Hernia, InguinalNCT02762747
Randomised Controlled Trial on Pre-peritoneal Drainage After Totally Extra-peritoneal Hernioplasty for Inguinal Hernia
A study testing preperitoneal suction drainage in people with Hernia, Inguinal, run by The University of Hong Kong at 1 site in China.
Trial summary
This is a RCT on drain versus no drain after laparoscopic totally extra-peritoneal hernioplasty. We will assess the difference in seroma formation after surgery in 2 two groups by an independent assessor clinically and radiologist to document the size of seroma after surgery. 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?
- preperitoneal suction drainage
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- May 2016to Aug 2018
- 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
- Age above 18 and below 80
- 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
- Co-morbidies
- Decline or not consent to surgery
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
WL Law, MBBS MS FRCS
About this study
Official title: Pre-peritoneal Drainage Versus No Drainage After Totally Extra-peritoneal Hernioplasty for Inguinal Hernia - a Randomised Controlled Study
This is a RCT on drain versus no drain after laparoscopic totally extra-peritoneal hernioplasty. We will assess the difference in seroma formation after surgery in 2 two groups by an independent assessor clinically and radiologist to document the size of seroma after surgery. Other secondary outcomes will be measured including post-operative pain, discomfort, analgesic used, patient satisfaction, recurrence of hernia, wound infection, etc.
Read the detailed description
Inguinal hernia is a common disease and causes significant morbidity if left untreated. With the advances of laparoscopic approach of extra-peritoneal hernioplasty, it significantly reduces the post-operative pain and lead to a better quality of life with higher acceptance to patients.However, similar to traditional Litchenstein approach, post operative seroma formation is still a common problem encountered after surgery. Numerous method has been described to reduce chance of seroma formation, however, none was proven to be effective except pre-peritoneal drainage. There are currently 2 large retrospective non-randomized cohort study to evaluate the effectiveness of preperitoneal drainage available for reference. We therefore study the feasibility and efficacy of preperitoneal drainage with large scale randomized trial.
Patient fulfill inclusion criteria and consent to surgery and study will be recruited. A standardized pre-peritoneal dissection and mesh placement will be adopted. Immediately before deflation of pre-peritoneal space, randomization will be performed by calling research assistant for study group using computer generated code. Drain will be placed for 23 hours after operation and ultrasonography will be performed immediately after removal of drain. USG will be repeated at post-operative 1 week, 1 month, 3 months, 6 months and 1 year after surgery. For non-drain group, a fake drain will be attach to the skin of the wound to achieve double blinding to patients and assessors. In addition to seroma, patient demographics and secondary outcome including post-operative pain score, discomfort, foreign body sensation, patient satisfaction, infection, recurrence, etc will be studied.
- Conditions
- Hernia, Inguinal
- Being tested
- preperitoneal suction drainage
- Keywords
- Hernia, Inguinal, Extraperitoneal Hernioplasty, Drain, Mesh Repair, Laparoscopic
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
preperitoneal suction drainageProcedure or surgery
preperitoneal suction drainage after laparoscopic totally extra-peritoneal hernioplasty for inguinal hernia
| Study group | Role | What they receive |
|---|---|---|
| Drain | Experimental | preperitoneal suction drainage after laparoscopic totally extra-peritoneal hernioplasty for inguinal hernia Receives: Procedure: preperitoneal suction drainage |
| No-drain | No intervention | No drainage after laparoscopic totally extra-peritoneal hernioplasty for inguinal hernia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seroma formation after TEP hernioplasty
Seroma will be assessed clinically by independent assessor who is blind to the group assigned and also by qualified radiologist who will perform USG to measure the exact size of seroma formation after TEP
Measured: post-operative day 1
Seroma formation after TEP hernioplasty
Seroma will be assessed clinically by independent assessor who is blind to the group assigned and also by qualified radiologist who will perform USG to measure the exact size of seroma formation after TEP
Measured: post-operative day 7
Seroma formation after TEP hernioplasty
Seroma will be assessed clinically by independent assessor who is blind to the group assigned and also by qualified radiologist who will perform USG to measure the exact size of seroma formation after TEP
Measured: post-operative 1 month
Seroma formation after TEP hernioplasty
Seroma will be assessed clinically by independent assessor who is blind to the group assigned and also by qualified radiologist who will perform USG to measure the exact size of seroma formation after TEP
Measured: post-operative 3 month
Seroma formation after TEP hernioplasty
Seroma will be assessed clinically by independent assessor who is blind to the group assigned and also by qualified radiologist who will perform USG to measure the exact size of seroma formation after TEP
Measured: post-operative 6 month
Seroma formation after TEP hernioplasty
Seroma will be assessed clinically by independent assessor who is blind to the group assigned and also by qualified radiologist who will perform USG to measure the exact size of seroma formation after TEP
Measured: post-operative 1 year
Secondary outcomes (5)
Post-operative pain after TEP hernioplasty
Post-operative pain after TEP hernioplasty will be assessed by self-evaluated VAS questionnaire during initial 7 days after operation. Then will be asked by independent assessor upon follow-up
Measured: post-operative day 1 to day 7, 1 month, 3 month, 6 month, 1 year
Analgesic used after after TEP hernioplasty
Number of analgesic used after after TEP hernioplasty will be assessed by self-evaluated questionnaire during initial 7 days after operation. Then will be asked by independent assessor upon follow-up
Measured: post-operative day 1 to day 7, 1 month, 3 month, 6 month, 1 year
Chronic discomfort after TEP hernioplasty
Chronic discomfort after TEP hernioplasty will be asked by independent assessor upon follow-up
Measured: post-operative 1 month, 3 month, 6 month, 1 year
Hernia recurrence after TEP hernioplasty
Hernia recurrence after TEP hernioplasty will be assessed by independent assessor upon follow-up
Measured: post-operative 1 month, 3 month, 6 month, 1 year
Patient satisfaction after TEP hernioplasty
Patient satisfaction after TEP hernioplasty will be asked by independent assessor upon follow-up
Measured: post-operative 1 month, 3 month, 6 month, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2016 (estimated)
- Study startMay 2016
- Primary completionMay 2018 (estimated)
- Study completionAug 2018 (estimated)
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 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
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- The University of Hong Kong-Shenzhen Hospital
- Responsible party
- Principal investigator, Dr. Joe King-Man Fan, The University of Hong Kong
- Investigators
- Joe KM Fan, MBBS,MS,FRCS, Study chair, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02762747
- Sponsor's protocol ID
- HERN-LAPDRAIN-01
- Status last verified
- May 2016
- First submitted
- 3 May 2016
- Last updated
- 10 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Ismail M, Garg M, Rajagopal M, Garg P. Impact of closed-suction drain in preperitoneal space on the incidence of seroma formation after laparoscopic total extraperitoneal inguinal hernia repair. Surg Laparosc Endosc Percutan Tech. 2009 Jun;19(3):263-6. doi: 10.1097/SLE.0b013e3181a4d0e1.
PubMed 19542859Gao 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 25238803
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-peritoneal Drainage Versus No Drainage After Totally Extra-peritoneal Hernioplasty for Inguinal Hernia - a Randomised Controlled Study
- ClinicalTrials.gov ID
- NCT02762747
- Acronym / sponsor ID
- HERN-LAPDRAIN-01
- Conditions
- Hernia, Inguinal
- Keywords
- Hernia, Inguinal, Extraperitoneal Hernioplasty, Drain, Mesh Repair, Laparoscopic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- The University of Hong Kong-Shenzhen Hospital
- Study start
- May 2016
- Primary completion
- May 2018 (estimated)
- Study completion
- Aug 2018 (estimated)
- First posted
- 5 May 2016 (estimated)
- 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.
This is a RCT on drain versus no drain after laparoscopic totally extra-peritoneal hernioplasty. We will assess the difference in seroma formation after surgery in 2 two groups by an independent assessor clinically and radiologist to document the size of seroma after surgery. Other secondary outcomes will be measured including post-operative pain, discomfort, analgesic used, patient satisfaction, recurrence of hernia, wound infection, etc.
Detailed description
Inguinal hernia is a common disease and causes significant morbidity if left untreated. With the advances of laparoscopic approach of extra-peritoneal hernioplasty, it significantly reduces the post-operative pain and lead to a better quality of life with higher acceptance to patients.However, similar to traditional Litchenstein approach, post operative seroma formation is still a common problem encountered after surgery. Numerous method has been described to reduce chance of seroma formation, however, none was proven to be effective except pre-peritoneal drainage. There are currently 2 large retrospective non-randomized cohort study to evaluate the effectiveness of preperitoneal drainage available for reference. We therefore study the feasibility and efficacy of preperitoneal drainage with large scale randomized trial.
Patient fulfill inclusion criteria and consent to surgery and study will be recruited. A standardized pre-peritoneal dissection and mesh placement will be adopted. Immediately before deflation of pre-peritoneal space, randomization will be performed by calling research assistant for study group using computer generated code. Drain will be placed for 23 hours after operation and ultrasonography will be performed immediately after removal of drain. USG will be repeated at post-operative 1 week, 1 month, 3 months, 6 months and 1 year after surgery. For non-drain group, a fake drain will be attach to the skin of the wound to achieve double blinding to patients and assessors. In addition to seroma, patient demographics and secondary outcome including post-operative pain score, discomfort, foreign body sensation, patient satisfaction, infection, recurrence, etc will be studied.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Drain | Experimental | Procedure: preperitoneal suction drainagepreperitoneal suction drainage after laparoscopic totally extra-peritoneal hernioplasty for inguinal hernia |
| No-drain | No intervention | –No drainage after laparoscopic totally extra-peritoneal hernioplasty for inguinal hernia |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age above 18 and below 80
- Male or female patients
- Unilateral inguinal hernia
- First occurrence hernia
- Consent to laparoscopic hernioplasty for inguinal hernia
Key exclusion criteria (8 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 |
|---|---|---|
| preperitoneal suction drainagepreperitoneal suction drainage after laparoscopic totally extra-peritoneal hernioplasty for inguinal hernia | Procedure or surgery | Drain |
Primary outcome
Seroma formation after TEP hernioplasty
Time frame: post-operative day 1
Seroma will be assessed clinically by independent assessor who is blind to the group assigned and also by qualified radiologist who will perform USG to measure the exact size of seroma formation after TEP
Seroma formation after TEP hernioplasty
Time frame: post-operative day 7
Seroma will be assessed clinically by independent assessor who is blind to the group assigned and also by qualified radiologist who will perform USG to measure the exact size of seroma formation after TEP
Seroma formation after TEP hernioplasty
Time frame: post-operative 1 month
Seroma will be assessed clinically by independent assessor who is blind to the group assigned and also by qualified radiologist who will perform USG to measure the exact size of seroma formation after TEP
Seroma formation after TEP hernioplasty
Time frame: post-operative 3 month
Seroma will be assessed clinically by independent assessor who is blind to the group assigned and also by qualified radiologist who will perform USG to measure the exact size of seroma formation after TEP
Seroma formation after TEP hernioplasty
Time frame: post-operative 6 month
Seroma will be assessed clinically by independent assessor who is blind to the group assigned and also by qualified radiologist who will perform USG to measure the exact size of seroma formation after TEP
Seroma formation after TEP hernioplasty
Time frame: post-operative 1 year
Seroma will be assessed clinically by independent assessor who is blind to the group assigned and also by qualified radiologist who will perform USG to measure the exact size of seroma formation after TEP
5 secondary outcomes
Post-operative pain after TEP hernioplasty
Time frame: post-operative day 1 to day 7, 1 month, 3 month, 6 month, 1 year
Analgesic used after after TEP hernioplasty
Time frame: post-operative day 1 to day 7, 1 month, 3 month, 6 month, 1 year
Chronic discomfort after TEP hernioplasty
Time frame: post-operative 1 month, 3 month, 6 month, 1 year
Hernia recurrence after TEP hernioplasty
Time frame: post-operative 1 month, 3 month, 6 month, 1 year
Patient satisfaction after TEP hernioplasty
Time frame: post-operative 1 month, 3 month, 6 month, 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2016.
- Results publication: PubMed 19542859Ismail M, Garg M, Rajagopal M, Garg P. Impact of closed-suction drain in preperitoneal space on the incidence of seroma formation after laparoscopic total extraperitoneal inguinal hernia repair. Surg Laparosc Endosc Percutan Tech. 2009 Jun;19(3):263-6. doi: 10.1097/SLE.0b013e3181a4d0e1.
- Results publication: 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.
- Individual participant dataSharing planned: Undecided
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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,FRCS study chair
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 preperitoneal suction drainage 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 5 inclusion and 8 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 10 May 2016. 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,FRCS (+86-18307555114, drjoefan@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Seroma formation after TEP hernioplasty (time frame: post-operative day 1). The study lists 6 primary outcomes in all. 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 NCT02762747, 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 10 May 2016.