Incisional HerniaTACKoMeshNCT03434301
Comparison of Mesh Fixation Techniques in Elective Laparoscopic Repair of Incisional Hernia - ReliaTack™ v ProTack™
A study testing ReliaTack™ and Protack™ in people with Incisional Hernia and Hernia, run by Manchester University NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
This study is designed to examine the effects on post operative pain after the use of a fixation device to secure a mesh in the abdomen to repair a hernia of the abdominal wall. The fixation devices to be used differ with one being made from titanium and is permanent and the other being made from an absorbable… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Incisional Hernia, Hernia, Abdominal Hernia
- What is being tested?
- ReliaTack™ and Protack™
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 20 Jul 2017to 22 Sep 2020
- 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
- All adults undergoing elective incisional hernia repair for midline abdominal incisional hernia, with a defect of 3-10cm in diameter.
Who cannot join
- Patients less than 18 years of age, or unable to give informed consent.
- Patients over 80 years of age.
- Females of reproductive age.
- Prisoners.
- Clinically small incisional hernia <3cm maximum diameter.
- Emergency procedures (for irreducible, strangulated or obstructed hernia).
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- Procedure involving dirty (purulent inflammation (e.g. abscess); preoperative perforation of respiratory, gastrointestinal, biliary or genitourinary tract; penetrating trauma >4 hours old) or contaminated (Non-purulent inflammation; gross spillage from gastrointestinal tract; entry into biliary or genitourinary tract in the presence of infected bile or urine; major break in technique; penetrating trauma <4 hours old; chronic open wounds to be grafted or covered) surgery.
- Patients with a Body Mass Index (BMI) >40 kg/m².
- Patients participating in any other study, whose concurrent participation in the TACK study might place them at undue risk or might confound the study data in the opinion of the chief investigators.
- Failure to close the anterior rectus sheath intraoperatively.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Manchester University NHS Foundation Trust
Manchester, M13 9WL
About this study
Official title: Comparison of Mesh Fixation Techniques in Elective Laparoscopic Repair of Incisional Hernia - ReliaTack™ v ProTack™ (TACKoMesh Study)
This study is designed to examine the effects on post operative pain after the use of a fixation device to secure a mesh in the abdomen to repair a hernia of the abdominal wall. The fixation devices to be used differ with one being made from titanium and is permanent and the other being made from an absorbable material. Both fixation devices are commonly used but two questions remain unanswered, does one cause more chronic pain and also what if any will be the effect on recurrence rates of the hernia. No trial has been undertaken to date which will not only examine the fixation device but in the setting where the hernia is closed first. The closure of the hernial defect by the keyhole technique is a relatively new and growing concept in the hernia world.
Read the detailed description
TACKoMESH study (Comparison of using absorbable tacks (ReliaTack™) against a non-absorbable tack (Protack™) to fixate Symbotex™ composite mesh in the elective repair of incisional hernia) is a prospective, single-centre, double blinded randomised trial which aims to establish whether the use of absorbable (ABS) compared to non-absorbable (Non-ABS) tacks in adult patients undergoing elective incisional hernia repair produces a lower rate of pain both immediately and long-term. Secondary outcomes to be explored include seroma formation, hernia recurrence, length of postoperative hospital stay, wound infection, reoperation rate, operation time, health related quality of life and time to return to normal daily activity.
Patients entering TACKoMesh will be randomised immediately prior to their operation with a 1:1 ratio of ABS versus Non-ABS tack arm allocation. The same composite mesh will be used for all operations. Follow-up is according to a predetermined schedule, using specifically designed Case Report Forms to collect the blinded data.
- Conditions
- Incisional Hernia, Hernia, Abdominal Hernia
- Being tested
- ReliaTack™, Protack™
- Keywords
- Surgery, Laparotomy, Tack, Non-absorbable Tack, Absorbable Tack, Pain
- Medical subject headings
- Incisional Hernia, Hernia, Hernia, Abdominal, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReliaTack™Device
Absorbable tack (ReliaTack™) to fixate Symbotex™ composite mesh in the elective repair of incisional hernia.
Protack™Device
Non-absorbable tack (Protack™) to fixate Symbotex™ composite mesh in the elective repair of incisional hernia.
| Study group | Role | What they receive |
|---|---|---|
| Mesh with absorbable tack fixation | Active comparator | Mesh with absorbable tack (ReliaTack™) fixation Receives: Device: ReliaTack™ |
| Mesh with non-absorbable fixation | Active comparator | Mesh with non-absorbable (Protack™) fixation Receives: Device: Protack™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain score
Pain Score at rest and activity at day 30 recorded using visual analogue pain score (VAS) (0-10cm).
Measured: 30 days
Secondary outcomes (10)
Visual analogue pain score (VAS).
Visual analogue pain score (VAS) pain score at days 1, 5-7 3 months and 1 year post-operative. A preoperative VAS score will also be recorded.
Measured: Day 1, days 5-7, 3 months, 1 year.
Seroma formation.
Seroma formation (no fixed time point) (a seroma will be defined as any clinically apparent fluid collection at the site of mesh placement).
Measured: Days 1, 6, 30, 3 months and 1 year post-operation.
Postoperative hospital stay.
The length of postoperative hospital stay.
Measured: Time from end of Surgery to patient discharge (up to end of study; 104 weeks).
Time to return to normal daily activity.
The time to return to normal daily activity.
Measured: From day of surgery to end of study (104 weeks).
Wound infection.
Any wound infection.
Measured: Days 1, 6, 30, 3 months and 1 year post-operation.
Operating time.
The time taken for the Operation - from start to finish.
Measured: Length of Operation.
Mesh fixation time.
Mesh fixation time after adhesions have been taken down and fascia closed.
Measured: Time during Operation.
Hernia recurrence.
Hernia recurrence at one year and at all time points.
Measured: Days 1, 6, 30, 3 months and 1 year post-operation.
Health-related quality of life.
Health-related quality of life - assessed using the Carolinas Comfort Score™ (which is specifically designed for hernia repair) (26) and Short Form 36™, at pre-operatively, 30 days and 1 year, (appendix K and SF-36).
Measured: 30 days and 1 year post-operation.
Adverse Events.
To capture any Adverse Events during the study duration.
Measured: Days 1, 6, 30, 3 months and 1 year post-operation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2018
- Study start20 Jul 2017
- Primary completion22 Sep 2020
- Study completion22 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Incisional HerniaStudies of the same condition, open and under way.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Manchester University NHS Foundation Trust
- Sponsor type
- Other government
- Collaborators
- Medtronic
- Responsible party
- Sponsor
- Investigators
- Aali J Sheen, Principal investigator, Manchester University NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03434301
- Sponsor's protocol ID
- R04484
- Acronym
- TACKoMesh
- Status last verified
- Dec 2021
- First submitted
- 29 Jan 2018
- Last updated
- 7 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sheen AJ, Pilkington JJ, Baltatzis M, Tyurkylmaz A, Stathakis P, Jamdar S, Siriwardena AK. Comparison of Mesh Fixation Techniques in Elective Laparoscopic Repair of Incisional Hernia-ReliaTack v ProTack (TACKoMesh) - A double-blind randomised controlled trial. BMC Surg. 2018 Jul 11;18(1):46. doi: 10.1186/s12893-018-0378-3.
PubMed 29996841
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Mesh Fixation Techniques in Elective Laparoscopic Repair of Incisional Hernia - ReliaTack™ v ProTack™ (TACKoMesh Study)
- ClinicalTrials.gov ID
- NCT03434301
- Acronym / sponsor ID
- TACKoMesh / R04484
- Conditions
- Incisional Hernia, Hernia, Abdominal Hernia
- Keywords
- Surgery, Laparotomy, Tack, Non-absorbable Tack, Absorbable Tack, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Manchester University NHS Foundation TrustOther government
- Collaborators
- Medtronic
- Study start
- 20 Jul 2017 (actual)
- Primary completion
- 22 Sep 2020 (actual)
- Study completion
- 22 Sep 2020 (actual)
- First posted
- 15 Feb 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.
This study is designed to examine the effects on post operative pain after the use of a fixation device to secure a mesh in the abdomen to repair a hernia of the abdominal wall. The fixation devices to be used differ with one being made from titanium and is permanent and the other being made from an absorbable material. Both fixation devices are commonly used but two questions remain unanswered, does one cause more chronic pain and also what if any will be the effect on recurrence rates of the hernia. No trial has been undertaken to date which will not only examine the fixation device but in the setting where the hernia is closed first. The closure of the hernial defect by the keyhole technique is a relatively new and growing concept in the hernia world.
Detailed description
TACKoMESH study (Comparison of using absorbable tacks (ReliaTack™) against a non-absorbable tack (Protack™) to fixate Symbotex™ composite mesh in the elective repair of incisional hernia) is a prospective, single-centre, double blinded randomised trial which aims to establish whether the use of absorbable (ABS) compared to non-absorbable (Non-ABS) tacks in adult patients undergoing elective incisional hernia repair produces a lower rate of pain both immediately and long-term. Secondary outcomes to be explored include seroma formation, hernia recurrence, length of postoperative hospital stay, wound infection, reoperation rate, operation time, health related quality of life and time to return to normal daily activity.
Patients entering TACKoMesh will be randomised immediately prior to their operation with a 1:1 ratio of ABS versus Non-ABS tack arm allocation. The same composite mesh will be used for all operations. Follow-up is according to a predetermined schedule, using specifically designed Case Report Forms to collect the blinded data.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mesh with absorbable tack fixation | Active comparator | Device: ReliaTack™Mesh with absorbable tack (ReliaTack™) fixation |
| Mesh with non-absorbable fixation | Active comparator | Device: Protack™Mesh with non-absorbable (Protack™) fixation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All adults undergoing elective incisional hernia repair for midline abdominal incisional hernia, with a defect of 3-10cm in diameter.
Key exclusion criteria (10 listed)
- Patients less than 18 years of age, or unable to give informed consent.
- Patients over 80 years of age.
- Females of reproductive age.
- Prisoners.
- Clinically small incisional hernia <3cm maximum diameter.
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 |
|---|---|---|
| ReliaTack™Absorbable tack (ReliaTack™) to fixate Symbotex™ composite mesh in the elective repair of incisional hernia. | Device | Mesh with absorbable tack fixation |
| Protack™Non-absorbable tack (Protack™) to fixate Symbotex™ composite mesh in the elective repair of incisional hernia. | Device | Mesh with non-absorbable fixation |
Primary outcome
Pain score
Time frame: 30 days
Pain Score at rest and activity at day 30 recorded using visual analogue pain score (VAS) (0-10cm).
10 secondary outcomes
Visual analogue pain score (VAS).
Time frame: Day 1, days 5-7, 3 months, 1 year.
Seroma formation.
Time frame: Days 1, 6, 30, 3 months and 1 year post-operation.
Postoperative hospital stay.
Time frame: Time from end of Surgery to patient discharge (up to end of study; 104 weeks).
Time to return to normal daily activity.
Time frame: From day of surgery to end of study (104 weeks).
Wound infection.
Time frame: Days 1, 6, 30, 3 months and 1 year post-operation.
Operating time.
Time frame: Length of Operation.
Mesh fixation time.
Time frame: Time during Operation.
Hernia recurrence.
Time frame: Days 1, 6, 30, 3 months and 1 year post-operation.
Health-related quality of life.
Time frame: 30 days and 1 year post-operation.
Adverse Events.
Time frame: Days 1, 6, 30, 3 months and 1 year 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 7 Dec 2021.
- Derived from this study: PubMed 29996841Sheen AJ, Pilkington JJ, Baltatzis M, Tyurkylmaz A, Stathakis P, Jamdar S, Siriwardena AK. Comparison of Mesh Fixation Techniques in Elective Laparoscopic Repair of Incisional Hernia-ReliaTack v ProTack (TACKoMesh) - A double-blind randomised controlled trial. BMC Surg. 2018 Jul 11;18(1):46. doi: 10.1186/s12893-018-0378-3.
- 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.
Aali J Sheen principal investigator
Manchester University NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ReliaTack™ and Protack™ in people with Incisional Hernia and Hernia, run by Manchester University NHS Foundation Trust at 1 site in United Kingdom.
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 1 inclusion and 10 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 7 Dec 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 United Kingdom. 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?
Pain score (time frame: 30 days). 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 NCT03434301, which also lists 1 linked publication.
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 7 Dec 2021.