Good Clinical Practice Recommendations during the COVID-19 Pandemic

In the current COVID-19 pandemic, whether to perform gynecological surgeries or not is a major dilemma that needs to be addressed.

The major risks of endoscopy surgery in a possible COVID positive case would be two fold; requirement of the general anaesthesia and the endoscopic surgical procedure. The risks of the GA would be the intubation of the airway, positive pressure ventilation and aerosol particle generation. This is compounded by the head low position and increased intra-abdominal pressure due to gas insufflations of peritoneal cavity. An endoscopy procedure may need the presence of more number of personnel in the operating room. Other aspects to deal with are the instrument sterilisation of small lumen articles and telescopes as well as the difficulty of the safe evacuation of smoke generated due to energy devices and CO2.
There are well-known benefits of laparoscopy over laparotomy in Gynec surgeries; short hospital stay, quicker recovery, and less painful. However, as there are significant risks involved to the surgical and anaesthesia teams, nursing personnel and the support staff in the OR, it is recommended to restrict the laparoscopy surgeries to emergency situations only, where general anaesthesia is also necessary. The general preference should be to perform surgeries via laparotomy under regional anaesthesia:
1. To avoid intubation of airways
2. To avoid insufflations of peritoneal cavity and raise intra-abdominal pressure
3. To avoid or minimize head - low position
4. To avoid or minimize the use of electrosurgery and other energy devices
5. To avoid contamination of room air due to leakage of gas & fumes from the peritoneal cavity
Points to remember
1. We need to emphasize that adequate “Personal Protective Equipment’ (PPE) need to be used whilst handling COVID positive or COVID suspected patients.
2. In defined hotspots around the country, it will be prudent to treat all patients as potentially positive and use adequate precautions.
3. The risk of transmission to ‘Health Care Workers’ (HCW) is highest during Aerosol Generating Procedures (AGP). HCW need to don full PPE during AGP. General anaesthesia (GA) is an AGP.
4. The CO2 gas and surgical plumes at laparoscopy are reported to carry viruses like HPV and HIV. Though it has not been demonstrated definitively that the SARS-COV2 viruses can be released during the evacuation of the CO2 gas, it would be better to err on the side of caution considering the limited data available. Moreover, SARS-COV2 is a respiratory virus transmitted during inhalation.
5. The benefits of laparoscopy on the other side, which need to be balanced against the higher morbidity with laparotomy especially in women with high BMI, DM etc.
6. There is a controversy about whether electrosurgery use in open surgery is AGP. Again we would advise erring on the safer side and assume that as AGP unless electrosurgery pencils (smoke pencils) with attached suctions are used.

THE GUIDELINES

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1. Elective surgeries should be strictly avoided during the Pandemic by using medical or other conservative management or deferring procedures when these can be safely done.

2.   A surgeon should avoid operating at multiple centres and restrict himself/herself to a single centre only to prevent cross-contamination between centres and avoid the need for isolating healthcare workers at multiple locations if someone tests positive.

3.     Laparoscopy should be performed only if;

• Emergency surgery is required
• General anaesthesia is required (Regional anaesthesia is preferred to avoid aerosol spread)
• Full safety measures in the OR including the PPE kits are available for entire team

4.   Laparoscopic procedures and general anaesthesia should be avoided on confirmed COVID positive cases. They are either postponed or are performed via a laparotomy in emergency situation under regional analgesia.

5.     Screening Protocols: All patients require screening before entering hospital

§  The patients are screened in isolated and separated room preferably outside the hospital building (avoid sharing of rooms, general wards)

§  All health personnel should wear mask, plastic apron and gloves (change gloves in between patients)

§  Patients & their relatives should continue to wear mask all the time in hospital

§  A Disclosure / Consent Form should be filled by the patient (attached)

§  History of Cough / Fever / Breathlessness / Travel / Contact/ Loss of sensation of taste or smell should be recorded

§  In event of a positive history, the patient is sent to hospitals managing COVID patients

§  Emergency surgeries where Laparoscopy may be offered are:

o   Ectopic

o   Acute adnexal conditions like torsion

o   Oncosurgery if other treatment options are not suitable ( e.g. early Ca Cervix in young patient, early endometrial cancer)

o   Severe AUB not responding to conservative therapy - Hysterectomy or TCRE

o   Postmenopausal bleeding requiring endometrial sampling/biopsy

o   Surgeries to treat post-op complications

o   Surgery cannot be deferred due to life-threatening conditions

o   Bowel surgery, or where a bowel trauma is anticipated; only Laparotomy with Full PPE is recommended

§  Consider medical management, vaginal or open surgeries in preference to laparoscopic surgeries so as to avoid GA required & contamination generated -aerosol/fume/leakage of contaminated CO2 gas.

6.     Types of PPE 

§  PPE- I: To avoid contact spread: Mask, Gloves & Hand wash with soap before and after examining the patient ((in OPD, when >3 ft away from patient, Not in OT)

§  PPE- II: To avoid droplet infection: Waterproof Gown , visor Mask / goggles , gloves + hand wash with soap (when within 3 ft of patient, i.e. examination, open procedures under regional anesthesia with no AGP)

§  PPE- III: To avoid aerosol spread: N 95 mask with additional mask, Goggles with PPE kit to all personnel in the operation theatre. (For GA/ laparoscopy, laparotomy with bowel surgery or extensive use of diathermy).

How to wear the PPE

7.    OT Protocols: Minimise number of people in OT (Most important)

§  AHU: Frequent air changes, AC with ventilation of fresh air is a must

§  Deep cleaning / Fumigation after every case

§  Only anaesthetist & required personnel to be present during induction of anaesthesia

§  Surgeon should enter only after induction is completed (preferably 20 min)

§  Minimal number of PPE per case, but to be used by everyone entering the OT

§  Trainees should not be allowed

8.     Anaesthesia

§  Avoid GA as far as possible

§  When GA is a must: Use specialised box over head of the patient to minimise aerosol spread

§  https://www.youtube.com/watch?v=0tjtN_9HwLI (Link for the video)

§  Consider the possibility of Regional Anaesthesia for laparoscopy for short procedures e.g. unruptured ectopic

§  Consider regional anaesthesia for hysteroscopy

9.   Intra-op Protocols

§  The use of a sterile Camera cover is mandatory

§  Minimal head low as possible so as to avoid pressure on diaphragm

§  Lowest intra abdominal pressure: Surgeon should use minimum possible pressure which is just adequate for a safe and comfortable laparoscopy procedure

§  Surgeon should ensure the there is no leakage from washers

§  Smaller skin incisions are recommended to avoid leaks from port site

a.    Open trocar entry is not used as it has more gas leaks (prior Veress insufflation or Direct trocar entry are preferable)

§  Energy devices are used minimally and with smallest duration possible to avoid fume generation

§  Low electrosurgery settings are recommended to avoid smoke generation

§  Use endo-loops and sutures where possible as an alternative to energy sources

§  Smoke evacuation techniques

ü  Sudden deflation of the abdomen is to be avoided
ü  A closed release of pneumoperitoneum through the suction is recommended over direct release through trocar valves or through vagina after colpotomy
ü  A central suction is preferred. If this is not feasible, a bottle suction with intervening fluid trap to filter gas/fumes should be used
ü  Fluid in the suction should be disposed as positive/contaminated fluid in the bottle
ü  Use of filters to the gas outflow is recommended
1.    Active Filters: Continuous smoke evacuation & filtration mode via a Ultra Low Penetrating Air (ULPA)
2.    Passive Filters: Acting like a sieve e.g. PALL / Airoclean Filter
ü  For smoke evacuation: Automated smoke evacuation devices are recommended e.g. those offered by Valleylab, Shalya, Storz etc.

§  Specimen delivery techniques

1. Specimen should be retrieved carefully after lowering the intra abdominal pressure to minimize gas leak by a slow deflation into closed system / suction machine

2.    Wait for 5 minutes followed by controlled delivery

10.     Postop Protocols

§  OT Fumigation between each case

§  Instruments washing - soaking in 1% Hypochlorite solution for 30 minutes / ETO

§  Handling of patient in wards

o   Patient & Relative should continue to wear mask

o   Single relative per patient

Disposal of waste including the PPE as contaminated fluids/objects

A core group of IAGE has deliberated the current experiences and advisories published, to arrive at following consensus for guiding IAGE members for safe and meaningful use of gynec endoscopy procedures in current scenario of COVID pandemic. These guidelines are based on the limited availability of data and will be updated in the future, once more information is available. Since the global and Indian scenario keeps changing very fast, these recommendations may be revised soon. Members should be on a regular lookout for updates to this.

Team members in alphabetical order Abhishek ChandavarkarAlka KriplaniAtul GanatraBhaskar PalKurian JosephNandita PalshetkarNutan JainPandit PalaskarParul KotdawalaP G PaulPragnesh ShahPrashant MangeshikarS KrishnakumarSandesh KadeSunita Tandulwadkar Disclaimer: IAGE does not endorse any particular brand or any instrument mentioned in this document