Ignite Creation Date:
2024-05-06 @ 8:06 PM
Last Modification Date:
2025-12-17 @ 6:19 AM
Study NCT ID:
NCT06250699
Status:
None
Last Update Posted:
2024-02-13 00:00:00
First Post:
2024-01-28 00:00:00
Brief Title:
A Single Center Randomized Controlled Study on the Promotion of Rapid Recovery
Sponsor:
Zhe Meng
Organization:
Zhongnan Hospital
Study Overview
Official Title:
A Single Center Randomized Controlled Study on the Promotion of Rapid Recovery Through Tubeless Laparoscopic Adrenalectomy
Status:
None
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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 SAS94 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 patients rapid recovery such as pain score first time out of bed intestinal ventilation time etc Safety evaluation methods mainly include the subjects blood routine and vital signs
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None