Comparison of muscle sparing thoracotomy and posterolateral thoracotomy for pulmonary lobectomy for lung cancer
| ISRCTN | ISRCTN17868937 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17868937 |
| Protocol serial number | N/A |
| Sponsor | Fondazione IRCCS Ospedale Maggiore Policlinico Mangiagalli Regina Elena (Italy) |
| Funders | Fondazione IRCCS Ospedale Maggiore Policlinico Mangiagalli Regina Elena (Italy), University of Milan (Italy) |
- Submission date
- 08/10/2009
- Registration date
- 20/10/2009
- Last edited
- 17/08/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
Not provided at time of registration
Contact information
Scientific
Via Francesco Sforza, 35
Milan
20122
Italy
| Phone | +39 (0)25 503 5513 |
|---|---|
| luigi.santambrogio@unimi.it |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single centre prospective randomised controlled double blind trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Muscle sparing versus posterolateral thoracotomy for pulmonary lobectomy for lung cancer: a single centre randomised, double blind, controlled trial |
| Study acronym | MST PLT |
| Study objectives | Muscle sparing thoracotomy should have more advantages in pain, muscle strength and pulmonary function than posterolateral thoracotomy. |
| Ethics approval(s) | Local Ethics Committee (Comitato Etico Ospedale Maggiore di Milano I.R.C.C.S) approved on the 20th June 2003 |
| Health condition(s) or problem(s) studied | Lung cancer |
| Intervention | 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 3 hours; the total duration of follow-up for all treatments are 3 years. |
| Intervention type | Other |
| Primary outcome measure(s) |
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. |
| Key secondary outcome measure(s) |
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 |
| Completion date | 31/07/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 100 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/07/2003 |
| Date of final enrolment | 31/07/2006 |
Locations
Countries of recruitment
- Italy
Study participating centre
20122
Italy
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/10/2010 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |