NCT01000116已完成不适用
Fibrin Glue Versus Tacked Fixation in Laparoscopic Groin Hernia Repair. A Randomized Double-blind Placebo-controlled Trial.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 112
- 试验地点
- 2
- 主要终点
- Early pain after operation
研究概览
简要总结
In this study the researchers want to compare fibrin glue versus tacked fixation in fixation of the mesh in laparoscopic groin hernia repair. The primary endpoints are early pain in the first 3 days postoperative days. Moreover, the researchers investigate general well-being, fatigue, seroma, haematoma, postoperative nausea and vomiting. Thirdly, they are investigating chronic pain and clinical recurrence.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •unilateral groin hernia
- •planned laparoscopic inguinal or femoral herniorrhaphy
- •ASA I-III
- •fluent Danish
排除标准
- •converting to open operation
- •low compliance
- •daily use of morphine or similar drugs daily in the last month
- •complications to the operation
结局指标
主要结局
Early pain after operation
时间窗: 1 month
次要结局
- haematoma in groin region(day 10)
- seroma in groin region(day 10)
- fatigue(10 days)
- discomfort(6 month)
- Use of Analgesics at PACU(1 day)
- Postoperative nausea and vomiting (PONV)(10 days)
研究者
Mette Astrup Madsen
M.D.
Zealand University Hospital
研究点 (2)
Loading locations...
相似试验
尚未招募
Unknown
se of Glue versus sutures in correction of deformity in eyelidsCTRI/2023/07/055654DR RP CENTRE FOR OPHTHALMIC SCIENCES
已完成
不适用
Comparisons of Human Fibrin Glue (Tisseel) Versus Suture and Robotic Versus Traditional Laparoscopy for Ovarian CystectomyWomen With Ovarian CystNCT05946889Far Eastern Memorial Hospital88
已完成
1 期
Assessment of Fibrin Glue in Pterygium Surgery and Other Forms of External Eye SurgeryOcular Surface Cicatrizing DiseasesPterygiumNCT00344201Singapore National Eye Centre32
终止
不适用
Fibrin Sealant in Preventing Fluid Build Up During Surgery in Patients Undergoing Breast ReconstructionPerioperative/Postoperative ComplicationsBreast CancerNCT01649505OHSU Knight Cancer Institute2
终止
不适用
Tacks Versus Glue for Mesh Fixation in Laparoscopic Ventral Hernia Repair Treating Defects Between 2 and 5 cm WidthVentral HerniaNCT03429374Duomed16