A Single Center Randomized Controlled Study on the Promotion of Rapid Recovery

Primary Aldosteronism Clinical Trial

Official title:

A Single Center Randomized Controlled Study on the Promotion of Rapid Recovery Through Tubeless Laparoscopic Adrenalectomy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06250699
• Other study ID #: 2023231
• Status: Recruiting
• Phase: N/A
• Start date: January 3, 2024
• Est. completion date: June 30, 2027

Study information

• Verified date: February 2024
• Source: Zhongnan Hospital
• Contact: meng zhe
• Phone: 15387041020
• Email: mengzhe[@]whu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this clinical trial is to exploring the role of tubeless after adrenalectomy surgery. The main questions it aims to answer are:

1. The safety of tubeless laparoscopic adrenalectomy；

2. The role of tubeless therapy in rapid recovery after adrenalectomy surgery Participants will be randomly divided into two groups: the non drainage group and the drainage group after laparoscopic adrenal surgery, and their pain, first time out of bed, and intestinal recovery time will be observed.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: June 30, 2027
• Est. primary completion date: December 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. According to the 2022 edition of the Chinese Guidelines for Diagnosis and Treatment of Urological Diseases, patients who meet the surgical indications

2. The patient has signed an informed consent form before joining the clinical trial, and the age at the time of signing the informed consent form is 18-70 years old.

Exclusion Criteria:

1. Patients with complications that seriously affect treatment or quality of life

2. The patient has any physical condition that the researcher believes will affect the clinical status

3. Patients who have placed vascular stents such as heart and cerebrovascular stents within the past year

4. Pregnant or lactating patients

Related Conditions & MeSH terms

• Adenoma
• Adrenocortical Adenoma
• Cushing Syndrome
• Hyperaldosteronism
• Primary Aldosteronism

Intervention

Procedure:
• Tubeless laparoscopic adrenalectomy
No drainage tube placed after laparoscopic adrenalectomy
• Drainage tube
Placing drainage tubes after laparoscopic adrenalectomy

Locations

Country	Name	City	State
China	Zhongnan hospital	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Zhe Meng

Country where clinical trial is conducted

China, 

References & Publications (2)

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. — View Citation

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. 2023 May 10. doi: 10.4103/jmas.jmas_319_22. Online ahead of print. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	First time up and about	First time up and about after laparoscopic adrenalectomy	1-3 days after surgery
Primary	Recovery time of intestinal function	Recovery time of intestinal function after laparoscopic adrenalectomy	1-3 days after surgery
Primary	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
Secondary	fever	Does the patient experience fever (The thermometer shows a temperature greater than 37.3 ° C) after laparoscopic adrenalectomy.	1-3 days after surgery