Incisional HerniaNCT06102551
A Retrospective Analysis of Incisional Hernia Repair's Postoperative Recurrence
An observational study of Incisional Hernia and Recurrent Hernia, run by Fudan University at 1 site in China.
Trial summary
ABSTRACT Purpose：A retrospective study was conducted among patients with incisional hernia in our hospital to analyse the factors associated with postoperative recurrence of abdominal wall incisional hernia. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Incisional Hernia, Recurrent Hernia
- What is being tested?
- Recurrence after surgery
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 157 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2023to 31 Aug 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Inclusion Criteria: * Inclusion criteria: diagnosis of incisional hernia of the abdominal wall and primary; surgical treatment for hernia repair at our hospital; all patients originating from outpatient clinics rather than emergency clinics; age of 18 to 80 years at the time of admission; and those with a well-established preoperative examination. Exclusion Criteria: * Exclusion criteria: severe organ dysfunction (ASA score of IV, V, VI); unconsciousness and poor cooperation with various preoperative examinations; correction of other types of abdominal hernia by perfect examination after admission; incomplete necessary information.
Who may be able to join
- Inclusion criteria: diagnosis of incisional hernia of the abdominal wall and primary; surgical treatment for hernia repair at our hospital; all patients originating from outpatient clinics rather than emergency clinics; age of 18 to 80 years at the time of admission; and those with a well-established preoperative examination.
Who cannot join
- Exclusion criteria: severe organ dysfunction (ASA score of IV, V, VI); unconsciousness and poor cooperation with various preoperative examinations; correction of other types of abdominal hernia by perfect examination after admission; incomplete necessary information.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Retrospective Study of Factors Associated With Postoperative Recurrence of Incisional Hernia Repair in the Abdominal Wall
ABSTRACT Purpose：A retrospective study was conducted among patients with incisional hernia in our hospital to analyse the factors associated with postoperative recurrence of abdominal wall incisional hernia.
Methods：Patients with a diagnosis of incisional hernia obtained from our hospital's electronic medical record system were divided into primary incisional hernia group and recurrent incisional hernia group according to whether or not they had a recurrence after surgery. Baseline information on these patients was recorded and statistically analysed after our review.
- Conditions
- Incisional Hernia, Recurrent Hernia
- Being tested
- Recurrence after surgery
- Medical subject headings
- Incisional Hernia, Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recurrence after surgeryBehavioural
Recurrence after repair was the main outcome
| Study group | Role | What they receive |
|---|---|---|
| The primary group | Not described | |
| The recurrent group | Not described Receives: Behavioral: Recurrence after surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrent
Recurrence after surgery repair
Measured: 2017.1-2023.8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2023
- Study start1 Mar 2023
- Primary completion1 Jul 2023
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Incisional HerniaStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 157 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhijun Bao, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06102551
- Sponsor's protocol ID
- HuadongHosptialHernia01
- Status last verified
- Oct 2023
- First submitted
- 23 Sep 2023
- Last updated
- 26 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Study of Factors Associated With Postoperative Recurrence of Incisional Hernia Repair in the Abdominal Wall
- ClinicalTrials.gov ID
- NCT06102551
- Acronym / sponsor ID
- HuadongHosptialHernia01
- Conditions
- Incisional Hernia, Recurrent Hernia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 157 participants (actual)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 26 Oct 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.
ABSTRACT Purpose：A retrospective study was conducted among patients with incisional hernia in our hospital to analyse the factors associated with postoperative recurrence of abdominal wall incisional hernia.
Methods：Patients with a diagnosis of incisional hernia obtained from our hospital's electronic medical record system were divided into primary incisional hernia group and recurrent incisional hernia group according to whether or not they had a recurrence after surgery. Baseline information on these patients was recorded and statistically analysed after our review.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The primary group | – | – |
| The recurrent group | – | Behavioral: Recurrence after surgery |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Inclusion Criteria: * Inclusion criteria: diagnosis of incisional hernia of the abdominal wall and primary; surgical treatment for hernia repair at our hospital; all patients originating from outpatient clinics rather than emergency clinics; age of 18 to 80 years at the time of admission; and those with a well-established preoperative examination. Exclusion Criteria: * Exclusion criteria: severe organ dysfunction (ASA score of IV, V, VI); unconsciousness and poor cooperation with various preoperative examinations; correction of other types of abdominal hernia by perfect examination after admission; incomplete necessary information.
Key inclusion criteria (1 listed)
- Inclusion criteria: diagnosis of incisional hernia of the abdominal wall and primary; surgical treatment for hernia repair at our hospital; all patients originating from outpatient clinics rather than emergency clinics; age of 18 to 80 years at the time of admission; and those with a well-established preoperative examination.
Key exclusion criteria (1 listed)
- Exclusion criteria: severe organ dysfunction (ASA score of IV, V, VI); unconsciousness and poor cooperation with various preoperative examinations; correction of other types of abdominal hernia by perfect examination after admission; incomplete necessary information.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Recurrence after surgeryRecurrence after repair was the main outcome | Behavioural | The recurrent group |
Primary outcome
Recurrent
Time frame: 2017.1-2023.8
Recurrence after surgery repair
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 26 Oct 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Incisional Hernia and Recurrent Hernia, run by Fudan University 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 1 inclusion and 1 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 26 Oct 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?
Recurrent (time frame: 2017.1-2023.8). 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 26 Oct 2023.