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

NCT03822338 | Unknown DMC

• 1 other identifier: NFH20180205
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Ischemia Reperfusion Injury

Keywords

Renal ischemia reperfusion injury; Pneumoperitoneum preconditioning; Laparoscopic partial nephrectomy

Outcome Measures

Primary Outcomes (2)

• The absolute change in glomerular filtration rate (GFR)

  Unilateral and overall GFR detected by 99mTc-DTPA renal scintigraphy.

  changes from baseline and postoperative 1, 6 months

• The absolute change in the level of serum Cystatin C (Cys C)

  The absolute change in the level of serum Cys C after desufflation.

  changes from baseline and 12, 24, 48 hours after desufflation

Secondary Outcomes (5)

• The level of serum creatinine (SCr)

  Baseline; 12, 24, 48 hours, and 1, 6 months after desufflation

• Estimated glomerular filtration rate (eGFR)

  Baseline; 12, 24, 48 hours, and 1, 6 months after desufflation

• The level of alanine transaminase (ALT)

  Baseline; 12, 24, 48 hours, and 1, 6 months after desufflation

• The level of serum amylase

  Baseline; 12, 24, 48 hours, and 1, 6 months after desufflation

• The level of intestinal fatty acid binding protein (I-FABP)

  Baseline; 12, 24, 48 hours, and 1, 6 months after desufflation

Other Outcomes (3)

• Duration of postoperative hospital stay

  6 months following surgery

• Incidence of adverse events

  6 months following surgery

• Rate of mortality

  6 months following surgery

Study Arms (2)

Pneumoperitoneum preconditioning group

EXPERIMENTAL

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.

Procedure: Pneumoperitoneum preconditioning

Control group

SHAM COMPARATOR

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

Procedure: Sham-Pneumoperitoneum preconditioning

Interventions

Pneumoperitoneum preconditioning PROCEDURE

Pneumoperitoneum preconditioning consists of three cycles of 5 min insufflation and 5 min desufflation, after complete anesthesia and successfully implanting the veress. This process will be induced by pneumoperitoneum machine, and the utilized gas will be carbon dioxide to maintain the intra-abdominal pressure at 15 mmHg. The whole duration will last 30 min.

Pneumoperitoneum preconditioning group

Sham-Pneumoperitoneum preconditioning PROCEDURE

Sham-Pneumoperitoneum preconditioning consists of three cycles without insufflation and subsequent desufflation. The whole duration will also last 30 min.

Control group

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nanjing First Hospital, Nanjing Medical University: lead

Study Sites (1)

Nanjing First Hospital

Nanjing, Jiangsu, 210006, China

RECRUITING

Related Publications (1)

• Zhou C, Xu L, Xu Z, Ge Y, Zhou L, Wang F, Liu J, Pan G, Yang T, Jia R. Pneumoperitoneum preconditioning for the prevention of renal function after laparoscopic partial nephrectomy: protocol for a double-blind randomised controlled trial. BMJ Open. 2020 May 26;10(5):e032002. doi: 10.1136/bmjopen-2019-032002.

  PMID: 32461289 DERIVED

MeSH Terms

Conditions

Reperfusion Injury

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Ruipeng Jia, MD, PHD

CONTACT

+86-02552271061; urojiarp@njmu.edu.cn

Changcheng Zhou, MD

CONTACT

+86-02552271048; zhoucc@njmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study Chair

Study Record Dates

• First Submitted: January 19, 2019
• First Posted: January 30, 2019
• Study Start: January 1, 2021
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: October 3, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)