Comparison of muscle sparing thoracotomy and posterolateral thoracotomy for pulmonary lobectomy for lung cancer

Muscle sparing versus posterolateral thoracotomy for pulmonary lobectomy for lung cancer: a single centre randomised, double blind, controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN17868937

Enrollment

100

Registered

2009-10-20

Start date

2003-07-01

Completion date

Unknown

Last updated

2015-01-13

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

Conditions

Lung cancer Cancer Malignant neoplasm of the lung

Interventions

Patients are randomly divided in two groups in respect to surgical access to the thorax: Group A: Posterolateral thoracotomy Group B: Muscle-sparing thoracotomy The duration of treatment is from 2 to

the total duration of follow-up for all treatments are 3 years.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Male and female 2. Aged greater than 18 and less than 80 years 3. Lung cancer (stage I and II) 4. Informed consent

Exclusion criteria

Exclusion criteria: 1. Previous thoracic surgery 2. Psychiatric disease 3. Non-controlled diabetes 4. Thoracic wall resection 5. Epidural analgesia 6. Severe cardiovascular or pulmonary disease 7. Drug abuse 8. Chronic pain syndromes

Design outcomes

Primary

Measure	Time frame
1. Pain severity, assessed by patients 4 times a day in a relaxed position, and during coughing using a visual analogue pain scale (0 = no pain, 10 = most severe pain). The eight scores were then averaged to produce a daily composite score. Pain scores were measured pre-operatively and daily after surgery to post-operative day 7. After 1, 3, 6, 12 months and 3 years following the operation, patients were asked about the occurrence of symptoms of post-thoracotomy pain or post-thoracotomy syndrome. 2. Analgesic consumption for pain at the site of the thoracotomy was recorded. An aggregate analgesic score (AAS) was computed adding 1 point for each mg of intravenous morphine used, 5 points for every dose of intravenous ketorolac (30 mg) and 4 points for each oral dose of acetaminophen-codeine (500/30 mg) administered.	—

Measure

Time frame

1. Pain severity, assessed by patients 4 times a day in a relaxed position, and during coughing using a visual analogue pain scale (0 = no pain, 10 = most severe pain). The eight scores were then averaged to produce a daily composite score. Pain scores were measured pre-operatively and daily after surgery to post-operative day 7. After 1, 3, 6, 12 months and 3 years following the operation, patients were asked about the occurrence of symptoms of post-thoracotomy pain or post-thoracotomy syndrome. 2. Analgesic consumption for pain at the site of the thoracotomy was recorded. An aggregate analgesic score (AAS) was computed adding 1 point for each mg of intravenous morphine used, 5 points for every dose of intravenous ketorolac (30 mg) and 4 points for each oral dose of acetaminophen-codeine (500/30 mg) administered.

—

Secondary

Measure	Time frame
1. Shoulder mobility and muscle strength was measured by a physiotherapist before surgery; the analyses were repeated at 1, 3 and 7 post-operative days and after 1 and 6 months by the same blinded observer. Muscle strength was recorded during adduction, abduction, flexion and extension on the operated side; the results were graded on a scale from 0 to 5 (5 = normal strength) according to the Daniels and Worthingham's muscle tests 2. Pulmonary function tests were obtained pre-operatively and daily after surgery to post-operative day 7. The spirometry was repeated at 1, 3, 6, 12 months and 3 years after the operation. 3. Major morbidity	—

Measure

Time frame

1. Shoulder mobility and muscle strength was measured by a physiotherapist before surgery; the analyses were repeated at 1, 3 and 7 post-operative days and after 1 and 6 months by the same blinded observer. Muscle strength was recorded during adduction, abduction, flexion and extension on the operated side; the results were graded on a scale from 0 to 5 (5 = normal strength) according to the Daniels and Worthingham's muscle tests 2. Pulmonary function tests were obtained pre-operatively and daily after surgery to post-operative day 7. The spirometry was repeated at 1, 3, 6, 12 months and 3 years after the operation. 3. Major morbidity

—

Countries

Italy

Outcome results

None listed

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