Pneumoperitoneum Preconditioning for the Prevention of Renal Function After Laparoscopic Partial Nephrectomy

Nanjing Medical University

Status: Enrolling

Conditions: Ischemia Reperfusion Injury

Treatments: Procedure: Pneumoperitoneum preconditioning; Procedure: Sham-Pneumoperitoneum preconditioning

Study type: Interventional

Funder types: Other

Identifiers

NCT03822338

NFH20180205

Details and patient eligibility

About

The present study is designed to investigate the short-term and long-term renoprotective role of pneumoperitoneum preconditioning in patients undergoing laparoscopic partial nephrectomy.

Full description

Renal ischemia reperfusion injury (IRI) is an inevitable event in patients undergoing laparoscopic partial nephrectomy (LPN), which can obviously affect the post-operational renal function. Pneumoperitoneum preconditioning (PP) is a promising strategy to render a protective effect on kidney, which has been already confirmed in some clinical settings. This study is designed as a randomized, prospective, double-blind and parallel controlled clinical trial to assess the short-term and long-term renoprotective role of pneumoperitoneum preconditioning in patients undergoing laparoscopic partial nephrectomy, and observe its effect on the other abdominal organs. Patients with renal tunours and willing to accept elective LPN will be screened as eligible participants. The investigators aim to enroll 86 subjects. Patients randomized to the treatment arm will receive PP consisted of three cycles of 5 min insufflation and 5 min desufflation before PLN, while the control arm receive a sham operation.

Enrollment: 86 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male and female patients aged 18 years and older;
• Patients with renal tumours (whether benign or malignant) and accept laparoscopic partial nephrectomy as the surgical method;
• The renal tumor must be stage T1a (assessed by MRI/CT), and tumor≤4cm in diameter;
• Unilateral renal tumour, and another contralateral renal function reveal normal (renal function >40% as determined by radionuclide scintigraphy);
• Patients volunteer for this study and provided written informed consent.

Exclusion criteria

• Large tumour (tumor>4cm in diameter);
• Severe renal insufficiency (glomerular filtration rate, GFR<30 ml/min/1.73m2) or needing preoperative dialysis (hemodialysis or peritoneal dialysis);
• Patients severe cardiopulmonary dysfunction;
• Pregnancy Women;
• Patients with other malignant tumours;
• Patients who have had a renal transplantation;
• Patients with a history of other abdominal viscera operations within one year (open or under laparoscope);
• American Society of Anesthesiologists (ASA)>Ⅲ.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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86 participants in 2 patient groups

Pneumoperitoneum preconditioning group

Experimental group

Description:

Participant assigned to the this group will receive a treatment consisting of three cycles of 5 min insufflation (intra-abdominal pressure at 15 mmHg) and 5 min desufflation, after complete anesthesia and successfully implanting the veress.

Treatment:

Procedure: Pneumoperitoneum preconditioning

Control group

Sham Comparator group

Description:

Participants in the control group will receive the same placement of the veress but without insufflation and subsequent desufflation.

Treatment:

Procedure: Sham-Pneumoperitoneum preconditioning