An interventional study of ReliaTack™ and Protack™ in Incisional Hernia, Hernia and Abdominal Hernia, sponsored by Manchester University NHS Foundation Trust. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-12-07.
Sponsored by Manchester University NHS Foundation Trust · Not applicable, Interventional, and Treatment
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.
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.
212 studies on the registry are indexed under Incisional Hernia; 58 are open to participants now.
This study's enrollment of 63 is below the median of 110 across 130 interventional studies indexed under Incisional Hernia.
Browse Incisional Hernia studies →Manchester University NHS Foundation Trust is the lead sponsor of 140 studies on the registry; 27 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Mesh with absorbable tack (ReliaTack™) fixation
Device: ReliaTack™
Mesh with non-absorbable (Protack™) fixation
Device: Protack™
Absorbable tack (ReliaTack™) to fixate Symbotex™ composite mesh in the elective repair of incisional hernia.
Non-absorbable tack (Protack™) to fixate Symbotex™ composite mesh in the elective repair of incisional hernia.
Pain score
Pain Score at rest and activity at day 30 recorded using visual analogue pain score (VAS) (0-10cm).
Time frame: 30 days
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.
Time frame: 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).
Time frame: Days 1, 6, 30, 3 months and 1 year post-operation.
Postoperative hospital stay.
The length of 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.
The time to return to normal daily activity.
Time frame: From day of surgery to end of study (104 weeks).
Wound infection.
Any wound infection.
Time frame: Days 1, 6, 30, 3 months and 1 year post-operation.
Operating time.
The time taken for the Operation - from start to finish.
Time frame: Length of Operation.
Mesh fixation time.
Mesh fixation time after adhesions have been taken down and fascia closed.
Time frame: Time during Operation.
Hernia recurrence.
Hernia recurrence at one year and at all time points.
Time frame: 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).
Time frame: 30 days and 1 year post-operation.
Adverse Events.
To capture any Adverse Events during the study duration.
Time frame: Days 1, 6, 30, 3 months and 1 year post-operation.
Plan to share: No
Ran from Jul 2017 to primary completion in Sep 2020, 38 months.
Of 59 non-industry interventional studies with no phase under Incisional Hernia, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 29 and three quarters within 59. This study's 38 months is below that.
Counting every sponsor, half of 66 studies reached it within 43 months; a quarter within 29 and three quarters within 60.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.
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Manchester University NHS Foundation Trust →