Hernia InguinalNCT07067281
A Comparative Study Between TAPP and Lichtenstein Techniques for Inguinal Hernia Surgery
A study testing Lichtenstein Tension-Free Mesh Hernioplasty and Laparoscopic Transabdominal Preperitoneal (TAPP) Repair in people with Hernia Inguinal, run by GSVM Medical College at 1 site in India.
Trial summary
This study is comperative study between TAPP And Lichtenstein Techniques for Inguinal Hernia surgery.The Lichtenstein tension-free open hernioplasty involves placing a tailored polypropylene mesh over the inguinal canal defect, secured to ligament and oblique fascia under local/regional anesthesia.Transabdominal… Read more about this study
- Who is it for?
- Ages 5 to 80 years
- Conditions the study is for
- Hernia Inguinal
- What is being tested?
- Lichtenstein Tension-Free Mesh Hernioplasty and Laparoscopic Transabdominal Preperitoneal (TAPP) 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 siteIndia
- Study dates
- 1 Apr 2024to 15 Aug 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 5 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Inclusion Criteria: 1. 5 -80 years 2. Any gender 3. Direct Hernia 4. Indirect hernia
-
Exclusion Criteria: 1 . Patient who are not fit for general anesthesia 2. Patient with lateral hernia 3 . Patient with complicated inguinal hernia like instructed and strangulated hernia
Trial locations and contacts
1 site in 1 country.
India1 site
Ganesh Shankar vidhyapthi Memorial Medical college kanpur
Kanpur, Uttar Pradesh, 208002
About this study
Official title: A Comparative Study Between TAPP And Lichtenstein Techniques for Inguinal Hernia Surgery, A Prospective Study
This study is comperative study between TAPP And Lichtenstein Techniques for Inguinal Hernia surgery.The Lichtenstein tension-free open hernioplasty involves placing a tailored polypropylene mesh over the inguinal canal defect, secured to ligament and oblique fascia under local/regional anesthesia.Transabdominal Preperitoneal (TAPP) hernia repair uses laparoscopic access via three ports (umbilicus and bilateral midclavicular lines), incises and closes a peritoneal flap, and places a large mesh in the preperitoneal space. Compression between these two procedure in terms of intraoperative ,postoperative complications and Long term follow up for recurrence of Hernia.
Read the detailed description
Comperative study between TAPP And Lichtenstein Techniques for Inguinal Hernia surgery.
Worldwide, inguinal hernia repair is one of the commonest surgeries. The best treatment option to primary hernia has been investigated, but there still remains lack of evidence about the ideal approach.
Therefore, this study aimed to compare the outcomes of inguinal hernia repair using Trans abdominal Pre peritoneal procedure(TAPP) \& Lichtenstein techniques. Primary outcomes are Operative time , Surgical site infection , Seroma , post operative ileus , bowel injury ,mesh infection , recurrence and quality of life .
- Conditions
- Hernia Inguinal
- Being tested
- Lichtenstein Tension-Free Mesh Hernioplasty, Laparoscopic Transabdominal Preperitoneal (TAPP) Repair
- Keywords
- Trans abdominal preperitoneal repair, Operative time, Surgical site infection, Recurrence, Seroma, Mesh infection
- Medical subject headings
- Hernia, Inguinal, Surgical Wound Infection, Recurrence, Seroma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lichtenstein Tension-Free Mesh HernioplastyProcedure or surgery
Open surgical repair of inguinal hernia using a tension-free mesh technique. A standard polypropylene mesh is placed over the posterior wall of the inguinal canal and fixed with non-absorbable sutures under spinal or local anesthesia. This is a conventional method widely used in open hernia surgery.
Laparoscopic Transabdominal Preperitoneal (TAPP) RepairProcedure or surgery
Laparoscopic approach to inguinal hernia repair performed under general anesthesia. Three ports are used to access the abdominal cavity, and a peritoneal flap is created to place a large polypropylene mesh in the preperitoneal space. The mesh is fixed with tacks or glue, and the peritoneal flap is closed. This minimally invasive method is designed to reduce postoperative pain and enhance recovery.
| Study group | Role | What they receive |
|---|---|---|
| Lichtenstein Techniques for Inguinal Hernia surgery using as conventional method | Active comparator | Participants randomized to this arm will undergo open Lichtenstein tension-free mesh repair for inguinal hernia under regional (spinal) or local anesthesia. A standard polypropylene mesh will be placed over the inguinal canal posterior wall and fixed to the inguinal ligament and conjoint tendon using non-absorbable sutures. The procedure is performed through a single inguinal incision. Patients will receive perioperative analgesia and standard postoperative care. This technique serves as the control group, reflecting conventional open hernia repair. Receives: Procedure: Lichtenstein Tension-Free Mesh Hernioplasty |
| TAPP Repair | Experimental | Participants in this arm will undergo laparoscopic Transabdominal Preperitoneal (TAPP) repair of inguinal hernia under general anesthesia. A standard 3-port laparoscopic technique will be used. After accessing the preperitoneal space, a large polypropylene mesh will be placed to cover the myopectineal orifice and fixed using tacks or glue. The peritoneal flap will be closed using absorbable sutures or staplers. Patients will receive standard laparoscopic postoperative care. This arm represents the minimally invasive surgical option. Receives: Procedure: Laparoscopic Transabdominal Preperitoneal (TAPP) Repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operative time
Total duration of surgery in minutes, measure skin incision to reversal of pneumoperitoneum
Measured: Intraoperative (measure during surgical procedure on day1)
Secondary outcomes (3)
Postoperative ileus
Delayed return of bowel function by flatus or bowel movement, abdominal distention or need for nasogastic tube decompression
Measured: Up to 5 days
Surgical site infection
Superficial and deep wound infection including erythema , discharge or wound dehiscence
Measured: Up to 30 days post operation
Hospital stay
Total number of days the date of operation to discharge from hospital
Measured: From date of surgery untill discharge , assessed upto 14days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2025
- Study start1 Apr 2024
- Primary completion15 Jul 2025 (estimated)
- Study completion15 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hernia InguinalStudies 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
- Randomized parallel Group,Active trial with computer generated randomization
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- GSVM Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shubham Chaubey, GSVM Medical College
- Investigators
- Shubham Chaubey, Principle investigator, MBBS, Principal investigator, GSVM MEDICAL COLLEGE KANPUR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07067281
- Sponsor's protocol ID
- EC/BMHR/2024/34
- Status last verified
- Jul 2025
- First submitted
- 5 Jul 2025
- Last updated
- 16 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participants( IPD ) related to operative time, hospital stay and post operative complications
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study Between TAPP And Lichtenstein Techniques for Inguinal Hernia Surgery, A Prospective Study
- ClinicalTrials.gov ID
- NCT07067281
- Acronym / sponsor ID
- EC/BMHR/2024/34
- Conditions
- Hernia Inguinal
- Keywords
- Trans abdominal preperitoneal repair, Operative time, Surgical site infection, Recurrence, Seroma, Mesh infection
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (actual)
- Lead sponsor
- GSVM Medical CollegeUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 15 Jul 2025 (estimated)
- Study completion
- 15 Aug 2025 (estimated)
- First posted
- 16 Jul 2025 (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 is comperative study between TAPP And Lichtenstein Techniques for Inguinal Hernia surgery.The Lichtenstein tension-free open hernioplasty involves placing a tailored polypropylene mesh over the inguinal canal defect, secured to ligament and oblique fascia under local/regional anesthesia.Transabdominal Preperitoneal (TAPP) hernia repair uses laparoscopic access via three ports (umbilicus and bilateral midclavicular lines), incises and closes a peritoneal flap, and places a large mesh in the preperitoneal space. Compression between these two procedure in terms of intraoperative ,postoperative complications and Long term follow up for recurrence of Hernia.
Detailed description
Comperative study between TAPP And Lichtenstein Techniques for Inguinal Hernia surgery.
Worldwide, inguinal hernia repair is one of the commonest surgeries. The best treatment option to primary hernia has been investigated, but there still remains lack of evidence about the ideal approach.
Therefore, this study aimed to compare the outcomes of inguinal hernia repair using Trans abdominal Pre peritoneal procedure(TAPP) \& Lichtenstein techniques. Primary outcomes are Operative time , Surgical site infection , Seroma , post operative ileus , bowel injury ,mesh infection , recurrence and quality of life .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized parallel Group,Active trial with computer generated randomization
| Arm | Type | Receives |
|---|---|---|
| Lichtenstein Techniques for Inguinal Hernia surgery using as conventional method | Active comparator | Procedure: Lichtenstein Tension-Free Mesh HernioplastyParticipants randomized to this arm will undergo open Lichtenstein tension-free mesh repair for inguinal hernia under regional (spinal) or local anesthesia. A standard polypropylene mesh will be placed over the inguinal canal posterior wall and fixed to the inguinal ligament and conjoint tendon using non-absorbable sutures. The procedure is performed through a single inguinal incision. Patients will receive perioperative analgesia and standard postoperative care. This technique serves as the control group, reflecting conventional open hernia repair. |
| TAPP Repair | Experimental | Procedure: Laparoscopic Transabdominal Preperitoneal (TAPP) RepairParticipants in this arm will undergo laparoscopic Transabdominal Preperitoneal (TAPP) repair of inguinal hernia under general anesthesia. A standard 3-port laparoscopic technique will be used. After accessing the preperitoneal space, a large polypropylene mesh will be placed to cover the myopectineal orifice and fixed using tacks or glue. The peritoneal flap will be closed using absorbable sutures or staplers. Patients will receive standard laparoscopic postoperative care. This arm represents the minimally invasive surgical option. |
Who may qualify
- Ages
- 5 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| Lichtenstein Tension-Free Mesh HernioplastyOpen surgical repair of inguinal hernia using a tension-free mesh technique. A standard polypropylene mesh is placed over the posterior wall of the inguinal canal and fixed with non-absorbable sutures under spinal or local anesthesia. This is a conventional method widely used in open hernia surgery. | Procedure or surgery | Lichtenstein Techniques for Inguinal Hernia surgery using as conventional method |
| Laparoscopic Transabdominal Preperitoneal (TAPP) RepairLaparoscopic approach to inguinal hernia repair performed under general anesthesia. Three ports are used to access the abdominal cavity, and a peritoneal flap is created to place a large polypropylene mesh in the preperitoneal space. The mesh is fixed with tacks or glue, and the peritoneal flap is closed. This minimally invasive method is designed to reduce postoperative pain and enhance recovery. | Procedure or surgery | TAPP Repair |
Primary outcome
Operative time
Time frame: Intraoperative (measure during surgical procedure on day1)
Total duration of surgery in minutes, measure skin incision to reversal of pneumoperitoneum
3 secondary outcomes
Postoperative ileus
Time frame: Up to 5 days
Surgical site infection
Time frame: Up to 30 days post operation
Hospital stay
Time frame: From date of surgery untill discharge , assessed upto 14days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2025.
- Individual participant dataSharing planned: Yes. De-identified individual participants( IPD ) related to operative time, hospital stay and post operative complications
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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.
Shubham Chaubey, Principle investigator, MBBS principal investigator
GSVM MEDICAL COLLEGE KANPUR
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lichtenstein Tension-Free Mesh Hernioplasty and Laparoscopic Transabdominal Preperitoneal (TAPP) Repair in people with Hernia Inguinal, run by GSVM Medical College 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?
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: under way, not looking for participants, as of the sponsor's last update on 16 Jul 2025. 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?
This study is still under way. Results are not available in the source record yet.
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: Intraoperative (measure during surgical procedure on day1)). 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 16 Jul 2025.