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Pain in Single Incision Laparoscopic Surgery Cholecystectomy

Randomized Controlled Study of Different Pain Scores in Single Transumbilical Incision Laparoscopic Cholecystectomy Versus Classic Laparoscopic Cholecystectomy

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00872287
Enrollment
40
Registered
2009-03-31
Start date
2008-09-30
Completion date
2008-12-31
Last updated
2009-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Laparoscopic Cholecystectomy

Keywords

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

Brief 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.

Interventions

PROCEDURELaparoscopic Cholecystectomy

Four ports classic laparoscopic cholecystectomy

PROCEDURESILS

Single transumbilical incision laparoscopic cholecystectomy

Sponsors

G. Hatzikosta General Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
28 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* Body Mass Index less than 30 * Attacks of cholelithiasis

Exclusion criteria

* Body Mass Index more than 30 * Signs of acute cholecystitis

Design outcomes

Primary

MeasureTime frame
SILS cholecystectomy, except the invisible scar, has significantly less abdominal and shoulder pain scores

Countries

Greece

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026