Inguinal Hernia RepairNCT07602647
Perioperative Safety and Long-Term Outcomes of Mesh Repair in Nonagenarians Undergoing Elective Inguinal Hernia Repair
An observational study of Inguinal Hernia Repair, run by Fudan University.
Trial summary
To evaluate the clinical characteristics, postoperative outcomes, and factors associated with Clavien-Dindo grade ≥II complications in nonagenarians undergoing elective inguinal hernia repair. Read more about this study
- Who is it for?
- Ages 90 years and older
- Conditions the study is for
- Inguinal Hernia Repair
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2026to 15 Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 90 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients aged 90 years or older who underwent elective inguinal hernia repair
Inclusion Criteria: patients aged 90 years or older who underwent elective inguinal hernia repair -
Exclusion Criteria: Patients underwent emergency surgery for incarcerated or strangulated hernia. Patients were also excluded if incomplete data, or valid follow-up information was unavailable.
-
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Perioperative Safety and Long-Term Outcomes of Mesh Repair in Nonagenarians Undergoing Elective Inguinal Hernia Repair: A Single-Center Retrospective Cohort Study
To evaluate the clinical characteristics, postoperative outcomes, and factors associated with Clavien-Dindo grade ≥II complications in nonagenarians undergoing elective inguinal hernia repair. Preoperative, intraoperative, and postoperative data of nonagenarians who underwent elective inguinal hernia repair were collected. The primary outcome was Clavien-Dindo grade ≥II complications. Univariable logistic regression was used to identify associated factors.
Read the detailed description
We included patients aged 90 years or older who underwent elective inguinal hernia repair at Huadong Hospital, Fudan University, between 2013 and 2025. Patients were excluded if they underwent emergency surgery for incarcerated or strangulated hernia. Patients were also excluded if incomplete data, or valid follow-up information was unavailable.
Patient data were collected from inpatient medical records, anesthesia records, nursing records, and follow-up records. Preoperative variables included age, sex, body mass index, functional status, American Society of Anesthesiologists class, comorbidities, and hernia-related characteristics. Intraoperative variables included anesthesia type, operative time, surgical approach, procedure type, mesh use, concomitant procedures, drain placement, and urinary catheterization. Postoperative variables included length of hospital stay, postoperative intensive care unit admission, postoperative complications, 30-day readmission, 30-day reoperation, in-hospital mortality, 30-day mortality, recurrence, chronic pain, reoperation for recurrence, and all-cause mortality during follow-up.
- Conditions
- Inguinal Hernia Repair
- Keywords
- Inguinal hernia, nonagenarians, Clavien-Dindo classification, functional status, mesh repair
- Medical subject headings
- Hernia, Inguinal
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 |
|---|---|---|
| nonagenarians | elective inguinal hernia repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clavien-Dindo grade ≥II complications
The Clavien-Dindo classification grades complications according to the intensity of treatment required. Grade II or higher complications generally include events requiring pharmacologic therapy, interventional treatment, surgery, or resulting in death.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start1 Jun 2026 (estimated)
- Primary completion14 Jun 2026 (estimated)
- Study completion15 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inguinal Hernia RepairStudies 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
- 150 participants (estimated)
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
- NCT07602647
- Sponsor's protocol ID
- HuadongHosptialHernia03
- Status last verified
- May 2026
- First submitted
- 16 May 2026
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- 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 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Safety and Long-Term Outcomes of Mesh Repair in Nonagenarians Undergoing Elective Inguinal Hernia Repair: A Single-Center Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT07602647
- Acronym / sponsor ID
- HuadongHosptialHernia03
- Conditions
- Inguinal Hernia Repair
- Keywords
- Inguinal hernia, nonagenarians, Clavien-Dindo classification, functional status, mesh repair
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 14 Jun 2026 (estimated)
- Study completion
- 15 Jun 2026 (estimated)
- First posted
- 22 May 2026 (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.
To evaluate the clinical characteristics, postoperative outcomes, and factors associated with Clavien-Dindo grade ≥II complications in nonagenarians undergoing elective inguinal hernia repair. Preoperative, intraoperative, and postoperative data of nonagenarians who underwent elective inguinal hernia repair were collected. The primary outcome was Clavien-Dindo grade ≥II complications. Univariable logistic regression was used to identify associated factors.
Detailed description
We included patients aged 90 years or older who underwent elective inguinal hernia repair at Huadong Hospital, Fudan University, between 2013 and 2025. Patients were excluded if they underwent emergency surgery for incarcerated or strangulated hernia. Patients were also excluded if incomplete data, or valid follow-up information was unavailable.
Patient data were collected from inpatient medical records, anesthesia records, nursing records, and follow-up records. Preoperative variables included age, sex, body mass index, functional status, American Society of Anesthesiologists class, comorbidities, and hernia-related characteristics. Intraoperative variables included anesthesia type, operative time, surgical approach, procedure type, mesh use, concomitant procedures, drain placement, and urinary catheterization. Postoperative variables included length of hospital stay, postoperative intensive care unit admission, postoperative complications, 30-day readmission, 30-day reoperation, in-hospital mortality, 30-day mortality, recurrence, chronic pain, reoperation for recurrence, and all-cause mortality during follow-up.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| nonagenarians | – | –elective inguinal hernia repair |
Who may qualify
- Ages
- 90 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients aged 90 years or older who underwent elective inguinal hernia repair
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
Clavien-Dindo grade ≥II complications
Time frame: 30 days
The Clavien-Dindo classification grades complications according to the intensity of treatment required. Grade II or higher complications generally include events requiring pharmacologic therapy, interventional treatment, surgery, or resulting in death.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Inguinal Hernia Repair, run by Fudan University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: opening soon, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact HEKAI SHI (+8618580290227, 25111280019@m.fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clavien-Dindo grade ≥II complications (time frame: 30 days). 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 22 May 2026.