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A single-centre, prospective, superior randomised controlled trial evaluating 8Fr pigtail tubes in combination with chest tubes for postoperative chest drainage

A single-centre, prospective, superior randomised controlled trial evaluating 8Fr pigtail tubes in combination with chest tubes for postoperative chest drainage

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500099417
Enrollment
Unknown
Registered
2025-03-24
Start date
2025-04-01
Completion date
Unknown
Last updated
2025-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung cancer

Interventions

Intervention group:After routine placement of a single chest tube along the surgical incision, an 8Fr caudal fibre tube is placed on the same side of the surgery, positioned from the mid-axillary or p
Reference group:A single chest tube is routinely placed along the surgical incision

Sponsors

The First Affiliated Hospital of Nanchang University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age >=18 years old, male or female; 2. Meet the perioperative standards of the eighth edition of the People's Health Publishing House of Surgery, with preoperative blood pressure controlled below 160/100 mmHg, blood glucose controlled at 5.6-11.2 mmol/L, and normal function of major organs such as the heart, lungs, liver, and kidneys, with the following main criteria: cardiac function test suggesting Goldman index grading of grade 1-2; lung FEV1 >=40% of the expected postoperative value and DLCO >=40%; total bilirubin =60 ml/min 3.ECOG (Eastern Cooperative Oncology ECOG (Eastern Cooperative Oncology Group classificantion) score of 0-1; 4. Patients who plan to undergo single-port thoracoscopic unilateral lung cancer resection (simple segmental or lobar resection) meet the indications for single-port thoracoscopic unilateral lung cancer resection; 5. Patients are able to understand the purpose of the trial, have a good adherence to the examination and follow-up, voluntarily participate in the clinical trial, and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Patients with active bacterial or fungal infections diagnosed prior to surgery; 2. Patients with a history of severe heart disease, heart failure, myocardial infarction, or angina pectoris attack within the last 6 months; 3. Female patients who are pregnant or breastfeeding, or menstruating; 4. Patients with severe psychiatric illnesses, psychiatric disorders, or psychiatric symptoms; 5. Patients with contraindications to surgery or excessive perioperative risk; 6. Patients who were converted from uniportal thoracoscopy to open surgery during the operation for any Patients who have been converted from single-port thoracoscopy to open surgery for any reason; 7. Patients who cannot fully understand the purpose and requirements of this clinical trial and are unable to comply with the required examinations and follow-up visits; 8. Patients who are assessed by the investigator to have other reasons for being unsuitable for participation in this clinical study.

Design outcomes

Primary

MeasureTime frame
Incidence of poor incision healing;Postoperative patient satisfaction scores for incision recovery;

Secondary

MeasureTime frame
Postoperative pain index in resting and coughing states;Total postoperative thoracic drainage volume and daily drainage volume;Duration of postoperative chest drainage;Rate of adverse respiratory events after extubation or rate of secondary extubation after extubation;Postoperative complication rate;Number of additional postoperative dressing changes;Length of postoperative stay;Postoperative pulmonary function recovery;

Countries

China

Contacts

Public ContactShaohua Dai

The First Affiliated Hospital of Nanchang University

ciccy516615@163.com+86 134 7916 5726

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026