Condition category
Cancer
Date applied
08/10/2009
Date assigned
20/10/2009
Last edited
17/08/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.policlinico.mi.it

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

  1. 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.

Additional files

Editorial Notes