Incarcerated Groin HerniaNCT05966285
Suture Repair vs Mesh Repair in the Treatment of Incarcerated Groin Hernia in Elderly Populations
An observational study of Incarcerated Groin Hernia, run by Fudan University.
Trial summary
Purpose: Tension-free hernia repair is the gold standard for groin hernia repair. However, there is no consensus on the optimal surgical treatment for incarcerated groin hernia in elderly populations, The aim of this study was to compare the clinical efficacy of mesh repair and suture repair in the treatment of… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Incarcerated Groin Hernia
- What is being tested?
- suture repair and mesh repair
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 30 Sep 2023to 20 Jul 2024
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients ≥65 years diagnosed with incarcerated groin hernia (IGH) who underwent emergency surgical repair.
Who may be able to join
- Patients diagnosed with incarcerated groin hernia (IGH).
- Aged ≥65 years
- Received emergency surgical repair (mesh or suture repair) at our center between January 2015 and June 2022.
Who cannot join
- IGH patients did not undergo either mesh repair or suture repair.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Suture Repair vs Mesh Repair in the Treatment of Incarcerated Groin Hernia in Elderly Populations: a Retrospective, Single-center Study
Purpose:
Tension-free hernia repair is the gold standard for groin hernia repair. However, there is no consensus on the optimal surgical treatment for incarcerated groin hernia in elderly populations, The aim of this study was to compare the clinical efficacy of mesh repair and suture repair in the treatment of incarcerated groin hernia in elderly patients.
Methods:
Patients ≥65 years who underwent urgent surgical groin hernia repair from January 2015 to June 2022 will be included. Patient demographic data and short-term and long-term postoperative outcomes will be retrospectively analyzed.
Read the detailed description
This study includes consecutive patients ≥65 years diagnosed with IGH who underwent emergency surgical repair at our center between January 2015 and June 2022. The study is conducted in compliance with the ethical standards laid down in the 1964 Declaration of Helsinki and its subsequent amendments.
Only true emergencies were included in the study, involving IGH patients who underwent urgent surgical repair within six hours of an emergency admission or patients who underwent emergency surgery due to sudden exacerbation while awaiting elective repair surgery during hospitalization. Various techniques were performed to repair IGH during the surgical procedure. In cases where there was no ischemic necrosis of the hernia contents, the hernia content was simply reduced, followed by high ligation of the hernia sac at the inner ring of the groin. Subsequently, mesh repair was conducted using a synthetic and biological mesh in the Lichtenstein or open preperitoneal techniques, while suture repair was utilized in the Bassini, Ferguson, or Halsted operation. For femoral hernias, McVay repair was used in suture repair while open preperitoneal techniques was used for mesh repair. In cases of IGH accompanied by intestinal necrosis, the initial procedure involved resection of the necrotic bowel followed by in vitro anastomosis through a groin incision. Subsequently, high ligation of the hernia sac was carried out, and the choice between mesh or tissue repair was left to the discretion of the surgeon. The choice of surgical techniques was based on the surgeons' experience and the overall condition of the patient. Based on the surgical method used, the researchers were categorized into two groups: suture repair and mesh repair groups.
After hospital discharge, the patient was scheduled for regular outpatient visits for at least 1 year of follow-up, physical Examination and patient's subjective perceptions were used to determine the presence of recurrence or other long-term complications. The end of the follow-up was June 2023. Recorded death, recurrence, or loss to follow-up were considered to be the endpoint.
Investigators collected data on the following three aspects: (1) patients' demographic information, including age, sex, American Society of Anesthesiologists (ASA) grade, previous abdominal operation, previous surgical repair of groin hernia, history of acute incarceration, comorbidities, and time from incarceration to surgery; (2) surgical details, such as the type of groin hernia, preoperative antibiotic use, nighttime surgery (the start time of surgery was from 5 p.m. to before 8 a.m. the next day), hernia contents, bowel resection, hernia sac size, area of the hernia ring, prosthetic material used, open or laparoscopic surgery, type of anesthesia (general anesthesia or spinal anesthesia), placement of the drainage; and (3) clinical outcomes, which included postoperative recurrence as a long-term outcome, and the surgery related death, surgical site infection (SSI) within 30 days, length of hospital stay, ICU admission, and overall wound complications as short-term outcomes.
- Conditions
- Incarcerated Groin Hernia
- Being tested
- suture repair, mesh repair
- Keywords
- Incarcerated groin hernia, Emergency
- Medical subject headings
- Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
suture repairOther
Suture repair was used to reinforce the abdominal wall, including Bassini, Ferguson, McVay, or Halsted technique.
mesh repairOther
Mesh repair was conducted using a synthetic and biological mesh in the Lichtenstein or open preperitoneal techniques.
| Study group | Role | What they receive |
|---|---|---|
| suture group | Patients ≥65 years who underwent urgent surgical groin hernia repair from January 2015 to June 2022 were included. Receives: Other: suture repair | |
| mesh repair | Patients ≥65 years who underwent urgent surgical groin hernia repair from January 2015 to June 2022 were included. Receives: Other: mesh repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence
Recurrence is determined by physical examination or the patient's subjective perceptions
Measured: at least one year
Secondary outcomes (5)
length of hospital stay
The number of days from hospitalization to discharge
Measured: up to 3 months
length of ICU stay
The number of days in ICU
Measured: up to 3 months
surgery-related death
Deaths occurring during the first hospital stay
Measured: within 30 days after surgery
surgical site infection
would infection
Measured: within 30 days after surgery
overall complications
combination of Outcome 1 to 6
Measured: at least 1 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2023
- Study start30 Sep 2023 (estimated)
- Primary completion20 Jul 2024 (estimated)
- Study completion20 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Incarcerated Groin 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
- 70 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
- NCT05966285
- Sponsor's protocol ID
- Huadong Hospital to FDU
- Status last verified
- Sep 2023
- First submitted
- 21 Jul 2023
- Last updated
- 14 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 14 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Suture Repair vs Mesh Repair in the Treatment of Incarcerated Groin Hernia in Elderly Populations: a Retrospective, Single-center Study
- ClinicalTrials.gov ID
- NCT05966285
- Acronym / sponsor ID
- Huadong Hospital to FDU
- Conditions
- Incarcerated Groin Hernia
- Keywords
- Incarcerated groin hernia, Emergency
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 30 Sep 2023 (estimated)
- Primary completion
- 20 Jul 2024 (estimated)
- Study completion
- 20 Jul 2024 (estimated)
- First posted
- 28 Jul 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.
Purpose:
Tension-free hernia repair is the gold standard for groin hernia repair. However, there is no consensus on the optimal surgical treatment for incarcerated groin hernia in elderly populations, The aim of this study was to compare the clinical efficacy of mesh repair and suture repair in the treatment of incarcerated groin hernia in elderly patients.
Methods:
Patients ≥65 years who underwent urgent surgical groin hernia repair from January 2015 to June 2022 will be included. Patient demographic data and short-term and long-term postoperative outcomes will be retrospectively analyzed.
Detailed description
This study includes consecutive patients ≥65 years diagnosed with IGH who underwent emergency surgical repair at our center between January 2015 and June 2022. The study is conducted in compliance with the ethical standards laid down in the 1964 Declaration of Helsinki and its subsequent amendments.
Only true emergencies were included in the study, involving IGH patients who underwent urgent surgical repair within six hours of an emergency admission or patients who underwent emergency surgery due to sudden exacerbation while awaiting elective repair surgery during hospitalization. Various techniques were performed to repair IGH during the surgical procedure. In cases where there was no ischemic necrosis of the hernia contents, the hernia content was simply reduced, followed by high ligation of the hernia sac at the inner ring of the groin. Subsequently, mesh repair was conducted using a synthetic and biological mesh in the Lichtenstein or open preperitoneal techniques, while suture repair was utilized in the Bassini, Ferguson, or Halsted operation. For femoral hernias, McVay repair was used in suture repair while open preperitoneal techniques was used for mesh repair. In cases of IGH accompanied by intestinal necrosis, the initial procedure involved resection of the necrotic bowel followed by in vitro anastomosis through a groin incision. Subsequently, high ligation of the hernia sac was carried out, and the choice between mesh or tissue repair was left to the discretion of the surgeon. The choice of surgical techniques was based on the surgeons' experience and the overall condition of the patient. Based on the surgical method used, the researchers were categorized into two groups: suture repair and mesh repair groups.
After hospital discharge, the patient was scheduled for regular outpatient visits for at least 1 year of follow-up, physical Examination and patient's subjective perceptions were used to determine the presence of recurrence or other long-term complications. The end of the follow-up was June 2023. Recorded death, recurrence, or loss to follow-up were considered to be the endpoint.
Investigators collected data on the following three aspects: (1) patients' demographic information, including age, sex, American Society of Anesthesiologists (ASA) grade, previous abdominal operation, previous surgical repair of groin hernia, history of acute incarceration, comorbidities, and time from incarceration to surgery; (2) surgical details, such as the type of groin hernia, preoperative antibiotic use, nighttime surgery (the start time of surgery was from 5 p.m. to before 8 a.m. the next day), hernia contents, bowel resection, hernia sac size, area of the hernia ring, prosthetic material used, open or laparoscopic surgery, type of anesthesia (general anesthesia or spinal anesthesia), placement of the drainage; and (3) clinical outcomes, which included postoperative recurrence as a long-term outcome, and the surgery related death, surgical site infection (SSI) within 30 days, length of hospital stay, ICU admission, and overall wound complications as short-term outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| suture group | – | Other: suture repairPatients ≥65 years who underwent urgent surgical groin hernia repair from January 2015 to June 2022 were included. |
| mesh repair | – | Other: mesh repairPatients ≥65 years who underwent urgent surgical groin hernia repair from January 2015 to June 2022 were included. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients ≥65 years diagnosed with incarcerated groin hernia (IGH) who underwent emergency surgical repair.
Key inclusion criteria (3 listed)
- Patients diagnosed with incarcerated groin hernia (IGH).
- Aged ≥65 years
- Received emergency surgical repair (mesh or suture repair) at our center between January 2015 and June 2022.
Key exclusion criteria (1 listed)
- IGH patients did not undergo either mesh repair or suture repair.
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 |
|---|---|---|
| suture repairSuture repair was used to reinforce the abdominal wall, including Bassini, Ferguson, McVay, or Halsted technique. | Other | suture group |
| mesh repairMesh repair was conducted using a synthetic and biological mesh in the Lichtenstein or open preperitoneal techniques. | Other | mesh repair |
Primary outcome
Recurrence
Time frame: at least one year
Recurrence is determined by physical examination or the patient's subjective perceptions
5 secondary outcomes
length of hospital stay
Time frame: up to 3 months
length of ICU stay
Time frame: up to 3 months
surgery-related death
Time frame: within 30 days after surgery
surgical site infection
Time frame: within 30 days after surgery
overall complications
Time frame: at least 1 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2023.
- Individual participant dataSharing planned: No
Related trials for Incarcerated Groin Hernia
Not yet recruiting
Bassini Repair Versus Desarda Technique in Urgent Complicated Inguinal Hernia Repair
Inguinal Hernia, Incarcerated Inguinal Hernia
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Incarcerated Groin Hernia, 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?
The sponsor lists 3 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: status not confirmed, as of the sponsor's last update on 14 Sep 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hekai Shi, M.D. (+86 18580290227, 22211280026@m.fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence (time frame: at least one year). 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 14 Sep 2023.