A Comparison Of Chronic Groin Pain And Quality Of Life after Totally Extrapertoneal (TEP) And Transabdominal Preperitoneal (TAPP) Laparoscopic Inguinal Hernia Repair- a prospective randomized controlled study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AIIMS
- 入组人数
- 314
- 试验地点
- 1
- 主要终点
- To compare the incidence of chronic groin pain and quality of life after transabdominal preperitoneal (TAPP) and totally exptraperitoneal (TEP) techniques of laparoscopic inguinal hernia repair
研究概览
简要总结
Background
Tocompare TEP and TAPP techniques of laparoscopic inguinal hernia repair andevaluate the factors related to chronic groin pain and the long term quality oflife.
Materialsand Methods
262 patients withgroin hernia were randomized either to transabdominal preperitoneal (TAPP) ortotally exptraperitoneal (TEP) techniques of laparoscopic inguinal herniarepair. Intra-operative details and postoperative complications were recorded. Painwas assessed with Visual analogue scale(VAS) preoperatively and postoperatively at 24 hours,1 week, 6 weeks; 3, 6 and 12 months and yearly thereafter. Quality of life was assessed in 162 patients withShort Form – 36 version 2 (SF 36v2) preoperatively and postoperatively at 3months follow up.
Results
The demographic and clinical profileswere well matched in both the groups. Both TEP and TAPPtechniques were comparable in terms of intaoperative complications and earlypostoperative outcomes. In the present study patients experienced significantlyhigher incidence of acute pain following TAPP repair (p=0.001), however theincidence of chronic groin pain was comparable in both TEP and TAPP techniques (p=0.683).Pre-operative pain, and immediate postoperative pain at 24 hours were found tobe associated with chronic groin pain. Improvement from preoperative to 3months postoperative was demonstrated in all domains in TEP group and this wasstatistically highly significant. In the TAPP group significant improvement wasseen in the domains of physical functions, role physical, bodily pain, generalhealth, role emotional and mental health. This significant improvement inquality of life mirrors less chronic pain and early return to normal activityafter both the laparoscopic repairs i.e. TEP and TAPP.Both TEP and TAPP groups were comparable in terms of quality of life outcomesin the postoperative period.
Conclusion
There was nodifference in late outcomes of chronic groin pain and quality of life after TEPor TAPP repair. Preoperative pain andpain in the immediate postoperative period 24 hours after surgery were found tobe significant risk factors for chronic groin pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified block randomization
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •All consecutive patients clinically diagnosed with uncomplicated symptomatic inguinal hernias were included in the study.
排除标准
- •Patients were excluded if there was (i)Co-morbid conditions making the patients unfit for general anesthesia (ii)Complicated hernias (irreducibility) (iii)Uncorrectable coagulopathy (iv)Suspected intra-abdominal or pelvic malignancy (v) Significant co-morbidities like hypertension, bronchial asthma, diabetes or any other systemic disease likely to delay the recovery of the patient.
结局指标
主要结局
To compare the incidence of chronic groin pain and quality of life after transabdominal preperitoneal (TAPP) and totally exptraperitoneal (TEP) techniques of laparoscopic inguinal hernia repair
时间窗: Patients were followed up at 1 and 6 weeks, 3, 6, 12 and 18 months and yearly thereafter
次要结局
- To study and compare the possible factors responsible for chronic groin pain after transabdominal preperitoneal (TAPP) and totally exptraperitoneal (TEP) techniques of laparoscopic inguinal hernia repair(Patients were followed up at 1 and 6 weeks, 3, 6, 12 and 18 months and yearly thereafter)