Hernia, InguinalTAPPNCT05839587
Transabdominal Preperitoneal Inguinal Hernia Repair
A study testing Robotic TAPP and Laparoscopic TAPP in people with Hernia, Inguinal and Laparoscopy, run by University of Southern Denmark at 1 site in Denmark.
Trial summary
The present study seeks to determine whether improved visual acuity and enhanced flexibility of the robotic platform results in a reduced surgical stress response and an improvement in indices of surgical outcome measures for simple and complex inguinal hernia repair Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hernia, Inguinal, Laparoscopy
- What is being tested?
- Robotic TAPP and Laparoscopic TAPP
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteDenmark
- Study dates
- 11 Nov 2022to 31 May 2025
- 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
- ASA 1- 3
- Clinical or radiologic diagnosis of inguinal hernia (unilateral, bilateral, recurrent, inguinoscrotal)
- Eligible for a laparoscopic procedure
- Informed concent
Who cannot join
- Incarcerated inguinal hernia requiring emergency surgery
- Pregnancy
- Patients with chronic pain due to arthritis, migraine or other illness requiring regular intake of pain relieve (paracetamol, NSAID etc)
- Active cancer
- History of psychiatric or additive disorder that prevent the patient from participating in the trial
- Co-existing inflammatory disease
- Co-existing immunological disease that requires medication of any kind
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Short-term Outcome and Inflammatory Stress Response Following Transabdominal Preperitoneal Inguinal Hernia Repair (TAPP) - A Prospective, Randomized Trial Comparing Laparoscopy to the Robotic-assisted Approach
The present study seeks to determine whether improved visual acuity and enhanced flexibility of the robotic platform results in a reduced surgical stress response and an improvement in indices of surgical outcome measures for simple and complex inguinal hernia repair
Read the detailed description
Complex inguinal hernia repair is challenging and requires both advanced skills in laparoscopic surgery and knowledge about the complex anatomy of the inguinal area. Whereas the repair of a small inguinal hernia usually is simple and straightforward, complex hernias (large inguinoscrotal and recurrent hernias) constitute a surgical challenge due to the risk of damage of the neurovascular structures in the inguinal area. It requires advanced laparoscopic skills to reduce the hernial sac in patients with large lateral hernias, where the hernial sac often extends deep into the scrotum in close vicinity to the spermatic cord and the testicular artery. This dissection is difficult with conventional laparoscopy, which may explain the risk of chronic pain, testicular hypotrophy and hernia recurrence. The aim of the study is to determine whether rTAPP of complex inguinal hernias is associated with a lower surgical stress response and a lower risk of postoperative complications compared to laparoscopic TAPP.
- Conditions
- Hernia, Inguinal, Laparoscopy
- Being tested
- Robotic TAPP, Laparoscopic TAPP
- Keywords
- Adult, Robotic surgical procedures, Abdomen
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic TAPPProcedure or surgery
Robotic TAPP consists of four different procedures. Part 2 and 3 will be the same for both procedures and will consist of hernia reduction and preparation of the preperitoneal space where the mesh is placed (part 2), mesh placement and suturing of the peritoneum (part 3). Part 1 consists of docking of the robot and port placement and part 4 consists of de-docking and skin closure
Laparoscopic TAPPProcedure or surgery
Laparoscopic TAPP consists of four different procedures. Part 2 and 3 will be the same for both procedures and will consist of hernia reduction and preparation of the preperitoneal space where the mesh is placed (part 2), mesh placement and suturing of the peritoneum (part 3). Part 1 consists of port placement only and part 4 consists of skin closure only.
| Study group | Role | What they receive |
|---|---|---|
| Robotic TAPP | Experimental | Repair of primary unilateral and bilateral hernias with robotic technology Receives: Procedure: Robotic TAPP |
| Laparoscopic TAPP | Active comparator | Repair of primary unilateral and bilateral hernias with laparoscopic repair Receives: Procedure: Laparoscopic TAPP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical stress response (CRP)
Change of serum CRP over time.
Measured: CRP will be measured preoperatively at baseline, 1 day postoperatively and 3 days postoperatively
Secondary outcomes (13)
Estimated intraoperative blood loss
The amount of intraoperative blood loss measured in mL, estimated by the primary surgeon
Measured: intraoperative (From first incision until last suture has been placed)
Intraoperative need of blood transfusion
The amount of blood transfused during surgery measured in mL
Measured: intraoperative (From first incision until last suture has been placed)
Length of hospital stay
The number of days patients spend in the hospital following the procedure.
Measured: Up to 3 months
Hernia defect size
The area of the hernial defect in cm2 measured at 8 mmHg
Measured: During surgery
Total surgical time
The procedure will be divided into 4 parts. Part 1 will be different for the 2 procedures. In rTAPP it will consist of docking of the robot and port placement while it only will consist of port placement in TAPP. Part 2 and 3 will be the same for both procedures and will consist of hernia reduction and preparation of the preperitoneal space where the mesh is placed (part 2), mesh placement and suturing of the peritoneum (part 3). Part 4 will also be different for the 2 procedures. In rTAPP it will consist of de-docking and skin closure while it only will consist of skin closure in TAPP. Total surgical time and each part will be measured individually in minutes and the 2 procedures will be compared
Measured: During surgery
Postoperative complications
Classified into grades (I-V) according to the Clavien-Dindo classification
Measured: From surgery until 6 months postoperatively
Life-quality
According to the EUropean Registry for Abdominal wall HerniaS Quality Of Life questionnaire (Eura-HS QoL). The total score ranges from 0 (best quality of life) to 90 (worst quality of life)
Measured: From inclusion until 6 months postoperatively
Sexual dysfunction
According to the Sexual Inguinal Hernia Questionnaire (SexIHQ) a 1-page, 8-question questionnaire including visual analogue scales and tick-boxes used to asses sexual dysfunction following inguinal hernia repair
Measured: From inclusion until 6 months postoperatively
Surgical stress response (IL1-β)
The change of serum IL1-β over time.
Measured: IL1-β will be measured preoperatively at baseline, 30 minutes after extubation and 120 minutes after extubation
Surgical stress response (IL-6)
The change of serum IL-6 over time.
Measured: IL-6 will be measured preoperatively at baseline, 30 minutes after extubation and 120 minutes after extubation
Surgical stress response (IL-8)
The change of serum IL-8 over time.
Measured: IL-8 will be measured preoperatively at baseline, 30 minutes after extubation and 120 minutes after extubation
Surgical stress response (IL-10)
The change of serum IL-10 over time.
Measured: IL-10 will be measured preoperatively at baseline, 30 minutes after extubation and 120 minutes after extubation
Surgical stress response (TNF-α)
The change of serum TNF-α over time.
Measured: TNF-α will be measured preoperatively at baseline, 30 minutes after extubation and 120 minutes after extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2023
- Study start11 Nov 2022
- Primary completion31 May 2024
- Study completion31 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- 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
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05839587
- Sponsor's protocol ID
- SHS-MT Kir - 1 - 2023
- Acronym
- TAPP
- Status last verified
- May 2026
- First submitted
- 28 Feb 2023
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
McCormack K, Scott NW, Go PM, Ross S, Grant AM; EU Hernia Trialists Collaboration. Laparoscopic techniques versus open techniques for inguinal hernia repair. Cochrane Database Syst Rev. 2003;2003(1):CD001785. doi: 10.1002/14651858.CD001785.
PubMed 12535413Podolsky D, Novitsky Y. Robotic Inguinal Hernia Repair. Surg Clin North Am. 2020 Apr;100(2):409-415. doi: 10.1016/j.suc.2019.12.010. Epub 2020 Feb 1.
PubMed 32169186Huerta S, Timmerman C, Argo M, Favela J, Pham T, Kukreja S, Yan J, Zhu H. Open, Laparoscopic, and Robotic Inguinal Hernia Repair: Outcomes and Predictors of Complications. J Surg Res. 2019 Sep;241:119-127. doi: 10.1016/j.jss.2019.03.046. Epub 2019 Apr 22.
PubMed 31022677Arunthavanathan D, Liu R, Inan I, Oztoprak M, Nielsen MF. Shorter operative times following robotic-assisted transabdominal preperitoneal inguinal hernia repair (TAPP) compared to laparoscopic TAPP: the Danish Inguinal Randomized Controlled Trial (DIRECT). Hernia. 2025 Jul 9;29(1):227. doi: 10.1007/s10029-025-03402-y.
PubMed 40632168Valorenzos A, Nielsen KA, Kaiser K, Petersen SR, Helligso P, Dorfelt A, Lambertsen KL, Ellebaek MB, Nielsen MF. Inflammatory response and short-term outcomes after laparoscopic versus robotic transabdominal preperitoneal inguinal hernia repair: randomized clinical trial (ROLAIS). Br J Surg. 2025 Mar 28;112(4):znaf074. doi: 10.1093/bjs/znaf074.
PubMed 40277023Valorenzos AV, Nielsen KA, Kaiser K, Helligso P, Ellebaek MB, Dorfelt A, Petersen SR, Pedersen AK, Nielsen MF. Short-term outcomes and inflammatory stress response following laparoscopy or robotic-assisted transabdominal preperitoneal inguinal hernia repair (TAPP): study protocol for a prospective, randomized trial (ROLAIS). Trials. 2024 Aug 8;25(1):529. doi: 10.1186/s13063-024-08361-w.
PubMed 39118135
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-term Outcome and Inflammatory Stress Response Following Transabdominal Preperitoneal Inguinal Hernia Repair (TAPP) - A Prospective, Randomized Trial Comparing Laparoscopy to the Robotic-assisted Approach
- ClinicalTrials.gov ID
- NCT05839587
- Acronym / sponsor ID
- TAPP / SHS-MT Kir - 1 - 2023
- Conditions
- Hernia, Inguinal, Laparoscopy
- Keywords
- Adult, Robotic surgical procedures, Abdomen
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Study start
- 11 Nov 2022 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 31 May 2025 (actual)
- First posted
- 3 May 2023 (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 present study seeks to determine whether improved visual acuity and enhanced flexibility of the robotic platform results in a reduced surgical stress response and an improvement in indices of surgical outcome measures for simple and complex inguinal hernia repair
Detailed description
Complex inguinal hernia repair is challenging and requires both advanced skills in laparoscopic surgery and knowledge about the complex anatomy of the inguinal area. Whereas the repair of a small inguinal hernia usually is simple and straightforward, complex hernias (large inguinoscrotal and recurrent hernias) constitute a surgical challenge due to the risk of damage of the neurovascular structures in the inguinal area. It requires advanced laparoscopic skills to reduce the hernial sac in patients with large lateral hernias, where the hernial sac often extends deep into the scrotum in close vicinity to the spermatic cord and the testicular artery. This dissection is difficult with conventional laparoscopy, which may explain the risk of chronic pain, testicular hypotrophy and hernia recurrence. The aim of the study is to determine whether rTAPP of complex inguinal hernias is associated with a lower surgical stress response and a lower risk of postoperative complications compared to laparoscopic TAPP.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robotic TAPP | Experimental | Procedure: Robotic TAPPRepair of primary unilateral and bilateral hernias with robotic technology |
| Laparoscopic TAPP | Active comparator | Procedure: Laparoscopic TAPPRepair of primary unilateral and bilateral hernias with laparoscopic repair |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ASA 1- 3
- Clinical or radiologic diagnosis of inguinal hernia (unilateral, bilateral, recurrent, inguinoscrotal)
- Eligible for a laparoscopic procedure
- Informed concent
Key exclusion criteria (7 listed)
- Incarcerated inguinal hernia requiring emergency surgery
- Pregnancy
- Patients with chronic pain due to arthritis, migraine or other illness requiring regular intake of pain relieve (paracetamol, NSAID etc)
- Active cancer
- History of psychiatric or additive disorder that prevent the patient from participating in the trial
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 |
|---|---|---|
| Robotic TAPPRobotic TAPP consists of four different procedures. Part 2 and 3 will be the same for both procedures and will consist of hernia reduction and preparation of the preperitoneal space where the mesh is placed (part 2), mesh placement and suturing of the peritoneum (part 3). Part 1 consists of docking of the robot and port placement and part 4 consists of de-docking and skin closure | Procedure or surgery | Robotic TAPP |
| Laparoscopic TAPPLaparoscopic TAPP consists of four different procedures. Part 2 and 3 will be the same for both procedures and will consist of hernia reduction and preparation of the preperitoneal space where the mesh is placed (part 2), mesh placement and suturing of the peritoneum (part 3). Part 1 consists of port placement only and part 4 consists of skin closure only. | Procedure or surgery | Laparoscopic TAPP |
Primary outcome
Surgical stress response (CRP)
Time frame: CRP will be measured preoperatively at baseline, 1 day postoperatively and 3 days postoperatively
Change of serum CRP over time.
13 secondary outcomes
Estimated intraoperative blood loss
Time frame: intraoperative (From first incision until last suture has been placed)
Intraoperative need of blood transfusion
Time frame: intraoperative (From first incision until last suture has been placed)
Length of hospital stay
Time frame: Up to 3 months
Hernia defect size
Time frame: During surgery
Total surgical time
Time frame: During surgery
Postoperative complications
Time frame: From surgery until 6 months postoperatively
Life-quality
Time frame: From inclusion until 6 months postoperatively
Sexual dysfunction
Time frame: From inclusion until 6 months postoperatively
Surgical stress response (IL1-β)
Time frame: IL1-β will be measured preoperatively at baseline, 30 minutes after extubation and 120 minutes after extubation
Surgical stress response (IL-6)
Time frame: IL-6 will be measured preoperatively at baseline, 30 minutes after extubation and 120 minutes after extubation
Surgical stress response (IL-8)
Time frame: IL-8 will be measured preoperatively at baseline, 30 minutes after extubation and 120 minutes after extubation
Surgical stress response (IL-10)
Time frame: IL-10 will be measured preoperatively at baseline, 30 minutes after extubation and 120 minutes after extubation
Surgical stress response (TNF-α)
Time frame: TNF-α will be measured preoperatively at baseline, 30 minutes after extubation and 120 minutes after extubation
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 14 May 2026.
- Background: PubMed 12535413McCormack K, Scott NW, Go PM, Ross S, Grant AM; EU Hernia Trialists Collaboration. Laparoscopic techniques versus open techniques for inguinal hernia repair. Cochrane Database Syst Rev. 2003;2003(1):CD001785. doi: 10.1002/14651858.CD001785.
- Background: PubMed 32169186Podolsky D, Novitsky Y. Robotic Inguinal Hernia Repair. Surg Clin North Am. 2020 Apr;100(2):409-415. doi: 10.1016/j.suc.2019.12.010. Epub 2020 Feb 1.
- Background: PubMed 31022677Huerta S, Timmerman C, Argo M, Favela J, Pham T, Kukreja S, Yan J, Zhu H. Open, Laparoscopic, and Robotic Inguinal Hernia Repair: Outcomes and Predictors of Complications. J Surg Res. 2019 Sep;241:119-127. doi: 10.1016/j.jss.2019.03.046. Epub 2019 Apr 22.
- Derived from this study: PubMed 40632168Arunthavanathan D, Liu R, Inan I, Oztoprak M, Nielsen MF. Shorter operative times following robotic-assisted transabdominal preperitoneal inguinal hernia repair (TAPP) compared to laparoscopic TAPP: the Danish Inguinal Randomized Controlled Trial (DIRECT). Hernia. 2025 Jul 9;29(1):227. doi: 10.1007/s10029-025-03402-y.
- Derived from this study: PubMed 40277023Valorenzos A, Nielsen KA, Kaiser K, Petersen SR, Helligso P, Dorfelt A, Lambertsen KL, Ellebaek MB, Nielsen MF. Inflammatory response and short-term outcomes after laparoscopic versus robotic transabdominal preperitoneal inguinal hernia repair: randomized clinical trial (ROLAIS). Br J Surg. 2025 Mar 28;112(4):znaf074. doi: 10.1093/bjs/znaf074.
- Derived from this study: PubMed 39118135Valorenzos AV, Nielsen KA, Kaiser K, Helligso P, Ellebaek MB, Dorfelt A, Petersen SR, Pedersen AK, Nielsen MF. Short-term outcomes and inflammatory stress response following laparoscopy or robotic-assisted transabdominal preperitoneal inguinal hernia repair (TAPP): study protocol for a prospective, randomized trial (ROLAIS). Trials. 2024 Aug 8;25(1):529. doi: 10.1186/s13063-024-08361-w.
- 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.
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 Robotic TAPP and Laparoscopic TAPP in people with Hernia, Inguinal and Laparoscopy, run by University of Southern Denmark at 1 site in Denmark.
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 4 inclusion and 7 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 14 May 2026. 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 Denmark. 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?
Surgical stress response (CRP) (time frame: CRP will be measured preoperatively at baseline, 1 day postoperatively and 3 days postoperatively). 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 NCT05839587, which also lists 6 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 14 May 2026.