Liver Transplant DisorderTOHERNCT05378451
Totally Extraperitoneal Repair of Groin Hernia in Liver Transplanted Patients
An observational study of Liver Transplant Disorder and Liver Cirrhosis, run by Hospital Clinic of Barcelona at 1 site in Spain.
Trial summary
Liver transplant recipients share the risk with cirrhotic patients for the development of inguinal hernias, but their liver failure pathophysiology has reversed following transplantation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Transplant Disorder, Liver Cirrhosis, Groin Hernia
- What is being tested?
- Totally Extraperitoneal Groin Hernia Repair
- Type of treatment
- Surgery or procedure
- How many people
- 10 participants
- Where
- 1 siteSpain
- Study dates
- 8 May 2022to 1 Jan 2024
- Phase
- Observational
- 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
Study population: Liver transplanted patients diagnosed with groin hernia planned to undergo ambulatory surgical repair will be considered for being included in the study after informed consent. Perioperative management will be provided as determined by the local clinical practice without modifications due to study inclusion.
Who may be able to join
- Patients older than 18 years of age.
- Liver transplanted patients diagnosed from groin hernia and proposed for ambulatory surgery.
- Signed informed consent for inclusion in the study
Who cannot join
- Patients under 18 years of age.
- Pregnancy or breastfeeding.
- Inability to give informed consent.
- Patients not candidates for surgical treatment.
- Contraindication to general anesthesia.
- Procedures performed in an emergency setting.
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- Patients non tributary to ambulatory surgery due to anesthesia management (ASA>III or decompensation in the last 3 months)
- Impossibility for the care of a responsible adult during first 24 hours after surgery.
- Domicile at a distance of more than 1 hour by vehicle from the hospital.
- Previous posterior approach for hernia repair.
- Previous cystectomy and prostatectomy surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Totally Extraperitoneal Repair of Groin Hernia in Liver Transplanted Patients: a Case Series Study. (TOHER)
Liver transplant recipients share the risk with cirrhotic patients for the development of inguinal hernias, but their liver failure pathophysiology has reversed following transplantation. Despite immunosuppression alters wound healing and infections, inguinal hernia repair in transplanted patients has shown better outcome compared to cirrhotic patients. Endoscopic inguinal hernia techniques have proved to be superior to open repair, due to lower incidence of postoperative complications and short-term convalescence, but there is no evidence of the use of this approach in liver transplanted patients. This prospective consecutive case series study will be the first study to describe the postoperative results of groin hernia repair in ambulatory surgery regimen in liver transplanted patients using totally extraperitoneal approach. The included patients will be prospectively registered in a standardized database. Rate of completion of surgery by totally extraperitoneal approach without the needing of conversion to anterior open approach or transabdominal preperitoneal approach due technical difficulties will be evaluated. Postoperative complications all along with quality standards criteria of ambulatory surgery will be reported for descriptive purposes.
Read the detailed description
This will be a single center prospective consecutive case series study. Liver transplanted patients diagnosed of groin hernia will be operated using endoscopic totally extraperitoneal approach in ambulatory surgery regimen. Main objective will be to evaluate the rate of completion of surgery by totally extraperitoneal approach without the needing of conversion to anterior open approach or transabdominal preperitoneal approach due technical difficulties. Secondary objectives will be to record postoperative complications all along with quality standards criteria of ambulatory surgery.
The sample size could not be formally calculated as this is a pilot study. It is the first time that the surgical team has considered this type of surgical approach and we wish to evaluate the feasibility of this technique. Since in our center the number of surgical procedures of groin hernia in liver transplanted patients could be around 20 per year, for this pilot study we propose recruiting between 15-20 patients. The results will be representative of this type of surgical activities in a tertiary university hospital.
Liver transplanted patients diagnosed with groin hernia planned to undergo ambulatory surgical repair will be considered for being included in the study after informed consent. Perioperative management will be provided as determined by the local clinical practice without modifications due to study inclusion.The included patients will be prospectively registered in a standardized database. Background information and details regarding the surgery will be retrieved from the patients' medical records.
Information regarding postoperative complications will be collected up to 30 days after surgery. Following routine clinical practice, including telephonic contact on first postoperative 24h, clinical control follow up at 10 days and at month after the surgery.
This case series has been reported in line with the PROCESS Guideline.
- Conditions
- Liver Transplant Disorder, Liver Cirrhosis, Groin Hernia
- Being tested
- Totally Extraperitoneal Groin Hernia Repair
- Keywords
- Liver Trasplant, Groin Hernia, Totally Extraperitoneal Repair
- Medical subject headings
- Liver Cirrhosis, Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Totally Extraperitoneal Groin Hernia RepairProcedure or surgery
Also called TEP
Patients will undergo totally extraperitoneal groin hernia repair, by a single senior experimented surgeon and without modifications from the routine clinical practice due to study inclusion. TEP approach will be assessed by placement of 3 trocars in the lower midline. Preperitoneal space will be dissected under direct vision using Spacemaker Dissection Balloon (Applied Medical®). Systematic complete dissection of the myopectineal orifice, Retzius and Bogros spaces will be performed to identify all potential sites of hernia formation. It will be used a laparoscopic self-fixating mesh (ProGrip™). Preperitoneal instillation of local anesthesia (15 mL of 0.5% bupivacaine) will be placed placed by the surgeon under direct visualization into "triangle of pain". Local anesthesia (levobupivacaine 10mL 1%) will be applied in all the incisions.
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of completion of surgery by totally extraperitoneal approach
Rate of completion of surgery by totally extraperitoneal approach without the needing of conversion to anterior open approach or transabdominal preperitoneal approach due technical difficulties.
Measured: 0 days (intraoperative)
Secondary outcomes (3)
Rate of intraoperative complications
Register intraoperative complications (intestinal lesions, urinary bladder lesions, major vascular lesions...)
Measured: 0 days (intraoperative)
Rate of postoperative complications
Register postoperative complications (acute urinary retention, urinary infection, hematoma, seroma, surgical wound infection...)
Measured: 30 days (postoperative)
Pain measurement
Control of pain assessed by Visual Analogue Score (at time of discharge, first postoperative day and after 10 days of surgery).
Measured: 10 days (postoperative).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2022
- Study start8 May 2022
- Primary completion1 Dec 2023
- Study completion1 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver Transplant DisorderStudies of the same condition, open and under way.
- More trials run by Hospital Clinic of BarcelonaThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paula Dominguez-Garijo, MD, Principal investigator, General Surgery, ICMDM, Hospital Clínic de Barcelona.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05378451
- Sponsor's protocol ID
- TOHER2021
- Acronym
- TOHER
- Status last verified
- May 2022
- First submitted
- 12 May 2022
- Last updated
- 20 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Totally Extraperitoneal Repair of Groin Hernia in Liver Transplanted Patients: a Case Series Study. (TOHER)
- ClinicalTrials.gov ID
- NCT05378451
- Acronym / sponsor ID
- TOHER / TOHER2021
- Conditions
- Liver Transplant Disorder, Liver Cirrhosis, Groin Hernia
- Keywords
- Liver Trasplant, Groin Hernia, Totally Extraperitoneal Repair
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Study start
- 8 May 2022 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 18 May 2022 (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.
Liver transplant recipients share the risk with cirrhotic patients for the development of inguinal hernias, but their liver failure pathophysiology has reversed following transplantation. Despite immunosuppression alters wound healing and infections, inguinal hernia repair in transplanted patients has shown better outcome compared to cirrhotic patients. Endoscopic inguinal hernia techniques have proved to be superior to open repair, due to lower incidence of postoperative complications and short-term convalescence, but there is no evidence of the use of this approach in liver transplanted patients. This prospective consecutive case series study will be the first study to describe the postoperative results of groin hernia repair in ambulatory surgery regimen in liver transplanted patients using totally extraperitoneal approach. The included patients will be prospectively registered in a standardized database. Rate of completion of surgery by totally extraperitoneal approach without the needing of conversion to anterior open approach or transabdominal preperitoneal approach due technical difficulties will be evaluated. Postoperative complications all along with quality standards criteria of ambulatory surgery will be reported for descriptive purposes.
Detailed description
This will be a single center prospective consecutive case series study. Liver transplanted patients diagnosed of groin hernia will be operated using endoscopic totally extraperitoneal approach in ambulatory surgery regimen. Main objective will be to evaluate the rate of completion of surgery by totally extraperitoneal approach without the needing of conversion to anterior open approach or transabdominal preperitoneal approach due technical difficulties. Secondary objectives will be to record postoperative complications all along with quality standards criteria of ambulatory surgery.
The sample size could not be formally calculated as this is a pilot study. It is the first time that the surgical team has considered this type of surgical approach and we wish to evaluate the feasibility of this technique. Since in our center the number of surgical procedures of groin hernia in liver transplanted patients could be around 20 per year, for this pilot study we propose recruiting between 15-20 patients. The results will be representative of this type of surgical activities in a tertiary university hospital.
Liver transplanted patients diagnosed with groin hernia planned to undergo ambulatory surgical repair will be considered for being included in the study after informed consent. Perioperative management will be provided as determined by the local clinical practice without modifications due to study inclusion.The included patients will be prospectively registered in a standardized database. Background information and details regarding the surgery will be retrieved from the patients' medical records.
Information regarding postoperative complications will be collected up to 30 days after surgery. Following routine clinical practice, including telephonic contact on first postoperative 24h, clinical control follow up at 10 days and at month after the surgery.
This case series has been reported in line with the PROCESS Guideline.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Liver transplanted patients diagnosed with groin hernia planned to undergo ambulatory surgical repair will be considered for being included in the study after informed consent. Perioperative management will be provided as determined by the local clinical practice without modifications due to study inclusion.
Key inclusion criteria (3 listed)
- Patients older than 18 years of age.
- Liver transplanted patients diagnosed from groin hernia and proposed for ambulatory surgery.
- Signed informed consent for inclusion in the study
Key exclusion criteria (11 listed)
- Patients under 18 years of age.
- Pregnancy or breastfeeding.
- Inability to give informed consent.
- Patients not candidates for surgical treatment.
- Contraindication to general anesthesia.
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 |
|---|---|---|
| Totally Extraperitoneal Groin Hernia RepairAlso: TEPPatients will undergo totally extraperitoneal groin hernia repair, by a single senior experimented surgeon and without modifications from the routine clinical practice due to study inclusion. TEP approach will be assessed by placement of 3 trocars in the lower midline. Preperitoneal space will be dissected under direct vision using Spacemaker Dissection Balloon (Applied Medical®). Systematic complete dissection of the myopectineal orifice, Retzius and Bogros spaces will be performed to identify all potential sites of hernia formation. It will be used a laparoscopic self-fixating mesh (ProGrip™). Preperitoneal instillation of local anesthesia (15 mL of 0.5% bupivacaine) will be placed placed by the surgeon under direct visualization into "triangle of pain". Local anesthesia (levobupivacaine 10mL 1%) will be applied in all the incisions. | Procedure or surgery | – |
Primary outcome
Rate of completion of surgery by totally extraperitoneal approach
Time frame: 0 days (intraoperative)
Rate of completion of surgery by totally extraperitoneal approach without the needing of conversion to anterior open approach or transabdominal preperitoneal approach due technical difficulties.
3 secondary outcomes
Rate of intraoperative complications
Time frame: 0 days (intraoperative)
Rate of postoperative complications
Time frame: 30 days (postoperative)
Pain measurement
Time frame: 10 days (postoperative).
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 20 Mar 2024.
- Individual participant dataSharing planned: Yes
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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.
Paula Dominguez-Garijo, MD principal investigator
General Surgery, ICMDM, Hospital Clínic de Barcelona.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Transplant Disorder and Liver Cirrhosis, run by Hospital Clinic of Barcelona at 1 site in Spain.
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 11 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 20 Mar 2024. 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 Spain. 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?
Rate of completion of surgery by totally extraperitoneal approach (time frame: 0 days (intraoperative)). 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 20 Mar 2024.