With Standard-Pressure and Low-Pressure Pneumoperitoneum

Further study details as provided by Medical University of Lublin:

Primary Outcome Measures:
  • IL-6, IL-8, IL-10, VEGF-A, Endostatin serum levels before the laparoscopies and 6, 24, and 48 h afterwards [ Time Frame: January 2006 - March 2006 ]

Biospecimen Retention:   Samples Without DNA
serum

Enrollment: 40
Study Start Date: January 2006
Study Completion Date: March 2006
Groups/Cohorts
I
Patients with cholelithiasis operated on using standard laparoscopy method
II
Patients with cholelithiasis operated on using low-pressure CO2 pneumoperitoneum laparoscopy

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

  • cholelithiasis

Exclusion Criteria:

  • symptoms of acute cholecystitis, diabetes, body mass indx above 36 kg/m2 and autoimmunological diseases.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00567125


Locations
Poland
Medical University of Lublin
Lublin, Poland, 20-950
Sponsors and Collaborators
Medical University of Lublin
Investigators
Study Chair: Ryszard Maciejewski, Md, PhD Medical University of Lublin
  More Information

Responsible Party: Maciejewski Ryszard, MD, PhD, Medical University of Lublin
ClinicalTrials.gov Identifier: NCT00567125     History of Changes
Other Study ID Numbers: PW 205
PW 205/07
First Submitted: December 1, 2007
First Posted: December 4, 2007
Last Update Posted: December 4, 2007
Last Verified: December 2007

Keywords provided by Medical University of Lublin:
low-pressure pneumoperitoneum
laparoscopy
cytokines
VEGF-A
endostatin

Additional relevant MeSH terms:
Pneumoperitoneum
Peritoneal Diseases
Digestive System Diseases