Inguinal HerniaSELFITACNCT03564535
Comparison of Self Fixating Mesh to Mesh Fixation With Metallic Tacks in Laparoscopic Inguinal Hernia Repair
A study testing Self fixating group and Tacker fixation group in people with Inguinal Hernia and Adult, run by All India Institute of Medical Sciences, Bhubaneswar at 1 site in India.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Inguinal Hernia, Adult
- What is being tested?
- Self fixating group and Tacker fixation group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteIndia
- Study dates
- 18 Apr 2018to Mar 2021
- 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
- Unilateral inguinal hernia
- Age 18-80years
- American Society of Anesthesiologists (ASA) Grade 1 or 2
Who cannot join
- Patient unfit for general anesthesia or laparoscopic surgery
- Large scrotal hernias
- Irreducible hernias
- Morbid obesity
- Previous pelvic surgery
- Coagulopathy
Show all 12Show fewer
- Those who cannot understand the VAS score
- Those who did not agree to participate in the study
- Gastritis
- Gastroesophageal reflux disease
- Liver dysfunction
- kidney dysfunction
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read the detailed description
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
- Conditions
- Inguinal Hernia, Adult
- Being tested
- Self fixating group, Tacker fixation group
- Keywords
- Adult, Inguinal hernia, Inflammatory, Surgical Mesh, Laparoscopy/Methods, Postoperative pain, Recurrence, Randomized Controlled Trials, Double-Blind Method, Pain, Chronic pain, Seroma, Total extraperitoneal repair, Tacker, Mesh fixation, Self gripping
- Medical subject headings
- Hernia, Inguinal, Pain, Postoperative, Recurrence, Pain, Chronic Pain, Seroma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self fixating groupDevice
Also called Monofilament polyester mesh with polylactic acid microgrips
Monofilament polyester mesh with polylactic acid (PLA) microgrips of size 11*15 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 will be used.
Tacker fixation groupDevice
Also called Polyester mesh with tack fixation
Patients will be undergoing polyester mesh fixation with non-absorbable tacks. The tacks would be used such that they avoid bony prominences and vascular and neural structures. One or two tacks will be 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 three.
| Study group | Role | What they receive |
|---|---|---|
| SELF FIXATING GROUP | Experimental | Monofilament polyester mesh with polylactic acid (PLA) microgrips of size 11*15 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 will be used. Receives: Device: Self fixating group |
| TACKER FIXATION GROUP | Active comparator | Patients will be undergoing mesh fixation with non-absorbable tacks. The tacks would be used such that they avoid bony prominences and vascular and neural structures. One or two tacks will be 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 three. Receives: Device: Tacker fixation group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in post operative pain
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.
Measured: 1 hour, 6 hours,12 hours, 24 hours, 7 days, 1 month and 3 months post surgery
Secondary outcomes (10)
Mesh displacement
Meshes will be marked with three 5-mm surgical clips at its medial inferior, medial superior and lateral inferior corners. Pelvic x ray will be done on post operative day 1 and at the end of 1 month to look for any displacement.
Measured: 24 hours and 1 month post surgery
Inflammatory markers
On the day of surgery, preoperative venous blood samples (baseline) will be withdrawn and assayed for C-reactive protein (CRP) levels, erythrocyte sedimentation rate (ESR), and total white blood cell count (WBC). Venous blood samples will be obtained 48 h post-surgery and assayed for CRP and WBC. ESR will be checked at 3 months postoperatively. Acute surgical trauma corresponding to postoperative acute pain will be measured using CRP and WBC, while chronic pain will be measured with ESR.
Measured: On the day of surgery (pre op), 48 hours post surgery, 3 months post surgery
Post operative complications
Various known post operative complications will be looked for such as
- Post-operative urinary retention
- Seroma
- Hematoma
- Early recurrence
- Wound infection
- Cord edema
- Testicular atrophy
Measured: 6 hours, 24 hours, 48 hours, 7 days, 1 month, 3 months post surgery
Operative time
Time required to complete the surgery i.e from incision time to closure time.
Measured: Time of skin incision to time of skin closure
Achieving criteria of fitness for discharge
Discharge criteria includes
- Pain adequately controlled by oral analgesics (VAS Score <4)
- Ambulation without help
- Absence of post operative complications requiring surgical interventions
Measured: Time of skin closure to time of discharge which will be approximately 2 days.
Resumption to normal activities
Return to normal activity will be assessed by recording the time taken by the patient to get in and out of bed and ambulate without help.
Measured: Immediate post operative period.
Total cost towards the mesh and its fixation
Total cost involved in the procedure would be measured in both the arms.
Measured: Immediate post operative period.
Quality of life using Carolinas Comfort Scale
Quality of life will be measured using Carolinas Comfort Scale (CCS), a validated post hernia quality of life and pain assessment tool developed by physician and researchers from Carolina laparoscopic and advanced surgery programme (CLASP), to monitor quality of life in patients undergoing hernia repair. The CCS is a 23-item, Likert type questionnaire that measures, on a scale of 0 to 5, severity of pain, sensation and movement limitations from the mesh.
Carolinas Comfort Scale questionnaire (maximum: 115 points)
Sensation of mesh, pain and movement limitations need to be graded on a scale of 0 to 5 or as not applicable
- While laying down,
- While bending over,
- While sitting up, 4.While performing activities of daily living (getting out of bed, bathing, getting dressed),
5 When coughing or deep breathing, 6 When walking or standing, 7 When walking up or down stairs, 8 When exercising (other than work-related), Total CCS score: ………
Measured: 6 hours, 24 hours, day 7 , 1 month and 3 month post surgery.
Mesh deployment time
Total time required from insertion of mesh into trocar till complete deployment is done. Mesh deployment satisfaction rate will also be noted.
Measured: Time from insertion of mesh into trocar till complete deployment is done.
Intra operative complications
Various intra operative complications will be recorded such as
- Bladder injury
- Vas Deferens injury
- Iliac vein injury
- Pneumoperitoneum
- Dropping down/Injury of inferior epigastric artery
- Bowel injury
Measured: Intra operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2018
- Study start18 Apr 2018
- Primary completionMar 2021 (estimated)
- Study completionMar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Inguinal HerniaStudies 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
- Patients of uncomplicated inguinal hernia presenting to the outpatient department of AIIMS, Bhubaneswar will be recruited to the study. They would be put either in the conventional tacker group or self-fixating mesh group based on the sealed envelope which will be revealed once the patient is intubated. Random allocation done using random allocation software. Surgeries would be performed by single surgery team experienced in laparoscopic hernia repair.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- All India Institute of Medical Sciences, Bhubaneswar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tushar Subhadarshan Mishra, All India Institute of Medical Sciences, Bhubaneswar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03564535
- Sponsor's protocol ID
- T/IM-NF/Surg/17/36
- Acronym
- SELFITAC
- Status last verified
- Feb 2021
- First submitted
- 10 Apr 2018
- Last updated
- 3 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Liew W, Wai YY, Kosai NR, Gendeh HS. Tackers versus glue mesh fixation: an objective assessment of postoperative acute and chronic pain using inflammatory markers. Hernia. 2017 Aug;21(4):549-554. doi: 10.1007/s10029-017-1611-1. Epub 2017 Apr 17.
PubMed 28417279Buyukasik K, Ari A, Akce B, Tatar C, Segmen O, Bektas H. Comparison of mesh fixation and non-fixation in laparoscopic totally extraperitoneal inguinal hernia repair. Hernia. 2017 Aug;21(4):543-548. doi: 10.1007/s10029-017-1590-2. Epub 2017 Feb 18.
PubMed 28214943Garg P, Rajagopal M, Varghese V, Ismail M. Laparoscopic total extraperitoneal inguinal hernia repair with nonfixation of the mesh for 1,692 hernias. Surg Endosc. 2009 Jun;23(6):1241-5. doi: 10.1007/s00464-008-0137-0. Epub 2008 Sep 24.
PubMed 18813990Bresnahan E, Bates A, Wu A, Reiner M, Jacob B. The use of self-gripping (Progrip) mesh during laparoscopic total extraperitoneal (TEP) inguinal hernia repair: a prospective feasibility and long-term outcomes study. Surg Endosc. 2015 Sep;29(9):2690-6. doi: 10.1007/s00464-014-3991-y. Epub 2014 Dec 18.
PubMed 25519425Teng YJ, Pan SM, Liu YL, Yang KH, Zhang YC, Tian JH, Han JX. A meta-analysis of randomized controlled trials of fixation versus nonfixation of mesh in laparoscopic total extraperitoneal inguinal hernia repair. Surg Endosc. 2011 Sep;25(9):2849-58. doi: 10.1007/s00464-011-1668-3. Epub 2011 Apr 13.
PubMed 21487873
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03564535
- Acronym / sponsor ID
- SELFITAC / T/IM-NF/Surg/17/36
- Conditions
- Inguinal Hernia, Adult
- Keywords
- Adult, Inguinal hernia, Inflammatory, Surgical Mesh, Laparoscopy/Methods, Postoperative pain, Recurrence, Randomized Controlled Trials
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 112 participants (actual)
- Lead sponsor
- All India Institute of Medical Sciences, BhubaneswarUniversity, hospital or other
- Study start
- 18 Apr 2018 (actual)
- Primary completion
- Mar 2021 (estimated)
- Study completion
- Mar 2021 (estimated)
- First posted
- 21 Jun 2018 (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.
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.
Detailed description
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients of uncomplicated inguinal hernia presenting to the outpatient department of AIIMS, Bhubaneswar will be recruited to the study. They would be put either in the conventional tacker group or self-fixating mesh group based on the sealed envelope which will be revealed once the patient is intubated. Random allocation done using random allocation software. Surgeries would be performed by single surgery team experienced in laparoscopic hernia repair.
| Arm | Type | Receives |
|---|---|---|
| SELF FIXATING GROUP | Experimental | Device: Self fixating groupMonofilament polyester mesh with polylactic acid (PLA) microgrips of size 11*15 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 will be used. |
| TACKER FIXATION GROUP | Active comparator | Device: Tacker fixation groupPatients will be undergoing mesh fixation with non-absorbable tacks. The tacks would be used such that they avoid bony prominences and vascular and neural structures. One or two tacks will be 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 three. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Unilateral inguinal hernia
- Age 18-80years
- American Society of Anesthesiologists (ASA) Grade 1 or 2
Key exclusion criteria (12 listed)
- Patient unfit for general anesthesia or laparoscopic surgery
- Large scrotal hernias
- Irreducible hernias
- Morbid obesity
- Previous pelvic surgery
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 |
|---|---|---|
| Self fixating groupAlso: Monofilament polyester mesh with polylactic acid microgripsMonofilament polyester mesh with polylactic acid (PLA) microgrips of size 11*15 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 will be used. | Device | SELF FIXATING GROUP |
| Tacker fixation groupAlso: Polyester mesh with tack fixationPatients will be undergoing polyester mesh fixation with non-absorbable tacks. The tacks would be used such that they avoid bony prominences and vascular and neural structures. One or two tacks will be 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 three. | Device | TACKER FIXATION GROUP |
Primary outcome
Change in post operative pain
Time frame: 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.
10 secondary outcomes
Mesh displacement
Time frame: 24 hours and 1 month post surgery
Inflammatory markers
Time frame: On the day of surgery (pre op), 48 hours post surgery, 3 months post surgery
Post operative complications
Time frame: 6 hours, 24 hours, 48 hours, 7 days, 1 month, 3 months post surgery
Operative time
Time frame: Time of skin incision to time of skin closure
Achieving criteria of fitness for discharge
Time frame: Time of skin closure to time of discharge which will be approximately 2 days.
Resumption to normal activities
Time frame: Immediate post operative period.
Total cost towards the mesh and its fixation
Time frame: Immediate post operative period.
Quality of life using Carolinas Comfort Scale
Time frame: 6 hours, 24 hours, day 7 , 1 month and 3 month post surgery.
Mesh deployment time
Time frame: Time from insertion of mesh into trocar till complete deployment is done.
Intra operative complications
Time frame: Intra operatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2021.
- Results publication: PubMed 28417279Liew W, Wai YY, Kosai NR, Gendeh HS. Tackers versus glue mesh fixation: an objective assessment of postoperative acute and chronic pain using inflammatory markers. Hernia. 2017 Aug;21(4):549-554. doi: 10.1007/s10029-017-1611-1. Epub 2017 Apr 17.
- Results publication: PubMed 28214943Buyukasik K, Ari A, Akce B, Tatar C, Segmen O, Bektas H. Comparison of mesh fixation and non-fixation in laparoscopic totally extraperitoneal inguinal hernia repair. Hernia. 2017 Aug;21(4):543-548. doi: 10.1007/s10029-017-1590-2. Epub 2017 Feb 18.
- Results publication: PubMed 18813990Garg P, Rajagopal M, Varghese V, Ismail M. Laparoscopic total extraperitoneal inguinal hernia repair with nonfixation of the mesh for 1,692 hernias. Surg Endosc. 2009 Jun;23(6):1241-5. doi: 10.1007/s00464-008-0137-0. Epub 2008 Sep 24.
- Results publication: PubMed 25519425Bresnahan E, Bates A, Wu A, Reiner M, Jacob B. The use of self-gripping (Progrip) mesh during laparoscopic total extraperitoneal (TEP) inguinal hernia repair: a prospective feasibility and long-term outcomes study. Surg Endosc. 2015 Sep;29(9):2690-6. doi: 10.1007/s00464-014-3991-y. Epub 2014 Dec 18.
- Results publication: PubMed 21487873Teng YJ, Pan SM, Liu YL, Yang KH, Zhang YC, Tian JH, Han JX. A meta-analysis of randomized controlled trials of fixation versus nonfixation of mesh in laparoscopic total extraperitoneal inguinal hernia repair. Surg Endosc. 2011 Sep;25(9):2849-58. doi: 10.1007/s00464-011-1668-3. Epub 2011 Apr 13.
- Individual participant dataSharing planned: No
Related trials for Inguinal Hernia
Recruiting
Permanent Versus Slowly Dissolving Stitches for Non-Mesh (Shouldice) Groin Hernia Repair
Inguinal Hernia
Recruiting
Watchful Waiting Versus Immediate Repair for Occult Contralateral Inguinal Hernias.
Inguinal Hernia Bilateral, Inguinal Hernia Unilateral
Recruiting
Primary Sac Abandonment and Distal Sac Fixation vs Complete Sac Dissection for Inguinoscrotal Hernias
Seroma, Inguinal Hernias
Recruiting
Comparing Two Laparoscopic Techniques for Hernia Repair in Children
Inguinal Hernia
Not yet recruiting
Lumbar ESP Block Versus TAP Block for Postoperative Pain Control in Children Undergoing Open Inguinal Hernia Repair
Inguinal Hernia, Postoperative Pain
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self fixating group and Tacker fixation group in people with Inguinal Hernia and Adult, run by All India Institute of Medical Sciences, Bhubaneswar at 1 site in India.
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 3 inclusion and 12 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 3 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in post operative pain (time frame: 1 hour, 6 hours,12 hours, 24 hours, 7 days, 1 month and 3 months post surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03564535, which also lists 5 linked publications.
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 3 Feb 2021.