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Completed

NCT Number: NCT04532983

Short Term Outcome of Laparoscopic Trans-abdominal Preperitoneal Inguinal Hernia Repair Without Mesh Fixation

comparison between two groups of participants suffering inguinal hernia each group 23 individual all underwent laparoscopic trans-abdominal inguinal hernia repair first group received mesh fixation the second underwent no fixation , results of follow up in the first year were compared together

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zagazig Faculty of Medicine

Zagazig, Sharqya, 44519, Egypt

About this study

This comparative study was performed in Zagazig university hospitals, general surgery department in the time period between july 2018 and june 2020 0n 46 patients undergoing laparoscopic trans abdominal preperitoneal (TAPP) repair for un complicated unilateral inguinal hernia.

Patient selection; In this study we enrolled patients above

  • 18 years old suffering unilateral,
  • non -recurrent,
  • un-complicated inguinal hernia. We excluded patients with
  • previous abdominal or pelvic surgery,
  • unfit with laparoscopic surgery,
  • those with ascites,
  • abdominal malignancy
  • on chemotherapy and immune-compromised patients.

Randomization; using computer generated random numbers , the study participants were randomly allocated into two equal groups each group 23 individual, the first group; group A; patients underwent laparoscopic TAPP repair of inguinal hernia and the mesh prosthesis was fixed in position using absorbable Vicryl tacks (abstack30 medtronic), and group B patient underwent laparoscopic TAPP repair of inguinal hernia and the mesh prosthesis was placed in position without fixation.

All the study participants were subjected to thorough history taking, detailed clinical examination, determination of the presence of inguinal hernia, measurement of the hernia defect diameter by ultrasound or computerized tomography in difficult cases, preoperative laboratory tests were performed as per usual

Follow up Early postoperative data during the admission were collected, a; pain score (measured by visual analogue scale (VAS), hematoma formation, early recurrence, time needed for ambulation.

Follow up was carried out in outpatients clinics by the attending surgeon after 1 week, 1 month,3 months and 6 months of the operation , the recorded follow up data included wound complications, seroma formation, foreign body sensation and recurrence.

The study was approved by the local ethical committee and institutional review board (IRB) of our university hospitals, all patients signed an informed written consent before participation in this study Preoperative, demographic, operative and postoperative data were collected and properly analyzed using t test, Z test in SPSS 22 program package

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 18 years old suffering unilateral,
  • non -recurrent,
  • un-complicated inguinal hernia.

Exclusion criteria

  • previous abdominal or pelvic surgery,
  • unfit with laparoscopic surgery,
  • those with ascites,
  • abdominal malignancy
  • on chemotherapy and immune-compromised patients.

Treatment and study plan

fixation of mesh prosthesis

Procedure

in the first group mesh was fixed in position with laparoscopic tacks

mesh placement without fixation

Procedure

mesh placement in preperitoneal space without fixation

Primary outcomes

  1. postoperative pain

    Time frame: 6 month

    pain in the first 6 month of surgery measured by visual analogue scale

  2. hernia recurrence

    Time frame: 1 year

    recurrence of inguinal hernia measured by computed tomography of the abdomen

Sponsors and collaborators

Lead sponsor

Zagazig University

Other Gov

Registry information

Official study title

Short Term Outcome of Laparoscopic Trans-abdominal Preperitoneal (TAPP) Inguinal Hernia Repair Without Mesh Fixation, Comparative Study

Acronym: professor

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Aug 31, 2020
Registry last updated
Aug 31, 2020

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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