Randomized Study of Self Gripping Semi-resorbable Mesh (PROGRIP) With Polypropylene Mesh in Open Inguinal Hernia Repair - the 6 Years Result
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Operating Time From Skin Incision to Wound Closure
研究概览
简要总结
Tension-less mesh repair is the most common procedure for inguinal hernia. Conventional heavy weight polypropylene meshes have been reported to stimulate inflammatory reaction and this is responsible for mesh shrinkage and postoperative chronic groin pain. Moreover, the fixation of the mesh with sutures is a tedious procedure and accounts for the majority of the operating time. A self gripping semi-absorbable mesh has been developed for anterior tension free inguinal hernia repair. It has the benefit of light weight property and does not require sutures for fixation. This study aims to compare the outcome of this self-gripping light weight mesh with the conventional heavy weight polypropylene mesh in inguinal hernia repair.
详细描述
Tension free mesh repair is the most common procedure for inguinal hernia repair. Conventional heavy weight polypropylene meshes have been reported to stimulate inflammatory reaction and this is responsible for mesh shrinkage when scar tissues are formed. In addition, the mesh requires fixation with sutures and there has been postulation that the fixation technique is related to postoperative chronic groin pain. Therefore, some authors have recommended the use of light-weight meshes and to limit the extent of fixation or to use non-compressive absorbable devices. In order to reduce the complications, a new self-gripping semi-resorbable mesh has been developed for anterior tension-free inguinal hernia repair.
The aim of this study is to compare the difference in operating time for open inguinal hernia repair with conventional prolene mesh and ProgripTM, which is a light-weight mesh with self-adhesive mechanism.
Methodology: Patients present with first episode of inguinal hernia are included into the study. Those with a sizable defect (>3cm defect), bilateral, inguino-scrotal hernia, irreducible, recurrence are excluded from study. Informed consents are signed before procedures and details of randomization are explained. Operations are performed by or under the supervision of specialist surgeons. Standardized inguinal dissection are performed. Randomization is carried out immediately before placement of mesh and after adequate inguinal dissection. PI / co-investigator phone to research assistant and ask for randomization result generated by computer. Total operative time, time from mesh placement to wound closure, blood loss, intra-operative complications, hospital stay, post-operative pain and analgesic used are documented.
Post-operative follow-up: Follow-up on day 14, 3 months, 6 months and 1 year post-op. Pain score, paraesthesia , chronic discomfort / pain, recurrence, seroma formation, testicular atrophy are documented. Thereafter, yearly follow-up is performed at clinic or by telephone to document the recurrence and chronic pain.
Parietene ProGrip™ (PP1208DR/ PP1208DL) Manufacturer: Sofradim Production Material: Monofilaments of polypropylene and polylactic acid (PLA) Color: Clear (undyed) Weight: 80g/m2 (before PLA resorbtion), 40g/m2 (after PLA resorbtion) Poresize: 1.7mm x 1mm
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Age above 18 and below 80
- •Male or female patients
- •Unilateral inguinal hernia
- •First occurrence hernia
排除标准
- •Inguino-scrotal hernia
- •Recurrent inguinal hernia
- •Incarcerated hernia
- •Bilateral inguinal hernia
结局指标
主要结局
Operating Time From Skin Incision to Wound Closure
时间窗: Intra-operative record
It measures the total operating time of 2 groups, measured from time started the skin incision to time finishing wound closure in terms of minutes.
次要结局
- Overall Recurrence at 6 Years(6 years after operation)
- Chronic Pain at 6 Years(6 years after operation)
- Seroma Formation at First Follow-up(1 week after operation)
- Patient With Palpable Mesh at 6 Years After Operation(6 years after operation)
- Pain or Discomfort Affecting Daily Activities at 6 Years After Operation(6 years after operation)
- Number of Participants Whose Response Was YES is Reported(1 week after operation)
- Patient With Chronic Discomfort at 6 Years After Operation(6 years after operation)
- Total Number of Analgesic Used(1 week after operation)
- Wound Pain at Rest at 1 Week After Operation(1 week after operation)
- Size of Mesh (Longitudinal)(intra-operative record)
- Size of Mesh (Vertical)(intra-operative record)
- Days go Outdoor(1 week after operation)
- Patient With Testicular Atrophy From Post-op to 6 Years After Operation(6 years after operations)
- Mesh Placement Time, Total Operative Time(Intra-operative record)
- Wound Pain on Coughing at 1 Week After Operation(1 week after operation)
- Post-operative Stay(1 week after operation)
- Wound Size(intra-operative record)
研究者
Dr. Joe King-Man Fan
Consultant
The University of Hong Kong