Zhongnan hospital
Wuhan, Hubei, 430071, China
Location status: Recruiting
NCT Number: NCT06250699
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.
Interested in participating?
Request Info18 year–70 year
All sexes
Interventional
Not applicable
Wuhan, Hubei, 430071, China
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
No drainage tube placed after laparoscopic adrenalectomy
Placing drainage tubes after laparoscopic adrenalectomy
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.
Time frame: 1-3 days after surgery
First time up and about after laparoscopic adrenalectomy
Time frame: 1-3 days after surgery
Recovery time of intestinal function after laparoscopic adrenalectomy
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.
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.
Contact information is provided by the study sponsor or research team.
Zhe Meng
Other
A Single Center Randomized Controlled Study on the Promotion of Rapid Recovery Through Tubeless Laparoscopic Adrenalectomy
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06980753
Adrenal Gland Diseases, Adrenal Insufficiency
São Paulo, Brazil
View Trial DetailsNCT05368090
Adrenal Cortex Diseases, Adrenal Cortex Neoplasms
Bergen, Norway
View Trial DetailsNCT00669266
Adenocarcinoma, Adrenal Cortex Diseases
Würzburg, Germany
View Trial DetailsNCT06495983
Adrenal Gland Diseases, Adrenocortical Hyperfunction
Bergen, Norway
View Trial Details