Comparison of Laparoscopic and Open Inguinal Hernia Repair in Elderly Patients

NCT06417346 | Recruiting

• 1 other identifier: 65646564
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

Inguinal hernia is one of the most frequently performed surgeries in general surgery. This surgery can be performed with both open and laparoscopic techniques. There is no clear consensus on whether inguinal hernia repair, which is one of the most frequently performed surgeries in elderly patients, should be performed open or laparoscopic. The application of the open technique with regional anesthesia methods such as spinal anesthesia and local anesthesia makes these methods attractive. The fact that laparoscopic techniques cause patients to recover faster also makes these techniques attractive. However, the fact that it is usually performed under general anesthesia is a significant disadvantage. Increasing comorbidities and increased drug use, especially in elderly patients, make surgeons think about which technique to prefer. The aim of this study is to compare open and laparoscopic inguinal hernia repair, which should be preferred in patients over 65 years of age.

Conditions

Urinary Retention; Postoperative Complications; Pain; Relapse

Outcome Measures

Primary Outcomes (1)

• rate of postoperative mortality

  postoperative 24 hours

Secondary Outcomes (4)

• rate of urinary retansion

  postoperative 24 hours

• rate of postoperative pain

  postoperative 24 hours

• Rate of Hernia recurrence

  first year

• Rate of Postoperative complications

  postoperative 24 hours and 1st month

Study Arms (2)

Laparoscopic TEP Repair under General Anesthesia

EXPERIMENTAL

A mini-incision was made at the umbilical margin, passing through the skin and subcutaneous tissue to expose the external sheath of the rectus muscle. The RS was incised, and the rectus muscle was laterally displaced. A 10-mm trocar was inserted into the preperitoneal space, and CO2 insufflation was performed with a pressure set at 12 mmHg. Two additional 5 mm trocars were inserted between the umbilicus and the symphysis pubis under laparoscopic guidance. Using laparoscopic dissectors and graspers, all steps of myopectineal orifice dissection were performed (16). A 15 × 10 cm prolene mesh was spread and secured to cover both direct and indirect hernia areas, extending approximately 2-3 cm beyond. Trocars were removed under camera surveillance after CO2 desufflation, and the skin was closed.

Procedure: Laparoscopic TEP Repair

Open Technique (Lichtenstein) under Spinal Anesthesia

ACTIVE COMPARATOR

Following a classic inguinal incision of approximately 5-7 cm extending laterally from the pubic tubercle, the external oblique aponeurosis was opened, the external ring was disrupted, and the spermatic cord/round ligament was suspended. The hernia sac was isolated from surrounding tissues and the spermatic cord/round ligament, then either reduced or ligated. Subsequently, a polypropylene mesh measuring approximately 60x110 mm² was placed to completely cover the transverse fascia, and continuous sutures were used to secure it laterally along the transverse arch starting from the pubic tubercle. Hemostasis was achieved, and the layers and skin were anatomically closed.

Procedure: Open Technique (Lichtenstein)

Interventions

Laparoscopic TEP Repair PROCEDURE

Laparoscopic TEP Repair performed

Laparoscopic TEP Repair under General Anesthesia

Open Technique (Lichtenstein) PROCEDURE

Open Technique (Lichtenstein) performed

Open Technique (Lichtenstein) under Spinal Anesthesia

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Patients with inguinal hernias.
• Patients aged over 65.

You may not qualify if:

• Younger than 65 years.
• Incarcerated or strangulated inguinal hernias.

Sponsors & Collaborators

• Mehmet Eşref Ulutaş: lead
• Van Training and Research Hospital: collaborator

Study Sites (1)

University of Health Science Van Training and Research Hospital

Van, Turkey (Türkiye)

RECRUITING

Related Publications (4)

• Vigneswaran Y, Gitelis M, Lapin B, Denham W, Linn J, Carbray J, Ujiki M. Elderly and octogenarian cohort: Comparable outcomes with nonelderly cohort after open or laparoscopic inguinal hernia repairs. Surgery. 2015 Oct;158(4):1137-43; discussion 1143-4. doi: 10.1016/j.surg.2015.08.002. Epub 2015 Aug 20.

  PMID: 26299283 RESULT

• Xi S, Chen Z, Lu Q, Liu C, Xu L, Lu C, Cheng R. Comparison of laparoscopic and open inguinal-hernia repair in elderly patients: the experience of two comprehensive medical centers over 10 years. Hernia. 2024 Aug;28(4):1195-1203. doi: 10.1007/s10029-024-03004-0. Epub 2024 Apr 4.

  PMID: 38573484 RESULT

• Bowling K, El-Badawy S, Massri E, Rait J, Atkinson J, Leong S, Stuart A, Srinivas G. Laparoscopic and open inguinal hernia repair: Patient reported outcomes in the elderly from a single centre - A prospective cohort study. Ann Med Surg (Lond). 2017 Aug 29;22:12-15. doi: 10.1016/j.amsu.2017.08.013. eCollection 2017 Oct.

  PMID: 28878892 RESULT

• Ulutas ME, Yilmaz AH. Comparison of open and laparoscopic inguinal hernia repair in the elderly patients: a randomized controlled trial. Hernia. 2025 May 23;29(1):179. doi: 10.1007/s10029-025-03368-x.

  PMID: 40407912 DERIVED

MeSH Terms

Conditions

Urinary Retention; Postoperative Complications; Pain; Recurrence

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms; Disease Attributes

Central Study Contacts

Abdullah Hilmi Yılmaz, MD

CONTACT

0432 222 00 10; drabdullahhilmi@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 11, 2024
• First Posted: May 16, 2024
• Study Start: October 4, 2023
• Primary Completion: June 4, 2024
• Study Completion: December 30, 2024
• Last Updated: May 16, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)