A Single Center Randomized Controlled Study on the Promotion of Rapid Recovery

NCT ID: NCT06250699

Last Updated: 2024-02-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-03
• Study Completion Date: 2027-06-30

Brief Summary

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.

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.

Conditions

Nonfunctional Adrenal Cortex Adenoma; Primary Aldosteronism; Cushing Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

no tube

no drainage tube after laparoscopic adrenalectomy

Group Type: EXPERIMENTAL

Tubeless laparoscopic adrenalectomy

Intervention Type: PROCEDURE

No drainage tube placed after laparoscopic adrenalectomy

Drainage tube

tube drainage after laparoscopic adrenalectomy

Group Type: EXPERIMENTAL

Drainage tube

Intervention Type: PROCEDURE

Placing drainage tubes after laparoscopic adrenalectomy

Interventions

Tubeless laparoscopic adrenalectomy

No drainage tube placed after laparoscopic adrenalectomy

Intervention Type: PROCEDURE

Drainage tube

Placing drainage tubes after laparoscopic adrenalectomy

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. According to the 2022 edition of the Chinese Guidelines for Diagnosis and Treatment of Urological Diseases, patients who meet the surgical indications

2. 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

1. Patients with complications that seriously affect treatment or quality of life

2. The patient has any physical condition that the researcher believes will affect the clinical status

3. Patients who have placed vascular stents such as heart and cerebrovascular stents within the past year

4. Pregnant or lactating patients

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhe Meng

OTHER

Sponsor Role: lead

Responsible Party

Zhe Meng

Deputy chief physician

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

meng zhe

Role: PRINCIPAL_INVESTIGATOR

Wuhan University

Locations

Zhongnan hospital

Wuhan, Hubei, China

Site Status: RECRUITING

Countries

China

Central Contacts

meng zhe

Role: CONTACT

mengzhe@whu.edu.cn

15387041020

Facility Contacts

meng zhe

Role: primary

mengzhe@whu.edu.cn

15387041020

References

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.

Reference Type: BACKGROUND

PMID: 34268075 (View on PubMed)

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. 2024 Apr 1;20(2):163-168. doi: 10.4103/jmas.jmas_319_22. Epub 2023 May 10.

Reference Type: BACKGROUND

PMID: 37282440 (View on PubMed)

Other Identifiers

2023231

Identifier Type: -

Identifier Source: org_study_id