AzTrials
AzTrials

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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

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.

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 groups in NCT05966285
Study groupRoleWhat they receive
suture groupPatients ≥65 years who underwent urgent surgical groin hernia repair from January 2015 to June 2022 were included.
Receives: Other: suture repair
mesh repairPatients ≥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.

  1. Recurrence

    Recurrence is determined by physical examination or the patient's subjective perceptions

    Measured: at least one year

Secondary outcomes (5)
  1. length of hospital stay

    The number of days from hospitalization to discharge

    Measured: up to 3 months

  2. length of ICU stay

    The number of days in ICU

    Measured: up to 3 months

  3. surgery-related death

    Deaths occurring during the first hospital stay

    Measured: within 30 days after surgery

  4. surgical site infection

    would infection

    Measured: within 30 days after surgery

  5. 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.

  1. First posted28 Jul 2023
  2. Study start30 Sep 2023 (estimated)
  3. Primary completion20 Jul 2024 (estimated)
  4. Study completion20 Jul 2024 (estimated)

Resources

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)
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

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in