Should surgical drainage after lateral transperitoneal laparoscopic adrenalectomy be routine?-A retrospective comparative study.
Shuaishuai Chai, Qiufeng Pan, Chaoqi Liang...
https://pubmed.ncbi.nlm.nih.gov/34268075Actively Recruiting
Phase Not Applicable
Age: 18Years - 70Years
All Genders
ID06250699
A Single Center Randomized Controlled Study on the Promotion of Rapid Recovery Through Tubeless Laparoscopic Adrenalectomy
Led by Zhe Meng · Updated on 2024-02-13
200
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This clinical trial investigates the safety and recovery benefits of tubeless laparoscopic adrenalectomy in patients undergoing adrenal gland removal surgery. The study aims to answer whether avoiding drainage tubes after surgery helps patients recover more quickly, focusing on pain, the time to first get out of bed, and the recovery of intestinal function. It is a prospective, single-center, randomized controlled study enrolling 200 patients who need laparoscopic adrenalectomy. Participants are randomly assigned to one of two groups: one group receives surgery without drainage tubes (tubeless group), and the other group has drainage tubes placed after surgery (drainage group). The study compares outcomes such as pain scores, blood tests, and recovery indicators between these groups. Follow-up includes adrenal ultrasounds at one and six months post-surgery to monitor recovery and safety. During the study, participants will have blood tests and assessments of pain, time to mobilization, and intestinal function for the first three days after surgery. Researchers will also monitor for complications like fever and wound infections. Follow-up ultrasound exams at one and six months will help evaluate longer-term recovery. The trial uses block randomization and collects data to assess whether tubeless surgery promotes faster and safer recovery after adrenalectomy.
CONDITIONS
Brief Title
A Single Center Randomized Controlled Study on the Promotion of Rapid Recovery
Who Can Participate
Age: 18Years - 70Years
All Genders
Eligibility Criteria
You may qualify if you...
- Patients who meet surgical indications according to the 2022 Chinese Guidelines for Diagnosis and Treatment of Urological Diseases
- Signed informed consent form before joining the trial
- Age between 18 and 70 years at the time of consent
You will not qualify if you...
- Patients with complications seriously affecting treatment or quality of life
- Any physical condition that may affect clinical status as judged by the researcher
- Patients with vascular stents (heart or brain) placed within the past year
- Pregnant or lactating patients
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Surgery and Immediate Post-operative Care
Duration - 1 to 3 days
Participants undergo laparoscopic adrenalectomy with or without drainage tube placement and receive post-operative monitoring.
Daily visits for 1 to 3 days after surgery
Post-operative Follow-up
Duration - 6 months
Participants have follow-up adrenal ultrasounds and assessments to monitor recovery and safety.
Visits at 1 month and 6 months after surgery
Trial Site Locations
Total: 1 location
1
Zhongnan hospital
Wuhan, Hubei, China, 430071
Actively Recruiting
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Research Team
M
meng zhe
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Application of enhanced recovery after surgery (ERAS) protocols in adrenal surgery: A retrospective, preliminary analysis.
Giulio Lelli, Alessandra Micalizzi, Angelo Iossa...
https://pubmed.ncbi.nlm.nih.gov/37282440