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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06175598
Other study ID # TJ-IRB20230739
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 1, 2023
Est. completion date December 7, 2023

Study information

Verified date December 2023
Source Tongji Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The goal of this observational study is to conducted a comprehensive analysis of the factors contributing to redo- Pull-through surgery for constipation recurrence in Children who are suffering from Hirschsprun' s disease (HSCR) and its allied disorders (ADHD) . The main question[s] it aims to answer are: 1. Our study focused on the treatment and prognosis of these conditions, drawing upon 16 years of patient data and clinical experiences" 2. What are the key risk factors affecting the prognosis of recurrent constipation patients undergoing repeat PT?


Recruitment information / eligibility

Status Completed
Enrollment 79
Est. completion date December 7, 2023
Est. primary completion date December 7, 2023
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: 1. Patients admitted to the department of pediatric surgery at Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, between January 2005 and December 2021; 2. HSCR and ADHD patients admitted due to "constipation recurrence" and requiring redo-PT. Exclusion Criteria: 1. Patients undergoing staged surgeries or undergoing internal sphincterotomy; 2. Patients with concomitant severe congenital anomalies such as Down syndrome; (3) Patients with incomplete postoperative follow-up data after redo-PT.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
China Department of Pediatric Surgery Wuhan Hubei

Sponsors (1)

Lead Sponsor Collaborator
Feng Jiexiong

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Participants with redo-pull-through surgery for recurrent constipation After utilizing the terms "Hirschsprung" and "Redo pull-through" in searches across "PubMed" and "Web of Science" for references published between 1990 and 2023, and subsequent removal of duplicate and incomplete documents, we compiled clinical information from the remaining literature. This compilation facilitated a review of relevant literature on the causes of redo-PT for recurrent constipation, enabling an assessment of classification types, which we categorized into five groups: Incomplete Resection of Affected Intestinal Segments (IRAIS), Acquire Aganglionosis (AA), Intestinal Dysmotility (ID), Anastomotic Complications (AC), and Intestinal Neurodevelopmental Impairment (INI). 1990-2023
Primary Participants with and without postoperative complications Group the data by gender, age groups, surgical techniques, and surgical approaches. Then, calculate the number of cases with and without postoperative complications through study completion, an average of 33 year
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