NCT00567125

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2006

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2006

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

December 1, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 4, 2007

Completed
Last Updated

December 4, 2007

Status Verified

December 1, 2007

First QC Date

December 1, 2007

Last Update Submit

December 3, 2007

Conditions

Laparoscopy.

Keywords

low-pressure pneumoperitoneumlaparoscopycytokinesVEGF-Aendostatin

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

I

Patients with cholelithiasis operated on using standard laparoscopy method

II

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

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • cholelithiasis

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Lublin

Lublin, Lublin Voivodeship, 20-950, Poland

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum

Study Officials

  • Ryszard Maciejewski, Md, PhD

    Medical University of Lublin

    STUDY CHAIR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 1, 2007

First Posted

December 4, 2007

Study Start

January 1, 2006

Study Completion

March 1, 2006

Last Updated

December 4, 2007

Record last verified: 2007-12

Locations

PL(1)