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Not yet recruitingNCT05966285Updated Sep 14, 2023

Suture Repair vs Mesh Repair in the Treatment of Incarcerated Groin Hernia in Elderly Populations

An observational study in Incarcerated Groin Hernia, sponsored by Fudan University. Not yet recruiting. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2023-09-14.

Sponsored by Fudan University · Observational

From the registry’s dates

  • Primary completion was expected by Jul 2024, 2 years 2 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
70
Ages
65 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Incarcerated Groin Hernia

Keywords

  • Incarcerated groin hernia
  • Emergency
03

In context

Hernia

1,096 studies on the registry are indexed under Hernia; 132 are open to participants now.

This study's planned enrollment of 70 is below the median of 120 across 327 observational studies indexed under Hernia.

Browse Hernia studies →

Lead sponsor

Fudan University is the lead sponsor of 1,270 studies on the registry; 623 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients ≥65 years diagnosed with incarcerated groin hernia (IGH) who underwent emergency surgical repair.

Inclusion criteria

  1. Patients diagnosed with incarcerated groin hernia (IGH).
  2. Aged ≥65 years
  3. Received emergency surgical repair (mesh or suture repair) at our center between January 2015 and June 2022.

Exclusion criteria

Exclusion Criteria:

  • IGH patients did not undergo either mesh repair or suture repair.
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
70 participants (estimated)
Patient registry
No

Groups and cohorts

  • suture group

    Patients ≥65 years who underwent urgent surgical groin hernia repair from January 2015 to June 2022 were included.

    Other: suture repair

  • mesh repair

    Patients ≥65 years who underwent urgent surgical groin hernia repair from January 2015 to June 2022 were included.

    Other: mesh repair

Interventions

  • Othersuture repair

    Suture repair was used to reinforce the abdominal wall, including Bassini, Ferguson, McVay, or Halsted technique.

  • Othermesh repair

    Mesh repair was conducted using a synthetic and biological mesh in the Lichtenstein or open preperitoneal techniques.

06

What researchers measure

Primary outcomes

  1. Recurrence

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

    Time frame: at least one year

Secondary outcomes

  1. length of hospital stay

    The number of days from hospitalization to discharge

    Time frame: up to 3 months

  2. length of ICU stay

    The number of days in ICU

    Time frame: up to 3 months

  3. surgery-related death

    Deaths occurring during the first hospital stay

    Time frame: within 30 days after surgery

  4. surgical site infection

    would infection

    Time frame: within 30 days after surgery

  5. overall complications

    combination of Outcome 1 to 6

    Time frame: at least 1 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 14, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05966285
Lead sponsor
Fudan University
Responsible party
Zhijun Bao (Director, Fudan University) — Principal investigator
First posted
Jul 28, 2023
Start date
Sep 30, 2023 (estimated)
Primary completion
Jul 20, 2024 (estimated)
Completion
Jul 20, 2024 (estimated)
Last update
Sep 14, 2023

Study contacts

Hekai Shi, M.D.
Contact
22211280026@m.fudan.edu.cn
+86 18580290227

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.

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