Comparison of muscle sparing thoracotomy and posterolateral thoracotomy for pulmonary lobectomy for lung cancer
| ISRCTN | ISRCTN17868937 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17868937 |
| Secondary identifying numbers | N/A |
- 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
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Luigi Santambrogio
Scientific
Scientific
Via Francesco Sforza, 35
Milan
20122
Italy
| Phone | +39 (0)25 503 5513 |
|---|---|
| luigi.santambrogio@unimi.it |
Study information
| Study design | Single centre prospective randomised controlled double blind trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | 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 outcome measures | 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 |
| Overall study start date | 01/07/2003 |
| Completion date | 31/07/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 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
Via Francesco Sforza, 35
Milan
20122
Italy
20122
Italy
Sponsor information
Fondazione IRCCS Ospedale Maggiore Policlinico Mangiagalli Regina Elena (Italy)
Research organisation
Research organisation
University of Milan
Via Francesco Sforza, 35
Milan
20122
Italy
| Phone | +39 (0)25 503 5513 |
|---|---|
| luigi.santambrogio@unimi.it | |
| Website | http://www.policlinico.mi.it |
"ROR" |
https://ror.org/016zn0y21 |
Funders
Funder type
Research organisation
Fondazione IRCCS Ospedale Maggiore Policlinico Mangiagalli Regina Elena (Italy)
No information available
University of Milan (Italy)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
