Is Laparoscopic Fundoplication Better Than Open Fundoplication in Children ?

Gastroesophageal Reflux Clinical Trial

Official title:

IS Laparoscopic Fundoplication Superior to Open Fundoplication in Children - a Randomized Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01551134
• Other study ID #: S-03082
• Status: Terminated
• Phase: N/A
• First received: March 8, 2012
• Last updated: March 9, 2012
• Start date: January 2003
• Est. completion date: December 2009

Study information

• Verified date: March 2012
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Regional Ethics Commitee
• Study type: Interventional

Clinical Trial Summary

The aim of the study was to compare short- and longterm outcomes after laparoscopic and open Nissen fundoplication in children.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 88
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 15 Years

Eligibility

Inclusion Criteria:

• Age 0-15 years

• All patients accepted for primary fundoplication at Oslo University Hospital

Exclusion Criteria:

• Age over 16 years

• Parents not speaking Norwegian or English well

• Prior fundoplication

• Patients with comorbidities considered as unsuited for laparoscopic surgery (diaphragma hernia, several previous abdominal operations etc)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastroesophageal Reflux

Intervention

Procedure:
• Fundoplication
Primary fundoplication
• Fundoplication
Primary fundoplication

Locations

Country	Name	City	State
Norway	Oslo University Hospital	Oslo

Sponsors (2)

Lead Sponsor	Collaborator
Oslo University Hospital	University of Oslo

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence of reflux	GER symptoms and GER on pH monitoring. Need for redo fundoplication. PPI.	12, 24 and 48 months	No
Secondary	Postoperative complication rate	Perioperative complications. Duration of surgery. Postoperative complications. Lenght of hospital stay. Readmission to hospital.	30 days	No
Secondary	Inflammatory response	indicies of inflammatory response	The first 4 p.o days	No
Secondary	Parental stress	Indicies of parental stress caused by GER pre- and postoperatively	12 and 24 months	No