Liver Transplant; ComplicationsDRALITNCT05688137
Abdominal Drainage in the Postoperative Period of Liver Transplantation (DRALIT)
A study testing Abdominal drainage in people with Liver Transplant; Complications and Drainage, run by Hospital Universitario Virgen de la Arrixaca.
Trial summary
Classically, in the postoperative period of liver transplantation (LT), abdominal drainage has been used as a way to make the early diagnosis of hemorrhages, bile leaks and other postsurgical complications, as well as an evacuation route for ascites. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Liver Transplant; Complications, Drainage
- What is being tested?
- Abdominal drainage
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 365 participants
- Where
- No sites listed yet
- Study dates
- 15 Jan 2023to 1 Jul 2024
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients of both sexes aged between 18 and 75 years included in the waiting list for HT by the committee of the Virgen de la Arrixaca University Hospital.
- Sign Informed Consent.
Who cannot join
- Having been rejected for liver transplantation by said committee.
- Age less than 18 years or greater than 75.
- Any contraindication by the main surgeon that makes the placement of an intra-abdominal drain necessary.
- Not having signed the Informed Consent.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Abdominal Drainage in the Postoperative Period of Liver Transplantation (DRALIT): Multi-institutional Randomized Clinical Trial
Classically, in the postoperative period of liver transplantation (LT), abdominal drainage has been used as a way to make the early diagnosis of hemorrhages, bile leaks and other postsurgical complications, as well as an evacuation route for ascites. The use of it routinely is currently under discussion due to the morbidities associated with its use.
Read the detailed description
LT has become in recent years a procedure with an increasing number of indications and with a greater number of donations given the social knowledge of the donation process and donation in controlled asystole. The Spanish Registry of Liver Transplantation (RETH) shows a total of 28,609 TH in the period 1986-2019, which represents an average of 867 TH per year in Spain. These data place Spain among the first countries in terms of HT.
In LT, abdominal drainage has historically been used prophylactically as a way to identify early intra-abdominal postoperative complications such as hemorrhage, bile leakage, and others.
In transplant patients, the use of post-surgical abdominal drains on a routine basis has shown an increase in total protein losses in patients with refractory ascites, an increase in ascending infections secondary to drainage, infection and pain at the insertion point of the drain, as well as as, an increase in hospital stay. Nor can a higher rate of postsurgical bleeding and bile leakage be ruled out in patients with abdominal drainage.
Currently, in the few studies that there are in reference to the systematic use of abdominal drains in lTH, the need for them prophylactically is being discussed as an early diagnosis of postoperative intra-abdominal complications is not observed, but complications are seen to increase secondary to drainage. Therefore, the need to use it systematically in all patients is currently under discussion.
Currently, is facing an increase in ERASⓇ (Enhanced Recovery After Surgey) programs, which began in 2008 with colorectal surgery and are currently expanding to other surgical procedures. These programs advocate reducing the number of drains and even not using them in patients with a low risk of post-surgical complications.
In the current bibliography, the methodology of the studies is varied, with the majority being non-randomized retrospective studies, which is why it is a subject that requires studies with a better methodological design and a higher number of patients to obtain conclusions of clinical relevance. that can set the direction in this area that is in constant discussion.
Given the absence of any randomized non-inferiority clinical trial that studies the routine use of abdominal drainage in the postoperative period of liver transplantation, consider that it is necessary to carry it out to increase the evidence.
The number of HT performed in each center is limited and variable annually, which is why consider that the best design for this clinical trial is a European multicenter.
- Conditions
- Liver Transplant; Complications, Drainage
- Being tested
- Abdominal drainage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abdominal drainageProcedure or surgery
The patients with intervention will take an abdominal drainage.
| Study group | Role | What they receive |
|---|---|---|
| DRAINAGE GROUP (D) | Active comparator | This patients will take the abdominal drainage. Receives: Procedure: Abdominal drainage |
| NON DRAINAGE GROUP (ND) | No intervention | This patients will not take the abdominal drainage. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abdominal drainage complications
To assess whether the prophylactic use of abdominal drains in the postoperative period of LT increases the number of abdominal complications in the 90 postoperative days (Clavien-Dindo)
Measured: 90 days
Secondary outcomes (2)
Assessment of quality of life (QoL) during the perioperative process using the SF-36 questionnaire.
Assessment of the quality of life (QoL) of transplant recipients, whether or not they are drainage recipients, during the perioperative process using the SF-36 questionnaire.
Measured: 120 days
Evaluation of in-hospital stay after surgery.
Evaluate the postoperative stay in both groups from the hospital admission to discharge measured in days of admission.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2023
- Study start15 Jan 2023 (estimated)
- Primary completion1 Jul 2024 (estimated)
- Study completion1 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Liver Transplant; ComplicationsStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2 groups of equal size, total n = 365 patients. Simple intraoperative randomization prior to closure of the abdominal wall after fulfilling all the inclusion criteria and none of the exclusion criteria.
- Masking
- None (open label)
- Enrolment
- 365 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Virgen de la Arrixaca
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alvaro Cerezuela Fernandez de Palencia, Hospital Universitario Virgen de la Arrixaca
- Investigators
- Álvaro Cerezuela Fernández de Palencia, Principal investigator, Hospital Universitario Virgen de la Arrixaca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05688137
- Sponsor's protocol ID
- 2022-3-9-HCUVA
- Acronym
- DRALIT
- Status last verified
- Jan 2023
- First submitted
- 31 May 2022
- Last updated
- 18 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hobeika C, Cauchy F, Weiss E, Chopinet S, Sepulveda A, Dondero F, Khoy-Ear L, Grigoresco B, Dokmak S, Durand F, Le Roy B, Paugam-Burtz C, Soubrane O. Practical model to identify liver transplant recipients at low risk of postoperative haemorrhage, bile leakage and ascites. BJS Open. 2021 Jan 8;5(1):zraa031. doi: 10.1093/bjsopen/zraa031.
PubMed 33609380Schwarz C, Soliman T, Gyori G, Silberhumer G, Schoppmann SF, Muhlbacher F, Berlakovich GA. Abdominal drainage after liver transplantation from deceased donors. Langenbecks Arch Surg. 2015 Oct;400(7):813-9. doi: 10.1007/s00423-015-1338-3. Epub 2015 Sep 4.
PubMed 26341224Rodriguez-Laiz GP, Melgar-Requena P, Alcazar-Lopez CF, Franco-Campello M, Villodre-Tudela C, Pascual-Bartolome S, Bellot-Garcia P, Rodriguez-Soler M, Miralles-Macia CF, Mas-Serrano P, Navarro-Martinez JA, Martinez-Adsuar FJ, Gomez-Salinas L, Jaime-Sanchez FA, Perdiguero-Gil M, Diaz-Cuevas M, Palazon-Azorin JM, Such-Ronda J, Lluis-Casajuana F, Ramia-Angel JM. Fast-Track Liver Transplantation: Six-year Prospective Cohort Study with an Enhanced Recovery After Surgery (ERAS) Protocol. World J Surg. 2021 May;45(5):1262-1271. doi: 10.1007/s00268-021-05963-2. Epub 2021 Feb 23.
PubMed 33620540Gurusamy KS, Naik P, Davidson BR. Routine drainage for orthotopic liver transplantation. Cochrane Database Syst Rev. 2011 Jun 15;(6):CD008399. doi: 10.1002/14651858.CD008399.pub2.
PubMed 21678376Arita J, Sakamaki K, Saiura A, Konishi M, Sakamoto Y, Hashimoto M, Sano T, Uesaka K, Kokudo N, Yamanaka T, Shimada K. Drain Placement After Uncomplicated Hepatic Resection Increases Severe Postoperative Complication Rate: A Japanese Multi-institutional Randomized Controlled Trial (ND-trial). Ann Surg. 2021 Feb 1;273(2):224-231. doi: 10.1097/SLA.0000000000004051.
PubMed 33064385Weiss S, Messner F, Huth M, Weissenbacher A, Denecke C, Aigner F, Brandl A, Dziodzio T, Sucher R, Boesmueller C, Oellinger R, Schneeberger S, Oefner D, Pratschke J, Biebl M. Impact of abdominal drainage systems on postoperative complication rates following liver transplantation. Eur J Med Res. 2015 Aug 21;20(1):66. doi: 10.1186/s40001-015-0163-z.
PubMed 26293656Brustia R, Monsel A, Skurzak S, Schiffer E, Carrier FM, Patrono D, Kaba A, Detry O, Malbouisson L, Andraus W, Vandenbroucke-Menu F, Biancofiore G, Kaido T, Compagnon P, Uemoto S, Rodriguez Laiz G, De Boer M, Orloff S, Melgar P, Buis C, Zeillemaker-Hoekstra M, Usher H, Reyntjens K, Baird E, Demartines N, Wigmore S, Scatton O. Guidelines for Perioperative Care for Liver Transplantation: Enhanced Recovery After Surgery (ERAS) Recommendations. Transplantation. 2022 Mar 1;106(3):552-561. doi: 10.1097/TP.0000000000003808.
PubMed 33966024Tang R, Yu LH, Han JW, Lin JY, An JJ, Lu Q. Abdominal drainage systems in modified piggyback orthotopic liver transplantation. Hepatobiliary Pancreat Dis Int. 2021 Feb;20(1):99-102. doi: 10.1016/j.hbpd.2020.09.003. Epub 2020 Sep 13. No abstract available.
PubMed 32967814Fernandez-Aguilar JL, Suarez Munoz MA, Santoyo Santoyo J, Sanchez-Perez B, Perez-Daga JA, Aranda Narvaez JM, Ramirez Plaza C, Becerra Ortiz R, Titos Garcia A, Gonzalez Sanchez A, Montiel Casado C. Is liver transplantation without abdominal drainage safe? Transplant Proc. 2010 Mar;42(2):647-8. doi: 10.1016/j.transproceed.2010.02.007.
PubMed 20304214Fernandez-Aguilar JL, Suarez-Munoz MA, Sanchez-Perez B, Gamez Cordoba E, Pulido Roa Y, Aranda Narvaez J, Perez Daga A, Montiel Casado C, Gonzalez Sanchez A, Santoyo Santoyo J. Liver transplantation without abdominal drainage. Transplant Proc. 2012 Nov;44(9):2542-4. doi: 10.1016/j.transproceed.2012.09.039.
PubMed 23146448Liu CL, Fan ST, Lo CM, Wong Y, Ng IO, Lam CM, Poon RT, Wong J. Abdominal drainage after hepatic resection is contraindicated in patients with chronic liver diseases. Ann Surg. 2004 Feb;239(2):194-201. doi: 10.1097/01.sla.0000109153.71725.8c.
PubMed 14745327Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.
PubMed 15273542Petrowsky H, Demartines N, Rousson V, Clavien PA. Evidence-based value of prophylactic drainage in gastrointestinal surgery: a systematic review and meta-analyses. Ann Surg. 2004 Dec;240(6):1074-84; discussion 1084-5. doi: 10.1097/01.sla.0000146149.17411.c5.
PubMed 15570212de Rougemont O, Dutkowski P, Weber M, Clavien PA. Abdominal drains in liver transplantation: useful tool or useless dogma? A matched case-control study. Liver Transpl. 2009 Jan;15(1):96-101. doi: 10.1002/lt.21676.
PubMed 19109839Sanada Y, Mizuta K, Urahashi T, Umehara M, Wakiya T, Okada N, Hayashida M, Egami S, Hishikawa S, Kawano Y, Ushijima K, Otomo S, Sakamoto K, Fujiwara T, Sakuma Y, Hyodo M, Yasuda Y, Kawarasaki H. Management of intra-abdominal drain after living donor liver transplantation. Transplant Proc. 2010 Dec;42(10):4555-9. doi: 10.1016/j.transproceed.2010.09.159.
PubMed 21168736
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Abdominal Drainage in the Postoperative Period of Liver Transplantation (DRALIT): Multi-institutional Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05688137
- Acronym / sponsor ID
- DRALIT / 2022-3-9-HCUVA
- Conditions
- Liver Transplant; Complications, Drainage
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 365 participants (estimated)
- Lead sponsor
- Hospital Universitario Virgen de la ArrixacaUniversity, hospital or other
- Study start
- 15 Jan 2023 (estimated)
- Primary completion
- 1 Jul 2024 (estimated)
- Study completion
- 1 Jul 2024 (estimated)
- First posted
- 18 Jan 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.
Classically, in the postoperative period of liver transplantation (LT), abdominal drainage has been used as a way to make the early diagnosis of hemorrhages, bile leaks and other postsurgical complications, as well as an evacuation route for ascites. The use of it routinely is currently under discussion due to the morbidities associated with its use.
Detailed description
LT has become in recent years a procedure with an increasing number of indications and with a greater number of donations given the social knowledge of the donation process and donation in controlled asystole. The Spanish Registry of Liver Transplantation (RETH) shows a total of 28,609 TH in the period 1986-2019, which represents an average of 867 TH per year in Spain. These data place Spain among the first countries in terms of HT.
In LT, abdominal drainage has historically been used prophylactically as a way to identify early intra-abdominal postoperative complications such as hemorrhage, bile leakage, and others.
In transplant patients, the use of post-surgical abdominal drains on a routine basis has shown an increase in total protein losses in patients with refractory ascites, an increase in ascending infections secondary to drainage, infection and pain at the insertion point of the drain, as well as as, an increase in hospital stay. Nor can a higher rate of postsurgical bleeding and bile leakage be ruled out in patients with abdominal drainage.
Currently, in the few studies that there are in reference to the systematic use of abdominal drains in lTH, the need for them prophylactically is being discussed as an early diagnosis of postoperative intra-abdominal complications is not observed, but complications are seen to increase secondary to drainage. Therefore, the need to use it systematically in all patients is currently under discussion.
Currently, is facing an increase in ERASⓇ (Enhanced Recovery After Surgey) programs, which began in 2008 with colorectal surgery and are currently expanding to other surgical procedures. These programs advocate reducing the number of drains and even not using them in patients with a low risk of post-surgical complications.
In the current bibliography, the methodology of the studies is varied, with the majority being non-randomized retrospective studies, which is why it is a subject that requires studies with a better methodological design and a higher number of patients to obtain conclusions of clinical relevance. that can set the direction in this area that is in constant discussion.
Given the absence of any randomized non-inferiority clinical trial that studies the routine use of abdominal drainage in the postoperative period of liver transplantation, consider that it is necessary to carry it out to increase the evidence.
The number of HT performed in each center is limited and variable annually, which is why consider that the best design for this clinical trial is a European multicenter.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 2 groups of equal size, total n = 365 patients. Simple intraoperative randomization prior to closure of the abdominal wall after fulfilling all the inclusion criteria and none of the exclusion criteria.
| Arm | Type | Receives |
|---|---|---|
| DRAINAGE GROUP (D) | Active comparator | Procedure: Abdominal drainageThis patients will take the abdominal drainage. |
| NON DRAINAGE GROUP (ND) | No intervention | –This patients will not take the abdominal drainage. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients of both sexes aged between 18 and 75 years included in the waiting list for HT by the committee of the Virgen de la Arrixaca University Hospital.
- Sign Informed Consent.
Key exclusion criteria (4 listed)
- Having been rejected for liver transplantation by said committee.
- Age less than 18 years or greater than 75.
- Any contraindication by the main surgeon that makes the placement of an intra-abdominal drain necessary.
- Not having signed the Informed Consent.
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 |
|---|---|---|
| Abdominal drainageThe patients with intervention will take an abdominal drainage. | Procedure or surgery | DRAINAGE GROUP (D) |
Primary outcome
Abdominal drainage complications
Time frame: 90 days
To assess whether the prophylactic use of abdominal drains in the postoperative period of LT increases the number of abdominal complications in the 90 postoperative days (Clavien-Dindo)
2 secondary outcomes
Assessment of quality of life (QoL) during the perioperative process using the SF-36 questionnaire.
Time frame: 120 days
Evaluation of in-hospital stay after surgery.
Time frame: 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2023.
- Background: PubMed 33609380Hobeika C, Cauchy F, Weiss E, Chopinet S, Sepulveda A, Dondero F, Khoy-Ear L, Grigoresco B, Dokmak S, Durand F, Le Roy B, Paugam-Burtz C, Soubrane O. Practical model to identify liver transplant recipients at low risk of postoperative haemorrhage, bile leakage and ascites. BJS Open. 2021 Jan 8;5(1):zraa031. doi: 10.1093/bjsopen/zraa031.
- Background: PubMed 26341224Schwarz C, Soliman T, Gyori G, Silberhumer G, Schoppmann SF, Muhlbacher F, Berlakovich GA. Abdominal drainage after liver transplantation from deceased donors. Langenbecks Arch Surg. 2015 Oct;400(7):813-9. doi: 10.1007/s00423-015-1338-3. Epub 2015 Sep 4.
- Background: PubMed 33620540Rodriguez-Laiz GP, Melgar-Requena P, Alcazar-Lopez CF, Franco-Campello M, Villodre-Tudela C, Pascual-Bartolome S, Bellot-Garcia P, Rodriguez-Soler M, Miralles-Macia CF, Mas-Serrano P, Navarro-Martinez JA, Martinez-Adsuar FJ, Gomez-Salinas L, Jaime-Sanchez FA, Perdiguero-Gil M, Diaz-Cuevas M, Palazon-Azorin JM, Such-Ronda J, Lluis-Casajuana F, Ramia-Angel JM. Fast-Track Liver Transplantation: Six-year Prospective Cohort Study with an Enhanced Recovery After Surgery (ERAS) Protocol. World J Surg. 2021 May;45(5):1262-1271. doi: 10.1007/s00268-021-05963-2. Epub 2021 Feb 23.
- Background: PubMed 21678376Gurusamy KS, Naik P, Davidson BR. Routine drainage for orthotopic liver transplantation. Cochrane Database Syst Rev. 2011 Jun 15;(6):CD008399. doi: 10.1002/14651858.CD008399.pub2.
- Background: PubMed 33064385Arita J, Sakamaki K, Saiura A, Konishi M, Sakamoto Y, Hashimoto M, Sano T, Uesaka K, Kokudo N, Yamanaka T, Shimada K. Drain Placement After Uncomplicated Hepatic Resection Increases Severe Postoperative Complication Rate: A Japanese Multi-institutional Randomized Controlled Trial (ND-trial). Ann Surg. 2021 Feb 1;273(2):224-231. doi: 10.1097/SLA.0000000000004051.
- Background: PubMed 26293656Weiss S, Messner F, Huth M, Weissenbacher A, Denecke C, Aigner F, Brandl A, Dziodzio T, Sucher R, Boesmueller C, Oellinger R, Schneeberger S, Oefner D, Pratschke J, Biebl M. Impact of abdominal drainage systems on postoperative complication rates following liver transplantation. Eur J Med Res. 2015 Aug 21;20(1):66. doi: 10.1186/s40001-015-0163-z.
- Background: PubMed 33966024Brustia R, Monsel A, Skurzak S, Schiffer E, Carrier FM, Patrono D, Kaba A, Detry O, Malbouisson L, Andraus W, Vandenbroucke-Menu F, Biancofiore G, Kaido T, Compagnon P, Uemoto S, Rodriguez Laiz G, De Boer M, Orloff S, Melgar P, Buis C, Zeillemaker-Hoekstra M, Usher H, Reyntjens K, Baird E, Demartines N, Wigmore S, Scatton O. Guidelines for Perioperative Care for Liver Transplantation: Enhanced Recovery After Surgery (ERAS) Recommendations. Transplantation. 2022 Mar 1;106(3):552-561. doi: 10.1097/TP.0000000000003808.
- Background: PubMed 32967814Tang R, Yu LH, Han JW, Lin JY, An JJ, Lu Q. Abdominal drainage systems in modified piggyback orthotopic liver transplantation. Hepatobiliary Pancreat Dis Int. 2021 Feb;20(1):99-102. doi: 10.1016/j.hbpd.2020.09.003. Epub 2020 Sep 13. No abstract available.
- Background: PubMed 20304214Fernandez-Aguilar JL, Suarez Munoz MA, Santoyo Santoyo J, Sanchez-Perez B, Perez-Daga JA, Aranda Narvaez JM, Ramirez Plaza C, Becerra Ortiz R, Titos Garcia A, Gonzalez Sanchez A, Montiel Casado C. Is liver transplantation without abdominal drainage safe? Transplant Proc. 2010 Mar;42(2):647-8. doi: 10.1016/j.transproceed.2010.02.007.
- Background: PubMed 23146448Fernandez-Aguilar JL, Suarez-Munoz MA, Sanchez-Perez B, Gamez Cordoba E, Pulido Roa Y, Aranda Narvaez J, Perez Daga A, Montiel Casado C, Gonzalez Sanchez A, Santoyo Santoyo J. Liver transplantation without abdominal drainage. Transplant Proc. 2012 Nov;44(9):2542-4. doi: 10.1016/j.transproceed.2012.09.039.
- Background: PubMed 14745327Liu CL, Fan ST, Lo CM, Wong Y, Ng IO, Lam CM, Poon RT, Wong J. Abdominal drainage after hepatic resection is contraindicated in patients with chronic liver diseases. Ann Surg. 2004 Feb;239(2):194-201. doi: 10.1097/01.sla.0000109153.71725.8c.
- Background: PubMed 15273542Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.
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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.
Álvaro Cerezuela Fernández de Palencia principal investigator
Hospital Universitario Virgen de la Arrixaca
Questions about this trial
What is this clinical trial studying?
A study testing Abdominal drainage in people with Liver Transplant; Complications and Drainage, run by Hospital Universitario Virgen de la Arrixaca.
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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 18 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Álvaro F Cerezuela Fernández de Palencia (620047702 ext. +34, alvaro.cerezuela@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Abdominal drainage complications (time frame: 90 days). 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 NCT05688137, which also lists 18 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 18 Jan 2023.