OPEN Research Support
head

Consultant
Nessn Htum Azawi
Department of Urology, Odense University Hospital


Projekt styring
Projekt status    Sampling ongoing
 
Data indsamlingsdatoer
Start 01.05.2016  
Slut 30.04.2020  
 



Can an intensive rehabilitating program improve the quality of life after renal surgery?

Short summary

Partial nephrectomy has become an acceptable approach for small renal tumors, with an acceptable oncological outcome. Although certain patients who undergo partial or total nephrectomy have renal failure, most patients continue to have long-term, stable renal function. Because more than 70% of patients with localized tumors, experience ten years of cancer-specific survival, their quality of life (QoL) after surgery is important. In a recently published study, the QoL was lower than expected (69 point) according to the standard European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire 30 (EORTC QLQ-C30), and patients underwent total nephrectomy experiences poor QoL compared to partial nephrectomy.

Hypothesis: The use of rehabilitating program after renal surgery can improve QoL of patients after renal surgery.

Purpose: The aim of this study is to explore the impact of intensive rehabilitating program on postoperative QoL of patients with renal cancer.


Rationale

Partial nephrectomy has become an acceptable approach for small renal tumors, with an acceptable oncological outcome. Although certain patients who undergo partial or total nephrectomy have renal failure, most patients continue to have long-term, stable renal function. Because more than 70% of patients with localized tumors, experience ten years of cancer-specific survival, their quality of life (QoL) after surgery is important. In a recently published study 3 the QoL was lower than expected (69 point) according to the standard European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire 30 (EORTC QLQ-C30), and patients underwent total nephrectomy experiences poor QoL compared to partial nephrectomy. Moreover, patients reported 24% complicated course of treatment while there was only 5% complications rate reported in patients' charts, which may indicate misunderstanding for treatment course between patients and medical staff. The same group had also been reported that patients had a poor QoL in the first 2 years after surgery compared to 4 years and more after surgery. This study was a retrospective and there was missing to the preoperative baseline QoL, which may bias these results.

Moreover, few studies have explored QoL following renal surgery. Different questionnaires have been developed to examine the QoL of cancer patients, but no specific questionnaire related to renal cancer exists. Thus, more studies must explore patients' needs after renal surgery to give this large cohort a better QoL.


Description of the cohort

Design: Prospective randomized one to one clinical trial. Patients with renal cancer will be randomly allocated into two groups, 100 patients in each group. Group A, will be scheduled to receive routine follow-up program and group B, will receive modified follow-up program after renal surgery.

Inclusion Criteria:

  1. Any patient undergoing laparoscopic Total/partial nephrectomy
  2. Age ranges 30-75
  3. Can read and understand Danish
  4. Able to give informed consent

Exclusion Criteria:

  1. Inability to understand written consent forms or give consent
  2. Any conversion to open surgery

Recruitment:

The project will be reported to the regional ethical committee. The patients will be informed about the project and a written consent from the patient will be obtained. The patients will be guided how to use questionnaire. Patients have to answer the questionnaire before surgery, three months and one year after surgery.

Methods:

A 1:1 randomized controlled trial including renal cancer patients treated at one surgical department in Denmark. Patients allocated to the control group received usual treatment and care including usual supervision of the care pathway and usual patient support. Case management group patients received usual treatment and care, supplemented by care pathway supervision and outreaching support from a nurse case manager, see (Forløbskoordinatorernes hovedopgaver). Feasibility of the intervention was based on calculations from case notes made by the case managers. 


Collaborating researchers and departments

Department of Urology, Sjaelland University Hospital

Department of Urology, Odense University Hospital