Neoplasms

All Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Carcinoma

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Carcinoma, Bronchogenic

Bronchial Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

One thoracic tube (28fr drainage tube) was inserted through intercostal incision, and one microtubule (7fr × 20cm) was punctured through the middle line of clavicle

Two conventional chest tubes (28fr or 24fr) were placed through intercostal incision

This is a kind of venous catheter commonly used in clinic. It may bring less pain after being inserted into the chest, with an equivalent drainage effect with traditional thick drainage tube from our experience, especially in the aspect of gas drainage effect.

prophylactic air-extraction catheter drainage

Xing Wang, MD

Jiang Fan, MD

Nan Song, MD

Wenxin He, MD

Liang Duan, MD

Tao Ge, MD

Hao Li, MD

Tao Gui, MD

Traditional drainage for uniportal video assisted thoracoscopic surgery (VATS) is a routine method, usually with one or two chest tubes at intercostal incisions, but postoperative pain due to the chest tube and unsatisfied drainage effect was noted.

In this study, the investigators are going to explore whether a prophylactic air-extraction catheter combined with chest tube drainage may not increase complications in uniportal VATS for upper lung lobectomy. The patients would be assigned to two arms, one with a prophylactic air-extraction catheter combined with chest tube, and another with two chest tubes, and the effect of the combined drainage strategy will be evaluated.

Research purpose and background:

Surgical resection is still one of the most important treatment methods for early stage non-small cell lung cancer. Complete resection and reasonable dissection of mediastinal lymph nodes are the key of cancer cure. Lobectomy has always been the standard surgical method for lung cancer radical resection. It can remove the lesion and retain normal lung function by resecting the lung lobe where the lesion is and preserve the remaining lobe. In recent years, the development of uniport video-assisted thoracic surgery (VATS) has further reduced the trauma, with treatment benefit similar with that of two-port and three-port thoracoscopy. However, based on the single hole thoracoscopic lung recruitment, incision drainage and other issues also need further evidence support.

No tube technology, such as no tracheal intubation, drainage tube, nor catheter combined with video-assisted thoracoscopy, can significantly improve the rehabilitation of patients, and further shorten the postoperative hospital stay. In addition, the safety of tubeless drainage has been supported by more and more studies. However, poor drainage may also increase the incidence of pneumothorax and postoperative pulmonary dysfunction.

After upper lobe lobectomy, the cavity needs to be filled by the full recruitment of the remaining lobes. theoretically, there is a higher demand for the strategy of the drainage tube. The investigatorstried to compare the safety and effectiveness of the prophylactic air-extraction catheter (later known as microtubule) combined with thoracic tube drainage with traditional double drainage tube alone. Therefore, the investigators conducted a prospective, randomized, non inferiority trial to verify the hypothesis that microtubule combined with thoracic catheter drainage after uniport VATS upper lobectomy will not increase the related perioperative complications compared with traditional thoracic tube drainage.

Quality assurance plan:

1. The doctors participating in the operation and catheterization in clinical trials should be at least attendings, so as to ensure the safety of operation and chest tube placement.
2. The chest tube placement was carried out randomly with two arms.
3. From our previous clinical experience, the tube is placed for 3 days to 2 weeks, so it last for a short time, and all of them can be extubated by doctors above the attending level, so the detachment rate of the experiment is low and the quality can be guaranteed.
4. The trial team has written the test related procedures into the team medical process, including but not limited to the time point of chest X-ray.

Data checks:

Data checks will be performed by a individual attending doctor with GCP to compare data entered into the registry against predefined rules for range or consistency with other data fields in the registry.

Source data verification:

Source data verification will be performed by a individual attending doctor with GCP to assess the accuracy, completeness, or representativeness of registry data by comparing the data to external data sources (for example, medical records, paper or electronic case report forms, or interactive voice response systems).

Data dictionary:

video assisted thoracoscopic surgery, VATS prophylactic air-extraction catheter, PAEC Randomized clinical trial, RCT Non small cell lung cancer, NSCLC

Standard Operating Procedures:

Patients recruitment The subjects were recruited on a voluntary basis. If they decide to participate in this study, the personal data of subjects participating in the trial are confidential. The subject's blood samples will be identified by the study number, not the subject's name. Information that identifies the subject will not be disclosed to members outside the study team unless permission is obtained from the subject. All study members and study sponsors were asked to keep their identities confidential. The subjects' files will be kept in a locked file cabinet for researchers' reference only. In order to ensure that the study is carried out in accordance with the regulations, members of the government administration or the ethics review committee may access the subject's personal data in the research unit as required. At the time of publication, no personal information will be disclosed.

data collection All the patients learned about the two kinds of operation through preoperative education, and voluntarily joined the research group and signed the ethical agreement. In this clinical trial, patients were enrolled in the randomized controlled trial. The members of the experimental group were only responsible for the inclusion and exclusion of patients. The surgeons and assistants did not participate in the preoperative evaluation and postoperative management. The pain assessment team, postoperative management personnel and follow-up evaluators did not know what group the patients belonged to (patients could wear wide clothes to cover the drainage tube after operation)

change management In cases with serious medical risk caused by the operation technology of the trial, or the research indicates that the difference between the groups is too obvious, the researcher should stop the trial and fill in the report form of violation of protocol deviation and report to the ethics committee.

If the patients were enrolled normally and reached the number of cases required for the trial, the trial was finished.

reporting for adverse events

1. The sponsor shall provide the safety research data of the technology and other safety related information.
2. In the design scheme, the definition of adverse events should be clearly defined, and the criteria for judging the severity of adverse events, as well as the classification criteria for judging the relationship between adverse events and experimental operation (such as positively related, possibly related, possibly unrelated, irrelevant and unable to be determined). The protocol requires researchers to truthfully fill in the adverse event record form, recording the occurrence time, severity, duration, measures taken and outcome.
3. Before starting the trial, the members of the research team must be familiar with the contents of the prevention and treatment of subjects and emergency plans in medical treatment.
4. In case of SAE, the research physician must report to the project leader, the food and drug administration, the sponsor, the medical ethics committee of our hospital, the center ethics, and the office of drug clinical trial institution within 24 hours. When and by what means (e.g. telephone, fax or written) to whom SAE was reported should be recorded in the original data.
5. The original medical ethics committee reports the paper version, including the receipt page (with PI signature), SAE form and processing process in triplicate, and then reports the electronic version of PPT, which is then sent to wangxing5447@126.com
6. To study the doctor according to the implementation of treatment, if necessary, start to prevent and deal with medical subjects and emergency plans.
7. At the same time, the research doctor should make a record of SAE, including at least the description of adverse events, occurrence time, termination time, degree and frequency of seizures, and the treatment given.
8. The medical ethics committee will hold a meeting to organize experts to report and discuss the SAE and the treatment process in our hospital, and require the follow-up of SAE.

Sample size assessment

The purpose of this study was to verify whether the new strategy is not inferior to traditional method in uniport VATS upper lobe lobectomy. In terms of the incidence of pneumothorax (primary), based on previous observational studies, the probability of postoperative pneumothorax in new method and traditional method was about 10% and 6%. Considering 25% of non-inferiority margin, efficacy analysis estimated that 75 patients in each group were required to achieve power of 0.99 (via version 15.0; NCSs, Kaysville, UT, USA) with unilateral α of 0.025. Considering some out of groups due to clinical factors or other criteria (e.g., changing surgical methods according to pathological results during operation, combined with other lobectomy, etc.), a total of 75 subjects in each group were required, and 400 is the anticipating case number.

Plan for missing data The investigators made a plan for missing data to address situations where variables are reported as missing, unavailable, non-reported, uninterpretable, or considered missing because of data inconsistency or out-of-range results.

First, sufficient case is planned for the missing data generated from changes in surgery, as combined lobectomy or sublobectomies. Second, all the surgeons in our department will be informed of this study, and the changes in surgical method should be avoided to their best effort.

Statistical analysis plan

Statistical analysis will be performed to these select two groups in terms of clinical parameters, including the incidence of pneumothorax, reintubation rate, pain score and other parameters, respectively using t test, chi square test, rank sum test and other means. SPSS 20 will be validated to compare the primary and secondary observation end points between the two groups.

The study is a prospective, randomized, non-inferiority trial, two different drainage strategy will be performed, and both were used routinely in clinical practice. One should be one thoracic tube (28fr drainage tube) was inserted through intercostal incision, and one microtubule (7fr × 20cm) was punctured through the middle line of clavicle, and another will be two conventional chest tubes (28fr or 24fr) were placed through intercostal incision.

Data collected from the X-rays and the pain score evaluation will be masked and the outcomes assessor have no method to get randomized information.

The Effect of a Combined Drainage Strategy in Uniportal Upper Lung Lobectomy

The Drainage Effect of a Chest Tube Plus Prophylactic Air-extraction Catheter vs Traditional Drainage Strategy in Uniportal Upper Lung Lobectomy

The incidence of pneumothorax on day 1 after operation

Total volume of pleural effusion on the first day after operation

Tongji University

Associate professor

Symptoms and General Pathology

Gland and Hormone Related Diseases

Rare Diseases

Syndrome

Adenoma

Cushing Syndrome

Hyperaldosteronism

Adrenocortical Adenoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adrenocortical Hyperfunction

Adrenal Gland Diseases

Endocrine System Diseases

Adrenal Cortex Neoplasms

Adrenal Gland Neoplasms

Endocrine Gland Neoplasms

Adrenal Cortex Diseases

Cushing's Syndrome

Adenoma of the Adrenal Gland

Hyperadrenalism

no drainage tube after laparoscopic adrenalectomy

tube drainage after laparoscopic adrenalectomy

No drainage tube placed after laparoscopic adrenalectomy

Tubeless laparoscopic adrenalectomy

Placing drainage tubes after laparoscopic adrenalectomy

Drainage tube

meng zhe

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.

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.

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

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

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.

First time up and about after laparoscopic adrenalectomy

Recovery time of intestinal function after laparoscopic adrenalectomy

Detection of obvious hematoma (Hematoma area\> 4cm x 4cm) in the surgical area through color ultrasound. The results are expressed as yes or no.

Does the patient experience fever (The thermometer shows a temperature greater than 37.3 ° C) after laparoscopic adrenalectomy.

Zhe Meng

Deputy chief physician

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

No place the drainage tube after the intraperitoneal laparoscopic radical prostatectomy

Place the drainage tube after the intraperitoneal laparoscopic radical prostatectomy

No place the drainage tube after the intraperitoneal Laparoscopic Radical Prostatectomy

Intraperitoneal Laparoscopic Radical Prostatectomy Without Drainage Tube

Place the drainage tube after the intraperitoneal Laparoscopic Radical Prostatectomy

Intraperitoneal Laparoscopic Radical Prostatectomy With Drainage Tube

Biming He

Haifeng Wang

This is a randomized controlled and non-inferiority trial in comparison of intraperitoneal laparoscopic radical prostatectomy without drainage tube between intraperitoneal laparoscopic radical prostatectomy with drainage tube in the safety in men with a localized prostate cancer.

This trial is a prospective, single-centre, randomized controlled, and non-inferiority study in which all men with localized prostate cancer. This study aims to determine whether intraperitoneal laparoscopic radical prostatectomy without drainage tube is non-inferior to intraperitoneal laparoscopic radical prostatectomy with drainage tube in the safety in men with a localized prostate cancer.

Evaluation of the Safety of Intraperitoneal Laparoscopic Radical Prostatectomy With or Without Drainage Tube

Evaluation of the Safety of Intraperitoneal Laparoscopic Radical Prostatectomy With or Without Drainage Tube: a Singlecentre, Randomised Controlled, and Non-inferiority Study

Any adverse event according to the Clavien-Dindo classification will be recorded

The difference between postoperative hemoglobin and preoperative hemoglobin

The time between the patient's first time out of bed and the end of the surgical procedure

The first time to eat after the operation, the first time to exit gas after the operation,the first time to defecation after the operation

The ultrasound and CT to detect if there is abdominal effusion and cyst

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
The Effect of a Combined Drainage Strategy in Uniportal Upper Lung Lobectomy	NCT04461652	Carcinoma, Non-...	prophylactic ai...	18 Years - 75 Years	Tongji University
A Single Center Randomized Controlled Study on the Promotion of Rapid Recovery	NCT06250699	Nonfunctional A... Primary Aldoste... Cushing Syndrom...	Tubeless laparo... Drainage tube	18 Years - 70 Years	Zhongnan Hospital
Evaluation of the Safety of Intraperitoneal Laparoscopic Radical Prostatectomy With or Without Drainage Tube	NCT04457882	Prostate Cancer	Intraperitoneal... Intraperitoneal...	18 Years - 85 Years	Shanghai East Hospital
A Single Center Randomized Controlled Study on the Promotion of Rapid Recovery	NCT06250699	Nonfunctional A... Primary Aldoste... Cushing Syndrom...	Tubeless laparo... Drainage tube	18 Years - 70 Years	Zhongnan Hospital

Spots Global Cancer Trial Database for drainage tube