Sutures or No Sutures (SONS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 2
- 主要终点
- Post-op Pain
研究概览
简要总结
This is a randomized study between two accepted techniques of mesh fixation for laparoscopic hernia repair.
详细描述
This is a randomized study in which subjects will undergo one or two currently accepted techniques of mesh fixation during laparoscopic ventral hernia repair. Subject will undergo mesh fixation with either trans-abdominal sutures and metallic tacks or metallic tacks only.
Pain will be assessed through week 12, and hernia recurrence will be assessed for 2 years after surgery. Subjects will complete pain questionnaires at baseline, each day during hospital stay, and at follow-up visits at 2, 6, and 12 weeks after discharge. Quality of life questionnaires will be completed at baseline, at discharge from hospital, and during follow-up visits at 2, 6, and 12 weeks after discharge.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 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
- •Demographics:
- •Age ≥ 18 years old
- •If female, negative pregnancy test
- •Pre-Operative Findings:
- •Presence of an abdominal hernia associated with previous surgical incision
- •Midline ventral\incisional hernia demonstrated either on physical examination by investigators or radiologic imaging tests.
- •CT scan, MRI, Ultrasound
- •No evidence of incarceration, strangulation
- •Size of hernia ≥ 4 centimeters or ≤ 20 centimeters (cross-sectional diameter)
- •Multiple hernias cumulative size ≤ 20 centimeters in cross-sectional diameter
排除标准
- •Pre-Operative History:
- •Severe medical co-morbidities that prevent safe performance of laparoscopic surgery including coronary artery disease, obstructive pulmonary disease, etc.
- •History of the following:
- •Connective tissue or wound healing disorder (e.g. Ehlers-Danlos syndrome)
- •Chronic use (defined as greater than 3 months) of narcotic analgesic for pain other than from the hernia that is intended to be repaired
- •Allergy to products used in hernia repair including surgical mesh
- •Any abdominal ventral incisional hernia previously repaired with permanent synthetic mesh placed inside the peritoneal cavity
- •Loss of abdominal domain (i.e. majority of abdominal organs lie outside confines of the abdominal musculature and fascia)
- •Presence of simultaneous intra-abdominal infection
- •Simultaneous presence of a bowel obstruction
- •History of suspected or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years.
- •Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the Investigator, may interfere with study assessments or compliance.
- •Intra-operative Findings:
- •Simultaneous performance of another surgical procedure during hernia repair other than acts necessary to complete hernia repair (e.g. cutting of abdominal adhesions)
- •Intra-operative identification of full thickness injury to intestine (i.e. enterotomy), liver, bladder, etc.
结局指标
主要结局
Post-op Pain
时间窗: 12 Weeks
Short-Form McGill Pain Questionnaire (SFMP)
次要结局
- Hernia recurrence(2 Years)
研究者
Don Selzer
Associate Professor of Surgery
Indiana University