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Use of Diathermy Versus Blunt Dissection in TEP for Inguinal Hernia

Primary Purpose

Seroma, Hernia, Inguinal

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Monopolar energy
Blunt dissection
Sponsored by
The University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Seroma

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Diathermy preferred

Blunt dissection preferred

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Seroma at 23 hours post-operation
Size of seroma at 23 hours post-operation measured by ultrasonography in 3 dimension in mm.
Seroma at 1 week post-operation
Size of seroma at 1 week post-operation measured by ultrasonography in 3 dimension in mm.
Pain score at first 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.
Seroma at 1 month post-operation
Size of seroma at 1 month post-operation measured by ultrasonography in 3 dimension in mm.

Full Information

First Posted
August 31, 2018
Last Updated
March 23, 2020
Sponsor
The University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT03665883
Brief Title
Use of Diathermy Versus Blunt Dissection in TEP for Inguinal Hernia
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
September 1, 2018 (Actual)
Primary Completion Date
October 1, 2019 (Actual)
Study Completion Date
December 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Hong Kong

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Seroma, Hernia, Inguinal

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantInvestigatorOutcomes Assessor
Masking Description
Patients, assessors and investigators will be blinded on patient group.
Allocation
Randomized
Enrollment
103 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Diathermy preferred
Arm Type
Active Comparator
Arm Description
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
Arm Title
Blunt dissection preferred
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
Monopolar energy
Intervention Description
Monopolar energy in TEP for inguinal hernia
Intervention Type
Procedure
Intervention Name(s)
Blunt dissection
Intervention Description
Blunt dissection in TEP for inguinal hernia
Primary Outcome Measure Information:
Title
Drain output at 23 hours post-operation
Description
pre-peritoneal drain output (in ml) at 23 hours post-operation
Time Frame
23 hours post operation
Secondary Outcome Measure Information:
Title
Seroma at 23 hours post-operation
Description
Size of seroma at 23 hours post-operation measured by ultrasonography in 3 dimension in mm.
Time Frame
23 hours post operation
Title
Seroma at 1 week post-operation
Description
Size of seroma at 1 week post-operation measured by ultrasonography in 3 dimension in mm.
Time Frame
1 week post operation
Title
Pain score at first week
Description
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.
Time Frame
1 week
Title
Seroma at 1 month post-operation
Description
Size of seroma at 1 month post-operation measured by ultrasonography in 3 dimension in mm.
Time Frame
1 month post-operation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joe KM FAN, MS(HKU)
Organizational Affiliation
The University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Surgery, The University of Hong Kong - Shenzhen Hospital
City
Shenzhen
State/Province
Guangdong
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29681018
Citation
Fan JKM, Liu J, Chen K, Yang X, Xu X, Choi HK, Chan FSY, Chiu KWH, Lo CM. Reply to Comment to: Preperitoneal closed-system suction drainage after totally extraperitoneal hernioplasty in the prevention of early seroma formation: a prospective double-blind randomized controlled trial. Hernia. 2018 Jun;22(3):469-470. doi: 10.1007/s10029-018-1764-6. Epub 2018 Apr 21. No abstract available.
Results Reference
background
PubMed Identifier
29332240
Citation
Fan JKM, Liu J, Chen K, Yang X, Xu X, Choi HK, Chan FSY, Chiu KWH, Lo CM. Preperitoneal closed-system suction drainage after totally extraperitoneal hernioplasty in the prevention of early seroma formation: a prospective double-blind randomised controlled trial. Hernia. 2018 Jun;22(3):455-465. doi: 10.1007/s10029-018-1731-2. Epub 2018 Jan 13.
Results Reference
result

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Use of Diathermy Versus Blunt Dissection in TEP for Inguinal Hernia

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