Use of Diathermy Versus Blunt Dissection in TEP for Inguinal Hernia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

103 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-01

Study Completion Date

2019-12-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Randomised Controlled Trial on Pre-peritoneal Drainage After Totally Extra-peritoneal Hernioplasty for Inguinal Hernia

NCT02762747

Hernia, Inguinal

UNKNOWN NA

Use of Pre-peritoneal Drainage in rTAPP - a Comparative Study

NCT04960267

Hernia, Inguinal

UNKNOWN NA

Prospective Randomized Trial Comparing Three-port and Single-port TEP Repair in Adults

NCT01591395

Inguinal Hernia

UNKNOWN NA

SIngle Port vs Standard TEP for Primary Inguinal Hernia Repair

NCT02302937

Primary Unilateral Inguinal Hernia

COMPLETED NA

Quality of Life of TEP vs Lichtenstein Hernioplasty

NCT02723045

Inguinal Hernia

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Seroma Hernia, Inguinal

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Patients, assessors and investigators will be blinded on patient group.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type ACTIVE_COMPARATOR

Monopolar energy

Intervention Type PROCEDURE

Monopolar energy in TEP for inguinal hernia

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

Group Type ACTIVE_COMPARATOR

Blunt dissection

Intervention Type PROCEDURE

Blunt dissection in TEP for inguinal hernia

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Monopolar energy

Monopolar energy in TEP for inguinal hernia

Intervention Type PROCEDURE

Blunt dissection

Blunt dissection in TEP for inguinal hernia

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No