NCT01094379

Brief Summary

Laparoscopic cholecystectomy has been established as the treatment of choice for symptomatic gallstone disease. The main advantages of laparoscopic surgery are the cosmetic result, reduced postoperative pain, shorter hospital stay and rapid return to normal activity. Although reduced, however, pain is still substantial and constitutes the main clinical problem after laparoscopic cholecystectomy, especially for planned day case procedures. Recently, a new technique of laparoscopic cholecystectomy has been developed, in which all instruments are inserted through the same umbilical incision. The single incision laparoscopic surgery (SILS) technique for cholecystectomy has been proved to be feasible and safe by several studies. The purpose of the study is to compare postoperative pain and operating time, nausea, vomiting, tissue damage, pulmonary function, cosmetic result, quality of life between SILS and standard laparoscopic cholecystectomy.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2010

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

March 23, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 26, 2010

Completed
6 days until next milestone

Study Start

First participant enrolled

April 1, 2010

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
Last Updated

June 25, 2010

Status Verified

June 1, 2010

Enrollment Period

1 year

First QC Date

March 23, 2010

Last Update Submit

June 24, 2010

Conditions

Cholecystectomy, Laparoscopic

Keywords

cholecystectomylaparoscopicpainsingle incision

Outcome Measures

Primary Outcomes (1)

  • Postoperative pain

    Postoperative pain will be assessed using a visual analogue pain score

    24h

Secondary Outcomes (6)

  • operating time

    Duration of surgical procedure

  • nausea or vomiting

    24 h

  • tissue damage

    24h

  • pulmonary function

    24h

  • cosmetic result

    4 weeks

  • +1 more secondary outcomes

Study Arms (2)

Standard lap chole

ACTIVE COMPARATOR

Laparoscopic cholecystectomy using four entry sites to the abdominal cavity

Procedure: Standard laparoscopic cholecystectomy

Single incision lap chole

ACTIVE COMPARATOR

Laparoscopic cholecystectomy using one entry site to the abdominal cavity

Procedure: Single incision laparoscopic cholecystectomy

Interventions

Standard laparoscopic cholecystectomyPROCEDURE

Laparoscopic cholecystectomy using four entry sites to the abdominal cavity

Also known as: Traditional laparoscopic cholecystectomy
Standard lap chole
Single incision laparoscopic cholecystectomyPROCEDURE

Laparoscopic cholecystectomy using one entry site to the abdominal cavity

Also known as: One port laparoscopic cholecystectomy
Single incision lap chole

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with symptomatic cholelithiasis, admitted for laparoscopic cholecystectomy

You may not qualify if:

  • Patients with acute cholecystitis
  • Patients with extensive upper abdominal incisions
  • Patients with body mass index \>30
  • Patients on regular analgesic medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Academic Department of Surgery, Aretaieion Hospital

Athens, 11528, Greece

RECRUITING

Related Publications (3)

  • Tacchino R, Greco F, Matera D. Single-incision laparoscopic cholecystectomy: surgery without a visible scar. Surg Endosc. 2009 Apr;23(4):896-9. doi: 10.1007/s00464-008-0147-y. Epub 2008 Sep 25.

    PMID: 18815836BACKGROUND

  • Chow A, Purkayastha S, Aziz O, Paraskeva P. Single-incision laparoscopic surgery for cholecystectomy: an evolving technique. Surg Endosc. 2010 Mar;24(3):709-14. doi: 10.1007/s00464-009-0655-4. Epub 2009 Aug 18.

    PMID: 19688389BACKGROUND

  • Steinemann DC, Raptis DA, Lurje G, Oberkofler CE, Wyss R, Zehnder A, Lesurtel M, Vonlanthen R, Clavien PA, Breitenstein S. Cosmesis and body image after single-port laparoscopic or conventional laparoscopic cholecystectomy: a multicenter double blinded randomised controlled trial (SPOCC-trial). BMC Surg. 2011 Sep 12;11:24. doi: 10.1186/1471-2482-11-24.

    PMID: 21910897DERIVED

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Antonios Vezakis, lecturer

    University of Athens

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Antonios Vezakis, Lecturer

CONTACT

00306977405605avezakis@hotmail.com

George Polymeneas, Professor

CONTACT

00306944738558gpolym@med.uoa.gr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 23, 2010

First Posted

March 26, 2010

Study Start

April 1, 2010

Primary Completion

April 1, 2011

Study Completion

April 1, 2011

Last Updated

June 25, 2010

Record last verified: 2010-06

Locations

GR(1)