Comparison of Mesh Fixation Techniques in Elective Laparoscopic Repair of Incisional Hernia - ReliaTack™ v ProTack™ (TACKoMesh)
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|ClinicalTrials.gov Identifier: NCT03434301|
Recruitment Status : Recruiting
First Posted : February 15, 2018
Last Update Posted : July 30, 2019
|Condition or disease||Intervention/treatment||Phase|
|Incisional Hernia Hernia Abdominal Hernia||Device: ReliaTack™ Device: Protack™||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||136 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Care Provider)|
|Official Title:||Comparison of Mesh Fixation Techniques in Elective Laparoscopic Repair of Incisional Hernia - ReliaTack™ v ProTack™ (TACKoMesh Study)|
|Actual Study Start Date :||July 20, 2017|
|Estimated Primary Completion Date :||December 21, 2020|
|Estimated Study Completion Date :||February 1, 2021|
Active Comparator: Mesh with absorbable tack fixation
Mesh with absorbable tack (ReliaTack™) fixation
Absorbable tack (ReliaTack™) to fixate Symbotex™ composite mesh in the elective repair of incisional hernia.
Active Comparator: Mesh with non-absorbable fixation
Mesh with non-absorbable (Protack™) fixation
Non-absorbable tack (Protack™) to fixate Symbotex™ composite mesh in the elective repair of incisional hernia.
- Pain score [ Time Frame: 30 days ]Pain Score at rest and activity at day 30 recorded using visual analogue pain score (VAS) (0-10cm).
- Visual analogue pain score (VAS). [ Time Frame: Day 1, days 5-7, 3 months, 1 year. ]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.
- Seroma formation. [ Time Frame: Days 1, 6, 30, 3 months and 1 year post-operation. ]Seroma formation (no fixed time point) (a seroma will be defined as any clinically apparent fluid collection at the site of mesh placement).
- Postoperative hospital stay. [ Time Frame: Time from end of Surgery to patient discharge (up to end of study; 104 weeks). ]The length of postoperative hospital stay.
- Time to return to normal daily activity. [ Time Frame: From day of surgery to end of study (104 weeks). ]The time to return to normal daily activity.
- Wound infection. [ Time Frame: Days 1, 6, 30, 3 months and 1 year post-operation. ]Any wound infection.
- Operating time. [ Time Frame: Length of Operation. ]The time taken for the Operation - from start to finish.
- Mesh fixation time. [ Time Frame: Time during Operation. ]Mesh fixation time after adhesions have been taken down and fascia closed.
- Hernia recurrence. [ Time Frame: Days 1, 6, 30, 3 months and 1 year post-operation. ]Hernia recurrence at one year and at all time points.
- Health-related quality of life. [ Time Frame: 30 days and 1 year post-operation. ]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).
- Adverse Events. [ Time Frame: Days 1, 6, 30, 3 months and 1 year post-operation. ]To capture any Adverse Events during the study duration.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03434301
|Contact: Emily Weaver||0161 701 8558 ext 18558||Emily.Weaver@mft.nhs.uk|
|Contact: Nicola Marpole||0161 701 6671 ext 16671||Nicola.Marpole@mft.nhs.uk|
|Manchester University NHS Foundation Trust||Recruiting|
|Manchester, United Kingdom, M13 9WL|
|Contact: Emily Weaver 0161 701 8558 ext 18558 Emily.Weaver@mft.nhs.uk|
|Principal Investigator: Aali J Sheen, MD, FRCS|
|Principal Investigator:||Aali J Sheen||Manchester University NHS Foundation Trust|