跳至主要内容
临床试验/NCT05666973
NCT05666973尚未招募不适用

A Comparative Study on Electrocautery Versus Scalpel for Skin Incision in Inguinal Hernia Repair : A Randomized Controlled Trial

Tribhuvan University Teaching Hospital, Institute Of Medicine.0 个研究点目标入组 60 人开始时间: 2023年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
60
主要终点
To Compare the incidence of post-operative pain between two groups.

研究概览

简要总结

The Groin hernia repair is a commonly performed general surgery procedure in both adults and children with inguinal hernias constituting more than 95% of all groin hernia repairs. Inguinal hernia repair is a commonly performed surgical procedure in our part of the world and is one of the common cause of hospital admission from the emergency or out patient department. Traditionally, surgical skin incisions have been made with surgical scalpel while modern method of making incisions with electrocautery had made it more sharp, precise and less time consuming.

The cases of inguinal hernia are being managed in our center, Tribhuvan University Teaching Hospital. Generally, these patients are seen by the residents and supervised by the faculties in the emergency and in OPD and later if required admitted in the wards. Clinical examination and imaging are done for the diagnosis . Then severity assessment is performed and the management is done accordingly.

The proposed study will be a hospital based comparative study and aims to observe the overview of the surgical management of OPD based day care surgery of inguinal hernia and also to observe whether the surgical incision is being performed with scalpel or electrocautery. The patients fulfilling the inclusion criteria are selected for the study. Sample will be selected by non-probability (convenience) method and study variables will be recorded in proforma. Statistical analysis will be done using SPSS version 23. Results obtained from the study will be reviewed and discussed with published literature.

详细描述

Inguinal hernia is formed by the protrusion of the peritoneum with its contents through an opening; and the contents - that is, any tissue or organ that protrudes through the neck into the hernia sac. The inguinal hernias are either direct or indirect and both types of hernias protrude above the inguinal ligament.1 Incision is a cut or slit to gain access to underlying structures . Cauterization is a medical term describing burning of body skin to remove or close a part of it. Electrocautery is used increasingly for tissue dissection, although fears of excessive scarring and poor wound healing have curtailed its widespread use for skin incision.2

Traditionally, surgical skin incisions have been made with steel blade. This method of making skin incision is an old method and surgeons have always been in search of some new methods for making surgical skin incisions because incision made by scalpel were supposed to be more bloody, time consuming and more painful.3 Electrocautery which is available in all surgical theaters is less frequently used for skin incisions for the fear of tissue damage, fear of post operative pain and scarring. Recent advances and studies have shown that electrocautery can be used for skin incision without any postoperative complications like wound infection and scarring and less post operative pain.4,5

It has now become an integral and evolving part of surgical practice. However, most surgeons still make skin incision with a scalpel and divide the deeper structures with coagulation diathermy. Modern surgical scalpels are usually made of hardened steel for better sharpness and precision. Basic scalpel design has remained almost the same but there has been a substantial improvement in the electrosurgical instruments.5 Fear of deep burns with diathermy and the resultant scarring continues compared with the scalpel, which produces a clean, incised wound with minimal tissue destruction. Cutting diathermy incision with an electrode delivering pure sinusoidal current allows tissue cleavage by rapid cell vaporization without damage to surrounding areas. This may explain the absence of tissue charring and subsequent healing with minimal scarring. Cutting diathermy can make hemostasis quicker and satisfactory, save the operative time, and can produce an incised wound that heals like the one created by cold scalpel.6,7 Many other studies have been conducted to compare electrocautery skin incision over scalpel skin incision in terms of time taken for incision, postoperative pain and wound healing especially in cases of inguinal hernia surgery, some have reported that the use of diathermy for skin incision during inguinal hernioplasty is as safe as the use of scalpel in terms of wound healing .4

There are other studies which reported that the use of diathermy reduces the use of analgesics requirements in the postoperative period. But still, some studies have reported that the postoperative analgesic requirement are similar in both the techniques and likewise postoperative complications. This study is undertaken to alleviate the fear of using electrocautery for skin incisions in surgical community.

Patients with the provisional diagnosis of inguinal hernia were seen by the residents and supervised by the faculty in the emergency. The severity grading of those patients were done and later admitted in the ward for further management accordingly.

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, Investigator)

盲法说明

Patients will be randomly distributed in two groups manually by writing specific numbers that will be concealed in sequentially numbered, opaque sealed envelopes. The envelopes will be opened by an attending nurse not involved in the study just before the procedure. The incision will be given by the attending general surgery resident who will perform the inguinal hernia repair. The assessment of pain and data collection, data analysis will be done by principle investigator who is blinded to procedure. Thus, the patients and investigating and analyzing personal will be blinded to the procedure.

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

入选标准

  • Patients ≥ 18 years old who are operated with the diagnosis of inguinal hernia.

排除标准

  • Patients with recurrent inguinal hernia
  • Patients presenting with incarcerated, irreducible and strangulated hernia
  • Bilateral Inguinal Hernia
  • Patient taking steroids
  • Patient with contraindication to NSAIDs such as CKD, Drug hypersensitivity etc
  • Patients who do not give written consent

结局指标

主要结局

To Compare the incidence of post-operative pain between two groups.

时间窗: Assessment of Pain will be done • immediately after surgery, 30 minutes , 1 hour • Day 1 to day 5 (Telephone conversation)

For assessment of pain; visual analog scale will be used in every patients.

次要结局

  • To compare the post-operative analgesic dose requirement between the two groups.(Day 1 to Day 5)
  • To Compare the incidence of other complications like SSI, Hematoma, Seroma and Urinary retention between the two groups.(Day 1 to Day 5)

研究者

发起方
Tribhuvan University Teaching Hospital, Institute Of Medicine.
申办方类型
Other
责任方
Principal Investigator
主要研究者

Sanjeeb Kumar Jha

Master of Surgery Resident, General Surgery

Tribhuvan University Teaching Hospital, Institute Of Medicine.

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