Use of Diathermy Versus Blunt Dissection in TEP for Inguinal Hernia

NCT03665883 | Completed

• 1 other identifier: HERN-MONOPOLAR-01
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 1

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.

Conditions

Seroma; Hernia, Inguinal

Outcome Measures

Primary Outcomes (1)

• Drain output at 23 hours post-operation

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

  23 hours post operation

Secondary Outcomes (4)

• Seroma at 23 hours post-operation

  23 hours post operation

• Seroma at 1 week post-operation

  1 week post operation

• Pain score at first week

  1 week

• Seroma at 1 month post-operation

  1 month post-operation

Study Arms (2)

Diathermy preferred

ACTIVE COMPARATOR

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

Blunt dissection preferred

ACTIVE COMPARATOR

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

Interventions

Monopolar energy PROCEDURE

Monopolar energy in TEP for inguinal hernia

Diathermy preferred

Blunt dissection PROCEDURE

Blunt dissection in TEP for inguinal hernia

Blunt dissection preferred

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

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

Shenzhen, Guangdong, China

Location

Related Publications (2)

• 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.

  PMID: 29681018 BACKGROUND

• 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.

  PMID: 29332240 RESULT

MeSH Terms

Conditions

Seroma; Hernia, Inguinal

Condition Hierarchy (Ancestors)

Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical

Study Officials

• Joe KM FAN, MS(HKU)

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Patients, assessors and investigators will be blinded on patient group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Honorary Consultant

Model Details: the effect on seroma formation and output of pre-peritoneal drain after TEP by monoploar diathermy or blunt dissection approach will be studied

Study Record Dates

• First Submitted: August 31, 2018
• First Posted: September 11, 2018
• Study Start: September 1, 2018
• Primary Completion: October 1, 2019
• Study Completion: December 1, 2019
• Last Updated: March 25, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)