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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04516824
Other study ID # 30
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 19, 2020
Est. completion date August 15, 2020

Study information

Verified date August 2020
Source Ghurki Trust and Teaching Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

After the frightful outbreak in the city of Wuhan, China and its evidence of being contagious, governments around the world particularly United States in an effort to stop the transmission- imposed travel restrictions to and from China. Though it's a novel virus and little is known about it, the spread was drastic across the world. In fact the spread was so rapid that by end of February 2020, the number of new cases outside China had leveled up to 13 fold as compared to the number of cases in China. Moreover, the number of infected countries with COVID-19 tripled. The first two reported cases in Pakistan were from Karachi and Islamabad on 27 February 2020. These two cases presented with a recent travel history from Iran. The current statistics showed the confirmed cases in Pakistan reached upto 284,121 till 9 August 2020.

During the lockdown period most of the public hospitals and trust closed their Outpatient departments and started to deal with emergency cases only. However even in such situation there are some trust hospitals worth mentioning who never closed their services and worked day and night to entertain their patients by observing all the precautions and safety measures. Ghurki trust teaching hospital is one of them. This hospital adopted a SMART STRATEGY or SMART hospital lockdown.

Since 19th March 2020 till 13th July 2020, the period of lockdown, two thousand one hundred and sixty surgeries were performed by the orthopaedic team of Ghurki hospital. The breakup of surgeries during lockdown was as follows: 1514 cases of trauma, 173 procedures of spine, 51 for arthroplasty, 51 for arthroscopy, 21 for tumors and 350 miscellaneous. The team was available 24 hours, 7 days a week under the supervisor of Professor Amer Aziz, to play their part in these terrible circumstances.


Description:

After the frightful outbreak in the city of Wuhan, China and its evidence of being contagious, governments around the world particularly United States in an effort to stop the transmission- imposed travel restrictions to and from China. Though it's a novel virus and little is known about it, the spread was drastic across the world. In fact the spread was so rapid that by end of February 2020, the number of new cases outside China had levelled up to 13 fold as compared to the number of cases in China. Moreover, the number of infected countries with COVID-19 tripled. The first two reported cases in Pakistan were from Karachi and Islamabad on 27 February 2020. These two cases presented with a recent travel history from Iran. The current statistics showed the confirmed cases in Pakistan reached upto 284,121 till 9 August 2020.

Regarding the Pakistan's government response to COVID-19, quick steps were taken to curtail the transmission of virus as China is in northeast of Pakistan and also shares its borders with Iran where the number of cases are increasing exceptionally. As an initial response Pakistan closed its borders with China and implies strict methods at the Pakistan-Iran border. Still, in the initial days of pandemic Pakistan lacked the diagnosis kits and relied on China and Japan for testing purpose. However, later Pakistan was able to receive kits and started testing samples.

Pakistan's federal government along with the Ministry of Health (Moh) initiated a plan known as "National Action Plan for Corona Virus Disease Pakistan". The basic motive behind developing this plan was to generate policies and methods to combat with the deadly virus across Pakistan. MoH managed to deliver crucial supplies like masks, gloves and suits to the doctors and paramedical staffs working at frontlines. A state of confusion existed at different levels in health care system in Pakistan, particularly in Orthopaedic departments of hospital where elective and emergency services were severely affected during the lockdown period that started from 19 March 2020.

Orthopaedic and Spine Center Ghurki Trust Teaching Hospital Lahore:

During the lockdown period most of the public hospitals and trust closed their Outpatient departments and started to deal with emergency cases only. Even the private hospitals were reluctant to perform elective and emergency orthopaedic procedures. This attitude was may be due to the information published from other countries on the post operative complications and reduction of orthopaedic procedures during the period. The closure of orthopaedic health services brings a great shock to poor people for whom trusts and foundations is the last hope as they cannot afford the private setups for their health care facilities. However even in such situation there are some trust hospitals worth mentioning who never closed their services and worked day and night to entertain their patients by observing all the precautions and safety measures. Ghurki trust teaching hospital is one of them. This hospital adopted a SMART STRATEGY or SMART hospital lockdown. The orthopaedic department divided the members into five teams performing a 1:5 rotations. Each team comprised of one professor, one assistant professor, one senior registrar and ten trainee residents. Similarly the other departments like anesthesia, paramedics, nurses and physiotherapists were also subdivided. Out of two hundred staff, thirty were tested positive for COVID-19 but they all were managed and returned to normal after home quarantine.

Orthopaedic Surgeries during COVID-19:

Since 19th March 2020 till 13th July 2020, the period of lockdown, two thousand one hundred and sixty surgeries were performed by the orthopaedic team of Ghurki hospital. The breakup of surgeries during lockdown was as follows: 1514 cases of trauma, 173 procedures of spine, 51 for arthroplasty, 51 for arthroscopy, 21 for tumors and 350 miscellaneous. The team was available 24 hours, 7 days a week under the supervisor of Professor Amer Aziz, to play their part in these terrible circumstances. The team started their day with recitation of Quranic prayer which is translated as "In the name of Allah by whose name harm cannot be done by anything in the earth or in heavens. He is All-Hearing, All-Seeing" (Tirmidhi, Hadith: 3388). The smart approach utilized was that the patients were operated as soon as possible preferably within first twenty four hours and discharged them early also one to two days post op in most cases with complete education. All the patients were screened for COVID but Polymerase Chain Reaction test (PCR) and Pulmonary High-Resolution Computed Tomography (HRCT) was not done in all the patients unless if they presented with suspicious history. Fortunately, none of the patient tested positive pre operatively. Strict asepsis was observed during the period.


Recruitment information / eligibility

Status Completed
Enrollment 2160
Est. completion date August 15, 2020
Est. primary completion date July 13, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- Patients indicated for surgical procedure

- Less affording patients coming from remote areas with the need of immediate orthopaedic surgery

- Urgent elective and emergency procedures

Exclusion Criteria:

- Elective surgery cases which were not urgent

- Patients in whom conservative management could be considered.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Orthopaedic Surgical Procedures
Intramedullary nails, Dynamic Compression Plate, Dynamic Hip Screw, Manipulation Under Anaesthesia POP, Ilizarov, Cannulated Screw Fixators, Bipolar Hemiarthroplasty, Locking Compression Plate, AO External fixators, Tension Band Wiring Patella, Pelvis and Acetabulum Fixations, Elbow Reconstructions, K wiring, Disc Excision, Spine Fracture i-e TPSF, Posterior Cervical Decompression and LMS, Dura repair, AD cage,Bilateral Total Hip Replacement, Unilateral Total Hip Replacement, Bilateral Total Knee Replacement, Unilateral Total Knee Replacement, Knee Arthroscopy for Mensicectomy, Arthroscopic Anterior Cruciate Ligament reconstruction,Removal of Implant, Amputations, VAC dressings,Wound wash, Arthrotomy for Septic Arthritis, Biopsy

Locations

Country Name City State
Pakistan Ghurki trust hospital Lahore Punjab

Sponsors (1)

Lead Sponsor Collaborator
Ghurki Trust and Teaching Hospital

Country where clinical trial is conducted

Pakistan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Clinical and functional characteristics Describe the clinical and functional level of patients after surgery, hospitalized during lockdown period in our hospital [Through study period, average 3 months]
Secondary Patient's journey Describe patient's experience during the period of lockdown in our center [Through study period, average 3 months]
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