Post-operative Pain, AcuteNCT05666973
To Compare the Skin Incision Made by the Electrocautery and Scalpel in Inguinal Hernia Repair
A study testing Open Mesh Hernioplasty in people with Post-operative Pain, Acute, run by Tribhuvan University Teaching Hospital, Institute Of Medicine..
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Post-operative Pain, Acute
- What is being tested?
- Open Mesh Hernioplasty
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jan 2023to Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients ≥ 18 years old who are operated with the diagnosis of inguinal hernia.
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Comparative Study on Electrocautery Versus Scalpel for Skin Incision in Inguinal Hernia Repair : A Randomized Controlled Trial
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.
Read the detailed description
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.
Field Block(Infiltration):
Anesthetic agent:
- Local:
- Lidoocaine hydrochloride 2% with Adrenaline 1:2,00,000
- Each ml ;Lidocaine 20mg, Adrenaline 5mcg
- Maximum safe dose: 7mg/kg (maximum 500mg;25 ml)
- Local
- Bupivacaine hydrochloride 0.5%
- Each ml ;Bupivacaine hydrochloride 5 mg
- Maximum safe dose: 3mg/kg (maximum 225mg;45 ml)
- Local Anesthesia:
- Field block : With 20 ml Lidocaine 2% and 10 ml Bupivacaine 0.5 % mixed with 20 ml Normal Saline and infiltration in the desired field done.
- Steps of surgery:
- Injection Ceftriaxone 50 mg/kg iv stat dose will be given pre-operatively
- Incision:
- medial 3/5 and 2.5 cms above and parallel to inguinal ligament extending from pubic tubercle upto 1 cm lateral to mid point of inguinal ligament.
- Group 1- Incision with scalpel , bleeding controlled by forcep coagulation.
- Group 2- Incision with electro cautery needle, hemostasis will be achieved with electrocautery coagulation.
- Cut the subcutaneous tissues,external oblique aponeurosis opened in layers
- Nerve Iliohypogastric \& ilioinguinal will be preserved (by taking aside from the field)
- Intra-operative Injection Tramadol(50 mg) and ondansetron(4 mg) iv stat dose given
- Sac ligated with Polygalactin 2-0 suture.
- Lichtenstein method of repair
- Mesh type: large pore polypropylene mesh
- Mesh size: 3 x 6 inches(7.5 x 15 cms)
- Mesh Fixation: polypropylene 2-0
- External oblique closure
- Skin closure: Ethilon 2 - 0 suture
- Postoperative:
- Antibiotic:
- Tab. Cefixime 200 mg PO x BD x 5 days
- Analgesic :
- Tab Paracetamol 1gm PO x QID x 3 days and SOS
- Tab ketorolac 10 mg PO x SOS
- Tab Pantoprazole 40 mg PO x OD x 5 days The medical records including vital signs, laboratory data, medications and physical examination findings of patients would be reviewed throughout their hospitalization period.
- Conditions
- Post-operative Pain, Acute
- Being tested
- Open Mesh Hernioplasty
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open Mesh HernioplastyProcedure or surgery
- Steps of surgery:
- Injection Ceftriaxone 50 mg/kg iv stat dose will be given pre-operatively
- Incision:
- Incision given over medial 3/5 and 2.5 cms above and parallel to inguinal ligament extending from pubic tubercle upto 1 cm lateral to mid point of inguinal ligament.
- bleeding controlled by forcep coagulation.
- Cut the subcutaneous tissues,external oblique aponeurosis opened in layers
- Nerve Iliohypogastric \& ilioinguinal will be preserved (by taking aside from the field)
- Intra-operative Injection Tramadol(50 mg) and ondansetron(4 mg) iv stat dose given
- Sac ligated with Polygalactin 2-0 suture.
- Lichtenstein method of repair
- Mesh type: large pore polypropylene mesh
- Mesh size: 3 x 6 inches(7.5 x 15 cms)
- Mesh Fixation: polypropylene 2-0
- External oblique closure
- Skin closure: Ethilon 2 - 0 suture
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Scalpel | Active comparator | Skin Incision for inguinal hernia repair will be given by Stainless steel blade no.10.
Open Mesh Hernioplasty Receives: Procedure: Open Mesh Hernioplasty |
| Group 2 : Electrocautery | Experimental | Open Mesh Hernioplasty
Skin Incision for inguinal hernia repair will be given by following:
* Cautery machine: Erbe VIO 300 S
* Cut setting: Cut:30 Coagulate:30
* Cautery tip (tip pointed)
* Mode: Monopolar Receives: Procedure: Open Mesh Hernioplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
To Compare the incidence of post-operative pain between two groups.
For assessment of pain; visual analog scale will be used in every patients.
Measured: Assessment of Pain will be done • immediately after surgery, 30 minutes , 1 hour • Day 1 to day 5 (Telephone conversation)
Secondary outcomes (2)
To compare the post-operative analgesic dose requirement between the two groups.
For assessment of analgesic dose requirement; will be asked using the telephone conversation.
Measured: Day 1 to Day 5
To Compare the incidence of other complications like SSI, Hematoma, Seroma and Urinary retention between the two groups.
For assessment of other post-operative complications ; patient will be followed up in OPD after telephone conversation.
Measured: Day 1 to Day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2022
- Study startJan 2023 (estimated)
- Primary completionApr 2023 (estimated)
- Study completionApr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-operative Pain, AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are assigned to study where two groups of treatments Group 1 (Scalpel) and Group 2 (Electrocautery) are given so that Group 1 will receive skin incision only by Scalpel and another group will receive skin incision by Electrocautery for the duration of study.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tribhuvan University Teaching Hospital, Institute Of Medicine.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sanjeeb Kumar Jha, Tribhuvan University Teaching Hospital, Institute Of Medicine.
- Investigators
- Yogendra Pd Singh, MBBS,MS, Study chair, Tribhuvan University Teaching Hospital, Institute Of Medicine.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05666973
- Sponsor's protocol ID
- SKJha
- Status last verified
- Dec 2022
- First submitted
- 15 Dec 2022
- Last updated
- 10 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study on Electrocautery Versus Scalpel for Skin Incision in Inguinal Hernia Repair : A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05666973
- Acronym / sponsor ID
- SKJha
- Conditions
- Post-operative Pain, Acute
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Tribhuvan University Teaching Hospital, Institute Of Medicine.University, hospital or other
- Study start
- Jan 2023 (estimated)
- Primary completion
- Apr 2023 (estimated)
- Study completion
- Apr 2023 (estimated)
- First posted
- 28 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Field Block(Infiltration):
Anesthetic agent:
- Local:
- Lidoocaine hydrochloride 2% with Adrenaline 1:2,00,000
- Each ml ;Lidocaine 20mg, Adrenaline 5mcg
- Maximum safe dose: 7mg/kg (maximum 500mg;25 ml)
- Local
- Bupivacaine hydrochloride 0.5%
- Each ml ;Bupivacaine hydrochloride 5 mg
- Maximum safe dose: 3mg/kg (maximum 225mg;45 ml)
- Local Anesthesia:
- Field block : With 20 ml Lidocaine 2% and 10 ml Bupivacaine 0.5 % mixed with 20 ml Normal Saline and infiltration in the desired field done.
- Steps of surgery:
- Injection Ceftriaxone 50 mg/kg iv stat dose will be given pre-operatively
- Incision:
- medial 3/5 and 2.5 cms above and parallel to inguinal ligament extending from pubic tubercle upto 1 cm lateral to mid point of inguinal ligament.
- Group 1- Incision with scalpel , bleeding controlled by forcep coagulation.
- Group 2- Incision with electro cautery needle, hemostasis will be achieved with electrocautery coagulation.
- Cut the subcutaneous tissues,external oblique aponeurosis opened in layers
- Nerve Iliohypogastric \& ilioinguinal will be preserved (by taking aside from the field)
- Intra-operative Injection Tramadol(50 mg) and ondansetron(4 mg) iv stat dose given
- Sac ligated with Polygalactin 2-0 suture.
- Lichtenstein method of repair
- Mesh type: large pore polypropylene mesh
- Mesh size: 3 x 6 inches(7.5 x 15 cms)
- Mesh Fixation: polypropylene 2-0
- External oblique closure
- Skin closure: Ethilon 2 - 0 suture
- Postoperative:
- Antibiotic:
- Tab. Cefixime 200 mg PO x BD x 5 days
- Analgesic :
- Tab Paracetamol 1gm PO x QID x 3 days and SOS
- Tab ketorolac 10 mg PO x SOS
- Tab Pantoprazole 40 mg PO x OD x 5 days The medical records including vital signs, laboratory data, medications and physical examination findings of patients would be reviewed throughout their hospitalization period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Participants are assigned to study where two groups of treatments Group 1 (Scalpel) and Group 2 (Electrocautery) are given so that Group 1 will receive skin incision only by Scalpel and another group will receive skin incision by Electrocautery for the duration of study.
| Arm | Type | Receives |
|---|---|---|
| Group 1: Scalpel | Active comparator | Procedure: Open Mesh HernioplastySkin Incision for inguinal hernia repair will be given by Stainless steel blade no.10. Open Mesh Hernioplasty |
| Group 2 : Electrocautery | Experimental | Procedure: Open Mesh HernioplastyOpen Mesh Hernioplasty Skin Incision for inguinal hernia repair will be given by following: * Cautery machine: Erbe VIO 300 S * Cut setting: Cut:30 Coagulate:30 * Cautery tip (tip pointed) * Mode: Monopolar |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients ≥ 18 years old who are operated with the diagnosis of inguinal hernia.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Open Mesh Hernioplasty* Steps of surgery: * Injection Ceftriaxone 50 mg/kg iv stat dose will be given pre-operatively * Incision: * Incision given over medial 3/5 and 2.5 cms above and parallel to inguinal ligament extending from pubic tubercle upto 1 cm lateral to mid point of inguinal ligament. * bleeding controlled by forcep coagulation. * Cut the subcutaneous tissues,external oblique aponeurosis opened in layers * Nerve Iliohypogastric \& ilioinguinal will be preserved (by taking aside from the field) * Intra-operative Injection Tramadol(50 mg) and ondansetron(4 mg) iv stat dose given * Sac ligated with Polygalactin 2-0 suture. * Lichtenstein method of repair * Mesh type: large pore polypropylene mesh * Mesh size: 3 x 6 inches(7.5 x 15 cms) * Mesh Fixation: polypropylene 2-0 * External oblique closure * Skin closure: Ethilon 2 - 0 suture | Procedure or surgery | Group 1: Scalpel, Group 2 : Electrocautery |
Primary outcome
To Compare the incidence of post-operative pain between two groups.
Time frame: 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.
2 secondary outcomes
To compare the post-operative analgesic dose requirement between the two groups.
Time frame: Day 1 to Day 5
To Compare the incidence of other complications like SSI, Hematoma, Seroma and Urinary retention between the two groups.
Time frame: Day 1 to Day 5
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yogendra Pd Singh, MBBS,MS study chair
Tribhuvan University Teaching Hospital, Institute Of Medicine.
Questions about this trial
What is this clinical trial studying?
A study testing Open Mesh Hernioplasty in people with Post-operative Pain, Acute, run by Tribhuvan University Teaching Hospital, Institute Of Medicine..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sanjeeb kr Jha, MBBS (+977-9851127004, dr.sanjeeb.jha@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To Compare the incidence of post-operative pain between two groups. (time frame: Assessment of Pain will be done • immediately after surgery, 30 minutes , 1 hour • Day 1 to day 5 (Telephone conversation)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2023.