Inguinal HernioplastyNCT03052023
Comparative Study Between Lap. Dual Approach, Lap. Trans Abdominal Pre-peritoneal and Lichtenstein Procedures
A study testing dual approach laparoscopic inguinal hernioplasty, TAPP and (lichtenstein) repair in people with Inguinal Hernioplasty, run by Assiut University at 1 site in Egypt.
Trial summary
This study designed to compare the new laparoscopic dual approach to inguinal hernia repair with trans-abdominal preperitoneal (TAPP) and lichtenstein repair (open procedure) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inguinal Hernioplasty
- What is being tested?
- dual approach laparoscopic inguinal hernioplasty, TAPP and (lichtenstein) repair
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- Nov 2016to Apr 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult male patient (older than 18y).
- Not complicated.
- No previous lower abdominal incisions (lower abdominal midline and lower paramedian incision in the same side of hernia).
- No contraindication for general anesthesia.
- Not recurrent.
Who cannot join
- any one not in fulfill inclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Inguinal Hernioplasty: Comparative Study Between Laparoscopic Dual Approach, Laparoscopic Trans Abdominal Preperitoneal and Lichtenstein Procedures. A Prospective Randomized Controlled Trial
This study designed to compare the new laparoscopic dual approach to inguinal hernia repair with trans-abdominal preperitoneal (TAPP) and lichtenstein repair (open procedure)
Read the detailed description
inguinal hernioplasty is a procedures where synthetic mesh is used to strengthen the inguinal tissues sites for hernia repair different methods used which is either anterior approach (open Lichtenstein) or laparoscopic posterior approach through the abdomen (TAPP) comparing these two methods by new approach which is considered to some extent a modified TAPP by pneumo-dissection of pre-peritoneal space with abdominal approach by lap. repair
- Conditions
- Inguinal Hernioplasty
- Being tested
- dual approach laparoscopic inguinal hernioplasty, TAPP, (lichtenstein) repair
- Keywords
- dual approach, laparoscopic hernioplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dual approach laparoscopic inguinal hernioplastyProcedure or surgery
after pneumoperitoneum is done preperitoneal pneumo-dissection is done and then peritoneal incision done . dissection preperitoneally and sac dissection will be easy approached
TAPPProcedure or surgery
pneumoperitoneum is done and then through abdominal approach peritoneal dissection in done and sac reduction and then mesh fixation
(lichtenstein) repairProcedure or surgery
inguinal incision is done and inguinal canal approach anteriorly and then sac dissection and excision then mesh fixation to posterior wall and closure the incision in layers
| Study group | Role | What they receive |
|---|---|---|
| group A (dual approach lap hernioplasty) | Experimental | dual approach laparoscopic inguinal hernioplasty by combination of TAPP (group B) and pneumo-dissection preperitoneal instead of sharp dissection Receives: Procedure: dual approach laparoscopic inguinal hernioplasty |
| group B (TAPP) | Active comparator | trans-abdominal preperitoneal hernioplasty (TAPP) after induction of pneumoperitoneum through peritoneal approach peritoneal incision and preperitoneal dissection then mesh fixation done Receives: Procedure: TAPP |
| group C (Lichtenstein hernioplasty) | Active comparator | open inguinal hernioplasty (lichtenstein) repair through inguinal incision and dissection of the sac anteriorly , excision of the sac and then mesh fixation in the posterior wall of inguinal canal Receives: Procedure: (lichtenstein) repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
operative time
operative time will be measured in minutes for each procedure.and comparing three groups ( dual approach , TAPP and Lichtenstein ) in operative time which determined as follow:
- from the inflation of the abdomen till deflation and port closure
- for Lichtenstein from skin incision to skin closure
Measured: from the inflation of the abdomen till deflation and port closure ---for lichtenstein from skin incision to skin closure.
Secondary outcomes (6)
intraoperative injuries
abdominal visceral injuries cord structure injuries
Measured: intra operative
intra operative bleeding
mild bleeding and oozing controlled by cautery bleeding from inferior epigastric artery or testicular artery major vascular injury
Measured: intraoperative
post operative pain
pain measured by visual analog scale from 0 no pain to 10 the worst pain ever.
Measured: immediately post operative and 6 ,12, 24 hours and two weeks post operative
post operative wound complication
wound seroma , hematoma either small with conservative treatment and large need intervention wound infection either superficial skin and S.C. or mesh infection
Measured: 2 weeks post operative ,3 ,6 and 12 months postoperative
post operative chronic pain
post operative paraesthesia , bricking pain, dull-aching pain. measured by visual analog scale (VAS) from 0 no pain to 10 the worst pain ever
Measured: follow up at 3 months , 6 months and one year for pain assessment by VAS
recurrence
post operative inguinal swelling confirmed clinically as a recurrent hernia
Measured: 3 months, 6 months and one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2017
- Study startNov 2016
- Primary completionApr 2019
- Study completionApr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Inguinal HernioplastyStudies 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
- comparative study between three procedures of inguinal hernioplasty; open (LICHTENSTEIN), TAPP, and laparoscopic DUAL APPROACH (modified TAPP)
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sulaiman Abdulqader Saif Alshameri, Assiut University
- Investigators
- mostafa A. hamad, professor, Principal investigator, Assiut university hospital faculty of medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03052023
- Sponsor's protocol ID
- IHPP3
- Status last verified
- Jan 2020
- First submitted
- 2 Feb 2017
- Last updated
- 9 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Nasr MM. Early results of dual approach hernioplasty (DAH): an innovative laparoscopic inguinal hernioplasty technique. Surg Endosc. 2016 Mar;30(3):1113-8. doi: 10.1007/s00464-015-4308-5. Epub 2015 Jun 23.
PubMed 26099622
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inguinal Hernioplasty: Comparative Study Between Laparoscopic Dual Approach, Laparoscopic Trans Abdominal Preperitoneal and Lichtenstein Procedures. A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03052023
- Acronym / sponsor ID
- IHPP3
- Conditions
- Inguinal Hernioplasty
- Keywords
- dual approach, laparoscopic hernioplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- Apr 2019 (actual)
- Study completion
- Apr 2019 (actual)
- First posted
- 14 Feb 2017 (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 designed to compare the new laparoscopic dual approach to inguinal hernia repair with trans-abdominal preperitoneal (TAPP) and lichtenstein repair (open procedure)
Detailed description
inguinal hernioplasty is a procedures where synthetic mesh is used to strengthen the inguinal tissues sites for hernia repair different methods used which is either anterior approach (open Lichtenstein) or laparoscopic posterior approach through the abdomen (TAPP) comparing these two methods by new approach which is considered to some extent a modified TAPP by pneumo-dissection of pre-peritoneal space with abdominal approach by lap. repair
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- comparative study between three procedures of inguinal hernioplasty; open (LICHTENSTEIN), TAPP, and laparoscopic DUAL APPROACH (modified TAPP)
| Arm | Type | Receives |
|---|---|---|
| group A (dual approach lap hernioplasty) | Experimental | Procedure: dual approach laparoscopic inguinal hernioplastydual approach laparoscopic inguinal hernioplasty by combination of TAPP (group B) and pneumo-dissection preperitoneal instead of sharp dissection |
| group B (TAPP) | Active comparator | Procedure: TAPPtrans-abdominal preperitoneal hernioplasty (TAPP) after induction of pneumoperitoneum through peritoneal approach peritoneal incision and preperitoneal dissection then mesh fixation done |
| group C (Lichtenstein hernioplasty) | Active comparator | Procedure: (lichtenstein) repairopen inguinal hernioplasty (lichtenstein) repair through inguinal incision and dissection of the sac anteriorly , excision of the sac and then mesh fixation in the posterior wall of inguinal canal |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult male patient (older than 18y).
- Not complicated.
- No previous lower abdominal incisions (lower abdominal midline and lower paramedian incision in the same side of hernia).
- No contraindication for general anesthesia.
- Not recurrent.
Key exclusion criteria (1 listed)
- any one not in fulfill inclusion criteria
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 |
|---|---|---|
| dual approach laparoscopic inguinal hernioplastyafter pneumoperitoneum is done preperitoneal pneumo-dissection is done and then peritoneal incision done . dissection preperitoneally and sac dissection will be easy approached | Procedure or surgery | group A (dual approach lap hernioplasty) |
| TAPPpneumoperitoneum is done and then through abdominal approach peritoneal dissection in done and sac reduction and then mesh fixation | Procedure or surgery | group B (TAPP) |
| (lichtenstein) repairinguinal incision is done and inguinal canal approach anteriorly and then sac dissection and excision then mesh fixation to posterior wall and closure the incision in layers | Procedure or surgery | group C (Lichtenstein hernioplasty) |
Primary outcome
operative time
Time frame: from the inflation of the abdomen till deflation and port closure ---for lichtenstein from skin incision to skin closure.
operative time will be measured in minutes for each procedure.and comparing three groups ( dual approach , TAPP and Lichtenstein ) in operative time which determined as follow: * from the inflation of the abdomen till deflation and port closure * for Lichtenstein from skin incision to skin closure
6 secondary outcomes
intraoperative injuries
Time frame: intra operative
intra operative bleeding
Time frame: intraoperative
post operative pain
Time frame: immediately post operative and 6 ,12, 24 hours and two weeks post operative
post operative wound complication
Time frame: 2 weeks post operative ,3 ,6 and 12 months postoperative
post operative chronic pain
Time frame: follow up at 3 months , 6 months and one year for pain assessment by VAS
recurrence
Time frame: 3 months, 6 months and one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2020.
- Results publication: PubMed 26099622Nasr MM. Early results of dual approach hernioplasty (DAH): an innovative laparoscopic inguinal hernioplasty technique. Surg Endosc. 2016 Mar;30(3):1113-8. doi: 10.1007/s00464-015-4308-5. Epub 2015 Jun 23.
- Individual participant dataSharing planned: No
Related trials for Inguinal Hernioplasty
Not yet recruiting
Mesh Fixation Versus Non Fixation in Laparoscopic Inguinal Hernioplasty
Laparoscopic, Inguinal Hernia
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.
mostafa A. hamad, professor principal investigator
Assiut university hospital faculty of medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dual approach laparoscopic inguinal hernioplasty, TAPP and (lichtenstein) repair in people with Inguinal Hernioplasty, run by Assiut University at 1 site in Egypt.
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 5 inclusion and 1 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: finished, as of the sponsor's last update on 9 Jan 2020. 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 Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
operative time (time frame: from the inflation of the abdomen till deflation and port closure ---for lichtenstein from skin incision to skin closure.). 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 NCT03052023, which also lists 1 linked publication.
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 9 Jan 2020; AzTrials last refreshed its copy on 27 Oct 2026.