Comparison of Mesh Fixation With Tackers to Use of Self Fixating Mesh in Total Extra Peritoneal Inguinal Hernia Repair: A Double Blinded Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 112
- 试验地点
- 2
- 主要终点
- Change in post operative pain
研究概览
简要总结
This study compares the use of self-fixating mesh to mesh fixation with tackers in the management of inguinal hernia by laparoscopic method. Half of the participants in the study will be treated using self-fixating mesh, while the other half will be treated using conventional mesh fixed with tackers.
详细描述
Conventional tacker mesh fixation group Patients will be undergoing mesh fixation with non-absorbable tacks. Monofilament polyester mesh of size 15*11cm will be used. The tacks would be used such that they avoid bony prominences and vascular and neural structures. One tack will put at the Cooper's ligament and another applied laterally superior to the iliopubic tract in the anterior abdominal wall. In any patient, the maximum number of tacks applied will not exceed four. Preperitoneal space will be deflated under direct visualization after the mesh is placed. Hernia sac and any cord lipoma will be placed behind the mesh. During the deflation process, repositioning of the peritoneal sac on the mesh, in particular the dorsal edge of the latter would be carefully performed to avoid displacement or folding of the mesh.
Self-fixating mesh group In this group,Monofilament polyester mesh with polylactic acid (PLA) microgrips of size 15*11 will be used. It is an isoelastic large-pore knitted fabric with a density of 73g/m2 at implantation and 38g/m2 after microgrips absorption which will be at 18 months. The resorbable micro grips provide immediate adherence to surrounding muscle and adipose tissue during the initial days post hernia surgery, serving as an alternate method of fixation to traditional sutures, tacks, staples, or fibrin sealants. No additional tacks, staples, sutures, or fibrin sealant is used
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
- Double (Participant, Outcomes Assessor)
盲法说明
Both patients and follow-up clinician will be blinded regarding the use of mesh fixation. The mesh fixation technique will only be entered in the master chart of the student but not in the Operation notes, in order to prevent accidental disclosure by a curious patient or follow up evaluator instead the phrase, "TEP done by 11x15cm mesh will be written.'' For legal reasons details of the tack applicator device will be recorded on the nursing count sheet.) Follow-up will be performed by a different clinician to the operating surgeon. There would be no external clues such as differences in the location or size of skin incisions to indicate whether fixation had been performed or not.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Unilateral inguinal hernia
- •Age 18-80years
- •American Society of Anesthesiologists (ASA) Grade 1 or 2
排除标准
- •Patient unfit for general anesthesia or laparoscopic surgery
- •Large scrotal hernias
- •Irreducible hernias
- •Morbid obesity
- •Previous pelvic surgery
- •Coagulopathy
- •Those who cannot understand the VAS score
- •Those who did not agree to participate in the study
- •Gastroesophageal reflux disease
- •Liver dysfunction
- •kidney dysfunction
结局指标
主要结局
Change in post operative pain
时间窗: 1 hour, 6 hours,12 hours, 24 hours, 7 days, 1 month and 3 months post surgery
Postoperative pain will be evaluated using Visual Analogue Scale (0 TO 10) at follow up at ward, Out Patient Department/patient's pain diary/by telephonic call/by e-mail. In the first 6hours, if the VAS score \>4 Inj.Paracetamol 1gm I V will be given, if the VAS score \>4 after 30min of previous dose, inj diclofenac 75mg iv will be given, if VAS score is still \>4 inj.Tramadol 100mg will be given. After 6 hours pain killers will be given in the same order and same dose orally as a tablet depending upon the requirement and pain score. Highest pain score at any given point of time and average pain score will be calculated.
次要结局
- Achieving criteria of fitness for discharge(Time of skin closure to time of discharge which will be approximately 2 days.)
- Resumption to normal activities(Immediate post operative period.)
- Post operative complications(6 hours, 24 hours, 48 hours, 7 days, 1 month, 3 months post surgery)
- Operative time(Time of skin incision to time of skin closure)
- Intra operative complications(Intra operatively)
- Mesh displacement(24 hours and 1 month post surgery)
- Inflammatory markers(On the day of surgery (pre op), 48 hours post surgery, 3 months post surgery)
- Total cost towards the mesh and its fixation(Immediate post operative period.)
- Quality of life using Carolinas Comfort Scale(6 hours, 24 hours, day 7 , 1 month and 3 month post surgery.)
- Mesh deployment time(Time from insertion of mesh into trocar till complete deployment is done.)
研究者
Tushar Subhadarshan Mishra
Additional Professor
All India Institute of Medical Sciences, Bhubaneswar