Inguinal HerniaTIPPNCT03438786
Trans-inguinal Pre-peritoneal Hernioplasty Versus Lichtnestein's Technique in Inguinal Hernia Repair
A study testing Trans-inguinal Pre-peritoneal Hernioplasty and Lichtnestein's hernioplasty in people with Inguinal Hernia, run by Assiut University.
Trial summary
Mesh repair of inguinal hernia is the most common operation performed on general surgical patients. Approximately 20 million groin hernioplasties are performed each year worldwide. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Inguinal Hernia
- What is being tested?
- Trans-inguinal Pre-peritoneal Hernioplasty and Lichtnestein's hernioplasty
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Mar 2018to 30 Jun 2020
- 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 with unilateral non complicated inguinal hernia who will undergo hernioplasty in surgery department at AUH
Who cannot join
- Patients who were unfit for operation.
- Patients with bilateral or recurrent inguinal hernia
- Patients aged below 18 years,
- Patients undergoing emergency hernia repairs
Trial locations and contacts
No sites are listed yet.
faculty of medicine - assiut university faculty of medicine - assiut university contact
About this study
Official title: Trans-inguinal Pre-peritoneal (TIPP) Hernioplasty Versus Lichtnestein's Technique in Inguinal Hernia Repair
Mesh repair of inguinal hernia is the most common operation performed on general surgical patients. Approximately 20 million groin hernioplasties are performed each year worldwide. Countless studies have been reported in the medical literature in attempts to improve the overall outcomes following hernia operations and, due to this fact, the procedure has evolved immensely, especially over the last few decades. Recurrence of inguinal hernia was initially a significant problem. Lichtenstein repair (LR), recurrence rate has consistently been reported as low as 1-4%[2], a drop from up to 10%. But increased incidence of chronic groin pain following LR.
Transinguinal preperitoneal (TIPP) inguinal hernia repair with soft mesh has been reported as a safe anterior approach with a preperitoneal mesh position .
Theoretically, TIPP repair may be associated with lesser chronic postoperative pain than Lichtenstein's technique due to the placement of mesh in the preperitoneal space to avoid direct regional nerves dissection and their exposure to bio-reactive synthetic mesh. The placement of mesh in this plane without using any suture for fixation and lack of mesh exposure to regional nerves was assumed to result in the reduced risk of developing chronic groin pain. So aim of our study to prove less hospital stay and complication and cost effectiveness for preperitoneal meshplasty
Read the detailed description
This study is a prospective randomized study including all Patients with unilateral non complicated inguinal hernia who will undergo hernioplasty in surgery department at AUH during the period from 3- 2018 to 6- 2020
Methodology:
Patients will be classified into two groups according to the surgical procedure performed as follows:
- Group A: Patients undergoing TIPP hernioplasty
- Group B: Patients undergoing lichtnestein's technique hernioplasty
Sample size:15 patients for each group.
- Exclusion criteria:
- Patients who were unfit for operation.
- Patients with bilateral or recurrent inguinal hernia
- Patients aged below 18 years,
- Patients undergoing emergency hernia repairs
- Conditions
- Inguinal Hernia
- Being tested
- Trans-inguinal Pre-peritoneal Hernioplasty, Lichtnestein's hernioplasty
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trans-inguinal Pre-peritoneal HernioplastyProcedure or surgery
Also called TIPP Technique
patients were catheterised pre-operatively, to prevent any injury to the bladder and aid in preperitoneal dissection. The catheter was removed after 48 hours post-operatively.
Incision of TIPP is same as that of Lichtenstein technique . After dissection of the sac, the transversalis is fascia is incised to enter the preperitoneal space. The preperitoneal space is developed by dissection with index finger. The space extends from rectus muscle medially, arcuate line cranially, a little beyond the anterior superior iliac spine over the psoas muscle laterally and the lilipubic tract caudally. A 15 cm x 15 cm polypropylene mesh, cut into dimension 15 cm x 12 cm, the inferior medial angle of the mesh is trimmed in a semicircular fashion to prevent trauma to the bladder neck. The mesh is placed in the preperitoneal space and anchored to the Cooper's ligament with a single 2-0 interrupted prolene suture
Lichtnestein's hernioplastyProcedure or surgery
incision 1 cm above and parallel to inguinal ligament,Opening subcutaneous fat ,Opening Scarpa fascia to external oblique aponeurosis ,visualization of external ring and lower border of the inguinal ligament,Opening deep fascia of the thigh,checking for a femoral hernia ,Division of external oblique aponeurosis from external ring laterally for 5 cm, safeguarding ilioinguinal nerve ,Mobilization of superior and inferior flaps of external oblique aponeurosis exposing underlying structures ,Mobilization of spermatic cord along with the cremaster, including (ilioinguinal ,genitofemoral) nerves, and spermatic vessels; all of these structures may be encircled in a tape ,Opening of the coverings of spermatic cord, identification and isolation of the hernia sac ,Inversion, division, resection, or ligation of the sac ,Placement and fixation of mesh to edges of the defect or weakness in the posterior wall of inguinal canal creating artificial internal ring,Closure
| Study group | Role | What they receive |
|---|---|---|
| group A | Experimental | Patients undergoing trans-inguinal pre-peritoneal (TIPP) hernioplasty Receives: Procedure: Trans-inguinal Pre-peritoneal Hernioplasty |
| group B | Experimental | Patients undergoing lichtnestein's hernioplasty Receives: Procedure: Lichtnestein's hernioplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
comparison between the 2 techniques regarding presence and duration of post-operative chronic pain
post operative clinical examination for assessment of the presence and duration of chronic pain
Measured: visits will be within 6 months post operative
Secondary outcomes (5)
Duration of hospital stay post operative
comparison between the two techniques concerning Duration of hospital stay post operation after each procedure
Measured: first week post operative
presence of any wound complication by examining the wound
comparison between the two techniques concerning presence of any wound complications by wound examination
Measured: first 2 weeks post operative
recurrence rate
comparison between the two techniques concerning recurrence rate of inguinal hernia
Measured: 6 to 12 month post operative
operation time
comparison between the two techniques regarding operative time
Measured: intra-operative
time needed for the patient to return to work
comparison between the two techniques regarding needed time to return to work
Measured: 1 month post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2018
- Study startMar 2018 (estimated)
- Primary completion1 Jun 2020 (estimated)
- Study completion30 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Inguinal HerniaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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 will be randomized into two groups according to the surgical technique performed as follows :- * Group A: Patients undergoing TIPP hernioplasty * Group B: Patients undergoing lichtnestein's technique hernioplasty
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamad Hamdy, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03438786
- Sponsor's protocol ID
- inguinal hernia
- Acronym
- TIPP
- Status last verified
- Feb 2018
- First submitted
- 23 Jan 2018
- Last updated
- 20 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Clinical examination will be undertaken immediately post-operative looking for any wound complication or scrotal collection . Clinical examination will be undertaken at 1 , 3 ,6 months post-operative looking for :- * Wound complication * Scrotal collection * Chronic Pain * Recurrence
Publications
Cheek CM, Black NA, Devlin HB, Kingsnorth AN, Taylor RS, Watkin DF. Groin hernia surgery: a systematic review. Ann R Coll Surg Engl. 1998;80 Suppl 1:S1-80.
PubMed 11432408Heikkinen T, Bringman S, Ohtonen P, Kunelius P, Haukipuro K, Hulkko A. Five-year outcome of laparoscopic and Lichtenstein hernioplasties. Surg Endosc. 2004 Mar;18(3):518-22. doi: 10.1007/s00464-003-9119-4. Epub 2004 Jan 23.
PubMed 14735339Vironen J, Nieminen J, Eklund A, Paavolainen P. Randomized clinical trial of Lichtenstein patch or Prolene Hernia System for inguinal hernia repair. Br J Surg. 2006 Jan;93(1):33-9. doi: 10.1002/bjs.5235.
PubMed 16329082Gilbert AI, Felton LL. Infection in inguinal hernia repair considering biomaterials and antibiotics. Surg Gynecol Obstet. 1993 Aug;177(2):126-30.
PubMed 8251018Awad SS, Fagan SP. Current approaches to inguinal hernia repair. Am J Surg. 2004 Dec;188(6A Suppl):9S-16S. doi: 10.1016/j.amjsurg.2004.09.007.
PubMed 15610887Chung L, Norrie J, O'Dwyer PJ. Long-term follow-up of patients with a painless inguinal hernia from a randomized clinical trial. Br J Surg. 2011 Apr;98(4):596-9. doi: 10.1002/bjs.7355. Epub 2010 Nov 30.
PubMed 21656724Simons MP, Aufenacker T, Bay-Nielsen M, Bouillot JL, Campanelli G, Conze J, de Lange D, Fortelny R, Heikkinen T, Kingsnorth A, Kukleta J, Morales-Conde S, Nordin P, Schumpelick V, Smedberg S, Smietanski M, Weber G, Miserez M. European Hernia Society guidelines on the treatment of inguinal hernia in adult patients. Hernia. 2009 Aug;13(4):343-403. doi: 10.1007/s10029-009-0529-7. Epub 2009 Jul 28.
PubMed 19636493
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trans-inguinal Pre-peritoneal (TIPP) Hernioplasty Versus Lichtnestein's Technique in Inguinal Hernia Repair
- ClinicalTrials.gov ID
- NCT03438786
- Acronym / sponsor ID
- TIPP / inguinal hernia
- Conditions
- Inguinal Hernia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Mar 2018 (estimated)
- Primary completion
- 1 Jun 2020 (estimated)
- Study completion
- 30 Jun 2020 (estimated)
- First posted
- 20 Feb 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.
Mesh repair of inguinal hernia is the most common operation performed on general surgical patients. Approximately 20 million groin hernioplasties are performed each year worldwide. Countless studies have been reported in the medical literature in attempts to improve the overall outcomes following hernia operations and, due to this fact, the procedure has evolved immensely, especially over the last few decades. Recurrence of inguinal hernia was initially a significant problem. Lichtenstein repair (LR), recurrence rate has consistently been reported as low as 1-4%[2], a drop from up to 10%. But increased incidence of chronic groin pain following LR.
Transinguinal preperitoneal (TIPP) inguinal hernia repair with soft mesh has been reported as a safe anterior approach with a preperitoneal mesh position .
Theoretically, TIPP repair may be associated with lesser chronic postoperative pain than Lichtenstein's technique due to the placement of mesh in the preperitoneal space to avoid direct regional nerves dissection and their exposure to bio-reactive synthetic mesh. The placement of mesh in this plane without using any suture for fixation and lack of mesh exposure to regional nerves was assumed to result in the reduced risk of developing chronic groin pain. So aim of our study to prove less hospital stay and complication and cost effectiveness for preperitoneal meshplasty
Detailed description
This study is a prospective randomized study including all Patients with unilateral non complicated inguinal hernia who will undergo hernioplasty in surgery department at AUH during the period from 3- 2018 to 6- 2020
Methodology:
Patients will be classified into two groups according to the surgical procedure performed as follows:
- Group A: Patients undergoing TIPP hernioplasty
- Group B: Patients undergoing lichtnestein's technique hernioplasty
Sample size:15 patients for each group.
- Exclusion criteria:
- Patients who were unfit for operation.
- Patients with bilateral or recurrent inguinal hernia
- Patients aged below 18 years,
- Patients undergoing emergency hernia repairs
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- patients will be randomized into two groups according to the surgical technique performed as follows :- * Group A: Patients undergoing TIPP hernioplasty * Group B: Patients undergoing lichtnestein's technique hernioplasty
| Arm | Type | Receives |
|---|---|---|
| group A | Experimental | Procedure: Trans-inguinal Pre-peritoneal HernioplastyPatients undergoing trans-inguinal pre-peritoneal (TIPP) hernioplasty |
| group B | Experimental | Procedure: Lichtnestein's hernioplastyPatients undergoing lichtnestein's hernioplasty |
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 with unilateral non complicated inguinal hernia who will undergo hernioplasty in surgery department at AUH
Key exclusion criteria (4 listed)
- Patients who were unfit for operation.
- Patients with bilateral or recurrent inguinal hernia
- Patients aged below 18 years,
- Patients undergoing emergency hernia repairs
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 |
|---|---|---|
| Trans-inguinal Pre-peritoneal HernioplastyAlso: TIPP Techniquepatients were catheterised pre-operatively, to prevent any injury to the bladder and aid in preperitoneal dissection. The catheter was removed after 48 hours post-operatively. Incision of TIPP is same as that of Lichtenstein technique . After dissection of the sac, the transversalis is fascia is incised to enter the preperitoneal space. The preperitoneal space is developed by dissection with index finger. The space extends from rectus muscle medially, arcuate line cranially, a little beyond the anterior superior iliac spine over the psoas muscle laterally and the lilipubic tract caudally. A 15 cm x 15 cm polypropylene mesh, cut into dimension 15 cm x 12 cm, the inferior medial angle of the mesh is trimmed in a semicircular fashion to prevent trauma to the bladder neck. The mesh is placed in the preperitoneal space and anchored to the Cooper's ligament with a single 2-0 interrupted prolene suture | Procedure or surgery | group A |
| Lichtnestein's hernioplastyincision 1 cm above and parallel to inguinal ligament,Opening subcutaneous fat ,Opening Scarpa fascia to external oblique aponeurosis ,visualization of external ring and lower border of the inguinal ligament,Opening deep fascia of the thigh,checking for a femoral hernia ,Division of external oblique aponeurosis from external ring laterally for 5 cm, safeguarding ilioinguinal nerve ,Mobilization of superior and inferior flaps of external oblique aponeurosis exposing underlying structures ,Mobilization of spermatic cord along with the cremaster, including (ilioinguinal ,genitofemoral) nerves, and spermatic vessels; all of these structures may be encircled in a tape ,Opening of the coverings of spermatic cord, identification and isolation of the hernia sac ,Inversion, division, resection, or ligation of the sac ,Placement and fixation of mesh to edges of the defect or weakness in the posterior wall of inguinal canal creating artificial internal ring,Closure | Procedure or surgery | group B |
Primary outcome
comparison between the 2 techniques regarding presence and duration of post-operative chronic pain
Time frame: visits will be within 6 months post operative
post operative clinical examination for assessment of the presence and duration of chronic pain
5 secondary outcomes
Duration of hospital stay post operative
Time frame: first week post operative
presence of any wound complication by examining the wound
Time frame: first 2 weeks post operative
recurrence rate
Time frame: 6 to 12 month post operative
operation time
Time frame: intra-operative
time needed for the patient to return to work
Time frame: 1 month post operative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2018.
- Background: PubMed 11432408Cheek CM, Black NA, Devlin HB, Kingsnorth AN, Taylor RS, Watkin DF. Groin hernia surgery: a systematic review. Ann R Coll Surg Engl. 1998;80 Suppl 1:S1-80.
- Background: PubMed 14735339Heikkinen T, Bringman S, Ohtonen P, Kunelius P, Haukipuro K, Hulkko A. Five-year outcome of laparoscopic and Lichtenstein hernioplasties. Surg Endosc. 2004 Mar;18(3):518-22. doi: 10.1007/s00464-003-9119-4. Epub 2004 Jan 23.
- Background: PubMed 16329082Vironen J, Nieminen J, Eklund A, Paavolainen P. Randomized clinical trial of Lichtenstein patch or Prolene Hernia System for inguinal hernia repair. Br J Surg. 2006 Jan;93(1):33-9. doi: 10.1002/bjs.5235.
- Background: PubMed 8251018Gilbert AI, Felton LL. Infection in inguinal hernia repair considering biomaterials and antibiotics. Surg Gynecol Obstet. 1993 Aug;177(2):126-30.
- Background: PubMed 15610887Awad SS, Fagan SP. Current approaches to inguinal hernia repair. Am J Surg. 2004 Dec;188(6A Suppl):9S-16S. doi: 10.1016/j.amjsurg.2004.09.007.
- Background: PubMed 21656724Chung L, Norrie J, O'Dwyer PJ. Long-term follow-up of patients with a painless inguinal hernia from a randomized clinical trial. Br J Surg. 2011 Apr;98(4):596-9. doi: 10.1002/bjs.7355. Epub 2010 Nov 30.
- Background: PubMed 19636493Simons MP, Aufenacker T, Bay-Nielsen M, Bouillot JL, Campanelli G, Conze J, de Lange D, Fortelny R, Heikkinen T, Kingsnorth A, Kukleta J, Morales-Conde S, Nordin P, Schumpelick V, Smedberg S, Smietanski M, Weber G, Miserez M. European Hernia Society guidelines on the treatment of inguinal hernia in adult patients. Hernia. 2009 Aug;13(4):343-403. doi: 10.1007/s10029-009-0529-7. Epub 2009 Jul 28.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. Clinical examination will be undertaken immediately post-operative looking for any wound complication or scrotal collection . Clinical examination will be undertaken at 1 , 3 ,6 months post-operative looking for :- * Wound complication * Scrotal collection * Chronic Pain * Recurrence
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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.
faculty of medicine - assiut university faculty of medicine - assiut university contact
Questions about this trial
What is this clinical trial studying?
A study testing Trans-inguinal Pre-peritoneal Hernioplasty and Lichtnestein's hernioplasty in people with Inguinal Hernia, run by Assiut University.
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 4 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 20 Feb 2018. 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 mohamad hamdy, MBBS (01028086209, mohamdy.mh@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
comparison between the 2 techniques regarding presence and duration of post-operative chronic pain (time frame: visits will be within 6 months post operative). 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 NCT03438786, which also lists 7 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 20 Feb 2018.