NCT06175598

Brief 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. 1.Our study focused on the treatment and prognosis of these conditions, drawing upon 16 years of patient data and clinical experiences"
  2. 2.What are the key risk factors affecting the prognosis of recurrent constipation patients undergoing repeat PT?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
79

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2023

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

December 7, 2023

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 7, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 7, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 19, 2023

Completed
Last Updated

December 27, 2023

Status Verified

December 1, 2023

Enrollment Period

6 days

First QC Date

December 7, 2023

Last Update Submit

December 20, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (5)

Acquire Aganglionosis (AA)

Intestinal Dysmotility (ID)

Anastomotic Complications (AC)

Intestinal Neurodevelopmental Impairment (INI)

Incomplete Resection of Affected Intestinal Segments (IRAIS)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This study collected comprehensive clinical data and compiled postoperative follow-up data from patients who underwent corrective surgery for HSCR and ADHD and subsequently required redo-PT due to recurrent constipation.

You may qualify if:

  • 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;
  • HSCR and ADHD patients admitted due to "constipation recurrence" and requiring redo-PT.

You may not qualify if:

  • Patients undergoing staged surgeries or undergoing internal sphincterotomy;
  • Patients with concomitant severe congenital anomalies such as Down syndrome; (3) Patients with incomplete postoperative follow-up data after redo-PT.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Pediatric Surgery

Wuhan, Hubei, 430000, China

Location

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Leukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Jiexiong Feng, PhD

    Tongji Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 7, 2023

First Posted

December 19, 2023

Study Start

December 1, 2023

Primary Completion

December 7, 2023

Study Completion

December 7, 2023

Last Updated

December 27, 2023

Record last verified: 2023-12

Locations