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CompletedNCT01211743Updated Sep 29, 2010

Oxidative Stress in Standard Laparoscopic vs Single Port Cholecystectomy

A Phase 4 interventional study of Laparoscopic cholecystectomy and Single incision laparoscopic cholecystectomy in Uncomplicated Cholelithiasis, Cholecystectomy and Laparoscopy, sponsored by G. Hatzikosta General Hospital. Completed at 1 site in Greece. Open to participants aged 30 Years to 65 Years. Per ClinicalTrials.gov, last updated 2010-09-29.

Sponsored by G. Hatzikosta General Hospital · Phase 4, Interventional, and Basic science

Phase
Phase 4
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
30 Years to 65 Years
Sex
All
01

Study summary

Study of Oxidative Stress Markers in order to assess whether there are differences between standard laparoscopic cholecystectomy vs single port cholecystectomy for uncomplicated cholelithiasis

02

Conditions studied

  • Uncomplicated Cholelithiasis
  • Cholecystectomy
  • Laparoscopy
  • Standard Technique
  • Single Port Laparoscopy

Keywords

  • SILS
  • Oxidative Stress
  • 8-epiPGF2a
  • SILS vs standard laparoscopic cholecystectomy
03

In context

Cholelithiasis

286 studies on the registry are indexed under Cholelithiasis; 48 are open to participants now.

This study's enrollment of 20 is below the median of 90 across 197 interventional studies indexed under Cholelithiasis.

Browse Cholelithiasis studies →

Lead sponsor

G. Hatzikosta General Hospital is the lead sponsor of 7 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria:Uncomplicated cholelithiasis American Society of Anesthesiologists (ASA) I or II No previous operations in upper abdomen Body mass index (BMI) -

Exclusion Criteria:Cholecystitis ASA > II BMI>30 Previous operations in upper abdomen Previous operations in intestine Smokers Alcohol Drugs

-

05

Study design

Phase
Phase 4
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
20 participants (actual)

Study arms

  • Active comparator
    Lap Group

    Patients in this group are operated for uncomplicated cholelithiasis with standard 4 port laparoscopic cholecystectomy

    Other: Laparoscopic cholecystectomy · Other: Single incision laparoscopic cholecystectomy

  • Active comparator
    SILS group

    Patients in this group are operated for uncomplicated cholelithiasis with Single Incision Laparoscopic Cholecystectomy

    Other: Single incision laparoscopic cholecystectomy

Interventions

  • OtherLaparoscopic cholecystectomy

    Standard 4 port laparoscopic cholecystectomy

  • OtherSingle incision laparoscopic cholecystectomy

    One port placed through the umbilicus

06

Study locations

1 site
  • G Hatzikosta General Hospital of Ioannina
    Ioannina, Epirus 45001, Greece
07

References and documents

Publications

  • Pappas-Gogos G, Tellis CC, Trypsianis G, Tsimogiannis KE, Tsimoyiannis EC, Simopoulos CE, Pitiakoudis M, Tselepis AD. Oxidative stress in multi-port and single-port cholecystectomy. J Surg Res. 2015 Mar;194(1):101-6. doi: 10.1016/j.jss.2014.09.020. Epub 2014 Sep 28. PubMed 25438954 ↗
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 29, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01211743
Lead sponsor
G. Hatzikosta General Hospital
Collaborators
Demokrition University of Thrace, University of Ioannina
First posted
Sep 29, 2010
Start date
Jun 2010
Primary completion
Jun 2010
Completion
Sep 2010
Last update
Sep 29, 2010

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2010. You cannot join it, but the record below documents what was studied.

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