Comparison of Laparoscopic and Open Inguinal Hernia Repair in Elderly Patients

NCT ID: NCT06417346

Last Updated: 2024-05-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-04
• Study Completion Date: 2024-12-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Laparoscopic TEP Repair under General Anesthesia

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.

Group Type: EXPERIMENTAL

Laparoscopic TEP Repair

Intervention Type: PROCEDURE

Laparoscopic TEP Repair performed

Open Technique (Lichtenstein) under Spinal Anesthesia

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.

Group Type: ACTIVE_COMPARATOR

Open Technique (Lichtenstein)

Intervention Type: PROCEDURE

Open Technique (Lichtenstein) performed

Interventions

Laparoscopic TEP Repair

Laparoscopic TEP Repair performed

Intervention Type: PROCEDURE

Open Technique (Lichtenstein)

Open Technique (Lichtenstein) performed

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Van Training and Research Hospital

OTHER_GOV

Sponsor Role: collaborator

Mehmet Eşref Ulutaş

OTHER

Sponsor Role: lead

Responsible Party

Mehmet Eşref Ulutaş

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

University of Health Science Van Training and Research Hospital

Van, , Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Abdullah Hilmi Yılmaz, MD

Role: CONTACT

drabdullahhilmi@gmail.com

0432 222 00 10

Facility Contacts

Abdullah Hilmi Yılmaz, MD

Role: primary

drabdullahhilmi@gmail.com

0432 222 00 10

References

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.

Reference Type: RESULT

PMID: 26299283 (View on PubMed)

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.

Reference Type: RESULT

PMID: 38573484 (View on PubMed)

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.

Reference Type: RESULT

PMID: 28878892 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 40407912 (View on PubMed)

Other Identifiers

65646564

Identifier Type: -

Identifier Source: org_study_id