Prospective Pilot Trial of Laparoscopic High-Ligation Repair of Indirect Inguinal Hernias in Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 主要终点
- Number of patients with inguinal hernia recurrence
研究概览
简要总结
Inguinal hernia surgery has undergone significant and extensive transformation, including the advent of tissue-based repairs and later, tension-free repairs with the acceptance of prosthetic mesh. However, there is still significant pain associated with the use of mesh, as well as the risk of potential injury to neurovascular structures. In the pediatric population, non-mesh laparoscopic high-ligation repair of indirect inguinal hernias is one of the most common procedures performed. High-ligation of indirect inguinal hernias in the adolescent population is also effective, with a low recurrence rate and low incidence of chronic symptoms, but this technique is uncommonly used by adult hernia surgeons due to concern for recurrence.The purpose of this study is to conduct a pilot trial to examine the efficacy of high-ligation repair of indirect inguinal hernias in adult patients.
Our hypothesis is that the laparoscopic, non-mesh repair technique is an effective method of repairing indirect inguinal hernias, with an acceptable recurrence rate and decreased postoperative pain. This pilot trial will allow the design of a randomized clinical trial comparing the efficacy of this technique to other standard repair techniques.
详细描述
Recruitment:
The participants will be recruited from the Department of Digestive Surgery, University Hospital North Norway, Tromsø. The patient will be asked to participate in the study after evaluation by the principal investigator when candidacy has been established. The investigator or study staff will discuss the study with the patient and the study staff will participate in reviewing details and questions regarding the study if necessary. For each subject, written informed consent will be obtained prior to any protocol-related activities. As part of this procedure, the principal investigator or one of the associates must explain orally and in writing the nature, duration, and purpose of the study in such a manner that the subject is aware of the potential risks, inconveniences, or adverse effects that may occur. Patients should be informed that the subject may withdraw from the study at any time.
Preoperative evaluation:
All patients will undergo our standard pre-operative evaluation and at this visit it will be determined if the patient is a candidate for this study. At this study visit, the doctor will ask about past medical and surgical history and any medications the patient is taking and conduct a physical examination. If the patient qualifies for study participation, the patient will be asked to join the study. If the patient chooses to participate, the study staff will collect additional information such as gender, age, height, weight, medical and surgical history, and information relating to the hernia. Patients will be asked to fill out and complete 3 quality of life questionnaires (Short Form-36, Activities Assessment and a Surgical Site Pain Scale) that ask about activities and how the hernia impacts what they can do.
Study intervention:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Subjects who present to the office of the study investigators for repair of an indirect inguinal hernia
排除标准
- •Recurrent hernia
- •Emergent cases
- •Cirrhosis or liver disease (bilirubin > 3 mg/dL).
- •Subjects on dialysis
- •Subjects with collagen vascular disease
- •BMI over 35 kg/m2
- •Bilateral inguinal hernias
- •Direct inguinal hernia
结局指标
主要结局
Number of patients with inguinal hernia recurrence
时间窗: One month and one year after surgery
Number of patients with recurrence determined by clinical examination
次要结局
- Health related quality of life(Prior to surgery and one month and one year after surgery)
- physical activity levels assessed by scale(Prior to surgery and one month and one year after surgery)
- Degree of pain related to the hernia or hernia surgery(Prior to surgery and one month and one year after surgery)
研究者
Petter Fosse Gjessing
MD,PhD, Consultant Surgeon
University Hospital of North Norway