NCT00597194

Brief Summary

We compare laparoscopic and classic open operation for inguinal hernia in children. Attention is focused on the recovery, surgical result and the duration of the operation and hospital stay.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
89

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2002

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

October 1, 2002

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

January 8, 2008

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 17, 2008

Completed
Last Updated

January 17, 2008

Status Verified

December 1, 2007

Enrollment Period

4.3 years

First QC Date

January 8, 2008

Last Update Submit

January 16, 2008

Conditions

Inguinal Hernia

Keywords

inguinal hernialaparoscopic repairopen repairrandomized

Outcome Measures

Primary Outcomes (1)

  • recovery after inguinal hernia surgery = time to restore normal activities after surgery

    one week

Secondary Outcomes (3)

  • degree of postoperative pain

    3 days

  • duration of surgery and hospital stay

    1 day

  • long term surgical result

    2 years

Study Arms (2)

OH

ACTIVE COMPARATOR

Inguinal hernia operated using a classic open herniotomy(OH)

Procedure: Hernia repair

LH

ACTIVE COMPARATOR

Laparoscopic herniorraphy (LH) for inguinal hernia

Procedure: Hernia repair

Interventions

Hernia repairPROCEDURE

Hernia repair laparoscopically (LH) or by open operation (OH)

LHOH

Eligibility Criteria

Age4 Months - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • unilateral inguinal hernia
  • age age \> 4 months, \<16 years
  • fully descended testes
  • study consent signed

You may not qualify if:

  • previous abdominal or inguinal surgery
  • testes not fully descended
  • not healthy enough for day surgery
  • age \< 4months or \>16 years
  • study consent not signed

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital for Children and Adolescents

Helsinki, 000290, Finland

Location

Related Publications (4)

  • Butler RE, Burke R, Schneider JJ, Brar H, Lucha PA Jr. The economic impact of laparoscopic inguinal hernia repair: results of a double-blinded, prospective, randomized trial. Surg Endosc. 2007 Mar;21(3):387-90. doi: 10.1007/s00464-006-9123-6. Epub 2007 Jan 19.

    PMID: 17235721BACKGROUND

  • Eklund A, Rudberg C, Smedberg S, Enander LK, Leijonmarck CE, Osterberg J, Montgomery A. Short-term results of a randomized clinical trial comparing Lichtenstein open repair with totally extraperitoneal laparoscopic inguinal hernia repair. Br J Surg. 2006 Sep;93(9):1060-8. doi: 10.1002/bjs.5405.

    PMID: 16862612BACKGROUND

  • Schier F. Laparoscopic inguinal hernia repair-a prospective personal series of 542 children. J Pediatr Surg. 2006 Jun;41(6):1081-4. doi: 10.1016/j.jpedsurg.2006.02.028.

    PMID: 16769338BACKGROUND

  • Koivusalo AI, Korpela R, Wirtavuori K, Piiparinen S, Rintala RJ, Pakarinen MP. A single-blinded, randomized comparison of laparoscopic versus open hernia repair in children. Pediatrics. 2009 Jan;123(1):332-7. doi: 10.1542/peds.2007-3752.

    PMID: 19117900DERIVED

MeSH Terms

Conditions

Hernia, Inguinal

Interventions

Herniorrhaphy

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Plastic Surgery ProceduresSurgical Procedures, Operative

Study Officials

  • Antti I Koivusalo, MDPhD

    Hospital for Children and Adolescents,Helsinki,Finland

    PRINCIPAL INVESTIGATOR

  • Mikko P Pakarinen, MD PhD

    Hospital for Children and Adolescents,Helsinki,Finland

    PRINCIPAL INVESTIGATOR

  • Risto J Rintala, Professor

    Hospital for Children and Adolescents,Helsinki,Finland

    PRINCIPAL INVESTIGATOR

  • Christer Holmberg, Professor

    Hospital for Children and Adolescents,Helsinki,Finland

    STUDY DIRECTOR

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

January 8, 2008

First Posted

January 17, 2008

Study Start

October 1, 2002

Primary Completion

January 1, 2007

Study Completion

January 1, 2007

Last Updated

January 17, 2008

Record last verified: 2007-12

Locations

FI(1)