Sterile conditions vs maximal hygiene conditions in laparoscopic cholecystectomy

For decades, our focus has been on achieving the highest level of sterility to
reduce the likelihood of infectious complications following surgical
procedures. The foundations of this antiseptic approach can be traced back to
the pioneering work of Joseph Lister (1827-1912) and the subsequent sterile
practices established by Robert Koch (1843-1910), which were rooted in the
extensive surgical techniques of the 19th and early 20th centuries. More than
two centuries later, minimally invasive surgery has become the standard of
care, with endoscopic techniques now being the norm for several thoracic and
abdominal procedures. This transformation has substantially lowered
postoperative complications and morbidity rates. Intriguingly, while these
procedures are minimally invasive for patients, the equipment used has not
necessarily become less complex; in some instances, it has even become more
intricate. A significant portion of the equipment employed in modern surgery is
disposable, primarily driven by cost considerations. This decision is often
viewed as more economical when compared to the environmentally sustainable
alternative of sterilization and reuse.

With pressure mounting in every hospital to address escalating healthcare costs
while maintaining sustainability, it is only rational to scrutinize the
equipment used during laparoscopic surgery. One of the most frequently
performed laparoscopic surgeries in the Netherlands is the laparoscopic
cholecystectomy. Annually, approximately 35,000 patients are diagnosed with
gallstone disease in the Netherlands, leading to around 25,000 laparoscopic
cholecystectomies each year (1,2). The risk of wound infections associated with
this procedure is remarkably low, with an incidence rate of only approximately
2% (3,4). Consequently, the administration of preoperative antibiotics is
considered unnecessary for uncomplicated cholecystectomies (2,4-6). Moreover,
intra-abdominal infections that lead to peritonitis are also rare and typically
sterile, with gallic peritonitides being the norm (7). In instances where
infections do occur, they are often observed in patients with compromised
immune systems (8).

There is already evidence suggesting that there is no increase in the rate of
(wound) infections in a non-sterile setting during contaminated procedures,
such as perianal procedures (9-12). The same can be said for minor excisions
and the closure of traumatic wounds. Consequently, sterile conditions are no
longer maintaned for these operations at this hospital. It appears that washing
and sterilizing equipment previously used on patients is necessary, as there is
evidence of this dating back to Lister and Koch in the 18th/19th century
(13,14). Recalls have taken place due to inadequate sterilization of
intraluminal instruments (15,16). However, in a recall of 1800 patients, not a
single one appears to have been contaminated by an unsterilized endoscope (17).

Protective measures, such as surgical gowns, masks, and hairnets, seem to
primarily function as a form of protection for healthcare personnel rather than
providing direct benefits to the patient. Recent research conducted at Antoni
van Leeuwenhoek Hospital has shown that the use of masks by non-sterile
personnel does not lead to higher rates of wound infections. However, it does
result in a 42% reduction in mask consumption.(18). In a prospective clinical
study involving 200 patients undergoing hysterectomies, no differences were
found between standard sterile conditions and reduced aseptic conditions. (19).
This principle can be applied to laparoscopic cholecystectomies, as the removal
of the gallbladder does not involve intra-abdominal sources of infection; bile
and the gallbladder are essentially sterile. (20). The risk of infection from
external sources is not expected to be higher than usual. If any microorganisms
are introduced into the abdomen, the pathogenic microorganism load will be low
enough for a patient's immune system, without immune suppression, to clear
without difficulty. For instance, there is no evidence supporting the
initiation of antibiotic prophylaxis for other traumatic penetrating injuries,
such as gunshot wounds or non-organ-related knife wounds.

Proposal and Potential Impact

As mentioned previously, a significant number of laparoscopic cholecystectomies
are already being performed in the Netherlands, with yearly updates on
indications for this procedure. Between 13 to 22 percent of the population in
Western countries have gallstones (2). The size of the potential group
undergoing laparoscopic cholecystectomy is significant, resulting in high
levels of waste, CO2 emissions, and expenses. Therefore, limiting the use of
sterile packs could have a considerable impact on decreasing waste, emissions,
and expenses. A package containing frequently used items such as sterile gowns,
overlays, and plastic bowls has been compiled for each of these procedures (see
the Package Contents). This shipment includes excessive amounts of plastic and
other packing materials. Some hospitals even provide individual wrappings for
the aforementioned gowns, perpetuating the generation of waste. Therefore,
using (previously sterilized) materials left over from other packages (and thus
still maximally hygienic) could have a significant impact on operating room
sustainability. For other minimally invasive, short-term elective laparoscopic
surgeries (without the insertion of foreign body material), such as adnexal
extirpations, uterine extirpations, or cystectomies, the same materials are
used, making the potential impact even more significant.

With the research proposal presented here, we aim to explore the possibilities
of working under maximally hygienic conditions instead of sterile conditions
during laparoscopic cholecystectomies

The aim is to address the following research question:
Is there a higher incidence of postoperative (wound) infections when utilizing
maximally hygienic measures instead of sterile measures in elective
laparoscopic cholecystectomies?

Secondary Objectives:

- What is the difference in severity of the documented postoperative (wound)
infections between the two groups?
- Is the severity of the documented postoperative (wound) infections correlated
with underlying comorbidities?
- What are the costs andsustainability of using maximally hygienic materials
rather than sterile materials?

Randomized, double-blind, non-inferiority intervention study conducted at the
Deventer Hospital, involving the inclusion of 332 patients over a period of
1.5-2 years.

One group of patients will undergo surgery under normal (fully sterile)
conditions, while the other group of patients will undergo surgery under
maximally hygienic conditions.

This study does not differ significantly from standard care but involves more
precise monitoring of the patient and their wounds. There is one brief
outpatient visit once after the operation, lasting 5-15 minutes. This is a
regular visit that alway takes place after this type of surgery.

Risks: Participation in this study does not impact the level of discomfort the
patient experiences during or after the operation.
Benefits: This study contributes to a better understanding of sustainable
practices, allowing future surgeries to meet the same standards.