Clinical trial NCT06417346: Comparison of Laparoscopic and Open Inguinal Hernia Repair in Elderly Patients
Official title: Comparison of Laparoscopic and Open Inguinal Hernia Repair in Elderly Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Urinary Retention
Postoperative Complications
Pain
Relapse
Lead sponsor: Konya City Hospital
Sponsor class: OTHER
Collaborators: name: Van Training and Research Hospital
First posted: 2024-05-16
Enrollment: 160
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: rate of postoperative mortality
timeFrame: postoperative 24 hours
Secondary outcomes:
measure: rate of urinary retansion
timeFrame: postoperative 24 hours
measure: rate of postoperative pain
timeFrame: postoperative 24 hours
measure: Rate of Hernia recurrence
timeFrame: first year
measure: Rate of Postoperative complications
timeFrame: postoperative 24 hours and 1st month
Other outcomes:
Locations:
city: Van
country: Turkey
facility: University of Health Science Van Training and Research Hospital
Study officials:
References:
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. doi: 10.1016/j.surg.2015.08.002. Epub 2015 Aug 20.
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 Aug;28(4):1195-1203. doi: 10.1007/s10029-024-03004-0. Epub 2024 Apr 4.
citation: 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.