Prospective Randomized Evaluation of Open vs. Laparoscopic Operation of Ventral Incisional Eventrations. A Swedish Multicenter Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 157
- 试验地点
- 7
- 主要终点
- Postoperative pain recorded in SF-36
研究概览
简要总结
This purpose of this study is to compare the recovery after an operation of an incisional hernia within the limits of the rectus muscles of the abdominal wall. The use of a mesh in the repair of a postoperative hernia is considered obligatory. Placement of a retromuscular mesh is done by open or laparoscopic surgery. Focus is on the recovery phase assuming a less painful recovery after a laparoscopic procedure.
详细描述
Incisional ventral hernia after abdominal surgery is a fairly common condition. In recent years the use of a prosthesis in the repair procedure has proved very effective in preventing a new hernia. A retromuscular mesh placement seems to have superior results. The mesh may be placed retromuscular through an open surgical procedure or through a laparoscopic procedure in an intra-abdominal position. Both procedures are highly standardized. A heavy weight mesh is used in the open procedure, fixed in the midline only, and a composite mesh is used intraabdominally and fixed only with titanium tackers.
SF-36 is used to assess the quality of life, and its subscale BP (bodily pain) is used as primary outcome 3 weeks postoperatively. Secondary endpoints are return to daily life, pain, complications, recurrence, patient satisfaction and cosmetic outcome.
Subjects are assessed at 1,3,8 weeks post operation and after 12 months.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •Age over 18 years
- •Postoperative hernias in the region of the recti abdomini muscles with a defect of less than 10 cm transversal width
- •No contraindications to laparoscopic procedure
- •The patient should be able to adequate ventilation/respiration after reduction of hernia contents
- •Indications for elective surgery
排除标准
- •Pregnant women
- •Prior operation of abdominal hernia with mesh placement in the compartment of the rectus abdominus muscle (i.e. prior onlay mesh is acceptable)
- •Need of an interpreter
- •Current drug abuse, mental disorder or other condition which makes the patient incapable of postoperative follow up
- •Body Mass index (BMI) >40
- •Other planned concurrent operation
- •Current oral steroid treatment, or other immune system modulating treatment
- •Incarcerated incisional hernias
- •Parastomal hernias
- •Prior history of open abdomen
- •Enterocutaneous fistula or cutaneous infection
- •Hepatic cirrhosis or ascites
- •Generalized malignancy
- •History of radiation treatment in the abdomen.
- •ASA >III
结局指标
主要结局
Postoperative pain recorded in SF-36
时间窗: 3 weeks after surgery
Pain measured 3 weeks after surgery in SF36 subscale Bodily Pain
次要结局
未报告次要终点
研究者
Peder Rogmark
M.D.,
Skane University Hospital