Chronic Significant Pain and Functional Outcome After Laparoscopic Versus Open Groin Hernia Mesh Repair: Design of a Randomized Controlled Clinical Trial
试验速览
- 阶段
- 4 期
- 入组人数
- 260
- 试验地点
- 2
- 主要终点
- Chronic significant post operative pain
研究概览
简要总结
Background: Large acceptance of mesh reinforcement techniques in groin hernia repair lowered recurrence rates for all techniques. Recurrence rate alone is not the main quality criterion for hernia repair anymore. Chronic significant post operative pain is a common, clinically relevant, poorly understood and poorly studied entity which is 3 to 5 times more common than hernia recurrence. As a subgroup to chronic significant post operative pain or as a separate entity, sexual dysfunction due to ejaculatory and genital pain after inguinal hernia repair may happen in approximately 2.5% of patients. Patient's preoperative psychological profile as well as pain exposure history is showed to be important in the development of chronic significant post operative pain. The objective of this study is to analyse chronic significant post operative pain and the functional outcome status of patients after laparoscopic repair compared to open repair.
Methods: A randomized controlled non-blinded clinical trial is designed to compare open inguinal hernia mesh repair with laparoscopic totally extraperitoneal repair on chronic significant post operative pain, pain related sexual function disorders, complications, health related quality of life outcomes, recurrence rates, and cost. Volunteers will be recruited in Geneva University Hospital, department of surgery, visceral surgery unit. Eligibility criteria is male patient aged over 21 years, with reducible inguinal unilateral or bilateral primary hernia who are candidates for elective surgery and medically fit for general anesthesia.130 patients will be enrolled for each group to achieve an α-Level of 0.05 and a power of 80%. Follow-up will take place at 10th, 30th days as well as 3 12 and 24 post operative months by questionnaires and by clinical exam by independent expert. An overall cost-analysis will be realized. Patient enrollment in the study will start in April 2008 and estimated to end in may 2009.
详细描述
Hernia repair is the most frequent elective operation performed in general surgery. Chronic pain or persistent neuralgia has been recognized as a complication after inguinal hernia repair but was reported in the 1980s as a rare and infrequent condition. Studies from the mid 1990s have reported a higher frequency, with up to 50% of patients reporting pain after hernia repair more than 1 year after surgery. Chronic pain after hernia repair can be disabling, with considerable impact on quality of life. The natural history of postoperative pain, including its prevalence, etiology, duration, associated disability and it's social and economical impact remain undefined.
The Cooperative Hernia Study (1996) assessing postoperative pain in a prospective trial including 315 open non-mesh repair patients with 2 years follow-up found at 1 year, 62.9% of groin or inguinal pain and 11.9% of patients had moderate to severe pain; 53.6% had pain and 10.6% of patients continued to report moderate to severe pain 2 years postoperatively.
In a prospective consecutive case series study of 500 consecutive operations in 466 unselected adult patients for open groin hernia repair in Denmark (1994-1996), 1 year after surgery, 19% of patients had some degree of pain, 6% had moderate or severe pain. Pain restricted daily function 6% of patients.
A cross-sectional cohort study based on the Danish Hernia Database (1998) to determine the incidence of groin pain 1 year after inguinal hernia repair and to assess the influence of chronic groin pain on function, detected 28.7% of pain in the groin area and 11.0% of the patients reported that pain was interfering with work or leisure activity. There were no difference in the incidence of pain with regard to the different types of hernia, the different types of surgical repairs, or the different types of anesthesia.
A questionnaire survey of a historical cohort of 351 patients who underwent inguinal hernia surgery in Aberdeen - Scotland (1995-1997) reported 30% chronic pain. Character of this pain was predominantly neuropathic.
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
- None
入排标准
- 年龄范围
- 21 Years 至 70 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Informed consent
- •Diagnosis of primary, unilateral or bilateral, reducible groin hernias
- •Medically fit for general anesthesia
- •Comprehension and use of French language
- •Installed in the geographical region without foreseeable move for two years
排除标准
- •Female gender, recurrent hernia
- •Ongoing chronic pain syndrome, other than hernia origin
- •Coagulation disorders, prophylactic or therapeutic anticoagulation, un able to stop platelet antiaggregation therapy 10 days before surgery
- •Previous pelvic surgical procedures contraindicating laparoscopic technique
- •American Society of Anesthesiology Class 4 and 5 patients
- •Emergency surgery, peritonitis, bowel obstruction, strangulation, perforation
- •Mentally ill patients
- •Presence of local or systemic infection
- •Life expectancy < 2 years
- •Any cognitive impairment (Psychiatric disorder, Alzheimer's disease etc.)
结局指标
主要结局
Chronic significant post operative pain
时间窗: preoperative, 10, 30, 90, 365 and 730 postoperative days
次要结局
- Pain related sexual function disorders(preoperative, 10, 30, 90, 365 and 730 postoperative days)
- Health related quality of life(preoperative, 10, 30, 90, 365 and 730 postoperative days)
- Neuroticism(preoperative, 10, 30, 90, 365 and 730 postoperative days)
- Postoperative surgical and medical complications(preoperative, 10, 30, 90, 365 and 730 postoperative days)
- Recurrence rate(730th postoperative day)
- Overall cost analysis(730th postoperative day)