NCT01116492

Brief Summary

This is a study of the inflammatory reaction in standard 4 port laparoscopic cholecystectomy vs Single Port Laparoscopic (SIL) cholecystectomy. It is assumed that the reduced trauma in SIL Cholecystectomy causes reduced inflammatory reaction compared to the 4 port laparoscopic cholecystectomy.

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 not_applicable

Timeline
Completed

Started Jan 2010

Shorter than P25 for not_applicable

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, 2010

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

May 4, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 5, 2010

Completed
Last Updated

May 21, 2010

Status Verified

May 1, 2010

Enrollment Period

4 months

First QC Date

May 4, 2010

Last Update Submit

May 20, 2010

Conditions

CholelithiasisInflammatory Response

Keywords

SILSInflammatory reactiona-defensinsSILS 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 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

Single incision laparoscopic cholecystectomyOTHER

One port placed through the umbilicus

SILS group
Laparoscopic cholecystectomyOTHER

Standard 4 port laparoscopic cholecystectomy

Lap Group

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Uncomplicated cholelithiasis
  • American Society of Anesthesiologists (ASA) I or II
  • No previous operations in upper abdomen
  • Body mass index (BMI) \<30

You may not qualify if:

  • Cholecystitis
  • ASA \> II
  • BMI\>30
  • Previous operations in upper abdomen
  • Previous operations in intestine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

"G. Hatzikosta" General Hospital of Ioannina

Ioannina, 45001, Greece

Location

MeSH Terms

Conditions

CholelithiasisInflammation

Interventions

Cholecystectomy, Laparoscopic

Condition Hierarchy (Ancestors)

Biliary Tract DiseasesDigestive System DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 4, 2010

First Posted

May 5, 2010

Study Start

January 1, 2010

Primary Completion

May 1, 2010

Study Completion

May 1, 2010

Last Updated

May 21, 2010

Record last verified: 2010-05

Locations

GR(1)