Patient Reported Outcomes and Different Renal Artery Clamping Techniques During Robot Assisted Kidney Resection

NCT07853001 | Not Yet Recruiting DMC

• 1 other identifier: 987718
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

The target population for this study consists of all patients undergoing kidney surgery at Haukeland University Hospital, Norway, with the primary focus being patients undergoing robot-assisted partial nephrectomy. The study has two main objectives. First, the investigators aim to assess whether a flank approach to robot assisted partial nephrectomy may be superior to a trans abdominal approach with regard to postoperative pain, recovery, and quality of life. Second, while conducting this study, the investigators also seek to compare two methods of renal artery clamping during the partial nephrectomy procedure. Specifically, the investigators aim to determine whether a technique that reduces the duration of ischemia can be performed without causing an unacceptable increase in blood loss or postoperative complications.

Conditions

Renal Cell Carcinoma (Kidney Cancer)

Keywords

renal cell carcinoma; Robot-Assisted Partial Nephrectomy; Retroperitoneal Approach; Transperitoneal Approach; Patient-Reported Outcomes; Warm Ischemia Time; Postoperative Pain; Postoperative Recovery; Renal Function; Kidney Cancer; Early Declamping; Renal Artery Clamping

Outcome Measures

Primary Outcomes (2)

• Change in Brief Pain Inventory (BPI) pain severity score from baseline to postoperative day

  Pain severity will be assessed using the Brief Pain Inventory. The scale measures the patients subjective assessment of pain on 15 different items. The scale ranges from 0 to 10, where 0 indicates no pain, and 10 indicates worst thinkable pain. The outcome measure will be calculated as the change from baseline to postoperative day 1 using the mean score of items 3-6.

  First post operative day

• Intraoperative blood loss during robot-assisted partial nephrectomy

  Blood loss will be measured intraoperatively in milliliters and compared between early and standard renal artery declamping strategies.

  Day of Surgery

Secondary Outcomes (10)

• Total opioid consumption during the first 24 postoperative hours

  First postoperative day

• Change in Quality of Recovery-15 Norwegian version (QoR-15NO) score

  Baseline, first postoperative day, 6 weeks and 1 year after surgery

• Change in the European Organisation for Research and Treatment of Cancer quality of life 30 (EORTC QLQ 30)

  Baseline, 6 weeks and 1 year after surgery

• Warm ischemia time during robot-assisted partial nephrectomy

  Day of Surgery

• Incidence of postoperative complications

  30 and 90 days after surgery

Study Arms (2)

Early declamping

EXPERIMENTAL

Participants undergoing robot-assisted partial nephrectomy randomized to early renal artery declamping. After tumor excision and closure of the resection bed, the renal artery clamp is removed before completion of renorrhaphy. This strategy is intended to reduce warm ischemia time while maintaining acceptable bleeding and complication rates.

Procedure: Early declamping strategy

Standard declamping

ACTIVE COMPARATOR

Participants undergoing robot-assisted partial nephrectomy randomized to standard renal artery declamping. The renal clamping stays on until all renorraphy and adaptation of the resection surfaces are completed

Procedure: Standard clamping strategy

Interventions

Standard clamping strategy PROCEDURE

Patients randomized to standard declamping will have the clamp on until tumour resection, renorraphy and adaptation of the resection surfaces is performed

Standard declamping

Early declamping strategy PROCEDURE

The patients randomized to early declamping strategy will have the clamp on until tumour resection and ranorraphy is completed, but the clamp is removed before adaptation of the resection surfaces is performed

Early declamping

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed written informed consent obtained prior to any study specific procedures
• Patient must be willing and able to comply with the protocol
• Age \>18
• Patients scheduled for robot-assisted partial kidney resection with either the trans- or retroperitoneal access
• Other patients scheduled for surgery for kidney cancer, to be included as control group

You may not qualify if:

• Previous kidney surgery on the affected side
• Preexisting extensive intraabdominal adhesions preventing the use of the transabdominal access
• Preexisting severe pain condition requiring regular use of opioids adding up to more than equivalent of 10mg po morphine daily
• Confirmed metastatic renal cancer or any other metastatic cancer.

Sponsors & Collaborators

• Bjarte Almas: lead
• Haukeland University Hospital, Bergen, Norway: collaborator
• University of Bergen: collaborator

Study Sites (1)

Haukeland University Hospital

Bergen, Vestland, 5008, Norway

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell; Kidney Neoplasms; Pain, Postoperative

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Bjarte Almås, MD.PhD

  Haukeland University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bjarte Almås, MD, PhD

CONTACT

+4755971637; bjarte.almas@helse-bergen.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD.PhD Consultant urologist

Study Record Dates

• First Submitted: June 16, 2026
• First Posted: October 1, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): September 1, 2030
• Study Completion (Estimated): September 1, 2034
• Last Updated: October 1, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: The IPD sharing will start 12 months after the two main papers planned in the study has been published. Data sharing will be available as long as the data from the study is still available. The data is so far planned stored until 31.12.2041
• Access Criteria: Data will be made available to qualified researchers upon reasonable request. Requests must include a methodologically sound proposal and will be reviewed by an independent review committee. Approved requests will require a signed data use agreement prior to access. Supporting documents, including the study protocol and statistical analysis plan, will also be made available.

Locations

NO (1)