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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| no tube | Experimental | no drainage tube after laparoscopic adrenalectomy |
|
| Drainage tube | Experimental | tube drainage after laparoscopic adrenalectomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tubeless laparoscopic adrenalectomy | Procedure | No drainage tube placed after laparoscopic adrenalectomy |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1-3 days after surgery |
| First time up and about | First time up and about after laparoscopic adrenalectomy | 1-3 days after surgery |
| Recovery time of intestinal function | Recovery time of intestinal function after laparoscopic adrenalectomy | 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. | 1-3 days after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| fever | Does the patient experience fever (The thermometer shows a temperature greater than 37.3 ° C) after laparoscopic adrenalectomy. | 1-3 days after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| meng zhe | Contact | 15387041020 | mengzhe@whu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| meng zhe | Wuhan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongnan hospital | Recruiting | Wuhan | Hubei | 430071 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34268075 | Background | Chai S, Pan Q, Liang C, Zhang H, Xiao X, Li B. Should surgical drainage after lateral transperitoneal laparoscopic adrenalectomy be routine?-A retrospective comparative study. Gland Surg. 2021 Jun;10(6):1910-1919. doi: 10.21037/gs-20-829. | |
| 37282440 | Background | Lelli G, Micalizzi A, Iossa A, Fassari A, Concistre A, Circosta F, Petramala L, De Angelis F, Letizia C, Cavallaro G. Application of enhanced recovery after surgery (ERAS) protocols in adrenal surgery: A retrospective, preliminary analysis. J Minim Access Surg. 2024 Apr 1;20(2):163-168. doi: 10.4103/jmas.jmas_319_22. Epub 2023 May 10. |
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| ID | Term |
|---|---|
| D006929 | Hyperaldosteronism |
| D003480 | Cushing Syndrome |
| ID | Term |
|---|---|
| D000308 | Adrenocortical Hyperfunction |
| D000307 | Adrenal Gland Diseases |
| D004700 | Endocrine System Diseases |
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| Drainage tube | Procedure | Placing drainage tubes after laparoscopic adrenalectomy |
|