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Pain in Single Incision Laparoscopic Surgery Cholecystectomy

NCT ID: NCT00872287

Last Updated: 2009-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2008-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Laparoscopic Cholecystectomy

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Laparoscopic Cholecystectomy

Four ports classic laparoscopic cholecystectomy

Group Type ACTIVE_COMPARATOR

Laparoscopic Cholecystectomy

Intervention Type PROCEDURE

Four ports classic laparoscopic cholecystectomy

SILS

Single transumbilical incision laparoscopic cholecystectomy

Group Type ACTIVE_COMPARATOR

SILS

Intervention Type PROCEDURE

Single transumbilical incision laparoscopic cholecystectomy

Interventions

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Laparoscopic Cholecystectomy

Four ports classic laparoscopic cholecystectomy

Intervention Type PROCEDURE

SILS

Single transumbilical incision laparoscopic cholecystectomy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Body Mass Index less than 30
* Attacks of cholelithiasis

Exclusion Criteria

* Body Mass Index more than 30
* Signs of acute cholecystitis
Minimum Eligible Age

28 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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G. Hatzikosta General Hospital

OTHER

Sponsor Role lead

Responsible Party

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G. Hatzikosta General Hospital, Ioannina, Greece

Principal Investigators

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Evangelos C. Tsimoyiannis, M.D.

Role: STUDY_CHAIR

G. Hatzikosta General Hospital, Ioannina, Greece

Locations

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G. Hatzikosta General Hospital

Ioannina, Epirus, Greece

Site Status

Countries

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Greece

References

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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.

Reference Type DERIVED
PMID: 20174950 (View on PubMed)

Other Identifiers

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GHDS-12345-1

Identifier Type: -

Identifier Source: secondary_id

GH-1948-01

Identifier Type: -

Identifier Source: org_study_id