Rib Removal and Pain in Partial Nephrectomy | NCT06543095

Studies
Rib Removal and Pain in Partial Nephrectomy

NCT06543095

Sponsor

TC Erciyes University

Status

Completed

Last Update Posted

Aug 7, 2024Actual

Enrollment

50Actual

Phase

Not provided

Conditions

Pain
Partial Nephrectomy
Kidney Cancer

Interventions

Pain level

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2022Actual

Primary Completion Date

Oct 1, 2023Actual

Completion Date

Jan 1, 2024Actual

First Submitted Date

Aug 3, 2024

First Submission Date that Met QC Criteria

Aug 3, 2024

First Posted Date

Aug 7, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 3, 2024

Last Update Posted Date

Aug 7, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief 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. For this purpose, VAS score surveys were prepared for patients who underwent partial nephrectomy surgery in the early and late postoperative periods.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

3 Weeks

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group 1		who underwent rib removal during the partial nephrectomy	Other: Pain level
Group 2		who didn't underwent rib removal during the partial nephrectomy	Other: Pain level

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pain level	Other	Post-operative pain levels of the patients with detected using VAS score.	Group 1 Group 2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	days 0, 1, and 3 and week 3

Secondary Outcomes

Measure	Description	Time Frame
Complications		Postoperative 7 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients aged over 18 years who underwent open renal surgery due to kidney cancer were included in the study.

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

patients who underwent open partial nephrectomy with flank incision between July 2022 and October 2023 in our clinic.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Erciyes University		Kayseri		38080	Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Data available on request from the authors

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010146	Pain
D007680	Kidney Neoplasms

Ancestor Terms

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D014571	Urologic Neoplasms

Browse Leaves

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Browse Branches

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