The PAPYRUS Study: Permanent vs. Absorbable Sutures in PrimarY Repair of Umbilical HerniaS: A Multicentre, Single-blind, Non-inferiority, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 914
- 试验地点
- 10
- 主要终点
- Recurrence
研究概览
简要总结
Umbilical hernias can be found in over a quarter of the population and comprise of 15% of hernia repairs performed in Canada. While mesh repair is commonly used for larger hernias, smaller hernia defects are often closed with sutures alone. While non-absorbable sutures may have greater tensile strength, the use of absorbable sutures has been found to reduce the risk for wound infection and improve healing. The objective of this multi-centre, nationwide randomized controlled study is to determine whether there is a difference in hernia recurrence when the repair is completed with absorbable polydioxanone suture versus permanent polypropylene suture. The study will also explore post-operative complications and quality of life. Recruitment will take place over 5 years with follow-up at the 30-day, 12-month and 24-month mark following surgery. The results of this trial will be directly applicable to national and international hernia guidelines and will impact the care of thousands of patients.
详细描述
Umbilical hernias make up a notable proportion of abdominal wall hernia repairs annually. Up to 25% of the population have asymptomatic umbilical hernias when examined using ultrasound. Recent computed tomography studies have identified umbilical hernia in up to 62% of the population. In Canada in 2019, there were 66,234 hernia surgeries performed. Similarly, there are around 175,000 umbilical hernia repairs per year in the United States.
The European Hernia Society (EHS) guidelines classify umbilical hernias by size as small (0-1cm), medium (more than 1 cm up to 4cm), and large (over 4 cm) based on diameter. Although many hernias are asymptomatic, intra-abdominal contents, such as fat or bowel, can protrude through the defect and result in a surgical emergency. Up to 20% of patients with asymptomatic umbilical hernia will later require elective surgery, and another 4% will require emergency surgery.
The EHS guidelines recommend mesh for all hernia repairs to reduce rate of recurrence, but quality of evidence is limited for hernias less than 1cm in size and therefore suture repair can be considered in these situations. Despite EHS guidelines, in many cases, umbilical hernias up to 2 cm in size are repaired with suture based on intra-operative assessment, for example, to avoid enlarging the defect necessary to accommodate a pre-peritoneal mesh with an overlap of 3cm.
The Americas Hernia Society Quality Collaborative Database found that mesh repairs were used for 82% of umbilical hernias >1cm in diameter and 33% of those ≤1cm in diameter. For the National Health Service in England, 50% of umbilical hernias were repaired with mesh. This has led to the controversial reclassification of small hernias to those <2cm in size. Of small (<2cm) umbilical hernias captured by Herniamed, a hernia registry in Germany, Austria, and Switzerland, suture repair was performed for 76.5% of all cases.
The double-blind multicentre randomized controlled trial by Kauffmann and colleagues. compared suture to mesh repair of primary umbilical hernias and found an 8% recurrence rate following suture repair of umbilical hernias 1-2cm in size.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elective surgery for primary umbilical hernia with a defect ≤ 2 cm measured clinically or radiographically
- •Age 19 years or older
- •Patient able to give oral and written informed consent
排除标准
- •Umbilical hernia defect > 2 cm measured clinically, radiologically, or intraoperatively with ruler
- •Multiple defects
- •Incisional hernia: prior hernia in area of operation
- •Recurrent umbilical hernia
- •Epigastric hernia
- •Secondary operation performed simultaneously
- •Infected wounds
- •Acute operation (incarcerated or strangulated hernia)
- •BMI ≥ 35 kg/m^2
- •Ascites or liver cirrhosis
- •Peritoneal dialysis
- •Immunosuppression
- •Connective tissue disorder
- •Patient deemed unfit for primary repair at time of surgery based on surgeon discretion at time of operation (e.g. poor tissue quality or unexpected operative finding)
- •Defect is made in the umbilical skin or skin incision extended beyond paraumbilical incision (e.g. sigma or midline extended incision)
研究组 & 干预措施
Permenant Suture
Repair with permanent 0-0 polypropylene suture.
干预措施: Permanent Suture (Other)
Absorbable Suture
Repair with an 0-0 polydioxanone suture
干预措施: Absorbable (Other)
结局指标
主要结局
Recurrence
时间窗: 24 months
Recurrence will be diagnosed clinically at the time of follow-up. Clinical diagnosis of hernia recurrence will be determined by a standard medical assessment (ie. physical exam). In the event that clinical recurrence is uncertain, a computed tomography scan or ultrasound will be performed while the patient performs a Valsalva maneuver.
次要结局
- SSO(30 days, 12 months, 24 months)
- Quality of Life - HerQLes(30 days, 12 months, 24 months)
- Quality of Life - SF-12(30 days, 12 months, 24 months)
- Post-Operative Complications(30 days)
- SSO(30 days, 12 months, 24 months)
- SSOPI(30 days, 12 months, 24 months)
- Quality of Life - HerQLes(30 days, 12 months, 24 months)
- Quality of Life - SF-12(30 days, 12 months, 24 months)
- Post-Operative Complications(30 days)
研究者
Rachel Liu Hennessey
Clinical Assistant Professor, University of British Columbia; General Surgeon, Vancouver General Hospital
University of British Columbia