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OpenTrials
Completed

NCT Number: NCT00597194

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

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.

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Key information

Conditions

Inguinal Hernia Hernia Hernia, Abdominal Hernia, Inguinal Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

4 month–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital for Children and Adolescents

Helsinki, 000290, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hernia repair

Procedure

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

Primary outcomes

  1. recovery after inguinal hernia surgery = time to restore normal activities after surgery

    Time frame: one week

Secondary outcomes

  1. degree of postoperative pain

    Time frame: 3 days

  2. duration of surgery and hospital stay

    Time frame: 1 day

  3. long term surgical result

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Hospital for Children and Adolescents, Finland

Other

Registry information

Important dates

Study start
2002
Primary completion
2007
Study completion
2007
First posted
Jan 17, 2008
Registry last updated
Jan 17, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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