Clinical trial NCT06250699: A Single Center Randomized Controlled Study on the Promotion of Rapid Recovery
Official title: A Single Center Randomized Controlled Study on the Promotion of Rapid Recovery Through Tubeless Laparoscopic Adrenalectomy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Nonfunctional Adrenal Cortex Adenoma
Primary Aldosteronism
Cushing Syndrome
Keywords: tubeless
laparoscopic adrenalectomy
rapid recovery
Lead sponsor: Zhongnan Hospital
Sponsor class: OTHER
First posted: 2024-02-09
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain score
timeFrame: 1-3 days after surgery
measure: First time up and about
timeFrame: 1-3 days after surgery
measure: Recovery time of intestinal function
timeFrame: 1-3 days after surgery
measure: Hematoma
timeFrame: 1-3 days after surgery
Secondary outcomes:
measure: fever
timeFrame: 1-3 days after surgery
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Zhongnan hospital
state: Hubei
Study officials:
affiliation: Wuhan University
name: meng zhe
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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. 2024 Apr 1;20(2):163-168. doi: 10.4103/jmas.jmas_319_22. Epub 2023 May 10.