A Single Center Randomized Controlled Study on the Promotion of Rapid Recovery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorZhe Meng
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
According to the 2022 edition of the Chinese Guidelines for Diagnosis and Treatment of Urological Diseases, patients who meet the surgical indications
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.
Disqualifiers
Patients with complications that seriously affect treatment or quality of life
The patient has any physical condition that the researcher believes will affect the clinical status
Patients who have placed vascular stents such as heart and cerebrovascular stents within the past year
Pregnant or lactating patients
Trial design
Design model
Parallel
Treatments tested in this trial
Tubeless laparoscopic adrenalectomy
Procedure/SurgeryNo drainage tube placed after laparoscopic adrenalectomy
Drainage tube
Procedure/SurgeryPlacing drainage tubes after laparoscopic adrenalectomy
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: no tubeExperimental treatment 1 intervention
Group B: Drainage tubeExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
1-3 days after surgery2
First time up and about
First time up and about after laparoscopic adrenalectomy
Time frame
1-3 days after surgery3
Recovery time of intestinal function
Recovery time of intestinal function after laparoscopic adrenalectomy
Time frame
1-3 days after surgery4
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.
Time frame
1-3 days after surgerySecondary outcomes
1
fever
Does the patient experience fever (The thermometer shows a temperature greater than 37.3 ° C) after laparoscopic adrenalectomy.
Time frame
1-3 days after surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
Zhe Meng
Lead sponsor
Zhongnan Hospital
Sponsor institution
Source ClinicalTrials.gov