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OpenTrials
Completed

NCT Number: NCT00872287

Pain in Single Incision Laparoscopic Surgery Cholecystectomy

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.

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Key information

Age range

28 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

G. Hatzikosta General Hospital

Ioannina, Epirus, 45001, Greece

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Body Mass Index less than 30
  • Attacks of cholelithiasis

Exclusion criteria

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

Treatment and study plan

Laparoscopic cholecystectomy

Procedure

Four ports classic laparoscopic cholecystectomy

SILS

Procedure

Single transumbilical incision laparoscopic cholecystectomy

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

G. Hatzikosta General Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Mar 31, 2009
Registry last updated
Mar 31, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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