PainNCT06543095
Rib Removal and Pain in Partial Nephrectomy
An observational study of Pain and Partial Nephrectomy, run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial summary
In this study, the effect of rib removal on postoperative pain in kidney cancer patients undergoing retroperitoneal open partial nephrectomy with flank incision was investigated. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pain, Partial Nephrectomy, Kidney Cancer
- What is being tested?
- Pain level
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2022to 1 Jan 2024
- How long will I take part?
- 3 Weeks
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients who underwent open partial nephrectomy with flank incision between July 2022 and October 2023 in our clinic.
Who may be able to join
- Patients aged over 18 years who underwent open renal surgery due to kidney cancer were included in the study.
Who cannot join
- Patients with a preoperative (one day before surgery) VAS score greater than 0,
- Those with additional known diseases that could cause pain (herniated disc, urinary stone disease, inflammatory bowel diseases, other intra-abdominal pathologies),
- Intraoperative complications that could cause postoperative pain, metastasis, positive surgical margins or peri-renal invasion,
- Those who underwent laparoscopic surgery or those who converted to open surgery after laparoscopic surgery,
- Patients that regularly used painkillers for other reasons,
- Patients whose ribs other than the 11th rib were removed were excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Rib Removal in Retroperitoneal Open Partial Nephrectomy: Not As Painful As It Seems
In this study, the effect of rib removal on postoperative pain in kidney cancer patients undergoing retroperitoneal open partial nephrectomy with flank incision was investigated. For this purpose, VAS score surveys were prepared for patients who underwent partial nephrectomy surgery in the early and late postoperative periods.
- Conditions
- Pain, Partial Nephrectomy, Kidney Cancer
- Being tested
- Pain level
- Keywords
- Rib Removal, Partial nephrectomy, pain, renal cancer
- Medical subject headings
- Pain, Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain levelOther
Post-operative pain levels of the patients with detected using VAS score.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | who underwent rib removal during the partial nephrectomy Receives: Other: Pain level | |
| Group 2 | who didn't underwent rib removal during the partial nephrectomy Receives: Other: Pain level |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain level
Primary outcome of the study was to compare the pain intensities of the two groups at postoperative days 0, 1, and 3 and week 3 and to evaluate the additional pain burden induced by the rib removal procedure.
Measured: days 0, 1, and 3 and week 3
Secondary outcomes (1)
Complications
Measured: Postoperative 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2024
- Study start1 Jul 2022
- Primary completion1 Oct 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 PainStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
- Target duration
- 3 Weeks
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gokhan Sonmez, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06543095
- Sponsor's protocol ID
- 2022/589
- Status last verified
- Aug 2024
- First submitted
- 3 Aug 2024
- Last updated
- 7 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data available on request from the authors
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rib Removal in Retroperitoneal Open Partial Nephrectomy: Not As Painful As It Seems
- ClinicalTrials.gov ID
- NCT06543095
- Acronym / sponsor ID
- 2022/589
- Conditions
- Pain, Partial Nephrectomy, Kidney Cancer
- Keywords
- Rib Removal, Partial nephrectomy, pain, renal cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 1 Oct 2023 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 7 Aug 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.
In this study, the effect of rib removal on postoperative pain in kidney cancer patients undergoing retroperitoneal open partial nephrectomy with flank incision was investigated. For this purpose, VAS score surveys were prepared for patients who underwent partial nephrectomy surgery in the early and late postoperative periods.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Weeks
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Other: Pain levelwho underwent rib removal during the partial nephrectomy |
| Group 2 | – | Other: Pain levelwho didn't underwent rib removal during the partial nephrectomy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients who underwent open partial nephrectomy with flank incision between July 2022 and October 2023 in our clinic.
Key inclusion criteria (1 listed)
- Patients aged over 18 years who underwent open renal surgery due to kidney cancer were included in the study.
Key exclusion criteria (6 listed)
- Patients with a preoperative (one day before surgery) VAS score greater than 0,
- Those with additional known diseases that could cause pain (herniated disc, urinary stone disease, inflammatory bowel diseases, other intra-abdominal pathologies),
- Intraoperative complications that could cause postoperative pain, metastasis, positive surgical margins or peri-renal invasion,
- Those who underwent laparoscopic surgery or those who converted to open surgery after laparoscopic surgery,
- Patients that regularly used painkillers for other reasons,
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 |
|---|---|---|
| Pain levelPost-operative pain levels of the patients with detected using VAS score. | Other | Group 1, Group 2 |
Primary outcome
Pain level
Time frame: days 0, 1, and 3 and week 3
Primary outcome of the study was to compare the pain intensities of the two groups at postoperative days 0, 1, and 3 and week 3 and to evaluate the additional pain burden induced by the rib removal procedure.
1 secondary outcome
Complications
Time frame: Postoperative 7 days
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 7 Aug 2024.
- Individual participant dataSharing planned: Undecided. Data available on request from the authors
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain and Partial Nephrectomy, run by TC Erciyes University at 1 site in Turkey (Türkiye).
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 1 inclusion and 6 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 7 Aug 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 Turkey (Türkiye). 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?
Pain level (time frame: days 0, 1, and 3 and week 3). 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 7 Aug 2024.