Analysis of the Causes of Redo Pull-through for Recurrent Constipation and the Risk Factors Affecting the Prognosis of the Hirschsprung's Disease and Allied Disorders

NCT ID: NCT06175598

Last Updated: 2023-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

79 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-12-01

Study Completion Date

2023-12-07

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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?

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Surgery Pediatric ALL

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Acquire Aganglionosis (AA)

No interventions assigned to this group

Intestinal Dysmotility (ID)

No interventions assigned to this group

Anastomotic Complications (AC)

No interventions assigned to this group

Intestinal Neurodevelopmental Impairment (INI)

No interventions assigned to this group

Incomplete Resection of Affected Intestinal Segments (IRAIS)

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Feng Jiexiong

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Feng Jiexiong

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jiexiong Feng, PhD

Role: STUDY_DIRECTOR

Tongji Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Department of Pediatric Surgery

Wuhan, Hubei, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

TJ-IRB20230739

Identifier Type: -

Identifier Source: org_study_id