Hernia, InguinalDrainrTAPPNCT04960267
Use of Pre-peritoneal Drainage in rTAPP - a Comparative Study
A study testing Use of pre-peritoneal drainage after rTAPP in people with Hernia, Inguinal, run by The University of Hong Kong at 1 site in China.
Trial summary
The safety and efficacy of pre-peritoneal drain after TEP has been validated in our previous studies - which can effectively reduce seroma formation post-operatively and safe in clinical use. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hernia, Inguinal
- What is being tested?
- Use of pre-peritoneal drainage after rTAPP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2021to 1 Nov 2021
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Unilateral,
- First occurrence
- Reducible inguinal hernia
Who cannot join
- Not fit for GA,
- Bilateral hernia
- Recurrent hernia
- Irreducible hernia
- Inguino-scrotal extension hernia
- Non-inguinal hernia
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Surgery, The University of Hong Kong - Shenzhen Hospital
Shenzhen
Joe KM Fan, MBBS,MS,FRCS, +86-18307555114, drjoefan@hku.hk
JW Liu
About this study
Official title: Use of Pre-peritoneal Drainage in rTAPP - a Comparative Study With Laparoscopic TEP
The safety and efficacy of pre-peritoneal drain after TEP has been validated in our previous studies - which can effectively reduce seroma formation post-operatively and safe in clinical use. We shall extend the indication of pre-peritoneal drainage after robotic TAPP, results will be compared with our retrospective cohort from previous studies.
Read the detailed description
The safety and efficacy of pre-peritoneal drain after TEP has been validated in our previous studies - which can effectively reduce seroma formation post-operatively and safe in clinical use. We shall extend the indication of pre-peritoneal drainage after robotic TAPP, results will be compared with our retrospective cohort from previous studies.
Criteria of enrolling into trial is same as our previous experiment: aged 18-80, unilateral, first occurrence, reducible, non-inguino-scrotal inguinal hernia fit for GA for minimally invasive hernia repair. Routine robotic TAPP performed in standardized manner and pre-peritoneal drains are placed for drainage of 23 hours post-operatively. Drain output, pain scores, status of seroma formation (clinical, USG detected), post-operative recovery and recurrence will be monitored and compared.
- Conditions
- Hernia, Inguinal
- Being tested
- Use of pre-peritoneal drainage after rTAPP
- Keywords
- hernia, inguinal, seroma, drain, robotic, TAPP, rTAPP
- Medical subject headings
- Hernia, Inguinal, Hernia, Seroma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of pre-peritoneal drainage after rTAPPDevice
Use of pre-peritoneal drainage after rTAPP
| Study group | Role | What they receive |
|---|---|---|
| Use of pre-peritoneal drainage after rTAPP | Experimental | Use of pre-peritoneal drainage after rTAPP
Outcomes will be compared with retrospective cohort from our previous experiments Receives: Device: Use of pre-peritoneal drainage after rTAPP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pre-peritoneal Drainage output after rTAPP
Pre-peritoneal Drainage output (ml) after rTAPP
Measured: at 23 hours post-operation
Secondary outcomes (1)
Seroma formation
Clinical detectable seroma and size of seroma detected by USG after rTAPP with pre-peritoneal drainage
Measured: day 7, 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2021
- Study start1 Feb 2021
- Primary completion1 Sep 2021 (estimated)
- Study completion1 Nov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Hernia, InguinalStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- The safety and efficacy of pre-peritoneal drain after TEP has been validated in our previous studies - which can effectively reduce seroma formation post-operatively and safe in clinical use. We shall extend the indication of pre-peritoneal drainage after robotic TAPP, results will be compared with our retrospective cohort from previous studies.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
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, MBBS MS, Principal investigator, The University of Hong Kong-Shenzhen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04960267
- Sponsor's protocol ID
- HERN-rTAPPDRAIN-01
- Acronym
- DrainrTAPP
- Status last verified
- Jul 2021
- First submitted
- 10 Jun 2021
- Last updated
- 13 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- 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. 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 29332240Li J, Zhang W. Comment to: Preperitoneal closed-system suction drainage after totally extraperitoneal hernioplasty in the prevention of early seroma formation: a prospective double-blind randomised controlled trial. Fan JKM, Liu J, Chen K, Yang X, Xu X, Choi HK, Chan FSY, Chiu KWH, Lo CM. Hernia. 2018 Jun;22(3):467-468. doi: 10.1007/s10029-018-1762-8. Epub 2018 Apr 21. No abstract available.
PubMed 29681017Fan 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 29681018Gao D, Wei S, Zhai C, Chen J, Li M, Gu C, Wu H. Clinical research of preperitoneal drainage after endoscopic totally extraperitoneal inguinal hernia repair. Hernia. 2015 Oct;19(5):789-94. doi: 10.1007/s10029-014-1310-0. Epub 2014 Sep 20.
PubMed 25238803Fan JKM, Yip J, Foo DCC, Lo OSH, Law WL. Randomized trial comparing self gripping semi re-absorbable mesh (PROGRIP) with polypropylene mesh in open inguinal hernioplasty: the 6 years result. Hernia. 2017 Feb;21(1):9-16. doi: 10.1007/s10029-016-1545-z. Epub 2016 Nov 26.
PubMed 27889845Liu JW, Chen KJ, Xu XH, Deng Y, Zhang H, Chan FSY, Kim HJ, Fan JKM. Does the use of monopolar energy as the preferred mode of dissection effectively reduce seroma formation in laparoscopic total extra peritoneal hernioplasty? A prospective double-blinded randomized control trial. Hernia. 2020 Aug;24(4):821-829. doi: 10.1007/s10029-020-02136-3. Epub 2020 Feb 18.
PubMed 32072340
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Pre-peritoneal Drainage in rTAPP - a Comparative Study With Laparoscopic TEP
- ClinicalTrials.gov ID
- NCT04960267
- Acronym / sponsor ID
- DrainrTAPP / HERN-rTAPPDRAIN-01
- Conditions
- Hernia, Inguinal
- Keywords
- hernia, inguinal, seroma, drain, robotic, TAPP, rTAPP
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 1 Sep 2021 (estimated)
- Study completion
- 1 Nov 2021 (estimated)
- First posted
- 13 Jul 2021 (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.
The safety and efficacy of pre-peritoneal drain after TEP has been validated in our previous studies - which can effectively reduce seroma formation post-operatively and safe in clinical use. We shall extend the indication of pre-peritoneal drainage after robotic TAPP, results will be compared with our retrospective cohort from previous studies.
Detailed description
The safety and efficacy of pre-peritoneal drain after TEP has been validated in our previous studies - which can effectively reduce seroma formation post-operatively and safe in clinical use. We shall extend the indication of pre-peritoneal drainage after robotic TAPP, results will be compared with our retrospective cohort from previous studies.
Criteria of enrolling into trial is same as our previous experiment: aged 18-80, unilateral, first occurrence, reducible, non-inguino-scrotal inguinal hernia fit for GA for minimally invasive hernia repair. Routine robotic TAPP performed in standardized manner and pre-peritoneal drains are placed for drainage of 23 hours post-operatively. Drain output, pain scores, status of seroma formation (clinical, USG detected), post-operative recovery and recurrence will be monitored and compared.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The safety and efficacy of pre-peritoneal drain after TEP has been validated in our previous studies - which can effectively reduce seroma formation post-operatively and safe in clinical use. We shall extend the indication of pre-peritoneal drainage after robotic TAPP, results will be compared with our retrospective cohort from previous studies.
| Arm | Type | Receives |
|---|---|---|
| Use of pre-peritoneal drainage after rTAPP | Experimental | Device: Use of pre-peritoneal drainage after rTAPPUse of pre-peritoneal drainage after rTAPP Outcomes will be compared with retrospective cohort from our previous experiments |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Unilateral,
- First occurrence
- Reducible inguinal hernia
Key exclusion criteria (6 listed)
- Not fit for GA,
- Bilateral hernia
- Recurrent hernia
- Irreducible hernia
- Inguino-scrotal extension hernia
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 |
|---|---|---|
| Use of pre-peritoneal drainage after rTAPPUse of pre-peritoneal drainage after rTAPP | Device | Use of pre-peritoneal drainage after rTAPP |
Primary outcome
Pre-peritoneal Drainage output after rTAPP
Time frame: at 23 hours post-operation
Pre-peritoneal Drainage output (ml) after rTAPP
1 secondary outcome
Seroma formation
Time frame: day 7, 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2021.
- Background: 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.
- Background: PubMed 29681017Li J, Zhang W. Comment to: Preperitoneal closed-system suction drainage after totally extraperitoneal hernioplasty in the prevention of early seroma formation: a prospective double-blind randomised controlled trial. Fan JKM, Liu J, Chen K, Yang X, Xu X, Choi HK, Chan FSY, Chiu KWH, Lo CM. Hernia. 2018 Jun;22(3):467-468. doi: 10.1007/s10029-018-1762-8. Epub 2018 Apr 21. No abstract available.
- 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.
- Background: PubMed 25238803Gao D, Wei S, Zhai C, Chen J, Li M, Gu C, Wu H. Clinical research of preperitoneal drainage after endoscopic totally extraperitoneal inguinal hernia repair. Hernia. 2015 Oct;19(5):789-94. doi: 10.1007/s10029-014-1310-0. Epub 2014 Sep 20.
- Background: PubMed 27889845Fan JKM, Yip J, Foo DCC, Lo OSH, Law WL. Randomized trial comparing self gripping semi re-absorbable mesh (PROGRIP) with polypropylene mesh in open inguinal hernioplasty: the 6 years result. Hernia. 2017 Feb;21(1):9-16. doi: 10.1007/s10029-016-1545-z. Epub 2016 Nov 26.
- Results publication: PubMed 32072340Liu JW, Chen KJ, Xu XH, Deng Y, Zhang H, Chan FSY, Kim HJ, Fan JKM. Does the use of monopolar energy as the preferred mode of dissection effectively reduce seroma formation in laparoscopic total extra peritoneal hernioplasty? A prospective double-blinded randomized control trial. Hernia. 2020 Aug;24(4):821-829. doi: 10.1007/s10029-020-02136-3. Epub 2020 Feb 18.
- 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, MBBS MS principal investigator
The University of Hong Kong-Shenzhen Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Use of pre-peritoneal drainage after rTAPP in people with 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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 13 Jul 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joe KM FAN, MBBS MS(HKU) (+86-86913388, drjoefan@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pre-peritoneal Drainage output after rTAPP (time frame: at 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 NCT04960267, which also lists 6 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 13 Jul 2021.