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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00195949
Other study ID # 03-01-004
Secondary ID
Status Completed
Phase Phase 3
First received September 12, 2005
Last updated April 5, 2007
Start date April 2003
Est. completion date February 2006

Study information

Verified date September 2005
Source Children's Mercy Hospital Kansas City
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

Pyloric stenosis is a condition that develops in infants and that leads to an obstruction of the channel going out of the stomach. This study is being performed to determine if there is an advantage to the laparoscopic approach or the open approach for the surgical correction of the enlarged pylorus.


Description:

Pyloromyotomy for pyloric stenosis has traditionally been performed via an open technique. With advancements in minimally invasive surgery in infants a laparoscopic approach has been developed. These two approaches have never been critically evaluated with regard to superiority of one technique over the other. This is a prospective randomized trial involving infants with pyloric stenosis. It will enroll 100 patients in each arm (statistical and power analysis was performed by Steve Simon, PhD). Parental consent will be obtained and the patients will be randomized to undergo open or laparoscopic pyloromyotomy. Patient age at diagnosis, electrolyte disturbances at diagnosis, ultrasound findings, operative approach, length of pyloromyotomy, operative times, time to tolerating full feeds, number of emesis episodes, length of hospitalization, operative charges, and hospital charges will be collected for comparison between the groups.


Recruitment information / eligibility

Status Completed
Enrollment 200
Est. completion date February 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group N/A to 12 Weeks
Eligibility Inclusion Criteria:

- All infants less than 12 weeks of age who have undergone surgical consultation and abdominal ultrasound confirming the diagnosis of pyloric stenosis and whose parents have given consent for inclusion in the study.

Exclusion Criteria:

- All patients greater than 12 weeks of age, or without parental consent, or without pyloric stenosis will be excluded from the study.

Study Design

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


Intervention

Procedure:
Laparoscopic pyloromyotomy


Locations

Country Name City State
United States Children's Mercy Hospital Kansas CIty Missouri

Sponsors (1)

Lead Sponsor Collaborator
Children's Mercy Hospital Kansas City

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Operative Time
Secondary Time to full feeds
Secondary Length of hospitalization
Secondary Pain medication requirements
Secondary Emesis episodes
Secondary Complications
See also
  Status Clinical Trial Phase
Not yet recruiting NCT01159509 - The Effect of Hypertrophic Pyloric Stenosis (HPS) on Sodium Intake in Childhood N/A
Not yet recruiting NCT03095144 - Spinal Anesthesia and General Anesthesia for Pyloromyotomy - Surgical Outcomes a Comparison Retrospective Study N/A
Recruiting NCT05068622 - Gastric Tube in Pyloric Stenosis