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The present study is designed to investigate the short-term and long-term renoprotective role of pneumoperitoneum preconditioning in patients undergoing laparoscopic partial nephrectomy.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Control group | Sham Comparator | Participants in the control group will receive the same placement of the veress but without insufflation and subsequent desufflation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| The level of serum creatinine (SCr) | The absolute change in the level of serum SCr after desufflation. | Baseline; 12, 24, 48 hours, and 1, 6 months after desufflation |
| Estimated glomerular filtration rate (eGFR) |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of postoperative hospital stay | 6 months following surgery | |
| Incidence of adverse events | 6 months following surgery | |
| Rate of mortality |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ruipeng Jia, MD, PHD | Contact | +86-02552271061 | urojiarp@njmu.edu.cn | |
| Changcheng Zhou, MD | Contact | +86-02552271048 | zhoucc@njmu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nanjing First Hospital | Recruiting | Nanjing | Jiangsu | 210006 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32461289 | Derived | 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. |
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|
| Sham-Pneumoperitoneum preconditioning | Procedure | Sham-Pneumoperitoneum preconditioning consists of three cycles without insufflation and subsequent desufflation. The whole duration will also last 30 min. |
|
eGFR will be calculated by a combined formula.
| Baseline; 12, 24, 48 hours, and 1, 6 months after desufflation |
| The level of alanine transaminase (ALT) | Serum markers for detecting the insults of the liver. | Baseline; 12, 24, 48 hours, and 1, 6 months after desufflation |
| The level of serum amylase | Serum markers for detecting the insults of the pancreas. | Baseline; 12, 24, 48 hours, and 1, 6 months after desufflation |
| The level of intestinal fatty acid binding protein (I-FABP) | Serum markers for detecting the insults of the intestine. | Baseline; 12, 24, 48 hours, and 1, 6 months after desufflation |
| 6 months following surgery |
| ID | Term |
|---|---|
| D015427 | Reperfusion Injury |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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