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

NCT ID: NCT03822338

Last Updated: 2022-10-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 86 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-01
• Study Completion Date: 2023-06-01

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.

Detailed 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.

Conditions

Ischemia Reperfusion Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Pneumoperitoneum preconditioning group

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.

Group Type: EXPERIMENTAL

Pneumoperitoneum preconditioning

Intervention Type: 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.

Control group

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

Group Type: SHAM_COMPARATOR

Sham-Pneumoperitoneum preconditioning

Intervention Type: PROCEDURE

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

Interventions

Pneumoperitoneum preconditioning

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.

Intervention Type: PROCEDURE

Sham-Pneumoperitoneum preconditioning

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

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nanjing First Hospital, Nanjing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Ruipeng Jia

Study Chair

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Nanjing First Hospital

Nanjing, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

Ruipeng Jia, MD, PHD

Role: CONTACT

urojiarp@njmu.edu.cn

+86-02552271061

Changcheng Zhou, MD

Role: CONTACT

zhoucc@njmu.edu.cn

+86-02552271048

Facility Contacts

Ruipeng Jia, MD, PHD

Role: primary

urojiarp@njmu.edu.cn

+86-02552271061

References

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.

Reference Type: DERIVED

PMID: 32461289 (View on PubMed)

Other Identifiers

NFH20180205

Identifier Type: -

Identifier Source: org_study_id