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

NCT06250699 | Recruiting

• 1 other identifier: 2023231
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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. 1.The safety of tubeless laparoscopic adrenalectomy；
2. 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.

Conditions

Nonfunctional Adrenal Cortex Adenoma; Primary Aldosteronism; Cushing Syndrome

Keywords

tubeless; laparoscopic adrenalectomy; rapid recovery

Outcome Measures

Primary Outcomes (4)

• 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.

  1-3 days after surgery

• First time up and about

  First time up and about after laparoscopic adrenalectomy

  1-3 days after surgery

• Recovery time of intestinal function

  Recovery time of intestinal function after laparoscopic adrenalectomy

  1-3 days after surgery

• 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.

  1-3 days after surgery

Secondary Outcomes (1)

• fever

  1-3 days after surgery

Study Arms (2)

no tube

EXPERIMENTAL

no drainage tube after laparoscopic adrenalectomy

Procedure: Tubeless laparoscopic adrenalectomy

Drainage tube

EXPERIMENTAL

tube drainage after laparoscopic adrenalectomy

Procedure: Drainage tube

Interventions

Tubeless laparoscopic adrenalectomy PROCEDURE

No drainage tube placed after laparoscopic adrenalectomy

no tube

Drainage tube PROCEDURE

Placing drainage tubes after laparoscopic adrenalectomy

Drainage tube

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Zhe Meng: lead

Study Sites (1)

Zhongnan hospital

Wuhan, Hubei, 430071, China

RECRUITING

Related Publications (2)

• 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.

  PMID: 34268075 BACKGROUND

• 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.

  PMID: 37282440 BACKGROUND

MeSH Terms

Conditions

Hyperaldosteronism; Cushing Syndrome

Condition Hierarchy (Ancestors)

Adrenocortical Hyperfunction; Adrenal Gland Diseases; Endocrine System Diseases

Study Officials

• meng zhe

  Wuhan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

meng zhe

CONTACT

15387041020; mengzhe@whu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Deputy chief physician

Study Record Dates

• First Submitted: January 28, 2024
• First Posted: February 9, 2024
• Study Start: January 3, 2024
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: February 13, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)