SeromaNCT03665883
Use of Diathermy Versus Blunt Dissection in TEP for Inguinal Hernia
A study testing Monopolar energy and Blunt dissection in people with Seroma and Hernia, Inguinal, run by The University of Hong Kong at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Seroma, Hernia, Inguinal
- What is being tested?
- Monopolar energy and Blunt dissection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2018to 1 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age above 18 and below 90
- Male or female patients
- Unilateral inguinal hernia
- First occurrence hernia
- Consent to laparoscopic hernioplasty for inguinal hernia
Who cannot join
- inguino-scrotal hernia
- Recurrent inguinal hernia
- Incarcerated hernia
- Bilateral inguinal hernia
- Bleeding tendency
- On anti-platelet agent or anti-coagulant
Show all 9Show fewer
- Significant co-morbidies
- Patients with pacemaker
- Decline or not consent to
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Surgery, The University of Hong Kong - Shenzhen Hospital
Shenzhen, Guangdong
About this study
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
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.
Read the 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.
- Conditions
- Seroma, Hernia, Inguinal
- Being tested
- Monopolar energy, Blunt dissection
- Medical subject headings
- Seroma, Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monopolar energyProcedure or surgery
Monopolar energy in TEP for inguinal hernia
Blunt dissectionProcedure or surgery
Blunt dissection in TEP for inguinal hernia
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Procedure: Blunt dissection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Drain output at 23 hours post-operation
pre-peritoneal drain output (in ml) at 23 hours post-operation
Measured: 23 hours post operation
Secondary outcomes (4)
Seroma at 23 hours post-operation
Size of seroma at 23 hours post-operation measured by ultrasonography in 3 dimension in mm.
Measured: 23 hours post operation
Seroma at 1 week post-operation
Size of seroma at 1 week post-operation measured by ultrasonography in 3 dimension in mm.
Measured: 1 week post operation
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.
Measured: 1 week
Seroma at 1 month post-operation
Size of seroma at 1 month post-operation measured by ultrasonography in 3 dimension in mm.
Measured: 1 month post-operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2018
- Study start1 Sep 2018
- Primary completion1 Oct 2019
- Study completion1 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SeromaStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Joe King-Man Fan, The University of Hong Kong
- Investigators
- Joe KM FAN, MS(HKU), Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03665883
- Sponsor's protocol ID
- HERN-MONOPOLAR-01
- Status last verified
- Mar 2020
- First submitted
- 31 Aug 2018
- Last updated
- 25 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29681018Fan 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.
PubMed 29332240
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03665883
- Acronym / sponsor ID
- HERN-MONOPOLAR-01
- Conditions
- Seroma, Hernia, Inguinal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 1 Oct 2019 (actual)
- Study completion
- 1 Dec 2019 (actual)
- First posted
- 11 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Diathermy preferred | Active comparator | Procedure: Monopolar energyMonopolar 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 preferred | Active comparator | Procedure: Blunt dissectionBlunt 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 |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age above 18 and below 90
- Male or female patients
- Unilateral inguinal hernia
- First occurrence hernia
- Consent to laparoscopic hernioplasty for inguinal hernia
Key exclusion criteria (9 listed)
- inguino-scrotal hernia
- Recurrent inguinal hernia
- Incarcerated hernia
- Bilateral inguinal hernia
- Bleeding tendency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Monopolar energyMonopolar energy in TEP for inguinal hernia | Procedure or surgery | Diathermy preferred |
| Blunt dissectionBlunt dissection in TEP for inguinal hernia | Procedure or surgery | Blunt dissection preferred |
Primary outcome
Drain output at 23 hours post-operation
Time frame: 23 hours post operation
pre-peritoneal drain output (in ml) at 23 hours post-operation
4 secondary outcomes
Seroma at 23 hours post-operation
Time frame: 23 hours post operation
Seroma at 1 week post-operation
Time frame: 1 week post operation
Pain score at first week
Time frame: 1 week
Seroma at 1 month post-operation
Time frame: 1 month post-operation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2020.
- Background: PubMed 29681018Fan 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 publication: PubMed 29332240Fan 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joe KM FAN, MS(HKU) principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Monopolar energy and Blunt dissection in people with Seroma and Hernia, Inguinal, run by The University of Hong Kong at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Drain output at 23 hours post-operation (time frame: 23 hours post operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03665883, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2020.