Fast-track Surgery in the Treatment of Hirschsprung's Disease

Surgery Clinical Trial

— Fast-track  

Official title:

Fast-track Surgery in the Treatment of Hirschsprung's Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02350088
• Other study ID #: Tongji Fast-track surgery
• Status: Recruiting
• Phase: N/A
• First received: January 17, 2015
• Last updated: January 24, 2015
• Start date: January 2014
• Est. completion date: January 2016

Study information

• Verified date: January 2015
• Source: Tongji Hospital
• Contact: Zhi Li, MD PhD
• Phone: +8613387664883
• Email: lizhimdphd[@]163.com
• Is FDA regulated: No
• Health authority: China: National Natural Science Foundation
• Study type: Interventional

Clinical Trial Summary

To evaluate the safety and efficacy of Hirschsprung's disease

Description:

The patients are divided into two groups：fast-track surgery combined with laparoscope group and laparoscope with traditional managements group.Postoperative recovery,hospital stay,hospital cost and complcations were compared.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 18 Years

Eligibility

Inclusion Criteria:

1. surgical treatment for Hirschsprung's disease

2. The first procedure for Hirschsprung's disease

3. Age<14 years

Exclusion Criteria:

1. conservative treatment for Hirschsprung's disease

2. The reoperation for Hirschsprung's disease

3. Age>14 years

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hirschsprung Disease
• Surgery

Intervention

Drug:
• probiotics
probiotics
• placebo
placebo

Locations

Country	Name	City	State
China	Tongji Hospital	Wuhan	Hubei

Sponsors (2)

Lead Sponsor	Collaborator
Tongji Hospital	Children's Hospital Boston

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of participants with recovery of boewl movements		one year	No
Secondary	Duration of the hospital stay		one year	No