Surgical treatment outcomes in patients with different pulmonary diseases caused by Mycobacteria
| ISRCTN | ISRCTN66445153 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN66445153 |
| Secondary identifying numbers | U1111-1271-6052 |
- Submission date
- 14/11/2021
- Registration date
- 17/11/2021
- Last edited
- 09/01/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English summary of protocol
Background and study aims
Mycobacteria are a group of different bacteria that include those that cause tuberculosis (TB) among other illnesses. Nontuberculous mycobacterial pulmonary disease is a disease of the lungs caused by mycobacteria that do not cause tuberculosis. Nontuberculous mycobacterial pulmonary disease is an important public health issue because there is an increase in cases and medications are becoming less effective. This trial's aim is to find out how useful and safe surgery is for patients with nontuberculous mycobacterial pulmonary disease, a combination of nontuberculous mycobacterium lung disease and pulmonary tuberculosis compared with cavitary pulmonary tuberculosis.
Who can participate?
All patients who had lung operations because of nontuberculous mycobacterial pulmonary disease, a combination of nontuberculous mycobacterium lung disease, and pulmonary tuberculosis from 2011 to 2017, and cavitary pulmonary tuberculosis from 2016 to 2017 in Sechenov University Phthisiopulmonology Clinical Hospital.
What does the study involve?
In this study, patients will receive treatment as usual and are observed for the outcomes of this treatment. The treatment they received depends on their condition and drug resistance results. Patients received primary drug treatment in the way that the Russian Phthisiopulmonogy society recommends. They were received then offered surgery if their doctor thought it was needed. Participants also received medical treatment after surgery if required.
What are the possible benefits and risks of participating?
Participants included in the study are not at additional risk because they were treated as recommended. Their benefits are free examination and added observation and treatment.
Where is the study run from?
Federal State Autonomous Educational Institution of Higher Education I.M. Sechenov First Moscow State Medical University of the Ministry of Health of the Russian Federation, Sechenov University (Russian Federation)
When is the study starting and how long is it expected to run for?
From October 2019 to December 2021
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Severova Lyudmila Petrovna
severova_l_p@staff.sechenov.ru
Contact information
Scientific
House 16, Case 4
Planernaya street
Moscow
125481
Russian Federation
 ORCID ID |
0000-0002-7488-5281 |
|---|---|
| Phone | +79037394349 |
| severova_l_p@staff.sechenov.ru |
Public
House 16, Case 4
Planernaya street
Moscow
1255481
Russian Federation
| Phone | +79037394349 |
|---|---|
| severova_l_p@staff.sechenov.ru |
Study information
| Study design | Retrospective observational study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Retrospective cohort study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format. Please use the contact information to request a participant information sheet. |
| Scientific title | Surgical treatment outcomes in patients with a diagnosis of nontuberculous mycobacterial pulmonary disease, a combination of nontuberculous mycobacterium pulmonary disease and pulmonary tuberculosis, or cavitary pulmonary tuberculosis: a retrospective observational study |
| Study acronym | STOMDs |
| Study objectives | 1. Surgical treatment with a background of properly conducted chemotherapy allows for constant disease remission in patients with nontuberculous mycobacterial pulmonary disease, a combination of nontuberculous mycobacterium pulmonary disease and pulmonary tuberculosis, or cavitary pulmonary tuberculosis 2. Surgical treatment of nontuberculous mycobacterial pulmonary disease, a combination of nontuberculous mycobacterium pulmonary disease and pulmonary tuberculosis, or cavitary pulmonary tuberculosis is sufficiently safe for patients 3. Surgical treatment could be required in case of a rare combination of nontuberculous mycobacterium pulmonary disease and pulmonary tuberculosis 4. Video-assisted thoracoscopic surgery (VATS) technologies and the combination of lung resections with thoracoplasty can improve treatment outcomes |
| Ethics approval(s) | Approved 07/04/2021, I.M. Sechenov First Moscow State Medical University (Sechenov University) Local Ethics Committee (8 Trubetskaya str., Moscow, 119991; +8(495)622-97-06; iec@staff.sechenov.ru) |
| Health condition(s) or problem(s) studied | Surgical outcomes of patients with nontuberculous mycobacterial pulmonary disease, a combination of nontuberculous mycobacterium pulmonary disease and pulmonary tuberculosis, or cavitary pulmonary tuberculosis |
| Intervention | This study will investigate the outcomes of treatment in a cohort of patients admitted to hospital between January 2011 and December 2017, who underwent resectional lung surgery for nontuberculous mycobacterial pulmonary disease, a combination of nontuberculous mycobacterium lung disease and pulmonary tuberculosis, or cavitary pulmonary tuberculosis. Participants were treated according to their disease and treatment guidelines during the period of hospitalization. Some patients, especially those with bilateral lesions, have undergone multi-stage surgical treatment. All patients signed a consent form prior to medical intervention. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | 1. Sputum culture conversion after surgery measured using microscopic examination (AFB smear); samples, which were cultured on Lowenstein–Jensen (L-J) medium and molecular diagnostic testing after surgery 2. 30 -day postoperative mortality rate measured using patient records at 30 days post-surgery 3. Intra- and postoperative complications measured using patient follow-up at 1, 3, and 5 years post-surgery 4. Postoperative mortality due to pulmonary disease and any other possible causes measured using patient follow-up at 1, 3, and 5 years post-surgery |
| Secondary outcome measures | 1. Sputum culture conversion rate measured using microscopic examination (AFB smear); samples, which were cultured on Lowenstein–Jensen (L-J) medium and molecular diagnostic testing after surgery and at 1, 3, and 5 years post-surgery 2. Presence of cavities in pulmonary tissue (CV+/CV-) measured using CT scan/digital X-ray on discharge from hospital at 1, 3, and 5 years post-surgery 3. Five-year survival rate measured using patient follow-up at 5 years post-surgery |
| Overall study start date | 10/10/2019 |
| Completion date | 30/12/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | All |
| Sex | Both |
| Target number of participants | 83 |
| Total final enrolment | 83 |
| Key inclusion criteria | Surgery performed at Sechenov University Phthisiopulmonology Clinical Hospital to treat one of the following: 1. Nontuberculous mycobacterial pulmonary disease between 2011 and 2021 2. A combination of nontuberculous mycobacterium pulmonary disease and pulmonary tuberculosis between 2011 and 2021 3. Cavitary pulmonary tuberculosis from 2016 to 2017 |
| Key exclusion criteria | 1. Admitted before January 2011 and after December 2017 2. Received lung resections and/or do not have the nontuberculous mycobacterial pulmonary disease, a combination of nontuberculous mycobacterium lung disease and pulmonary tuberculosis, or cavitary pulmonary tuberculosis |
| Date of first enrolment | 11/06/2011 |
| Date of final enrolment | 26/10/2017 |
Locations
Countries of recruitment
- Russian Federation
Study participating centre
Moscow
127473
Russian Federation
Sponsor information
University/education
8-2 Trubetskaya str.
Moscow
119991
Russian Federation
| Phone | +7 (495) 622-95-86 |
|---|---|
| id@1msmu.ru | |
| Website | https://sechenov.ru/eng/ |
"ROR" |
https://ror.org/02yqqv993 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 30/01/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Published as a supplement to the results publication |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. The study protocol is available on request from the study contact. |
| IPD sharing plan | The datasets generated and analysed during the current study will be published as a supplement to the subsequent results publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Nontuberculous mycobacterial pulmonary disease and NTMPD and pulmonary tuberculosis results (NTMPD) and | 07/04/2022 | 11/04/2022 | Yes | No |
| Other publications | additional analysis to compare clinical and radiographic signs of NTMPD, XDR pTB, or a combination of NTMPD and pTB, | 09/06/2023 | 09/01/2024 | Yes | No |
Editorial Notes
09/01/2024: Publication reference added.
11/04/2022: Publication reference added.
16/11/2021: Trial’s existence confirmed by I.M. Sechenov First Moscow State Medical University (Sechenov University) Local Ethics Committee.
