Day Case Inguinal Hernia Repair in Children. Is Laparoscopic Approach Justified?

Inguinal Hernia Clinical Trial

Official title:

Day Case Inguinal Hernia Repair in Children. Is Laparoscopic Approach Justified?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00597194
• Other study ID #: 216L2002
• Secondary ID: T 1040L0007
• Status: Completed
• Phase: N/A
• First received: January 8, 2008
• Last updated: January 16, 2008
• Start date: October 2002
• Est. completion date: January 2007

Study information

• Verified date: December 2007
• Source: Hospital for Children and Adolescents, Finland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Ministry of Social Affairs and Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: January 2007
• Est. primary completion date: January 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Months to 16 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hernia
• Hernia, Inguinal
• Inguinal Hernia

Intervention

Procedure:
• Hernia repair
Hernia repair laparoscopically (LH) or by open operation (OH)

Locations

Country	Name	City	State
Finland	Hospital for Children and Adolescents	Helsinki

Sponsors (1)

Lead Sponsor	Collaborator
Hospital for Children and Adolescents, Finland

Country where clinical trial is conducted

Finland, 

References & Publications (3)

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. — View Citation

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. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	recovery after inguinal hernia surgery = time to restore normal activities after surgery		one week	No
Secondary	degree of postoperative pain		3 days	No
Secondary	duration of surgery and hospital stay		1 day	No
Secondary	long term surgical result		2 years	No