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OpenTrials
Completed

NCT Number: NCT05504122

Comparison of Laparoscopic Totally Extraperitoneal (TEP) and Lichtenstein Technique

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).

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Key information

Conditions

Hernia, Inguinal Hernia Hernia, Abdominal Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients who were diagnosed with inguinal hernia (primary, recurrent, unilateral, bilateral)
  • American Society of Anesthesiologists (ASA) score of I and II
  • Gave informed consent to participate in the study

Exclusion criteria

  • Patients with scrotal, strangulated, or obstructed hernia
  • Periumbilical or subumbilical incision scar (median, right or left paramedian)
  • Undergoing prostatectomy or abdominal bladder surgery
  • Pfannenstiel incision scar
  • ASA score >3

Treatment and study plan

inguinal hernia repair

Procedure

Patients who will undergo inguinal hernia repair will be divided into two groups(TEP versus Lichtenstein) according to the technique to be applied

Primary outcomes

  1. postoperative complication status

    Time frame: up to the first 10 days postoperatively

    number of patients with complications

  2. early period complication status

    Time frame: up to the first 3 months postoperatively

    number of patients with complications

  3. late period complication status

    Time frame: Postoperative 3rd to 84th month

    number of patients with complications

  4. early recurrence rate

    Time frame: up to the first 3 months postoperatively

    number of patients with recurrence

  5. late recurrence rate

    Time frame: Postoperative 3rd to 84th month

    number of patients with recurrence

Secondary outcomes

  1. Visual Analog Score for pain

    Time frame: postoperative 24th hour

    Units on a Scale; 0: no pain, 1-3: mild pain, 4-6: moderate pain, 7-9: severe pain, 10: worst pain possible.

  2. total analgesic requirement

    Time frame: postoperative 1 to 10 days

    the number of analgesics used.

  3. time to return to work after surgery

    Time frame: Postoperative 3rd month

    day

  4. early complication status

    Time frame: postoperative 1st month

    Number of patients with complications

Sponsors and collaborators

Lead sponsor

Kocaeli Derince Education and Research Hospital

Other

Registry information

Official study title

Comparison of Laparoscopic Totally Extraperitoneal (TEP) and Lichtenstein Technique in Long-term Follow-up

Important dates

Study start
2012
Primary completion
2014
Study completion
2022
First posted
Aug 17, 2022
Registry last updated
Aug 17, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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