Day Case Inguinal Hernia Repair in Children. Is Laparoscopic Approach Justified? - Full Text View

Purpose

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.

Condition	Intervention
Inguinal Hernia	Procedure: Hernia repair

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Official Title:	Day Case Inguinal Hernia Repair in Children. Is Laparoscopic Approach Justified?

Resource links provided by NLM:

Genetics Home Reference related topics: abdominal wall defect

MedlinePlus related topics: Hernia

U.S. FDA Resources

Further study details as provided by Hospital for Children and Adolescents, Finland:

Primary Outcome Measures:

recovery after inguinal hernia surgery = time to restore normal activities after surgery [ Time Frame: one week ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

degree of postoperative pain [ Time Frame: 3 days ] [ Designated as safety issue: No ]
duration of surgery and hospital stay [ Time Frame: 1 day ] [ Designated as safety issue: No ]
long term surgical result [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment:	89
Study Start Date:	October 2002
Study Completion Date:	January 2007
Primary Completion Date:	January 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: OH Inguinal hernia operated using a classic open herniotomy(OH)	Procedure: Hernia repair Hernia repair laparoscopically (LH) or by open operation (OH)
Active Comparator: LH Laparoscopic herniorraphy (LH) for inguinal hernia	Procedure: Hernia repair Hernia repair laparoscopically (LH) or by open operation (OH)

Detailed Description:

Background and objective : In adults the advantages laparoscopic inguinal hernia are less pain, shorter recovery, shorter sick leave and better cosmetic result. It is not known whether laparoscopic hernia repair produces similar results in children.The objective is to compare the duration of recovery, postoperative pain and long-term surgical results between day case laparoscopic and open inguinal hernia repair in children.

Key inclusion criteria: Children included in the study must be aged four months to sixteen years of age and not have undergone any previous surgery. Of male patients those with completely descended testes are accepted.

Study type: The study is randomized, single-blinded prospective comparison between laparoscopic and open day case inguinal hernia repair in children.

Target sample size: For the assumption that there is a difference of one day in time to restore normal activities after laparoscopic and open hernia repair, target sample size of 100 patients in the laparoscopic and 100 in open repair arm should reach 90% power with p < 0.05.

Recruitment status : From 10/ 2002 to 1/2007 89 patients (laparoscopic repair LH 47, open repair OH 42) are recruited. Primary outcome: The time to restore normal activity after surgery . Secondary Outcomes : The degree of postoperative pain, the duration of the operation, sick leave of parents, surgical result 6 months and 2 years after the repair.

Eligibility

Ages Eligible for Study:	4 Months to 16 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00597194

Locations

Finland
Hospital for Children and Adolescents
Helsinki, Finland, 000290

Sponsors and Collaborators

Hospital for Children and Adolescents, Finland

Investigators

Principal Investigator:	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
Study Director:	Christer Holmberg, Professor	Hospital for Children and Adolescents,Helsinki,Finland

More Information

Publications:

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. Epub 2007 Jan 19.

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.

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

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	Professor Christer Holmberg, Hospital for Children and Adolescents, Helsinki, Finland
ClinicalTrials.gov Identifier:	NCT00597194 History of Changes
Other Study ID Numbers:	216L2002, T 1040L0007
Study First Received:	January 8, 2008
Last Updated:	January 16, 2008
Health Authority:	Finland: Ministry of Social Affairs and Health

Keywords provided by Hospital for Children and Adolescents, Finland:

inguinal hernia
laparoscopic repair
open repair
randomized

Additional relevant MeSH terms:

Hernia
Hernia, Inguinal
Pathological Conditions, Anatomical
Hernia, Abdominal

ClinicalTrials.gov processed this record on June 17, 2013