Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06958848

Comparison of 16F Versus 24F Chest Drain After Minimally Invasive Pulmonary Lobectomy and/or Segmentectomy: a Monocentre Prospective Randomized Controlled Trial

Led by University Hospital, Basel, Switzerland · Updated on 2026-05-06

124

Participants Needed

1

Research Sites

17 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating postoperative pain in patients undergoing minimally invasive pulmonary lobectomy and/or segmentectomy for resectable non-small cell lung cancer (NSCLC). The study compares the use of small-bore (16F) chest drains to the standard large-bore (24F) chest drains. It aims to determine if smaller chest tubes and earlier removal can reduce pain and improve recovery without compromising safety. This is a prospective randomized controlled trial conducted at a single center. Participants are assigned to one of four groups: small-bore (16F) chest tubes removed early (2 to 6 hours after surgery), small-bore tubes removed at standard time (1 day post-op), large-bore (24F) tubes removed early, or large-bore tubes removed at standard time. The study monitors safety and feasibility of early chest drain removal and compares effects of tube size and timing on postoperative outcomes. During the study, pain levels are assessed multiple times within the first three days after surgery, at discharge, and during follow-ups at 30 and 180 days. Researchers also track analgesic use, duration of drainage, fluid output, hospital stay length, complications, rehospitalization, mortality, chronic pain, and quality of life. Participants can expect detailed monitoring and evaluations throughout hospitalization and at follow-up visits up to six months after surgery.

CONDITIONS

Brief Title

16F vs 24F Chest Drain After Minimally Invasive Lobectomy and/or Segmentectomy

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed informed consent from the patient (all sexes and genders)
  • Age 18 years or older at time of study inclusion
  • American Society of Anaesthesiologists (ASA) physical status classification I to IV
  • Patients with resectable non-small cell lung cancer (NSCLC) suitable for minimally invasive surgery
  • Undergoing minimally invasive anatomical lung resections such as lobectomy, lobectomy with wedge resection, lobectomy combined with segmentectomy, segmentectomy with wedge resection, or bilobectomy under general anaesthesia
Not Eligible

You will not qualify if you...

  • Previous thoracic surgery on the same side within 3 months
  • Lung cancer complicated with pleural empyema
  • Chronic pain patients using opioids, gabapentin, or pregabalin
  • Current use of opiates or benzodiazepines
  • Congestive heart failure NYHA Class III or IV
  • Liver cirrhosis Child-Pugh Class B or C
  • Renal insufficiency requiring dialysis or eGFR below 30 mL/min/1.73 m2
  • Coagulopathy or bleeding disorders such as von Willebrand disease, Hemophilia, or thrombocytopenia (platelets below 50 G/l) requiring transfusion
  • Neuralgia
  • Chest pain at surgery site without painkillers measured by VAS while coughing greater than 10 mm
  • Unhealed rib fractures on side of surgery within last 3 months
  • Open anatomical lung resections including pneumonectomy
  • Insertion of two or more chest tubes
  • Need for patient-controlled intravenous or epidural anaesthesia
  • Patients who are intubated or sedated and unable to complete pain surveys

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - Hospital stay up to 10 days

Participants undergo minimally invasive pulmonary lobectomy and/or segmentectomy with insertion of either a 16F or 24F chest drain. The chest drain is removed either early (2 to 6 hours after surgery) or standard (1 day postoperative) depending on the assigned group.

Daily visits during hospital stay

Post-operative Follow-up

Duration - Up to 6 months after surgery

Participants are followed up to assess postoperative pain, complications, and recovery including assessments at discharge and at 30 and 180 days after hospital discharge.

Visits at discharge, 30 days, and 180 days post-surgery

Trial Site Locations

Total: 1 location

1

University Hospital Basel

Basel, Switzerland, 4031

Actively Recruiting

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Research Team

H

Helga Bachmann, MSc Clinical Research

M

Makhmudbek Mallaev, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

4

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