Comparison of Laparoscopic and Open Inguinal Hernia Repair in Elderly Patients

Pain Clinical Trial

Official title:

Comparison of Laparoscopic and Open Inguinal Hernia Repair in Elderly Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06417346
• Other study ID #: 65646564
• Status: Recruiting
• Phase: N/A
• Start date: October 4, 2023
• Est. completion date: December 30, 2024

Study information

• Verified date: May 2024
• Source: Konya City Hospital
• Contact: Abdullah Hilmi Yilmaz, MD
• Phone: 0432 222 00 10
• Email: drabdullahhilmi[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: December 30, 2024
• Est. primary completion date: June 4, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• Patients with inguinal hernias.

• Patients aged over 65.

Exclusion Criteria:

• Younger than 65 years.

• Incarcerated or strangulated inguinal hernias.

Related Conditions & MeSH terms

• Hernia, Inguinal
• Pain
• Postoperative Complications
• Relapse
• Urinary Retention

Intervention

Procedure:
• Laparoscopic TEP Repair
Laparoscopic TEP Repair performed
• Open Technique (Lichtenstein)
Open Technique (Lichtenstein) performed

Locations

Country	Name	City	State
Turkey	University of Health Science Van Training and Research Hospital	Van

Sponsors (2)

Lead Sponsor	Collaborator
Mehmet Esref Ulutas	Van Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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 — View Citation

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. d — View Citation

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 Apr 4. doi: 10.1007/s10029-024-03004-0. Online — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	rate of postoperative mortality		postoperative 24 hours
Secondary	rate of urinary retansion		postoperative 24 hours
Secondary	rate of postoperative pain		postoperative 24 hours
Secondary	Rate of Hernia recurrence		first year
Secondary	Rate of Postoperative complications	such as wound infection, bleeding	postoperative 24 hours and 1st month