Hernia, AbdominalNCT02233569
Comparison of Two Mesh/Fixation Concepts for Laparoscopic Ventral and Incisional Hernia Repair
A study testing Intraperitoneal onlay mesh (IPOM) repair with the use of Phisiomesh implant and Securestrap fixation device., Intraperitoneal onlay mesh (IPOM) repair with the use of Ventralight ST implant with SorbaFix fixation device. and Ventralight ST implant in people with Hernia, Abdominal and Hernia,Ventral, run by Polish Hernia Study Group at 1 site in Poland.
Trial summary
This is a monocenter randomized controlled trial comparing two systems of mesh and fixation device for the laparoscopic ventral and incisional hernia repair with respect to pain. It has been designed as a superiority study to proof the concept of previously published mathematical model of front abdominal wall. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hernia, Abdominal, Hernia,Ventral
- What is being tested?
- Intraperitoneal onlay mesh (IPOM) repair with the use of Phisiomesh implant and Securestrap fixation device., Intraperitoneal onlay mesh (IPOM) repair with the use of Ventralight ST implant with SorbaFix fixation device. and Ventralight ST implant
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 sitePoland
- Study dates
- Nov 2012to Feb 2014
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Informed Consent Form (ICF) signed by the patient or his/her legal representative
- primary or secondary ventral hernia less than 20 cm in length and less than 11 cm in width requiring elective surgical repair
- recurrence after former abdominal hernia repair WITH MESH
- recurrence after suture abdominal hernia repair CAN be included
Who cannot join
- no written informed consent
- patient under 18 years old
- emergency surgery (incarcerated hernia)
- patients with expected life time shorter than one year for example due to generalised malignancy
- BMI exceeding 40.0kg/m²
- contaminated surgical fields
- patients on immunosuppression, steroid therapy, constant pain therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: COMPARISON OF TWO DIFFERENT CONCEPTS OF MESH AND FIXATION TECHNIQUE IN THE LAPAROSCOPIC OPERATIONS FOR VENTRAL AND INCISIONAL HERNIA - A RANDOMIZED CONTROLLED MONOCENTER TRIAL.
This is a monocenter randomized controlled trial comparing two systems of mesh and fixation device for the laparoscopic ventral and incisional hernia repair with respect to pain. It has been designed as a superiority study to proof the concept of previously published mathematical model of front abdominal wall.
- Conditions
- Hernia, Abdominal, Hernia,Ventral
- Being tested
- Intraperitoneal onlay mesh (IPOM) repair with the use of Phisiomesh implant and Securestrap fixation device., Intraperitoneal onlay mesh (IPOM) repair with the use of Ventralight ST implant with SorbaFix fixation device., Ventralight ST implant, ETHICON PHYSIOMESH®
- Keywords
- Laparoscopic hernia repair, Ventral hernia, Incisional hernia, IPOM
- Medical subject headings
- Hernia, Abdominal, Hernia, Ventral, Incisional Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraperitoneal onlay mesh (IPOM) repair with the use of Phisiomesh implant and Securestrap fixation device.Procedure or surgery
Also called ETHICON PHYSIOMESH® Flexible Composite Mesh, ETHICON SECURESTRAP® Fixation Device
Laparoscopic intraperitoneal onlay mesh repair for abdominal wall hernia with the use of specially designed mesh and fixation device systems: Physiomesh (mesh implant) and Securestrap (fixation device)
Intraperitoneal onlay mesh (IPOM) repair with the use of Ventralight ST implant with SorbaFix fixation device.Procedure or surgery
Also called BARD DAVOL INC., VENTRALIGHT™ ST Mesh, Proven Sepra® Technology in a Low Profile, Lightweight Mesh, ECHO PS™ Positioning System
Laparoscopic intraperitoneal onlay mesh repair for abdominal wall hernia with the use of specially designed mesh and fixation device systems: Ventralight ST (mesh implant) and SofbaFix (fixation device)
Ventralight ST implantDevice
ETHICON PHYSIOMESH®Device
| Study group | Role | What they receive |
|---|---|---|
| PH | Active comparator | Intraperitoneal onlay mesh (IPOM) repair with the use of Phisiomesh implant and Securestrap fixation device. Receives: Procedure: Intraperitoneal onlay mesh (IPOM) repair with the use of Phisiomesh implant and Securestrap fixation device.; Device: ETHICON PHYSIOMESH® |
| VS | Active comparator | Intraperitoneal onlay mesh (IPOM) repair with the use of Ventralight ST implant with SorbaFix fixation device. Receives: Procedure: Intraperitoneal onlay mesh (IPOM) repair with the use of Ventralight ST implant with SorbaFix fixation device.; Device: Ventralight ST implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain
Presence of pain 7 days after the surgery.
Measured: 7 days after the surgery
Pain
Presence of pain 3 months after the surgery.
Measured: 3 months after the surgery
Secondary outcomes (6)
Number of Participants with Recurrences
The recurrence rate in one year followup.
Measured: up to one year
Number of Participants with complications.
The description and percentage distribution of short and long term complications following surgery.
Measured: up to one year
Pain intensity
Intensity of pain measured on a visual analogue scale 7 days after the surgery
Measured: 7 days after the surgery
Pain intensity
Intensity of pain measured on a visual analogue scale 30 days after the surgery
Measured: 30 days after the surgery
Pain intensity
Intensity of pain measured on a visual analogue scale 3 months after the surgery.
Measured: 3 months after the surgery
Pain intensity
Intensity of pain measured on a visual analogue scale 6 months after the surgery.
Measured: 6 months after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2014 (estimated)
- Study startNov 2012
- Primary completionFeb 2014
- Study completionFeb 2014
Why it stopped: The high recurrence rate and the findings during the reoperations were considered as serious adverse events and were the reason for study termination.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Hernia, AbdominalStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Polish Hernia Study Group
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maciej Pawlak, Polish Hernia Study Group
- Investigators
- Maciej Pawlak, MD, Principal investigatorMaciej Śmietański, PhD, Study director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02233569
- Sponsor's protocol ID
- PHvsVS
- Status last verified
- Sep 2014
- First submitted
- 29 Aug 2014
- Last updated
- 8 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bansal VK, Misra MC, Kumar S, Rao YK, Singhal P, Goswami A, Guleria S, Arora MK, Chabra A. A prospective randomized study comparing suture mesh fixation versus tacker mesh fixation for laparoscopic repair of incisional and ventral hernias. Surg Endosc. 2011 May;25(5):1431-8. doi: 10.1007/s00464-010-1410-6. Epub 2010 Oct 26.
PubMed 20976495Beldi G, Wagner M, Bruegger LE, Kurmann A, Candinas D. Mesh shrinkage and pain in laparoscopic ventral hernia repair: a randomized clinical trial comparing suture versus tack mesh fixation. Surg Endosc. 2011 Mar;25(3):749-55. doi: 10.1007/s00464-010-1246-0. Epub 2010 Jul 23.
PubMed 20652715Bellows CF, Berger DH. Infiltration of suture sites with local anesthesia for management of pain following laparoscopic ventral hernia repairs: a prospective randomized trial. JSLS. 2006 Jul-Sep;10(3):345-50.
PubMed 17212893Byrd JF, Agee N, Swan RZ, Lau KN, Heath JJ, Mckillop IH, Sindram D, Martinie JB, Iannitti DA. Evaluation of absorbable and permanent mesh fixation devices: adhesion formation and mechanical strength. Hernia. 2011 Oct;15(5):553-8. doi: 10.1007/s10029-011-0826-9. Epub 2011 May 19.
PubMed 21594698Carter SA, Hicks SC, Brahmbhatt R, Liang MK. Recurrence and pseudorecurrence after laparoscopic ventral hernia repair: predictors and patient-focused outcomes. Am Surg. 2014 Feb;80(2):138-48.
PubMed 24480213Chelala E, Debardemaeker Y, Elias B, Charara F, Dessily M, Alle JL. Eighty-five redo surgeries after 733 laparoscopic treatments for ventral and incisional hernia: adhesion and recurrence analysis. Hernia. 2010 Apr;14(2):123-9. doi: 10.1007/s10029-010-0637-4. Epub 2010 Feb 14.
PubMed 20155431Clarke T, Katkhouda N, Mason RJ, Cheng BC, Algra J, Olasky J, Sohn HJ, Moazzez A, Balouch M. Fibrin glue for intraperitoneal laparoscopic mesh fixation: a comparative study in a swine model. Surg Endosc. 2011 Mar;25(3):737-48. doi: 10.1007/s00464-010-1244-2. Epub 2010 Jul 31.
PubMed 20680350Deeken CR, Abdo MS, Frisella MM, Matthews BD. Physicomechanical evaluation of absorbable and nonabsorbable barrier composite meshes for laparoscopic ventral hernia repair. Surg Endosc. 2011 May;25(5):1541-52. doi: 10.1007/s00464-010-1432-0. Epub 2010 Oct 26.
PubMed 20976479Deeken CR, Matthews BD. Ventralight ST and SorbaFix versus Physiomesh and Securestrap in a porcine model. JSLS. 2013 Oct-Dec;17(4):549-59. doi: 10.4293/108680813X13693422520125.
PubMed 24398196Eriksen JR, Bech JI, Linnemann D, Rosenberg J. Laparoscopic intraperitoneal mesh fixation with fibrin sealant (Tisseel) vs. titanium tacks: a randomised controlled experimental study in pigs. Hernia. 2008 Oct;12(5):483-91. doi: 10.1007/s10029-008-0375-z. Epub 2008 May 16.
PubMed 18483783Eriksen JR, Poornoroozy P, Jorgensen LN, Jacobsen B, Friis-Andersen HU, Rosenberg J. Pain, quality of life and recovery after laparoscopic ventral hernia repair. Hernia. 2009 Feb;13(1):13-21. doi: 10.1007/s10029-008-0414-9. Epub 2008 Aug 1.
PubMed 18670733Hanna EM, Voeller GR, Roth JS, Scott JR, Gagne DH, Iannitti DA. Evaluation of ECHO PS Positioning System in a Porcine Model of Simulated Laparoscopic Ventral Hernia Repair. ISRN Surg. 2013 May 23;2013:862549. doi: 10.1155/2013/862549. Print 2013.
PubMed 23762628Liang MK, Clapp M, Li LT, Berger RL, Hicks SC, Awad S. Patient Satisfaction, chronic pain, and functional status following laparoscopic ventral hernia repair. World J Surg. 2013 Mar;37(3):530-7. doi: 10.1007/s00268-012-1873-9.
PubMed 23212794Muysoms FE, Miserez M, Berrevoet F, Campanelli G, Champault GG, Chelala E, Dietz UA, Eker HH, El Nakadi I, Hauters P, Hidalgo Pascual M, Hoeferlin A, Klinge U, Montgomery A, Simmermacher RK, Simons MP, Smietanski M, Sommeling C, Tollens T, Vierendeels T, Kingsnorth A. Classification of primary and incisional abdominal wall hernias. Hernia. 2009 Aug;13(4):407-14. doi: 10.1007/s10029-009-0518-x. Epub 2009 Jun 3.
PubMed 19495920Smietanski M, Bigda J, Iwan K, Kolodziejczyk M, Krajewski J, Smietanska IA, Gumiela P, Bury K, Bielecki S, Sledzinski Z. Assessment of usefulness exhibited by different tacks in laparoscopic ventral hernia repair. Surg Endosc. 2007 Jun;21(6):925-8. doi: 10.1007/s00464-006-9055-1. Epub 2007 Jan 23.
PubMed 17242988
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COMPARISON OF TWO DIFFERENT CONCEPTS OF MESH AND FIXATION TECHNIQUE IN THE LAPAROSCOPIC OPERATIONS FOR VENTRAL AND INCISIONAL HERNIA - A RANDOMIZED CONTROLLED MONOCENTER TRIAL.
- ClinicalTrials.gov ID
- NCT02233569
- Acronym / sponsor ID
- PHvsVS
- Conditions
- Hernia, Abdominal, Hernia,Ventral
- Keywords
- Laparoscopic hernia repair, Ventral hernia, Incisional hernia, IPOM
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The high recurrence rate and the findings during the reoperations were considered as serious adverse events and were the reason for study termination.
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Polish Hernia Study GroupUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 8 Sep 2014 (estimated)
- 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 is a monocenter randomized controlled trial comparing two systems of mesh and fixation device for the laparoscopic ventral and incisional hernia repair with respect to pain. It has been designed as a superiority study to proof the concept of previously published mathematical model of front abdominal wall.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PH | Active comparator | Procedure: Intraperitoneal onlay mesh (IPOM) repair with the use of Phisiomesh implant and Securestrap fixation device., Device: ETHICON PHYSIOMESH®Intraperitoneal onlay mesh (IPOM) repair with the use of Phisiomesh implant and Securestrap fixation device. |
| VS | Active comparator | Procedure: Intraperitoneal onlay mesh (IPOM) repair with the use of Ventralight ST implant with SorbaFix fixation device., Device: Ventralight ST implantIntraperitoneal onlay mesh (IPOM) repair with the use of Ventralight ST implant with SorbaFix fixation device. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Informed Consent Form (ICF) signed by the patient or his/her legal representative
- primary or secondary ventral hernia less than 20 cm in length and less than 11 cm in width requiring elective surgical repair
- recurrence after former abdominal hernia repair WITH MESH
- recurrence after suture abdominal hernia repair CAN be included
Key exclusion criteria (7 listed)
- no written informed consent
- patient under 18 years old
- emergency surgery (incarcerated hernia)
- patients with expected life time shorter than one year for example due to generalised malignancy
- BMI exceeding 40.0kg/m²
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 |
|---|---|---|
| Intraperitoneal onlay mesh (IPOM) repair with the use of Phisiomesh implant and Securestrap fixation device.Also: ETHICON PHYSIOMESH® Flexible Composite Mesh, ETHICON SECURESTRAP® Fixation DeviceLaparoscopic intraperitoneal onlay mesh repair for abdominal wall hernia with the use of specially designed mesh and fixation device systems: Physiomesh (mesh implant) and Securestrap (fixation device) | Procedure or surgery | PH |
| Intraperitoneal onlay mesh (IPOM) repair with the use of Ventralight ST implant with SorbaFix fixation device.Also: BARD DAVOL INC., VENTRALIGHT™ ST Mesh, Proven Sepra® Technology in a Low Profile, Lightweight Mesh, ECHO PS™ Positioning SystemLaparoscopic intraperitoneal onlay mesh repair for abdominal wall hernia with the use of specially designed mesh and fixation device systems: Ventralight ST (mesh implant) and SofbaFix (fixation device) | Procedure or surgery | VS |
| Ventralight ST implant | Device | VS |
| ETHICON PHYSIOMESH® | Device | PH |
Primary outcome
Pain
Time frame: 7 days after the surgery
Presence of pain 7 days after the surgery.
Pain
Time frame: 3 months after the surgery
Presence of pain 3 months after the surgery.
6 secondary outcomes
Number of Participants with Recurrences
Time frame: up to one year
Number of Participants with complications.
Time frame: up to one year
Pain intensity
Time frame: 7 days after the surgery
Pain intensity
Time frame: 30 days after the surgery
Pain intensity
Time frame: 3 months after the surgery
Pain intensity
Time frame: 6 months after the surgery
Results and safety
The study was stopped early (reason given: The high recurrence rate and the findings during the reoperations were considered as serious adverse events and were the reason for study termination.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2014.
- Background: PubMed 20976495Bansal VK, Misra MC, Kumar S, Rao YK, Singhal P, Goswami A, Guleria S, Arora MK, Chabra A. A prospective randomized study comparing suture mesh fixation versus tacker mesh fixation for laparoscopic repair of incisional and ventral hernias. Surg Endosc. 2011 May;25(5):1431-8. doi: 10.1007/s00464-010-1410-6. Epub 2010 Oct 26.
- Background: PubMed 20652715Beldi G, Wagner M, Bruegger LE, Kurmann A, Candinas D. Mesh shrinkage and pain in laparoscopic ventral hernia repair: a randomized clinical trial comparing suture versus tack mesh fixation. Surg Endosc. 2011 Mar;25(3):749-55. doi: 10.1007/s00464-010-1246-0. Epub 2010 Jul 23.
- Background: PubMed 17212893Bellows CF, Berger DH. Infiltration of suture sites with local anesthesia for management of pain following laparoscopic ventral hernia repairs: a prospective randomized trial. JSLS. 2006 Jul-Sep;10(3):345-50.
- Background: PubMed 21594698Byrd JF, Agee N, Swan RZ, Lau KN, Heath JJ, Mckillop IH, Sindram D, Martinie JB, Iannitti DA. Evaluation of absorbable and permanent mesh fixation devices: adhesion formation and mechanical strength. Hernia. 2011 Oct;15(5):553-8. doi: 10.1007/s10029-011-0826-9. Epub 2011 May 19.
- Background: PubMed 24480213Carter SA, Hicks SC, Brahmbhatt R, Liang MK. Recurrence and pseudorecurrence after laparoscopic ventral hernia repair: predictors and patient-focused outcomes. Am Surg. 2014 Feb;80(2):138-48.
- Background: PubMed 20155431Chelala E, Debardemaeker Y, Elias B, Charara F, Dessily M, Alle JL. Eighty-five redo surgeries after 733 laparoscopic treatments for ventral and incisional hernia: adhesion and recurrence analysis. Hernia. 2010 Apr;14(2):123-9. doi: 10.1007/s10029-010-0637-4. Epub 2010 Feb 14.
- Background: PubMed 20680350Clarke T, Katkhouda N, Mason RJ, Cheng BC, Algra J, Olasky J, Sohn HJ, Moazzez A, Balouch M. Fibrin glue for intraperitoneal laparoscopic mesh fixation: a comparative study in a swine model. Surg Endosc. 2011 Mar;25(3):737-48. doi: 10.1007/s00464-010-1244-2. Epub 2010 Jul 31.
- Background: PubMed 20976479Deeken CR, Abdo MS, Frisella MM, Matthews BD. Physicomechanical evaluation of absorbable and nonabsorbable barrier composite meshes for laparoscopic ventral hernia repair. Surg Endosc. 2011 May;25(5):1541-52. doi: 10.1007/s00464-010-1432-0. Epub 2010 Oct 26.
- Background: PubMed 24398196Deeken CR, Matthews BD. Ventralight ST and SorbaFix versus Physiomesh and Securestrap in a porcine model. JSLS. 2013 Oct-Dec;17(4):549-59. doi: 10.4293/108680813X13693422520125.
- Background: PubMed 18483783Eriksen JR, Bech JI, Linnemann D, Rosenberg J. Laparoscopic intraperitoneal mesh fixation with fibrin sealant (Tisseel) vs. titanium tacks: a randomised controlled experimental study in pigs. Hernia. 2008 Oct;12(5):483-91. doi: 10.1007/s10029-008-0375-z. Epub 2008 May 16.
- Background: PubMed 18670733Eriksen JR, Poornoroozy P, Jorgensen LN, Jacobsen B, Friis-Andersen HU, Rosenberg J. Pain, quality of life and recovery after laparoscopic ventral hernia repair. Hernia. 2009 Feb;13(1):13-21. doi: 10.1007/s10029-008-0414-9. Epub 2008 Aug 1.
- Background: PubMed 23762628Hanna EM, Voeller GR, Roth JS, Scott JR, Gagne DH, Iannitti DA. Evaluation of ECHO PS Positioning System in a Porcine Model of Simulated Laparoscopic Ventral Hernia Repair. ISRN Surg. 2013 May 23;2013:862549. doi: 10.1155/2013/862549. Print 2013.
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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.
Maciej Pawlak, MD principal investigator
Maciej Śmietański, PhD study director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intraperitoneal onlay mesh (IPOM) repair with the use of Phisiomesh implant and Securestrap fixation device., Intraperitoneal onlay mesh (IPOM) repair with the use of Ventralight ST implant with SorbaFix fixation device. and Ventralight ST implant in people with Hernia, Abdominal and Hernia,Ventral, run by Polish Hernia Study Group at 1 site in Poland.
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: stopped early, as of the sponsor's last update on 8 Sep 2014. 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 Poland. 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 was stopped early (reason given: The high recurrence rate and the findings during the reoperations were considered as serious adverse events and were the reason for study termination.). Results are not available in the source record.
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?
Pain (time frame: 7 days after the surgery). The study lists 2 primary outcomes in all. 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 NCT02233569, which also lists 17 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 8 Sep 2014.