SurgeryNCT06175598
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
An observational study of Surgery and Pediatric ALL, run by Feng Jiexiong at 1 site in China.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Surgery, Pediatric ALL
- How many people
- 79 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2023to 7 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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:
- Our study focused on the treatment and prognosis of these conditions, drawing upon 16 years of patient data and clinical experiences"
- What are the key risk factors affecting the prognosis of recurrent constipation patients undergoing repeat PT?
- Conditions
- Surgery, Pediatric ALL
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Acquire Aganglionosis (AA) | Not described | |
| Intestinal Dysmotility (ID) | Not described | |
| Anastomotic Complications (AC) | Not described | |
| Intestinal Neurodevelopmental Impairment (INI) | Not described | |
| Incomplete Resection of Affected Intestinal Segments (IRAIS) | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
Measured: through study completion, an average of 33 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2023
- Study start1 Dec 2023
- Primary completion7 Dec 2023
- Study completion7 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Feng Jiexiong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Feng Jiexiong, Tongji Hospital
- Investigators
- Jiexiong Feng, PhD, Study director, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06175598
- Sponsor's protocol ID
- TJ-IRB20230739
- Status last verified
- Dec 2023
- First submitted
- 7 Dec 2023
- Last updated
- 27 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06175598
- Acronym / sponsor ID
- TJ-IRB20230739
- Conditions
- Surgery, Pediatric ALL
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Feng JiexiongUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 7 Dec 2023 (actual)
- Study completion
- 7 Dec 2023 (actual)
- First posted
- 19 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Our study focused on the treatment and prognosis of these conditions, drawing upon 16 years of patient data and clinical experiences"
- What are the key risk factors affecting the prognosis of recurrent constipation patients undergoing repeat PT?
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Acquire Aganglionosis (AA) | – | – |
| Intestinal Dysmotility (ID) | – | – |
| Anastomotic Complications (AC) | – | – |
| Intestinal Neurodevelopmental Impairment (INI) | – | – |
| Incomplete Resection of Affected Intestinal Segments (IRAIS) | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Participants with redo-pull-through surgery for recurrent constipation
Time frame: 1990-2023
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).
Participants with and without postoperative complications
Time frame: through study completion, an average of 33 year
Group the data by gender, age groups, surgical techniques, and surgical approaches. Then, calculate the number of cases with and without postoperative complications
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jiexiong Feng, PhD study director
Tongji Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgery and Pediatric ALL, run by Feng Jiexiong at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participants with redo-pull-through surgery for recurrent constipation (time frame: 1990-2023). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2023.