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Trial Title:
A Single Center Randomized Controlled Study on the Promotion of Rapid Recovery
NCT ID:
NCT06250699
Condition:
Nonfunctional Adrenal Cortex Adenoma
Primary Aldosteronism
Cushing Syndrome
Conditions: Official terms:
Adenoma
Adrenocortical Adenoma
Hyperaldosteronism
Cushing Syndrome
Conditions: Keywords:
tubeless
laparoscopic adrenalectomy
rapid recovery
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Tubeless laparoscopic adrenalectomy
Description:
No drainage tube placed after laparoscopic adrenalectomy
Arm group label:
no tube
Intervention type:
Procedure
Intervention name:
Drainage tube
Description:
Placing drainage tubes after laparoscopic adrenalectomy
Arm group label:
Drainage tube
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Zhongnan hospital
Address:
City:
Wuhan
Zip:
430071
Country:
China
Status:
Recruiting
Contact:
Last name:
meng zhe
Phone:
15387041020
Email:
mengzhe@whu.edu.cn
Start date:
January 3, 2024
Completion date:
June 30, 2027
Lead sponsor:
Agency:
Zhe Meng
Agency class:
Other
Source:
Zhongnan Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06250699
