NCT06543095

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2022

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 3, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 7, 2024

Completed
Last Updated

August 7, 2024

Status Verified

August 1, 2024

Enrollment Period

1.3 years

First QC Date

August 3, 2024

Last Update Submit

August 3, 2024

Conditions

Keywords

Rib RemovalPartial nephrectomypainrenal cancer

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • Complications

    Postoperative 7 days

Study Arms (2)

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

Post-operative pain levels of the patients with detected using VAS score.

Group 1Group 2

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erciyes University

Kayseri, 38080, Turkey (Türkiye)

Location

MeSH Terms

Conditions

PainKidney Neoplasms

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Weeks
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof.

Study Record Dates

First Submitted

August 3, 2024

First Posted

August 7, 2024

Study Start

July 1, 2022

Primary Completion

October 1, 2023

Study Completion

January 1, 2024

Last Updated

August 7, 2024

Record last verified: 2024-08

Locations