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The (Cost-) Effectiveness of Paediatric Laparoscopic Hernia Repair Compared to Open Hernia Repair

ConditionInguinal Hernia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age0-16
SponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

About this trial

This study assess the (cost-)effectiveness of open versus laparoscopic Percutaneous Inguinal Ring Suturing (PIRS) technique for unilateral inguinal hernia repair in children aged 0-16 years.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

incarcerated inguinal hernia, which have to be operated immediately,

recurrent hernia

ventricular-peritoneal drain

non-descended testis

Trial design

Design model

Parallel

Treatments tested in this trial

  • Percutaneous Inguinal Ring Suturing (PIRS) technique

    Procedure/Surgery

    Percutaneous Inguinal Ring Suturing (PIRS) technique

Treatment groups

464 Participants
are divided into 2 treatment groups
Group A: Intervention groupActive comparator 1 intervention
Group B: Control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Re-operation rate

Number of re-operations related to primary inguinal hernia repair

Time frame
within two years after the primary inguinal hernia repair

Secondary outcomes

1

Complications

Surgical and anesthesiological complications

Time frame
Within two years after the primary inguinal hernia repair
2

Duration of Surgery

Total duration of surgery (including anaesthesia and total duration of operating room time)

Time frame
Within two years after the primary inguinal hernia repair
3

Post-operative pain

Postoperative pain is as medication requirement and VAS-score (1-9 score, 9 point scale, higher score equals more pain)

Time frame
Within two years after the primary inguinal hernia repair
4

Length of hospital stay

Number of days

Time frame
Within two years after the primary inguinal hernia repair

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Lead sponsor

Source ClinicalTrials.gov
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