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CompletedNCT00872287Updated Mar 31, 2009

Pain in Single Incision Laparoscopic Surgery Cholecystectomy

A Phase 4 interventional study of Laparoscopic Cholecystectomy and SILS in Laparoscopic Cholecystectomy, sponsored by G. Hatzikosta General Hospital. Completed at 1 site in Greece. Open to participants aged 28 Years to 75 Years. Per ClinicalTrials.gov, last updated 2009-03-31.

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

Phase
Phase 4
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
28 Years to 75 Years
Sex
All
01

Study summary

The attempt to further reduce the operative trauma in laparoscopic cholecystectomy led in new techniques, as Natural Orifice Transluminal Endoscopic Surgery (NOTES) and Single Incision Laparoscopic Surgery (SILS). These new techniques are considered as painless procedures, but there are not any publications to study a possible different pain score in new techniques versus classic laparoscopic cholecystectomy. In this randomized controlled study the researchers have investigated the pain scores, the incidence of nausea and vomiting and analgesics request after the procedure.

02

Conditions studied

  • Laparoscopic Cholecystectomy

Keywords

  • minimally invasive surgery
  • scarless cholecystectomy
  • new techniques in laparoscopy
  • invisible scar
  • single port access
  • abdominal pain
  • shoulder pain
03

In context

Abdominal Pain

344 studies on the registry are indexed under Abdominal Pain; 53 are open to participants now.

This study's enrollment of 40 is below the median of 70 across 256 interventional studies indexed under Abdominal Pain.

Browse Abdominal Pain studies →

Lead sponsor

G. Hatzikosta General Hospital is the lead sponsor of 8 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
28 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Body Mass Index less than 30
  • Attacks of cholelithiasis

Exclusion criteria

Exclusion Criteria:

  • Body Mass Index more than 30
  • Signs of acute cholecystitis
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
40 participants (actual)

Study arms

  • Active comparator
    Laparoscopic Cholecystectomy

    Four ports classic laparoscopic cholecystectomy

    Procedure: Laparoscopic Cholecystectomy

  • Active comparator
    SILS

    Single transumbilical incision laparoscopic cholecystectomy

    Procedure: SILS

Interventions

  • ProcedureLaparoscopic Cholecystectomy

    Four ports classic laparoscopic cholecystectomy

  • ProcedureSILS

    Single transumbilical incision laparoscopic cholecystectomy

06

What researchers measure

Primary outcomes

  1. SILS cholecystectomy, except the invisible scar, has significantly less abdominal and shoulder pain scores

07

Study locations

1 site
  • G. Hatzikosta General Hospital
    Ioannina, Epirus 45001, Greece
08

References and documents

Publications

  • Tsimoyiannis EC, Tsimogiannis KE, Pappas-Gogos G, Farantos C, Benetatos N, Mavridou P, Manataki A. Different pain scores in single transumbilical incision laparoscopic cholecystectomy versus classic laparoscopic cholecystectomy: a randomized controlled trial. Surg Endosc. 2010 Aug;24(8):1842-8. doi: 10.1007/s00464-010-0887-3. Epub 2010 Feb 20. PubMed 20174950 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Sep 2008, a primary completion of Dec 2008 and a completion of Dec 2008. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 30, 2009
First posted
Mar 31, 2009
Start
Sep 2008
Primary completionActual
Dec 2008
CompletionActual
Dec 2008
Last update
Mar 31, 2009
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 31, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00872287
Lead sponsor
G. Hatzikosta General Hospital
First posted
Mar 31, 2009
Start date
Sep 2008
Primary completion
Dec 2008
Completion
Dec 2008
Last update
Mar 31, 2009

Study contacts

Evangelos C. Tsimoyiannis, M.D.
study chair · G. Hatzikosta General Hospital, Ioannina, Greece

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2009. You cannot join it, but the record below documents what was studied.

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Discussion

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