Acute Kidney InjuryPhase 4NCT06254183
Effect of Gabapentin on Kidney Function Following Laparoscopic Sleeve Gastrectomy (LSG)
A Phase 4 study testing Laparoscopic Sleeve Gastrectomy and gabapentin 1200 mg in people with Acute Kidney Injury and Obesity, run by Tanta University at 2 sites in Egypt.
Trial summary
This study evaluated the effect of a single preoperative dose of gabapentin on renal stress and kidney function following laparoscopic sleeve gastrectomy in adults with severe obesity. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acute Kidney Injury, Obesity
- What is being tested?
- Laparoscopic Sleeve Gastrectomy and gabapentin 1200 mg
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 Dec 2024to 30 Nov 2025
- Phase
- Phase 4
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18-65 years old.
- Participants with severe obesity (BMI ≥40 kg/m², without comorbidities or BMI ≥35 kg/m², in the presence of obesity-related comorbidities).
- Preserved kidney function at baseline.
- For the randomized surgical cohort (Groups II and III), participants with severe obesity scheduled to undergo laparoscopic sleeve gastrectomy.
- For the non-randomized external reference cohort (Group I), participants with severe obesity who did not undergo laparoscopic sleeve gastrectomy during the study period or receive the study intervention.
- Both sexes.
Who cannot join
- Advanced cancer receiving active treatment.
- End-stage renal, hepatic, or cardiopulmonary disease.
- Untreated schizophrenia or cognitive impairment.
- Use of psychiatric medications, as specified in the study protocol.
- Active substance abuse.
- Chronic use of gabapentin or known hypersensitivity to gabapentin.
- Pregnancy or breastfeeding.
- Use of medications that could interfere with the assessed study parameter
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Mansoura University hospitals
Al Mansurah
Tanta University hospitals
Tanta
About this study
Official title: Clinical Study Evaluating the Effect of Gabapentin on Kidney Function Following Laparoscopic Sleeve Gastrectomy (LSG) for Morbid Obese Patients
This study evaluated the effect of a single preoperative dose of gabapentin on renal stress and kidney function following laparoscopic sleeve gastrectomy in adults with severe obesity. Sixty participants undergoing laparoscopic sleeve gastrectomy were randomized in a 1:1 ratio to surgery without preoperative gabapentin or surgery after a single 1200-mg oral dose of gabapentin. An additional 30 non-operative participants with severe obesity served as a non-randomized external reference cohort. Renal assessment included conventional kidney function markers and biomarkers, including Dickkopf-3 (DKK3) and neutrophil gelatinase-associated lipocalin (NGAL). The prespecified primary endpoint was urinary DKK3 concentration at 24 hours postoperatively.
Read the detailed description
Obesity is an important risk factor for kidney disease because it is strongly associated with diabetes and hypertension, two major causes of end-stage kidney disease (ESKD). Adults with severe obesity are at increased risk of diabetes compared with lean individuals. Laparoscopic sleeve gastrectomy (LSG) is an established surgical treatment for obesity and obesity-related diseases.
Acute kidney injury (AKI) is an important postoperative complication associated with prolonged hospital stay, increased hospital costs, higher mortality, and an increased risk of subsequent chronic kidney disease. Non-steroidal anti-inflammatory drugs (NSAIDs) are commonly used postoperatively and may contribute to renal adverse effects in susceptible patients.
Gabapentin is an anticonvulsant widely used for neuropathic pain and has also been investigated in the perioperative setting for reducing postoperative pain and opioid requirements. Experimental studies have suggested that gabapentin may influence pathways related to oxidative stress and renal injury; however, its effects on perioperative renal stress in clinical settings remain uncertain.
Neutrophil gelatinase-associated lipocalin (NGAL) and Dickkopf-3 (DKK3) were evaluated as biomarkers of renal stress and kidney injury. NGAL has been investigated as an early biomarker of AKI, whereas urinary DKK3 has been proposed as a marker of renal tubular stress and risk of kidney injury.
The study included 90 participants. Sixty participants undergoing LSG were randomized in a 1:1 ratio to LSG without preoperative gabapentin or LSG after a single 1200-mg oral dose of gabapentin approximately 1 hour preoperatively. An additional 30 participants with severe obesity who did not undergo surgery served as a non-randomized external reference cohort. Blood and urine samples were obtained at baseline, 24 hours postoperatively, and 6 months after surgery in the randomized surgical groups, whereas the external reference cohort underwent a single assessment at enrollment.
- Conditions
- Acute Kidney Injury, Obesity
- Being tested
- Laparoscopic Sleeve Gastrectomy, gabapentin 1200 mg
- Keywords
- Gabapentin, Preoperative Medication, Obesity Surgery, AKI, Postoperative Complications, Bariatric Surgery, Laparoscopic Sleeve Gastrectomy, Kidney stress
- Medical subject headings
- Acute Kidney Injury, Obesity, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic Sleeve GastrectomyProcedure or surgery
Also called Bariatric Surgery, LSG, Sleeve Gastrectomy
Standard laparoscopic sleeve gastrectomy performed under general anesthesia according to institutional protocol, with gastric resection over a calibration bougie.
gabapentin 1200 mgDrug
Also called Neurontin
A single oral dose of 1200 mg gabapentin administered approximately 1 hour prior to induction of anesthesia for laparoscopic sleeve gastrectomy.
| Study group | Role | What they receive |
|---|---|---|
| Group III (Gabapentin + LSG) | Experimental | Thirty participants underwent laparoscopic sleeve gastrectomy after receiving a single 1200-mg oral dose of gabapentin approximately 1 hour preoperatively. Blood and urine samples were collected at baseline before administration of gabapentin, 24 hours postoperatively, and at 6 months after surgery. Receives: Procedure: Laparoscopic Sleeve Gastrectomy; Drug: gabapentin 1200 mg |
| Group I (External reference cohort) | No intervention | Thirty participants with severe obesity who did not undergo laparoscopic sleeve gastrectomy and did not receive the study intervention. Blood and urine samples were collected once at enrollment. |
| Group II (LSG Only) | Active comparator | Thirty participants underwent laparoscopic sleeve gastrectomy without receiving preoperative gabapentin or placebo. Blood and urine samples were collected at baseline before surgery, 24 hours postoperatively, and at 6 months after surgery. Receives: Procedure: Laparoscopic Sleeve Gastrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary Dickkopf-3 (DKK3) concentration
Urinary DKK3 was measured by ELISA at baseline, 24 hours postoperatively, and 6 months after surgery. The prespecified primary endpoint was the 24-hour postoperative urinary DKK3 concentration, with the primary comparison performed between the two randomized surgical groups (Group II and Group III) after adjustment for baseline urinary DKK3
Measured: Baseline, 24 hours postoperatively, and 6 months after surgery
Secondary outcomes (5)
Serum Dickkopf-3 concentration
Serum DKK3 concentration was measured by ELISA as a biomarker of renal stress.
Measured: Baseline, 24 hours postoperatively, and 6 months after surgery
Serum neutrophil gelatinase-associated lipocalin (NGAL) concentration
Serum NGAL concentration was measured by ELISA as a biomarker of acute kidney injury.
Measured: Baseline, 24 hours postoperatively, and 6 months after surgery
Serum creatinine (SCr) concentration
Serum creatinine (SCr) was measured to assess kidney function in the randomized surgical groups.
Measured: Baseline and 24 hours postoperatively
Blood urea nitrogen (BUN) concentration
Blood urea nitrogen (BUN) was measured as a conventional marker of kidney function in the randomized surgical groups.
Measured: Baseline and 24 hours postoperatively
Estimated glomerular filtration rate (eGFR)
Estimated glomerular filtration rate (eGFR) was calculated from serum creatinine using the 2021 CKD-EPI creatinine equation to assess kidney function.
Measured: Baseline and 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2024
- Study start1 Dec 2024
- Primary completion1 May 2025
- Study completion30 Nov 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 Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were enrolled into three study groups. Sixty participants undergoing laparoscopic sleeve gastrectomy were randomized in a 1:1 ratio to Group II (LSG without preoperative gabapentin; n = 30) or Group III (LSG after a single 1200-mg oral dose of gabapentin approximately 1 hour preoperatively; n = 30). Group I comprised 30 participants with severe obesity who did not undergo surgery and served as a non-randomized external reference cohort.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kholoud Salah Ibrahim Amin, Delta University for Science and Technology
- Investigators
- Kholoud Salah Ibraahim Amin, Bsc., Principal investigator, Delta university for Sciences and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06254183
- Sponsor's protocol ID
- Gabapentin use in LSG
- Status last verified
- Aug 2026
- First submitted
- 22 Jan 2024
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kovesdy CP, Furth SL, Zoccali C; World Kidney Day Steering Committee. Obesity and kidney disease: hidden consequences of the epidemic. J Nephrol. 2017 Feb;30(1):1-10. doi: 10.1007/s40620-017-0377-y.
PubMed 28214961Kovesdy CP, Furth SL, Zoccali C. Obesity and kidney disease: hidden consequences of the epidemic. Braz J Med Biol Res. 2017 Apr 13;50(5):e6075. doi: 10.1590/1414-431X20166075.
PubMed 28423118Hassani V, Pazouki A, Nikoubakht N, Chaichian S, Sayarifard A, Shakib Khankandi A. The effect of gabapentin on reducing pain after laparoscopic gastric bypass surgery in patients with morbid obesity: a randomized clinical trial. Anesth Pain Med. 2015 Feb 1;5(1):e22372. doi: 10.5812/aapm.22372. eCollection 2015 Feb.
PubMed 25789237Rupniewska-Ladyko A, Malec-Milewska M, Kraszewska E, Pirozynski M. Gabapentin before laparoscopic sleeve gastrectomy reduces postoperative oxycodone consumption in obese patients: a randomized double-blind placebo-controlled trial. Minerva Anestesiol. 2018 May;84(5):565-571. doi: 10.23736/S0375-9393.17.12194-2. Epub 2017 Nov 6.
PubMed 29108405Zewinger S, Rauen T, Rudnicki M, Federico G, Wagner M, Triem S, Schunk SJ, Petrakis I, Schmit D, Wagenpfeil S, Heine GH, Mayer G, Floege J, Fliser D, Grone HJ, Speer T. Dickkopf-3 (DKK3) in Urine Identifies Patients with Short-Term Risk of eGFR Loss. J Am Soc Nephrol. 2018 Nov;29(11):2722-2733. doi: 10.1681/ASN.2018040405. Epub 2018 Oct 2.
PubMed 30279273Kim CS, Oak CY, Kim HY, Kang YU, Choi JS, Bae EH, Ma SK, Kweon SS, Kim SW. Incidence, predictive factors, and clinical outcomes of acute kidney injury after gastric surgery for gastric cancer. PLoS One. 2013 Dec 9;8(12):e82289. doi: 10.1371/journal.pone.0082289. eCollection 2013.
PubMed 24349249
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study Evaluating the Effect of Gabapentin on Kidney Function Following Laparoscopic Sleeve Gastrectomy (LSG) for Morbid Obese Patients
- ClinicalTrials.gov ID
- NCT06254183
- Acronym / sponsor ID
- Gabapentin use in LSG
- Conditions
- Acute Kidney Injury, Obesity
- Keywords
- Gabapentin, Preoperative Medication, Obesity Surgery, AKI, Postoperative Complications, Bariatric Surgery, Laparoscopic Sleeve Gastrectomy, Kidney stress
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 1 May 2025 (actual)
- Study completion
- 30 Nov 2025 (actual)
- First posted
- 12 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluated the effect of a single preoperative dose of gabapentin on renal stress and kidney function following laparoscopic sleeve gastrectomy in adults with severe obesity. Sixty participants undergoing laparoscopic sleeve gastrectomy were randomized in a 1:1 ratio to surgery without preoperative gabapentin or surgery after a single 1200-mg oral dose of gabapentin. An additional 30 non-operative participants with severe obesity served as a non-randomized external reference cohort. Renal assessment included conventional kidney function markers and biomarkers, including Dickkopf-3 (DKK3) and neutrophil gelatinase-associated lipocalin (NGAL). The prespecified primary endpoint was urinary DKK3 concentration at 24 hours postoperatively.
Detailed description
Obesity is an important risk factor for kidney disease because it is strongly associated with diabetes and hypertension, two major causes of end-stage kidney disease (ESKD). Adults with severe obesity are at increased risk of diabetes compared with lean individuals. Laparoscopic sleeve gastrectomy (LSG) is an established surgical treatment for obesity and obesity-related diseases.
Acute kidney injury (AKI) is an important postoperative complication associated with prolonged hospital stay, increased hospital costs, higher mortality, and an increased risk of subsequent chronic kidney disease. Non-steroidal anti-inflammatory drugs (NSAIDs) are commonly used postoperatively and may contribute to renal adverse effects in susceptible patients.
Gabapentin is an anticonvulsant widely used for neuropathic pain and has also been investigated in the perioperative setting for reducing postoperative pain and opioid requirements. Experimental studies have suggested that gabapentin may influence pathways related to oxidative stress and renal injury; however, its effects on perioperative renal stress in clinical settings remain uncertain.
Neutrophil gelatinase-associated lipocalin (NGAL) and Dickkopf-3 (DKK3) were evaluated as biomarkers of renal stress and kidney injury. NGAL has been investigated as an early biomarker of AKI, whereas urinary DKK3 has been proposed as a marker of renal tubular stress and risk of kidney injury.
The study included 90 participants. Sixty participants undergoing LSG were randomized in a 1:1 ratio to LSG without preoperative gabapentin or LSG after a single 1200-mg oral dose of gabapentin approximately 1 hour preoperatively. An additional 30 participants with severe obesity who did not undergo surgery served as a non-randomized external reference cohort. Blood and urine samples were obtained at baseline, 24 hours postoperatively, and 6 months after surgery in the randomized surgical groups, whereas the external reference cohort underwent a single assessment at enrollment.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Participants were enrolled into three study groups. Sixty participants undergoing laparoscopic sleeve gastrectomy were randomized in a 1:1 ratio to Group II (LSG without preoperative gabapentin; n = 30) or Group III (LSG after a single 1200-mg oral dose of gabapentin approximately 1 hour preoperatively; n = 30). Group I comprised 30 participants with severe obesity who did not undergo surgery and served as a non-randomized external reference cohort.
| Arm | Type | Receives |
|---|---|---|
| Group III (Gabapentin + LSG) | Experimental | Procedure: Laparoscopic Sleeve Gastrectomy, Drug: gabapentin 1200 mgThirty participants underwent laparoscopic sleeve gastrectomy after receiving a single 1200-mg oral dose of gabapentin approximately 1 hour preoperatively. Blood and urine samples were collected at baseline before administration of gabapentin, 24 hours postoperatively, and at 6 months after surgery. |
| Group I (External reference cohort) | No intervention | –Thirty participants with severe obesity who did not undergo laparoscopic sleeve gastrectomy and did not receive the study intervention. Blood and urine samples were collected once at enrollment. |
| Group II (LSG Only) | Active comparator | Procedure: Laparoscopic Sleeve GastrectomyThirty participants underwent laparoscopic sleeve gastrectomy without receiving preoperative gabapentin or placebo. Blood and urine samples were collected at baseline before surgery, 24 hours postoperatively, and at 6 months after surgery. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age: 18-65 years old.
- Participants with severe obesity (BMI ≥40 kg/m², without comorbidities or BMI ≥35 kg/m², in the presence of obesity-related comorbidities).
- Preserved kidney function at baseline.
- For the randomized surgical cohort (Groups II and III), participants with severe obesity scheduled to undergo laparoscopic sleeve gastrectomy.
- For the non-randomized external reference cohort (Group I), participants with severe obesity who did not undergo laparoscopic sleeve gastrectomy during the study period or receive the study intervention.
Key exclusion criteria (8 listed)
- Advanced cancer receiving active treatment.
- End-stage renal, hepatic, or cardiopulmonary disease.
- Untreated schizophrenia or cognitive impairment.
- Use of psychiatric medications, as specified in the study protocol.
- Active substance abuse.
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 |
|---|---|---|
| Laparoscopic Sleeve GastrectomyAlso: Bariatric Surgery, LSG, Sleeve GastrectomyStandard laparoscopic sleeve gastrectomy performed under general anesthesia according to institutional protocol, with gastric resection over a calibration bougie. | Procedure or surgery | Group II (LSG Only), Group III (Gabapentin + LSG) |
| gabapentin 1200 mgAlso: NeurontinA single oral dose of 1200 mg gabapentin administered approximately 1 hour prior to induction of anesthesia for laparoscopic sleeve gastrectomy. | Drug | Group III (Gabapentin + LSG) |
Primary outcome
Urinary Dickkopf-3 (DKK3) concentration
Time frame: Baseline, 24 hours postoperatively, and 6 months after surgery
Urinary DKK3 was measured by ELISA at baseline, 24 hours postoperatively, and 6 months after surgery. The prespecified primary endpoint was the 24-hour postoperative urinary DKK3 concentration, with the primary comparison performed between the two randomized surgical groups (Group II and Group III) after adjustment for baseline urinary DKK3
5 secondary outcomes
Serum Dickkopf-3 concentration
Time frame: Baseline, 24 hours postoperatively, and 6 months after surgery
Serum neutrophil gelatinase-associated lipocalin (NGAL) concentration
Time frame: Baseline, 24 hours postoperatively, and 6 months after surgery
Serum creatinine (SCr) concentration
Time frame: Baseline and 24 hours postoperatively
Blood urea nitrogen (BUN) concentration
Time frame: Baseline and 24 hours postoperatively
Estimated glomerular filtration rate (eGFR)
Time frame: Baseline and 24 hours postoperatively
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 18 Aug 2026.
- Background: PubMed 28214961Kovesdy CP, Furth SL, Zoccali C; World Kidney Day Steering Committee. Obesity and kidney disease: hidden consequences of the epidemic. J Nephrol. 2017 Feb;30(1):1-10. doi: 10.1007/s40620-017-0377-y.
- Background: PubMed 28423118Kovesdy CP, Furth SL, Zoccali C. Obesity and kidney disease: hidden consequences of the epidemic. Braz J Med Biol Res. 2017 Apr 13;50(5):e6075. doi: 10.1590/1414-431X20166075.
- Background: PubMed 25789237Hassani V, Pazouki A, Nikoubakht N, Chaichian S, Sayarifard A, Shakib Khankandi A. The effect of gabapentin on reducing pain after laparoscopic gastric bypass surgery in patients with morbid obesity: a randomized clinical trial. Anesth Pain Med. 2015 Feb 1;5(1):e22372. doi: 10.5812/aapm.22372. eCollection 2015 Feb.
- Background: PubMed 29108405Rupniewska-Ladyko A, Malec-Milewska M, Kraszewska E, Pirozynski M. Gabapentin before laparoscopic sleeve gastrectomy reduces postoperative oxycodone consumption in obese patients: a randomized double-blind placebo-controlled trial. Minerva Anestesiol. 2018 May;84(5):565-571. doi: 10.23736/S0375-9393.17.12194-2. Epub 2017 Nov 6.
- Background: PubMed 30279273Zewinger S, Rauen T, Rudnicki M, Federico G, Wagner M, Triem S, Schunk SJ, Petrakis I, Schmit D, Wagenpfeil S, Heine GH, Mayer G, Floege J, Fliser D, Grone HJ, Speer T. Dickkopf-3 (DKK3) in Urine Identifies Patients with Short-Term Risk of eGFR Loss. J Am Soc Nephrol. 2018 Nov;29(11):2722-2733. doi: 10.1681/ASN.2018040405. Epub 2018 Oct 2.
- Background: PubMed 24349249Kim CS, Oak CY, Kim HY, Kang YU, Choi JS, Bae EH, Ma SK, Kweon SS, Kim SW. Incidence, predictive factors, and clinical outcomes of acute kidney injury after gastric surgery for gastric cancer. PLoS One. 2013 Dec 9;8(12):e82289. doi: 10.1371/journal.pone.0082289. eCollection 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.
Kholoud Salah Ibraahim Amin, Bsc. principal investigator
Delta university for Sciences and Technology
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Laparoscopic Sleeve Gastrectomy and gabapentin 1200 mg in people with Acute Kidney Injury and Obesity, run by Tanta University at 2 sites in Egypt.
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 6 inclusion and 8 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 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Urinary Dickkopf-3 (DKK3) concentration (time frame: Baseline, 24 hours postoperatively, and 6 months after surgery). 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 NCT06254183, 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 18 Aug 2026.