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RecruitingNCT06604572Updated Sep 19, 2024

TAPP and Open Repair for Recurrent Inguinal Hernia

An interventional study of Transabdominal preperitoneal approach in Recurrent Inguinal Hernia, sponsored by The Second Affiliated Hospital of Kunming Medical University. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-09-19.

Sponsored by The Second Affiliated Hospital of Kunming Medical University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Oct 2024, 2 years ago, but the record still lists the study as recruiting.
  • Registered 2 years 4 months after the study started (first participant enrolled May 2022, registered Sep 2024).
  • Started May 2022; still recruiting 4 years 5 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Recurrent Inguinal Hernia
03

In context

Recurrence

4,279 studies on the registry are indexed under Recurrence; 988 are open to participants now.

This study's planned enrollment of 70 is above the median of 50 across 3,374 interventional studies indexed under Recurrence.

Browse Recurrence studies →

Lead sponsor

The Second Affiliated Hospital of Kunming Medical University is the lead sponsor of 17 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • patch infection during the first surgery
  • multiple (≥ 2) relapses
  • inability to cooperate to complete follow-up after surgery
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Care provider, Investigator, Outcomes assessor)
Enrollment
70 participants (estimated)

Study arms

  • Experimental
    Transabdominal preperitoneal approach surgery group

    The enrolled patients were treated with Transabdominal preperitoneal approach

    Procedure: Transabdominal preperitoneal approach

  • Other
    Open tension-free hernia repair group

    The enrolled patients were treated with open tension-free hernia repair

    Procedure: Transabdominal preperitoneal approach

Interventions

  • ProcedureTransabdominal preperitoneal approach

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

    Also known as: Open tension-free hernia repair

06

What researchers measure

Primary outcomes

  1. Postoperation pain

    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.

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

Secondary outcomes

  1. Numbness and foreign body sensation

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

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

  2. Operating time

    Record the patient\'s operating time

    Time frame: During surgery

  3. Hemorrhage

    The amount of surgical bleeding was recorded

    Time frame: During surgery

  4. Urinary retention

    Urinary retention was observed and recorded after operation

    Time frame: One week after surgery

  5. Seroma

    The occurrence of postoperative seroma was observed and recorded

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

  6. Recurrence

    The recurrence of patients after operation was observed and recorded

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

  7. Fever

    The postoperative fever was observed and recorded

    Time frame: One week after surgery

  8. Length of hospital stay

    The patient\'s length of stay was recorded

    Time frame: Within a week of surgery

07

Study locations

1 of 1 sites recruiting
  • Clinical study of recurrent inguinal hernia
    Kunming, Yunnan 650000, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06604572
Lead sponsor
The Second Affiliated Hospital of Kunming Medical University
Responsible party
Weiming Li (director, The Second Affiliated Hospital of Kunming Medical University) — Principal investigator
First posted
Sep 19, 2024
Start date
May 1, 2022
Primary completion
Oct 1, 2024 (estimated)
Completion
Oct 28, 2025 (estimated)
Last update
Sep 19, 2024

Study contacts

Weiming Li
Contact
liweiming49@163.com
13114225597
Weiming Li, doctor
principal investigator · The Second Affiliated Hospital of Kunming Medical University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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