Does performing amputation of lower limb due to gangrene in critically ill patients in two stages allow improved results of treatment compared to single-stage amputation?
| ISRCTN | ISRCTN12604387 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12604387 |
- Submission date
- 06/07/2020
- Registration date
- 07/07/2020
- Last edited
- 16/03/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
The death of tissue as a result of deficient blood supply (ischaemic gangrene) is treated by amputation of the affected body part. This results in a large number of wound complications and death. There are two methods of amputation in common use, one-stage and two-stage.
Two-stage amputation is a well-known way to reduce wound complications in patients with a high risk of infection (e.g. contaminated trauma or infected diabetic foot), but there is still lack of evidence if it can lower the mortality in severely ill patients with a complicated background of diseases.
Who can participate?
Patients requiring urgent amputation.
What does the study involve?
Records were collected for patients who had either had amputation using intensive treatment during 24 - 72 hours before surgery, and then fulfil one-stage amputation, or immediate guillotine amputation followed by reampuation after stabilisation.
What are the possible benefits and risks of participating?
None (retrospective study)
Where is the study run from?
Vinogradov Moscow Municipal hospital (Russia)
When is the study starting and how long is it expected to run for?
December 2017 to December 2018
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Prof. Vitaly Tsvetkov, tsvetkow@yandex.ru
Contact information
Scientific
61, Vavilova str.
Moscow
117292
Russian Federation
 ORCID ID |
0000-0002-2889-702X |
|---|---|
| Phone | +7 9166312613 |
| tsvetkow@yandex.ru |
Study information
| Study design | Observational cohort retrospective study in two clinical centers |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | n/a (retrospective review of patient records) |
| Scientific title | Two-phase versus one-stage amputation of lower limbs among critically ill patients with ischemic gangrene as a way to reduce lethality and improve treatment outcome. Retrospective cohort trial. |
| Study acronym | TPACIP |
| Study objectives | Use of urgent guillotine amputation of lower limb in critically ill patients with ischaemic gangrene as the first stage of surgical treatment allows to reduce lethality, number of wound complications and improve functional result. |
| Ethics approval(s) | Approved 24/02/2018, Local Ethics Committee of the V.V. Vinogradov Moscow Municipal Hospital (61, Vavilova str., Moscow, Russia; no telephone number provided; ezhovalg@mail.ru), ref: none provided |
| Health condition(s) or problem(s) studied | Ischaemic gangrene of lower limb |
| Intervention | Retrospective comparison of two approaches to the treatment of critically ill patients who admit to the hospital due to ischaemic gangrene of lower limb. In 2011- 2014 (control group) the tactic was to perform intensive treatment during 24 - 72 hours before surgery, and then fulfil one-stage amputation with primary formation of the stump. In 2014 - 2018 (main group) the patients underwent urgent guillotine amputation or knee disarticulation, and then, after normalisation or stabilisation of general condition, reamputation with formation of the stump was performed. The goal of the study is to compare these surgical tactics and their influence at the lethality, number of wound complications and functional Records are gathered for patients in two groups: 1. Two-phase amputation including urgent guillotine amputation or knee disarticulation as a first stage an then reamputation with shaping of stump after stabilisation of patient general condition. 2. Intensive treatment before surgery, then one-stage amputation. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Lethality of procedure measured using patient records at a single time point |
| Secondary outcome measures | Measured using patient records at a single time point: 1. Number of wound complications 2. Levels of amputation |
| Overall study start date | 20/12/2017 |
| Completion date | 29/12/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 300 |
| Total final enrolment | 393 |
| Key inclusion criteria | 1. Need to perform urgent (within 72 hours after admission to the hospital) high amputation of the lower extremities in patients with critical limb ischemia who were admitted in a severe or extremely severe condition. The indication for amputation was gangrene accompanied by a progressive infection of soft tissues or a syndrome of endogenous intoxication caused by ischemic damage to the muscle tissue of the limb. |
| Key exclusion criteria | 1. Patients with surgical soft tissue infection but without occlusion of the main arteries (including patients with extensive limb phlegmons with a neuropathic form of diabetic foot syndrome) 2. Patients with planned indications for amputation (including those operated within 72 hours after admission), e.g., patients with critical ischemia and gangrene of the limb if angiosurgical intervention is impossible or unsuccessful 3. Patients in whom the indications for urgent amputation of the limbs occurred during their stay in the hospital |
| Date of first enrolment | 01/01/2011 |
| Date of final enrolment | 31/12/2018 |
Locations
Countries of recruitment
- Russian Federation
Study participating centres
Moscow
117292
Russian Federation
Moscow
115432
Russian Federation
Sponsor information
University/education
8, Trubetskaya str.
Moscow
119048
Russian Federation
| Phone | +7 (495) 609-14-00 |
|---|---|
| rektorat@sechenov.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 | 01/09/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Publication in peer-reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request after the results have been published. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 24/11/2020 | 16/03/2021 | Yes | No |
Editorial Notes
16/03/2021: Publication reference and total final enrolment added.
07/07/2020: Trial’s existence confirmed by Local Ethics Committee of the V.V. Vinogradov Moscow Municipal Hospital.
