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Completed

NCT Number: NCT03665883

Use of Diathermy Versus Blunt Dissection in TEP for Inguinal Hernia

There is a long debate whether monopoloar or blunt dissection should be adopted in TEP to minimise the chance of seroma formation. This study aims at study the effect on seroma formation (and pre-peritoneal drain output) by 2 techniques in randomised controlled trial.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Surgery, The University of Hong Kong - Shenzhen Hospital

Shenzhen, Guangdong, China

About this study

There is a long debate whether monopoloar or blunt dissection should be adopted in TEP to minimise the chance of seroma formation. This study aims at study the effect on seroma formation (and pre-peritoneal drain output) by 2 techniques in randomised controlled trial.

all male and female patients presented with first occurrence, unilateral inguinal hernia anticipated for laparoscopic TEP are included into study after informed consent. Patients are randomized into "diathermy-preferred" (DP) group and "blunt dissection-preferred" (BDP) group just before commence of operation after general anaethesia. Surgeons are instructed to use monopolar energy as main dissection method for whole operation if possible (DP), where as blunt dissection is the preferred choice in BDP group but it is allowed to use monopolar energy if needed. Total energy time is measured by a specially designed device attaching to the monopolar pedals as accurate as to millisecond (ms). Pre-peritoneal drains are inserted for drainage and removed 23 hours after operation. Energy time, drainage output, ultrasonic seroma sizes at day 1, day 6, 1 month post-operations, recurrence are compared between 2 groups.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age above 18 and below 90
  • Male or female patients
  • Unilateral inguinal hernia
  • First occurrence hernia
  • Consent to laparoscopic hernioplasty for inguinal hernia

Exclusion criteria

  • inguino-scrotal hernia
  • Recurrent inguinal hernia
  • Incarcerated hernia
  • Bilateral inguinal hernia
  • Bleeding tendency
  • On anti-platelet agent or anti-coagulant
  • Significant co-morbidies
  • Patients with pacemaker
  • Decline or not consent to

Treatment and study plan

Monopolar energy

Procedure

Monopolar energy in TEP for inguinal hernia

Blunt dissection

Procedure

Blunt dissection in TEP for inguinal hernia

Primary outcomes

  1. Drain output at 23 hours post-operation

    Time frame: 23 hours post operation

    pre-peritoneal drain output (in ml) at 23 hours post-operation

Secondary outcomes

  1. Seroma at 23 hours post-operation

    Time frame: 23 hours post operation

    Size of seroma at 23 hours post-operation measured by ultrasonography in 3 dimension in mm.

  2. Seroma at 1 week post-operation

    Time frame: 1 week post operation

    Size of seroma at 1 week post-operation measured by ultrasonography in 3 dimension in mm.

  3. Pain score at first week

    Time frame: 1 week

    Pain score at first week (from day 0 to day 6) will be measured in visual analogue scale from 0-10, with 0 is minimum and 10 is maximum score reported by patients.

  4. Seroma at 1 month post-operation

    Time frame: 1 month post-operation

    Size of seroma at 1 month post-operation measured by ultrasonography in 3 dimension in mm.

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Registry information

Official study title

Randomised Controlled Trial on Use of Monopolar Energy Versus Blunt Dissection in Totally Extra-peritoneal Hernioplasty (TEP) for Inguinal Hernia - the Effect on the Output of Pre-peritoneal Drain

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Sep 11, 2018
Registry last updated
Mar 25, 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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