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
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

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

Prof Vitaly Tsvetkov
Scientific

61, Vavilova str.
Moscow
117292
Russian Federation

ORCiD logoORCID ID 0000-0002-2889-702X
Phone +7 9166312613
Email tsvetkow@yandex.ru

Study information

Study designObservational cohort retrospective study in two clinical centers
Primary study designObservational
Secondary study designCohort study
Study setting(s)Hospital
Study typeTreatment
Participant information sheet n/a (retrospective review of patient records)
Scientific titleTwo-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 acronymTPACIP
Study objectivesUse 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) studiedIschaemic gangrene of lower limb
InterventionRetrospective 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 typeProcedure/Surgery
Primary outcome measureLethality of procedure measured using patient records at a single time point
Secondary outcome measuresMeasured using patient records at a single time point:
1. Number of wound complications
2. Levels of amputation
Overall study start date20/12/2017
Completion date29/12/2018

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants300
Total final enrolment393
Key inclusion criteria1. 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 criteria1. 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 enrolment01/01/2011
Date of final enrolment31/12/2018

Locations

Countries of recruitment

  • Russian Federation

Study participating centres

Vinogradov Moscow Municipal hospital
61, Vavilova str.
Moscow
117292
Russian Federation
Moscow Municipal Clinical hospital 53
26, Trophimova str
Moscow
115432
Russian Federation

Sponsor information

Sechenov University
University/education

8, Trubetskaya str.
Moscow
119048
Russian Federation

Phone +7 (495) 609-14-00
Email rektorat@sechenov.ru
Website https://sechenov.ru/eng/
ROR logo "ROR" https://ror.org/02yqqv993

Funders

Funder type

Other

Investigator initiated and funded

No information available

Results and Publications

Intention to publish date01/09/2020
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planPublication in peer-reviewed journal.
IPD sharing planThe 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.