- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06250699
A Single Center Randomized Controlled Study on the Promotion of Rapid Recovery
February 8, 2024 updated by: Zhe Meng
A Single Center Randomized Controlled Study on the Promotion of Rapid Recovery Through Tubeless Laparoscopic Adrenalectomy
The goal of this clinical trial is to exploring the role of tubeless after adrenalectomy surgery. The main questions it aims to answer are:
- The safety of tubeless laparoscopic adrenalectomy;
- 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.
Study Overview
Status
Recruiting
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Estimated)
200
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: meng zhe
- Phone Number: 15387041020
- Email: mengzhe@whu.edu.cn
Study Locations
-
-
Hubei
-
Wuhan, Hubei, China, 430071
- Recruiting
- Zhongnan Hospital
-
Contact:
- meng zhe
- Phone Number: 15387041020
- Email: mengzhe@whu.edu.cn
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: no tube
no drainage tube after laparoscopic adrenalectomy
|
No drainage tube placed after laparoscopic adrenalectomy
|
Experimental: Drainage tube
tube drainage after laparoscopic adrenalectomy
|
Placing drainage tubes after laparoscopic adrenalectomy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain score
Time Frame: 1-3 days after surgery
|
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.
|
1-3 days after surgery
|
First time up and about
Time Frame: 1-3 days after surgery
|
First time up and about after laparoscopic adrenalectomy
|
1-3 days after surgery
|
Recovery time of intestinal function
Time Frame: 1-3 days after surgery
|
Recovery time of intestinal function after laparoscopic adrenalectomy
|
1-3 days after surgery
|
Hematoma
Time Frame: 1-3 days after surgery
|
Detection of obvious hematoma (Hematoma area> 4cm x 4cm) in the surgical area through color ultrasound.
The results are expressed as yes or no.
|
1-3 days after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
fever
Time Frame: 1-3 days after surgery
|
Does the patient experience fever (The thermometer shows a temperature greater than 37.3 ° C) after laparoscopic adrenalectomy.
|
1-3 days after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: meng zhe, Wuhan University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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. 2023 May 10. doi: 10.4103/jmas.jmas_319_22. Online ahead of print.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 3, 2024
Primary Completion (Estimated)
December 30, 2026
Study Completion (Estimated)
June 30, 2027
Study Registration Dates
First Submitted
January 28, 2024
First Submitted That Met QC Criteria
February 7, 2024
First Posted (Actual)
February 9, 2024
Study Record Updates
Last Update Posted (Estimated)
February 13, 2024
Last Update Submitted That Met QC Criteria
February 8, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Endocrine System Diseases
- Endocrine Gland Neoplasms
- Adrenocortical Hyperfunction
- Adrenal Gland Diseases
- Adrenal Cortex Neoplasms
- Adrenal Gland Neoplasms
- Adrenal Cortex Diseases
- Adenoma
- Hyperaldosteronism
- Cushing Syndrome
- Adrenocortical Adenoma
Other Study ID Numbers
- 2023231
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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