Is Laparoscopic Fundoplication Better Than Open Fundoplication in Children ?

Sponsor

Oslo University Hospital (Other)

Overall Status

Terminated

CT.gov ID

NCT01551134

Collaborator

University of Oslo (Other)

Enrollment

Location

Arms

Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Gastroesophageal Reflux	Procedure: Fundoplication Procedure: Fundoplication	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

88 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jan 1, 2003

Actual Primary Completion Date :

Dec 1, 2009

Actual Study Completion Date :

Dec 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Open fundoplication Fundoplication performed with open surgery	Procedure: Fundoplication Primary fundoplication Other Names: Gastroesophageal reflux
Experimental: Lap fundoplication Primary fundoplication performed by laparoscopic surgery	Procedure: Fundoplication Primary fundoplication Other Names: Gastroesophageal reflux

Arm

Intervention/Treatment

Active Comparator: Open fundoplication

Fundoplication performed with open surgery

Procedure: Fundoplication

Primary fundoplication

Other Names:

Gastroesophageal reflux

Experimental: Lap fundoplication

Primary fundoplication performed by laparoscopic surgery

Procedure: Fundoplication

Primary fundoplication

Other Names:

Gastroesophageal reflux

Outcome Measures

Primary Outcome Measures

Recurrence of reflux [12, 24 and 48 months]
GER symptoms and GER on pH monitoring. Need for redo fundoplication. PPI.

Secondary Outcome Measures

Postoperative complication rate [30 days]
Perioperative complications. Duration of surgery. Postoperative complications. Lenght of hospital stay. Readmission to hospital.
Inflammatory response [The first 4 p.o days]
indicies of inflammatory response
Parental stress [12 and 24 months]
Indicies of parental stress caused by GER pre- and postoperatively

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 15 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Oslo University Hospital	Oslo		Norway	0424

Sponsors and Collaborators

Oslo University Hospital
University of Oslo

Investigators

Principal Investigator: Kristin Bjornland, MD, PhD, Department of hepatic, gastrointestinal and pediatric surgery, Oslo University Hospital HF, Rikshospitalet, Postboks 4950 Nydalen, 0424 Oslo, NORWAY.