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

• ClinicalTrials.gov Identifier: NCT05966285
• Recruitment Status: Not yet recruiting
• First Posted: July 28, 2023
• Last Update Posted: September 14, 2023
• Sponsor: Fudan University
• Information provided by (Responsible Party): Zhijun Bao, Fudan University

Study Description

Brief 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.

Condition or disease	Intervention/treatment
Incarcerated Groin Hernia	Other: suture repair; Other: mesh repair

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

• Study Type: Observational
• Estimated Enrollment: 70 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Suture Repair vs Mesh Repair in the Treatment of Incarcerated Groin Hernia in Elderly Populations: a Retrospective, Single-center Study
• Estimated Study Start Date: September 30, 2023
• Estimated Primary Completion Date: July 20, 2024
• Estimated Study Completion Date: July 20, 2024

Groups and Cohorts

Group/Cohort	Intervention/treatment
suture group; Patients ≥65 years who underwent urgent surgical groin hernia repair from January 2015 to June 2022 were included.	Other: suture repair; Suture repair was used to reinforce the abdominal wall, including Bassini, Ferguson, McVay, or Halsted technique.
mesh repair; Patients ≥65 years who underwent urgent surgical groin hernia repair from January 2015 to June 2022 were included.	Other: mesh repair; Mesh repair was conducted using a synthetic and biological mesh in the Lichtenstein or open preperitoneal techniques.

Outcome Measures

Primary Outcome Measures :

1. Recurrence [ Time Frame: at least one year ]
   Recurrence is determined by physical examination or the patient's subjective perceptions

Secondary Outcome Measures :

1. length of hospital stay [ Time Frame: up to 3 months ]
   The number of days from hospitalization to discharge
2. length of ICU stay [ Time Frame: up to 3 months ]
   The number of days in ICU
3. surgery-related death [ Time Frame: within 30 days after surgery ]
   Deaths occurring during the first hospital stay
4. surgical site infection [ Time Frame: within 30 days after surgery ]
   would infection
5. overall complications [ Time Frame: at least 1 months ]
   combination of Outcome 1 to 6

Eligibility Criteria

• Ages Eligible for Study: 65 Years and older (Older Adult)
• Sexes Eligible for Study: 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.

Criteria

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:

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

Contacts and Locations

Contacts

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

Sponsors and Collaborators

Fudan University

More Information

• Responsible Party: Zhijun Bao, Director, Fudan University
• ClinicalTrials.gov Identifier: NCT05966285
• Other Study ID Numbers: Huadong Hospital to FDU
• First Posted: July 28, 2023
• Last Update Posted: September 14, 2023
• Last Verified: September 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Zhijun Bao, Fudan University:

Incarcerated groin hernia; Emergency

Additional relevant MeSH terms:

Hernia; Hernia, Inguinal; Pathological Conditions, Anatomical; Hernia, Abdominal