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NCT Number: NCT06604572

TAPP and Open Repair for Recurrent Inguinal Hernia

The objective of this study was to explore the clinical efficacy of transabdominal preperitoneal approach (TAPP) and open tension-free hernia repair in the treatment of recurrent inguinal hernia. This study aims to provide a basis for selecting the optimal treatment methods for recurrent hernias.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinical study of recurrent inguinal hernia

Kunming, Yunnan, 650000, China

Location status: Recruiting

Location contact

Weiming Li

CONTACT

[email protected]

13114225597

About this study

The patients were randomly allocated to the TAPP group and the open tension-free repair group. We recorded the general situation, operation time, and intraoperative complications; postoperative visual analogue pain scale (VAS) scores at 24 and 48 h; and the incidence of complications such as seroma, chronic pain, inguinal numbness, foreign body sensation, and recurrence at 1 week, 1 month, 3 months, 6 months and 1 year after surgery. These indicators were compared between the two groups of patients.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • age ≥ 18 years
  • the diagnosis of recurrent inguinal hernia made by ultrasound or computed tomography (CT) during the present visit
  • ability to tolerate general anesthesia and local anesthesia surgery
  • all patients and their families agreed to participate in this study and sign relevant informed consent.

Exclusion criteria

  • patch infection during the first surgery
  • multiple (≥ 2) relapses
  • inability to cooperate to complete follow-up after surgery

Treatment and study plan

Transabdominal preperitoneal approach

Procedure

The enrolled patients underwent either open tension-free hernia repair or Transabdominal preperitoneal approach

Other names: Open tension-free hernia repair

Primary outcomes

  1. Postoperation pain

    Time frame: 24 hours, 48 hours, three months after surgery

    Postoperative pain was monitored using the VAS pain scoring system (0-10 points) and recorded at 24 and 48 h. Patients with groin pain for more than 3 months were recorded during follow-up.

Secondary outcomes

  1. Numbness and foreign body sensation

    Time frame: The mean follow-up time was 10 months after surgery

    The occurrence of groin numbness and foreign body sensation after operation was recorded

  2. Operating time

    Time frame: During surgery

    Record the patient's operating time

  3. Hemorrhage

    Time frame: During surgery

    The amount of surgical bleeding was recorded

  4. Urinary retention

    Time frame: One week after surgery

    Urinary retention was observed and recorded after operation

  5. Seroma

    Time frame: The mean follow-up time was 2 weeks after surgery

    The occurrence of postoperative seroma was observed and recorded

  6. Recurrence

    Time frame: The mean follow-up time was 1 year after surgery

    The recurrence of patients after operation was observed and recorded

  7. Fever

    Time frame: One week after surgery

    The postoperative fever was observed and recorded

  8. Length of hospital stay

    Time frame: Within a week of surgery

    The patient's length of stay was recorded

Study contacts

Contact information is provided by the study sponsor or research team.

Weiming Li

CONTACT

[email protected]

13114225597

Sponsors and collaborators

Lead sponsor

The Second Affiliated Hospital of Kunming Medical University

Other

Registry information

Official study title

Clinical Study of Transabdominal Preperitoneal Approach Versus Open Tension-free Hernia Repair for the Treatment of Recurrent Inguinal Hernia

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

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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