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Use of Diathermy Versus Blunt Dissection in TEP for Inguinal Hernia

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ClinicalTrials.gov Identifier: NCT03665883
Recruitment Status : Recruiting
First Posted : September 11, 2018
Last Update Posted : September 12, 2018
Sponsor:
Information provided by (Responsible Party):
Dr. Joe King-Man Fan, The University of Hong Kong

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Seroma Hernia, Inguinal Procedure: Monopolar energy Procedure: Blunt dissection Not Applicable

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: the effect on seroma formation and output of pre-peritoneal drain after TEP by monoploar diathermy or blunt dissection approach will be studied
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: Patients, assessors and investigators will be blinded on patient group.
Primary Purpose: Treatment
Official 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
Actual Study Start Date : August 1, 2018
Estimated Primary Completion Date : August 1, 2020
Estimated Study Completion Date : August 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

Arm Intervention/treatment
Active Comparator: Diathermy preferred
Monopolar energy is the preferred dissection approach in this group of patients undergo TEP. Total time of activation of monopolar machine will recorded by specially designed device
Procedure: Monopolar energy
Monopolar energy in TEP for inguinal hernia

Active Comparator: Blunt dissection preferred
Blunt dissection is the preferred dissection approach in this group of patients undergo TEP. Use of monopolar energy for haemostasis is still allowed upon surgeons' decision. Total time of activation of monopolar machine will recorded by specially designed device
Procedure: Blunt dissection
Blunt dissection in TEP for inguinal hernia




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03665883


Contacts
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Contact: Joe KM FAN, MS(HKU) 852-22553111 drfanj@gmail.com

Locations
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China, Guangdong
Department of Surgery, The University of Hong Kong - Shenzhen Hospital Recruiting
Shenzhen, Guangdong, China
Contact: Joe KM Fan, MBBS,MS,FRCS    +86-18307555114    drjoefan@hku.hk   
Principal Investigator: JW Liu         
Sub-Investigator: XF Yang         
Sub-Investigator: KJ Chen         
Sub-Investigator: L Jiang         
Sub-Investigator: ZH Liu         
Sub-Investigator: GX Zhang         
Sub-Investigator: Fion SY Chan, MBBS         
Sponsors and Collaborators
The University of Hong Kong
Investigators
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Principal Investigator: Joe KM FAN, MS(HKU) The University of Hong Kong

Publications of Results:
Other Publications:
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Responsible Party: Dr. Joe King-Man Fan, Honorary Consultant, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT03665883     History of Changes
Other Study ID Numbers: HERN-MONOPOLAR-01
First Posted: September 11, 2018    Key Record Dates
Last Update Posted: September 12, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Hernia
Hernia, Inguinal
Pathological Conditions, Anatomical
Hernia, Abdominal