Contact information
Type
Scientific
Primary contact
Prof Luigi Santambrogio
ORCID ID
Contact details
Via Francesco Sforza
35
Milan
20122
Italy
+39 (0)25 503 5513
luigi.santambrogio@unimi.it
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Muscle sparing versus posterolateral thoracotomy for pulmonary lobectomy for lung cancer: a single centre randomised, double blind, controlled trial
Acronym
MST PLT
Study hypothesis
Muscle sparing thoracotomy should have more advantages in pain, muscle strength and pulmonary function than posterolateral thoracotomy.
Ethics approval
Local Ethics Committee (Comitato Etico Ospedale Maggiore di Milano I.R.C.C.S) approved on the 20th June 2003
Study design
Single centre prospective randomised controlled double blind trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Applicable
Drug names
Primary outcome measures
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 trial start date
01/07/2003
Overall trial end date
31/07/2006
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
100
Participant 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
Recruitment start date
01/07/2003
Recruitment end date
31/07/2006
Locations
Countries of recruitment
Italy
Trial participating centre
Via Francesco Sforza, 35
Milan
20122
Italy
Sponsor information
Organisation
Fondazione IRCCS Ospedale Maggiore Policlinico Mangiagalli Regina Elena (Italy)
Sponsor details
University of Milan
Via Francesco Sforza
35
Milan
20122
Italy
+39 (0)25 503 5513
luigi.santambrogio@unimi.it
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
Fondazione IRCCS Ospedale Maggiore Policlinico Mangiagalli Regina Elena (Italy)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
University of Milan (Italy)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20643822
Publication citations
-
Results
Nosotti M, Baisi A, Mendogni P, Palleschi A, Tosi D, Rosso L, Muscle sparing versus posterolateral thoracotomy for pulmonary lobectomy: randomised controlled trial., Interact Cardiovasc Thorac Surg, 2010, 11, 4, 415-419, doi: 10.1510/icvts.2010.238840.