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/Actively Recruiting
Led by Zhe Meng · Updated on 2024-02-13
200
Participants Needed
1
Research Sites
26 weeks
Total Duration
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
A Single Center Randomized Controlled Study on the Promotion of Rapid Recovery
M
meng zhe
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Zhe Meng
Lead Sponsor
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Giulio Lelli, Alessandra Micalizzi, Angelo Iossa...
https://pubmed.ncbi.nlm.nih.gov/37282440/Shuaishuai Chai, Qiufeng Pan, Chaoqi Liang...
https://pubmed.ncbi.nlm.nih.gov/34268075/Zhe Meng
Lead Sponsor