An interventional study of inguinal hernia repair in Hernia, Inguinal, sponsored by Kocaeli Derince Education and Research Hospital. Completed. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2022-08-17.
Sponsored by Kocaeli Derince Education and Research Hospital · Not applicable, Interventional, and Treatment
Open tension-free mesh repair (Lichtenstein) and laparoscopic totally extraperitoneal (TEP) repair are the most commonly preferred techniques for inguinal hernia surgery. There's still a debate going on about which of these two techniques (open versus laparoscopic) is effective. This prospective randomized study aimed at comparing the early and long-term results of these two techniques (TEP vs. Lichtenstein).
Various studies comparing the laparoscopic totally extraperitoneal (TEP) and Lichtenstein techniques have been reported. These studies have shown that TEP repair is associated with less postoperative pain and faster recovery. However, there are different views on the long-term (recurrence, chronic pain, etc.) results of the two techniques. This study was designed to compare the short- and long-term outcomes of open tension-free mesh repair technique(Lichtenstein) and laparoscopic repair technique(TEP).
543 studies on the registry are indexed under Hernia, Inguinal; 92 are open to participants now.
This study's enrollment of 102 is above the median of 90 across 395 interventional studies indexed under Hernia, Inguinal.
Browse Hernia, Inguinal studies →Kocaeli Derince Education and Research Hospital is the lead sponsor of 28 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients who underwent Laparoscopic Totally Extraperitoneal (TEP) will be included in this group.
Procedure: inguinal hernia repair
Patients with open tension-free inguinal hernia(Lichtenstein) repair will be included in this group.
Procedure: inguinal hernia repair
Patients who will undergo inguinal hernia repair will be divided into two groups(TEP versus Lichtenstein) according to the technique to be applied
postoperative complication status
number of patients with complications
Time frame: up to the first 10 days postoperatively
early period complication status
number of patients with complications
Time frame: up to the first 3 months postoperatively
late period complication status
number of patients with complications
Time frame: Postoperative 3rd to 84th month
early recurrence rate
number of patients with recurrence
Time frame: up to the first 3 months postoperatively
late recurrence rate
number of patients with recurrence
Time frame: Postoperative 3rd to 84th month
Visual Analog Score for pain
Units on a Scale; 0: no pain, 1-3: mild pain, 4-6: moderate pain, 7-9: severe pain, 10: worst pain possible.
Time frame: postoperative 24th hour
total analgesic requirement
the number of analgesics used.
Time frame: postoperative 1 to 10 days
time to return to work after surgery
day
Time frame: Postoperative 3rd month
early complication status
Number of patients with complications
Time frame: postoperative 1st month
No study locations are listed for this record.
Plan to share: No
This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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Kocaeli Derince Education and Research Hospital