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OpenTrials
Completed

NCT Number: NCT01727050

Fibrin Sealant Spray Versus Mechanical Stapling in Laparoscopic Totally Extraperitoneal Hernioplasty

Laparoscopic totally extraperitoneal hernioplasty (TEP) is one of the treatment options for the repair of primary unilateral inguinal hernia. Previous studies showed that patients underwent TEP have less post-operative pain and earlier return to normal activities. However, chronic pain is still a major issue affecting quality of life after TEP with a reported incidence of 9.2-22.5%. Mechanical stapling is the most commonly used method of mesh fixation to prevent mesh migration but nerve entrapment by staples causing intractable pain had been reported. Recently several clinical trials showed that mesh fixation with fibrin sealant (FS) in TEP resulted in less chronic pain but increased incidence of seroma. A spraying device for application of FS laparoscopically is now available which can achieve mesh fixation by using fewer amounts of FS.

In this study, the investigators aim to compare the effectiveness of using fibrin spray for mesh fixation in reducing chronic pain after TEP. The investigators performed a randomized controlled trial by allocating patients in two study arm in random manner. The treatment group will have the mesh fixed by fibrin sealant spray, whereas the control group will have conventional mechanical staples for fixation. Operative procedures and post-operative management for the 2 groups will be identical. They will be follow-up at 1-month and 6-month after operation to evaluate the operative results and the incidence of chronic pain. Any complications related to the mesh and operation will also be recorded.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Department of Surgery, Prince of Wales Hospital

Hong Kong

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Consecutive male patients aged between 18 to 70 years with reducible unilateral inguinal hernia undergoing day-case TEP under general anaesthesia will be considered eligible.

Exclusion criteria

  • Bilateral hernia, recurrent hernia, partially reducible or strangulated hernia, large inguinal-scrotal hernia, previous abdominal incision (including previous contralateral hernia repair), peripheral neuropathy, coagulopathy or taking anticoagulation drugs, end-stage renal failure, cirrhosis, impaired cognitive function and those not consent to study.

Treatment and study plan

Fibrin sealant spray

Device

Fixation of mesh would be performed using fibrin sealant spray applied with a laparoscopic spray catheter

Mechanical stapling

Device

Fixation of mesh would be performed using mechanical staplers

Primary outcomes

  1. Incidence of chronic pain

    Time frame: 6 months

Secondary outcomes

  1. Severity of acute pain

    Time frame: 1 week

  2. Morbidities

    Time frame: 30 day

  3. Recurrence rate

    Time frame: 6 month

  4. Quality of life assessment

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

Randomized Prospective Trial of Fibrin Sealant Spray Versus Mechanical Stapling in Laparoscopic Totally Extraperitoneal Hernioplasty

Important dates

Study start
2007
Primary completion
2011
Study completion
2011
First posted
Nov 15, 2012
Registry last updated
Nov 20, 2012

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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