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NCT Number: NCT06250699

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

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.

Recruiting

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tubeless laparoscopic adrenalectomy

Procedure

No drainage tube placed after laparoscopic adrenalectomy

Drainage tube

Procedure

Placing drainage tubes after laparoscopic adrenalectomy

Primary outcomes

  1. 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.

  2. First time up and about

    Time frame: 1-3 days after surgery

    First time up and about after laparoscopic adrenalectomy

  3. Recovery time of intestinal function

    Time frame: 1-3 days after surgery

    Recovery time of intestinal function after laparoscopic adrenalectomy

  4. 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.

Secondary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

meng zhe

CONTACT

[email protected]

15387041020

Sponsors and collaborators

Lead sponsor

Zhe Meng

Other

Registry information

Official study title

A Single Center Randomized Controlled Study on the Promotion of Rapid Recovery Through Tubeless Laparoscopic Adrenalectomy

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Feb 9, 2024
Registry last updated
Feb 13, 2024

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.

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