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Completed

NCT Number: NCT02920307

Study of Laparoscopic Inguinal Hernia Repair

Although mesh fixation has been associated to an increased incidence of nerve injury and involves increased operative costs, many surgeons feel that fixation is necessary to reduce the risk of hernia recurrence. The aim of this study is to evaluate the outcomes of laparoscopic herniorrhaphies performed with and without mesh fixation at our institution.

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Key information

Conditions

Hernia, Inguinal Disease Attributes Hernia Hernia, Abdominal Hernia, Femoral Inguinal Hernia, Direct Inguinal Hernia, Indirect Nervous System Diseases Neuralgia Neuralgia, Atypical Neuralgia, Iliohypogastric Nerve Neuralgia, Ilioinguinal Neurologic Manifestations Neuromuscular Diseases Pain Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Recurrence Signs and Symptoms

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical Park Gaziantep Hospital

Gaziantep, 27090, Turkey (Türkiye)

About this study

A randomized prospective study was conducted. Four groups of patients were constituted: (1) TEP with mesh fixation (2) TEP without fixation, (3) TAPP with mesh fixation, (4) TAPP without fixation. 120 patients were randomized to each group. The principal outcomes assessed were postoperative chronic groin pain assessed by visual analogue pain scale (VAS), hernia recurrence, other morbidity rates and hospital costs. Patients were reviewed in outpatient unit at 1 week and at 1, 6, 12 and 24 months.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • unilateral hernia
  • uncomplicated hernia
  • medical fitness for general anesthesia

Exclusion criteria

  • unfit for general anesthesia
  • complicated hernia
  • uncorrectable coagulopathy
  • BMI > 35
  • concomitant pathologies requiring simultaneous surgery
  • bilateral hernia

Treatment and study plan

TEP without fixation

Procedure

Standard totally extraperitoneal preperitoneal (TEP) inguinal hernia repair

Other names: TEP no fixation

TEP with fixation

Procedure

Standard totally extraperitoneal preperitoneal (TEP) inguinal hernia repair

Other names: Standard TEP

TAPP without fixation

Procedure

Standard transabdominal preperitoneal (TAPP) inguinal hernia repair without mesh fixation

Other names: TAPP no fixation

TAPP with fixation

Procedure

Standard transabdominal preperitoneal (TAPP) inguinal hernia repair

Other names: Standard TAPP

Primary outcomes

  1. Change from preoperative pain levels at 2 years assessed by the visual analogue pain scale (VAS)

    Time frame: preoperative and postoperative 2nd year

    neuralgia, inguinal

  2. Change from preoperative pain levels at 1 year assessed by the VAS

    Time frame: preoperative and postoperative 1st year

    neuralgia, inguinal

  3. Change from preoperative pain levels at 6 months assessed by the VAS

    Time frame: preoperative and postoperative 6th month

    neuralgia, inguinal

  4. Change from preoperative pain levels at 3 months assessed by the VAS

    Time frame: preoperative and postoperative 3th month

    neuralgia, inguinal

  5. Change from preoperative pain levels at 1 month assessed by the VAS

    Time frame: preoperative and postoperative 1 month

    neuralgia, inguinal

  6. Change from preoperative pain levels at 1 week assessed by the VAS

    Time frame: preoperative and postoperative 1th week

    neuralgia, inguinal

Secondary outcomes

  1. Total hospital costs

    Time frame: up to 24 months

    consisted all costs of hospital stays and outpatient treatments

  2. conversion rate

    Time frame: through the first day

    conversion to open surgery

  3. recurrence rate

    Time frame: up to 24 months

    clinical and radiological diagnosed

  4. rate of minor and major complications

    Time frame: 2 year

    it was assessed as; no complication, minor complications, major complications and complications needed reoperation

Sponsors and collaborators

Lead sponsor

Medical Park Gaziantep Hospital

Other

Collaborators

  • Bahçeşehir University
  • Muğla Sıtkı Koçman University

Registry information

Official study title

Prospective, Randomized and Controlled Study Comparing Fixation Versus no Fixation of Mesh in Laparoscopic Inguinal Hernia Repair

Important dates

Study start
2010
Primary completion
2014
Study completion
2016
First posted
Sep 30, 2016
Registry last updated
Sep 30, 2016

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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