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
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.
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.
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 →Fudan University is the lead sponsor of 1,270 studies on the registry; 623 are open to participants now.
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Patients ≥65 years diagnosed with incarcerated groin hernia (IGH) who underwent emergency surgical repair.
Exclusion Criteria:
Patients ≥65 years who underwent urgent surgical groin hernia repair from January 2015 to June 2022 were included.
Other: suture repair
Patients ≥65 years who underwent urgent surgical groin hernia repair from January 2015 to June 2022 were included.
Other: mesh repair
Suture repair was used to reinforce the abdominal wall, including Bassini, Ferguson, McVay, or Halsted technique.
Mesh repair was conducted using a synthetic and biological mesh in the Lichtenstein or open preperitoneal techniques.
Recurrence
Recurrence is determined by physical examination or the patient's subjective perceptions
Time frame: at least one year
length of hospital stay
The number of days from hospitalization to discharge
Time frame: up to 3 months
length of ICU stay
The number of days in ICU
Time frame: up to 3 months
surgery-related death
Deaths occurring during the first hospital stay
Time frame: within 30 days after surgery
surgical site infection
would infection
Time frame: within 30 days after surgery
overall complications
combination of Outcome 1 to 6
Time frame: at least 1 months
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
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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Fudan University