Comparison of Mesh Fixation Techniques in Elective Laparoscopic Repair of Incisional Hernia - ReliaTack™ v ProTack™ (TACKoMesh Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 2
- 主要终点
- Pain score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All adults undergoing elective incisional hernia repair for midline abdominal incisional hernia, with a defect of 3-10cm in diameter.
排除标准
- •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).
- •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.
结局指标
主要结局
Pain score
时间窗: 30 days
Pain Score at rest and activity at day 30 recorded using visual analogue pain score (VAS) (0-10cm).
次要结局
- Visual analogue pain score (VAS).(Day 1, days 5-7, 3 months, 1 year.)
- Seroma formation.(Days 1, 6, 30, 3 months and 1 year post-operation.)
- Postoperative hospital stay.(Time from end of Surgery to patient discharge (up to end of study; 104 weeks).)
- Time to return to normal daily activity.(From day of surgery to end of study (104 weeks).)
- Wound infection.(Days 1, 6, 30, 3 months and 1 year post-operation.)
- Health-related quality of life.(30 days and 1 year post-operation.)
- Adverse Events.(Days 1, 6, 30, 3 months and 1 year post-operation.)
- Mesh fixation time.(Time during Operation.)
- Hernia recurrence.(Days 1, 6, 30, 3 months and 1 year post-operation.)
- Operating time.(Length of Operation.)