Comparison of the post operative pain in hernial sac invagination versus ligation in Lichtenstein’s tension free mesh hernioplasty for indirect inguinal hernia: A Randomised control trial
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- To compare Post operative pain intensity in patients undergoing invagination vs ligation of the hernial sac
研究概览
简要总结
The gold standard technique employed by surgeons to treat inguinal hernias is considered to be Lichtenstein’s tension free mesh hernioplasty. High ligation and excision of the hernial sac is being used as the method of managing the indirect inguinal hernia sac. However, studies indicate that this could lead to an increase in the post operative pain due to peritoneal injury. Thus, the need for ligation of the sac is being questioned.
Thus our study aims to compare the post operative pain between invagination of the hernia sac and ligation and excision of the sac in Lichtenstein tension free mesh hernioplasty for indirect inguinal hernia.
Study protocol
Study will be conducted among patients undergoing indirect inguinal hernia repair in Department of General Surgery of KLES Dr. Prabhakar Kore Hospital and MRC, Belagavi.
A random number table created by computer software will be used for the randomization process. An assignment to a random treatment will be made using opaque, sealed, serially numbered envelopes. These envelopes will be opened right before the procedure and patients will subsequently be split into two research groups: Group A, i.e. invagination of the hernial sac, and Group B, i.e. ligation and excision of the sac
In group A, the prolapsing viscera and the sac will be returned to the abdomen without the sac being opened. In group B, after the sac is opened, the bowel loops or omentum will placed back into the abdomen after which high ligation will be carried out with an absorbable suture, and the extra sac will cut out. Following that, a Lichtenstein tension-free mesh hernioplasty will carried out on each patient. Plain polypropylene mesh will be used which will be positioned at the posterior wall of the inguinal canal and secured using polypropylene sutures
Following the surgery, the patient will be assessed at 6, 12, 24 hours and post operative day 3 for post operative pain using visual analogue scale (VAS) of 1–10
Seroma formation would be defined as fluid collection or swelling at the surgical site or in the scroÂtum. It will be assessed by physical examination of the patient on post operative day 7 and 1 month as a palpable budge at the site operative site.
Length of hospital stay is defined as the total number of nights spent in the hospital after the operation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients with uncomplicated incomplete indirect inguinal hernias Patients willing to give consent to participate in the surgery.
排除标准
- •Patients under 18 years or more than 75 years Patients with direct inguinal hernia Patients with complete inguinal hernia Patients with irreducible, recurrent or incarcerated indirect inguinal hernias Patients not willing to give consent.
结局指标
主要结局
To compare Post operative pain intensity in patients undergoing invagination vs ligation of the hernial sac
时间窗: 6, 12, 24 hours and post operative day 3
次要结局
- To compare incidence of seroma formation in patients undergoing invagination vs ligation of the hernial sac(post operative day 1 and 1 month)
- To compare operative time in patients undergoing invagination vs ligation of the hernial sac(Intraoperative)
- To compare length of hospital stay in patients undergoing invagination vs ligation of the hernial sac(total number of nights spent in the hospital after the operation)
研究者
Dr Kritie Saluja
Jawaharlal Nehru Medical College
