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

NCT ID: NCT00567125

Last Updated: 2007-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-01-31

Study Completion Date

2006-03-31

Brief Summary

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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

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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.

Conditions

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Laparoscopy.

Keywords

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low-pressure pneumoperitoneum laparoscopy cytokines VEGF-A endostatin

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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I

Patients with cholelithiasis operated on using standard laparoscopy method

No interventions assigned to this group

II

Patients with cholelithiasis operated on using low-pressure CO2 pneumoperitoneum laparoscopy

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* cholelithiasis

Exclusion Criteria

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

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Lublin

OTHER

Sponsor Role lead

Responsible Party

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Medical University of Lublin

Principal Investigators

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Ryszard Maciejewski, Md, PhD

Role: STUDY_CHAIR

Medical University of Lublin

Locations

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Medical University of Lublin

Lublin, Lublin Voivodeship, Poland

Site Status

Countries

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Poland

Other Identifiers

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PW 205/07

Identifier Type: -

Identifier Source: secondary_id

PW 205

Identifier Type: -

Identifier Source: org_study_id