An interventional study of Tubeless laparoscopic adrenalectomy and Drainage tube in Nonfunctional Adrenal Cortex Adenoma, Primary Aldosteronism and Cushing Syndrome, sponsored by Zhe Meng. Recruiting at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-02-13.
Sponsored by Zhe Meng · Not applicable, Interventional, and Treatment
The goal of this clinical trial is to exploring the role of tubeless after adrenalectomy surgery. The main questions it aims to answer are:
The design type of this study is a prospective single center randomized controlled study, with a plan to recruit 200 patients who underwent laparoscopic adrenalectomy for the study. The intervention measures mainly include whether to indwelling drainage tubes. Prior to the start of the trial, our center had performed laparoscopic adrenalectomy on 89 patients without any obvious retroperitoneal fluid accumulation, redness, swelling, or fever, and the recovery was smooth. Step 1 of the research: Select patients who meet the criteria for laparoscopic adrenalectomy Step 2: Sign informed consent form Step 3: Randomly draw lots and divide them into two groups: no tube group (experimental group of 100 cases) and indwelling drainage tube group (control group of 100 cases) Step 4: Perform surgical plan according to grouping results Step 5: Test blood routine and ERAS related indicators 1-3 days after surgery Step 6: Follow up adrenal ultrasound at 1 month and 6 months after surgery Step 7: Follow up and analyze data Random plan Use block randomization method, using software SAS9.4 TS1M7, random seed number 2023092311 Observation items and testing time points 1. Test hemoglobin and drainage volume on 1-3 days after surgery Pain score, first time out of bed, intestinal ventilation time, adrenal ultrasound, postoperative fever, wound infection, and other indicators; During the follow-up one month after surgery, the adrenal region color ultrasound should also be tested; 3. During the follow-up examination at 6 months after surgery, ultrasound of the adrenal region should also be detected; Efficacy evaluation criteria and effectiveness evaluation methods: Whether the indwelling drainage tube has a promoting effect on the patient's rapid recovery (such as pain score, first time out of bed, intestinal ventilation time, etc.). Safety evaluation methods mainly include the subject's blood routine and vital signs.
657 studies on the registry are indexed under Adenoma; 98 are open to participants now.
This study's planned enrollment of 200 is below the median of 250 across 412 interventional studies indexed under Adenoma.
Browse Adenoma studies →This is the only study on the registry with Zhe Meng as lead sponsor.
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Exclusion Criteria:
no drainage tube after laparoscopic adrenalectomy
Procedure: Tubeless laparoscopic adrenalectomy
tube drainage after laparoscopic adrenalectomy
Procedure: Drainage tube
No drainage tube placed after laparoscopic adrenalectomy
Placing drainage tubes after laparoscopic adrenalectomy
Pain score
Pain rating scale after laparoscopic adrenalectomy by VAS（visual analog scale for pain ） scale. The score ranges from 1 to 10, and the degree of pain gradually increases.
Time frame: 1-3 days after surgery
First time up and about
First time up and about after laparoscopic adrenalectomy
Time frame: 1-3 days after surgery
Recovery time of intestinal function
Recovery time of intestinal function after laparoscopic adrenalectomy
Time frame: 1-3 days after surgery
Hematoma
Detection of obvious hematoma (Hematoma area\> 4cm x 4cm) in the surgical area through color ultrasound. The results are expressed as yes or no.
Time frame: 1-3 days after surgery
fever
Does the patient experience fever (The thermometer shows a temperature greater than 37.3 ° C) after laparoscopic adrenalectomy.
Time frame: 1-3 days after surgery
Plan to share: No
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