NCT01211743

Brief 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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jun 2010

Shorter than P25 for phase_4

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

June 1, 2010

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

September 28, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 29, 2010

Completed
Last Updated

September 29, 2010

Status Verified

September 1, 2010

Enrollment Period

Same day

First QC Date

September 28, 2010

Last Update Submit

September 28, 2010

Conditions

Uncomplicated CholelithiasisCholecystectomyLaparoscopyStandard TechniqueSingle Port Laparoscopy

Keywords

SILSOxidative Stress8-epiPGF2aSILS vs standard laparoscopic cholecystectomy

Study Arms (2)

Lap Group

ACTIVE COMPARATOR

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

Other: Laparoscopic cholecystectomyOther: Single incision laparoscopic cholecystectomy

SILS group

ACTIVE COMPARATOR

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

Other: Single incision laparoscopic cholecystectomy

Interventions

Laparoscopic cholecystectomyOTHER

Standard 4 port laparoscopic cholecystectomy

Lap Group
Single incision laparoscopic cholecystectomyOTHER

One port placed through the umbilicus

Lap GroupSILS group

Eligibility Criteria

Age30 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

G Hatzikosta General Hospital of Ioannina

Ioannina, Epirus, 45001, Greece

Location

Related Publications (1)

  • 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.

    PMID: 25438954DERIVED

MeSH Terms

Interventions

Cholecystectomy, Laparoscopic

Intervention Hierarchy (Ancestors)

CholecystectomyBiliary Tract Surgical ProceduresDigestive System Surgical ProceduresSurgical Procedures, OperativeLaparoscopyEndoscopyMinimally Invasive Surgical Procedures

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 28, 2010

First Posted

September 29, 2010

Study Start

June 1, 2010

Primary Completion

June 1, 2010

Study Completion

September 1, 2010

Last Updated

September 29, 2010

Record last verified: 2010-09

Locations

GR(1)