Gossypibomas in India - A systematic literature review.

PURPOSE OF REVIEW: Gossypibomas remain a dreaded and unwanted complication of surgical practice. Despite significant interest and numerous guidelines, the number of reported cases remains sparse due to various factors, including potential legal implications. Herein, we review related data from India to ascertain if the problem is better or worse than that reported in world literature.
MATERIALS AND METHODS: A literature search was performed on PubMed and Google Scholar, to collect and analyze all case reports and case reviews regarding the condition in India.
RESULTS: On analysis of the results, there were 100 publications reporting a total of 126 events. The average patient age was 38.65 years. Average time to discovery was 1225.62 days. Forty-nine percent of reported cases were discovered within the 1 st year. The most common clinical features were pain (73.8%), palpable mass (47.6%), vomiting (35%), abdominal distention (26%), and fever (12.6%). Spontaneous expulsion of the gossypiboma was noted in five cases (3.96%). Transmural migration was seen in 36 cases (28.57%).
CONCLUSIONS: Despite advancements in surgical approaches and preventive measures, gossypibomas continue to be a cause of significant morbidity. A safe working culture, open communication, teamwork, and an accurate sponge count remain our best defence against this often unpredictable complication of surgery.

Introduction

Worldwide over 200 million major surgeries are performed each year.[1] Retained foreign body (RFB) is an uncommon, unwanted, avoidable, and omnipresent complication of surgery compromising with patient safety. The reported estimate of RFB is 0.01%–0.001%, and in 80% of these cases, the culprit is a surgical sponge, often reported as a gossypiboma.[2] Published cases and reviews of the condition perhaps represent only the tip of the iceberg as there is a mismatch between the number of surgeries performed and the reported incidence of gossypibomas.[3] This may be due to under-reporting, possible legal implications, and the reputation of the surgical team as well as the hospital. RFB is a well-accepted “never event” of the National Quality Forum of the USA and is also part of patient safety guidelines issued by the Health Department of the UK.[4] It is an identifiable and preventable event of patient safety. The condition has been reported after almost every surgery-abdominal, thoracic, head, and neck as well as limb surgeries and has catastrophic effects on patients, health professionals, and health-care providers.[45] It has protean manifestations. Herein, we present a systematic literature review as well as proposed pathogenesis and sequelae of this condition.

Materials and Methods

Search strategy

We performed a literature search in PubMed and Google Scholar, with the terms “gossypiboma,” “textiloma,” “retained surgical sponge,” and “retained surgical towel,” limiting results from India. The search was performed on August 7, 2016, limiting articles from January 1969 to July 2016. Articles were screened for relevance and completeness of data. Ethical approval was not sought as the review is an analysis of previously reported cases.

Exclusions

Articles mentioning nonhuman cases were excluded from the study. There was no language restriction. All results were further scrutinized and results mentioning foreign bodies apart from surgical sponge/gauze were excluded including stents, pessaries, meshes, lenses, dentures, gel foam, surgical instruments, tracheostomy tubes, needles, silicone scleral buckles, or cases of “drug packers.” Eleven cases were excluded due to either incomplete data or nonavailability of complete articles [Figure 1].

Figure 1

Search flowchart. The search was developed by including synonyms - “gossypibomas,” “retained surgical sponge,” “retained surgical towel,” and “textiloma”

Three authors independently compiled data from retrieved articles onto a standardized Microsoft Excel spreadsheet, which included age, sex, time to discovery, primary operative procedure performed, clinical signs and symptoms, location of the retained sponge, and evidence of transmural migration. Differences between reviewers were resolved by reexamination of the original manuscript until a consensus was reached.

Results

After applying exclusion criteria as mentioned above, from a total of 137 cases, there were 100 publications reporting a total of 126 events. The average patient age was 38.65 years (standard deviation 13.80, range 2–80 years). Average time to discovery was 1225.62 days (3.35 years), ranging from under 3 days to 35 years. The median was 365 days (1 year). Forty-nine percent of reported cases were discovered within the 1st year. 98 (77.77%) cases were women [Table 1].

Table 1

Summary table of gossypibomas in India

Summary table of gossypibomas	n=126
Sex distribution (n)
Male	26
Female	98
Age (years)
Mean	38.65
Median	38.5
Range	2-80
Time to discovery (days)
Mean	1225.6
Median	365
Range	4-12,775
Quartiles	90 and 1500
Clinical features (%)
Pain	73.8
Palpable mass	47.6
Vomiting	35
Abdominal distention	26
Fever	12.6
Spontaneous expulsion	3.98
Transmural migration	28.57
Asymptomatic	0.79
Initial surgery performed (%)
Gynecological surgery	41.2
Abdominal surgery	35.7
Urological surgery	8.7
Orthopedic surgery	3.96
Neurosurgery	3.96
Cardiothoracic and vascular	3.17
Thyroid	1.58
Laparoscopic/endoscopic technique used	3.17
Location (%)
Abdomen	51.5
Pelvis	28.5
Limbs	4.76
Head and neck	3.96
Spine	3.17
Thorax	3.17

In order of frequency, the most common clinical features were pain (73.8%), palpable mass (47.6%), vomiting (35%), abdominal distention (26%), and fever (12.6%). Eight percent of cases had more than one symptom; one patient (0.79%) was asymptomatic.

Spontaneous expulsion of the gossypiboma was noted in five cases (3.96%). Transmural migration, was seen in 36 cases (28.57%).

On grouping the cases, it was found that gossypibomas were most frequently reported following gynecological surgery (41.2%), abdominal surgery (35.7%), urological surgery (8.7%), orthopedic surgery (3.96%), neurosurgery (3.96%), cardiothoracic and vascular surgery (3.17%), and thyroid surgery (1.58%). Of note, in four cases (3.17%), the first surgery was done using laparoscopic/endoscopic techniques.

Common locations for the gossypibomas included the abdomen (51.5%) and the pelvis (28.57). The longest duration after which a gossypiboma was discovered was postorthopedic surgery, after 35 years.

Discussion

Limitations

There are certain limitations to our review. Our source for the review has been case reports and case series. Since there exists an inclination to report rare and unique cases, our data set is likely to have selection bias. Therefore, conclusions drawn from our review do not imply causation and are only limited to associations and inferences. Furthermore, other indexes were not used; hence, some published cases may not have been included in the study.

Surgery is underscored by teamwork involving the surgical team, anesthesia team, operation theater assistants, staff nurse, and medical students. Despite a large number of trained/under training staff in the operation theater, retained foreign bodies still remain an undesirable and horrifying evil of surgery and repeatedly raise questions about the safety of patients. Newer devices using sponges, such as negative pressure wound therapy, are also not immune to the phenomenon.[6] Surgical sponges are sometimes left intentionally as in damage control surgery to control bleeding and are subsequently removed during definitive surgery which is performed when patient becomes stable.[7] Surgical sponges are also used to reinforce intracranial aneurysms which are unsuitable for microsurgical clipping.[8] Even these “therapeutic” surgical sponges may become symptomatic.

An unintentionally retained surgical sponge after surgery is known by various terms. Linguistically, they often have a unique combination of words derived from two different languages. The name “Gossypiboma” is derived from “Gossypium,” which is Latin for cotton, and “boma” which is Sinhalese for a concealed mass after surgery. Other terms referring to the same entity include, “Gauzoma” from gauze-induced granuloma, “Textiloma” from “textilis” which means weave in Latin and “oma” meaning tumor or mass in Greek, “Cottonoma” and “Cottonoma” from textile or cotton cloth and “oma” from mass or tumor and “oid” from like. “Muslinoma” is another name derived from “muslin” meaning fine hand woven yarn from an ancient Indian port Masulipatnam also known as Maisolos from India or possibly from Musola in Iraq and “oma” from disease, mass, or tumor in Greek.[8910] The reported incidence of gossypiboma varies between 1/100 and 1/3000 for all surgical interventions and from 1/1000 to 1/1500 for intraabdominal operations.[11]

Pathogenesis

Based on experimental evidence, a RFB inside the abdomen initiates an inflammatory reaction of variable severity in different individuals.[12] The inflammatory response is described as either exudative or fibrinous.[13] The antigenic potential of the foreign body and the degree of inflammatory response elicited within an individual determine the nature of response. Exudative response is favored by a higher antigenic potential and/or a severe inflammatory reaction, with outpouring of capillary contents. This response occurs early and leads to abscess formation around the foreign body. Gradually as the pressure increases, it may rupture toward its weaker wall, which is often the intestinal wall resulting in fistula formation, eventually pushing the surgical sponge partially into the lumen of intestine. Peristaltic waves may further withdraw the gauge completely into the lumen.[12] Removal of surgical sponge from the abdomen downregulates the inflammatory response and the process of healing starts by stimulation of fibroblasts which may close the tract with or without a scar leaving no evidence of perforation of intestinal wall.[14] Once inside the lumen, it is propelled forward by peristalsis. Depending on its size, it may either pass spontaneously in the feces without the knowledge of the patient or it may get stuck at the narrowest part of the intestinal lumen such as ileocecal valve and results in complete or partial intestinal obstruction.[121516] In case of partial intestinal obstruction, with the passage of time undigested food residue accumulates proximal to the site of obstruction, followed by a few episodes of partial obstruction before this becomes complete. If the abscess abuts the abdominal wall it may result in a septic mass and rupture of abdominal wall can result in fistulization as well. Proximity to the diaphragm can cause rupture and the surgical sponge can migrate into the thoracic cavity.[17]

The fibrinous response is favored by low level of antigenicity and/or milder inflammatory response and usually occurs late. This can result in encapsulation of the sponge, result in the formation of a mass, or result in the formation of bands and adhesions, calcification, degradation, and uncommonly migration of the sponge as in the exudative response.[12] In contrast with the tissue surrounding foreign material at other anatomical sites, the tissue encapsulating foreign objects in the peritoneal cavity is avascular in nature. Inflammatory cytokines may cause anorexia, malaise, weight loss, and fever. Inside the lumen, the sponge may interfere with the absorption of nutrients resulting in malnutrition or worsen preexisting malnutrition [Figure 2].[1819]

Figure 2

Pathogenesis and sequelae of gossypiboma

Recent evidence also suggests that gossypibomas may induce tumor formation, with the most likely malignancy being a sarcoma. The mechanism postulated is inflammation-based carcinogenesis.[20]

Sponges may remain asymptomatic for a variable period depending on the size, site, and inflammatory response of body to it and may be detected incidentally. The longest interval of 40 years is reported in literature for clinical presentation.[21] It may also present with vague ill health, weight loss, fever with chills and rigors, altered bowel habits, anorexia, nausea, vomiting, tenesmus, diarrhea, discharging sinus, nonhealing wound, subacute or acute intestinal obstruction, malabsorption, and abdominal mass.[22] The abdominal mass may present as an abscess or as a pseudotumor. At times, the sponge may pass spontaneously in feces.[23] The abdominal mass may be considered as primary pseudotumor or as secondary one if retained following surgery for the primary tumor or if it misdiagnosed as various infective or noninfective conditions presenting as mass. A mass lesion may be confused with site-specific common masses such as tubo-ovarian mass or even a hydatid cyst of the liver in the right hypochondrium.[2425]

Various risk factors have been reported in literature. Emergency surgery, prolonged surgery, unplanned change in the surgical procedure, multiple operating teams, change of members of operating team, obesity, female gender, inexperienced staff, improper counting of surgical towels, sticking of towels, small sponges, hemodynamic instability, and poor communication among the surgical team were observed in reported cases/series.[2627]

Radiological evaluation plays an important role in the diagnosis. Radiopaque thread impregnated surgical sponges were introduced in 1929 by Cahn, and came to general use in the USA by the 1940's and by the 1980's in Asian countries.[28] Plain X-ray abdomen may detect a retained surgical gauge with a radiopaque marker as a wavy or banded pattern. The radiopaque marker may be lost due twisting, folding, or after prolonged, thus behaving like an ordinary sponge. Some centers recommend its use routinely after surgery, but this method is also not fool proof.[2930] Ultrasound, computed tomography (CT) scan, and magnetic resonance imaging (MRI) are helpful in diagnosis. Sonology detects it as a well-defined mass with linear or wavy internal echogenic area with intense posterior acoustic shadows due to attenuation of beam by the surgical sponge. CT scan is investigation of choice, with detection of the sponge as a mass with a well-defined capsule, layering, and spongiform or mottled appearance due to air bubbles and if inside, the intestinal lumen barium inside it may be seen.[2829] On MRI, the sponge shows up as a well-defined mass with low intensity peripheral wall on T1- and T2-weighted images accompanied by peripheral wall enhancement and central stripes on gadolinium enhancement on T1-weighted imaging.[218]

In our review, transmural migration was seen in 36 cases (28.57%). This is in sharp contradistinction to Zantvoord et al. who reported the phenomenon in only 65 cases in a worldwide systematic review.[17] Furthermore, in four cases (3.17%), the first surgery was done using laparoscopic/endoscopic techniques. This is also in sharp contrast to the seminal study by Gawande et al. who proposed that laparoscopic or endoscopic was unlikely to result in a forgotten sponge [Table 1].[27]

Medicolegal implications

A retained surgical sponge leads to allegations of medical negligence. This is often reported as “Res Ipsa Loquitur” meaning that “the thing speaks for itself,” and that the issue at hand would not have happened if there was no negligence on the part of the surgeon. Thorough documentation is essential for the surgeon as it may absolve him partly of the responsibility. Exceptional circumstances where the surgeon could not carry out the search for the sponge without endangering the life of the patient can also be used as an argument by the operating surgeon. It must also be emphasized that despite nurse assistants being crucial members of the team, efforts to shift the blame onto them have not been accepted by the courts.[31] If a case of gossypiboma requires a second surgery, reluctance to report a fellow medical colleague to juridical authorities is a defined responsibility according to the Turkish Penal Code.[32] Since no similar law exists in our country, the lawyers may use this as an example to attack the operating surgeon in court. The punishment for such cases can range from suspension to monetary compensation as high as Rs 350,000, based on the judges’ discretion.[3334]

Prevention

The first step toward prevention is accepting the fact that surgical sponges still remain inside the human body after surgery and contribute to patient morbidity and mortality. The Institute of Medicine published in 2000, “To Err is Human: Building a safer Health System.” This manuscript states that between 44,000 and 98,000 deaths and over one million injuries occur each year due to medical errors (including retained surgical towels).[35] To avoid the medical errors, a modern approach, akin to other high-risk industries such as aviation and nuclear plants, needs to be employed. Surgery has been compared to nuclear plants as both are high-risk systems where even the smallest of errors can lead to catastrophe. Nuclear plants have low rates of errors as compared to surgery.[36] In the operation theater, hierarchy is often rife and surgeons are seen as intimidating characters preventing other staff from pointing the potential error.[37] The historical approach has been to blame the surgeon not appreciating that surgeon is a hardworking, well-trained individual and that admonishing him to be more careful or shaming or suing him is unlikely to reduce any error. The modern approach is to develop a “thinking system,” which holds that human will make mistakes, but that this system will anticipate errors and prevent or detect them before they cause harm. The “Swiss cheese” model as practiced in the aforementioned high-risk industries has shown an excellent safety record.[3638] It is futile to try and perfect human beings. Rather, it is better to develop multiple layers of protection allowing the holes in the “Swiss cheese” model to overlap and not allowing any error to slip. A mistake by one person in this safety conscious system is unlikely to cause harm as it must percolate through other layers of protection to cause harm. An environment of open and honest discussion is also necessary. The discussions should be interdisciplinary, with more emphasis on patient safety in various platforms such as seminars, symposia, morbidity and mortality meets, and various conferences of all surgical disciplines. In addition, communication between team members should be well maintained.[39] All commercial pilots must take a “crew resource management” course, in which they train to deal with emergencies with other crew members, learn to flatten their hierarchies preventing open communication, use of a checklist, and other systematic approaches. There is evidence that such intervention in surgical practice will improve safety of patients.[40] Negative behaviors such as bullying, “negative” peer pressure, bypassing established safety norms should be changed.[6] Surgical residents should have patient safety module with frequent refresher courses. One members of the surgical team should be made responsible for counting of sponges and getting it cross-checked by another team member. The WHO also lists counting of sponges in its surgical safety checklist though it has its own limitations.[41] All quadrants of abdomen should be explored for surgical sponges and instruments before closing the abdomen. A simple method of preventing a sponge from being forgotten is to tie the tail end of five sponges together and use them as a pack of five.[42] It has been suggested that the incidence of RFB will decrease with increasing numbers of laparoscopic procedures being performed, owing to usage of fewer sponges and smaller incisions.[4344] However, this is not true because there is no relationship between the number of items used and the risk of retention.[43] In terms of newer technologies, the currently available options are barcode scanning, radio frequency detection (RF), and radio frequency identification (RFID). A barcode scanning system consists of sponges, which have a tag, similar to those seen on items at a supermarket. The code is to be read as the sponges are added or removed from the surgical field. It has reportedly reduced the rate of retained sponges from 1 every 64 days to 0 after an 18-month period.[45] For radiofrequency systems, an RF chip is imbedded into the fabric of the sponges. A wand, connected to a detection console, is used to scan the patient. If a sponge is detected, the console triggers an alarm. A similar RF mat is also available, which aims to automate the scanning process, without usage of a wand. The sensitivity and specificity of the RF mat is 98.1% and 100.0%, respectively. Moreover, the sensitivity and specificity of the wand is 100.0%.[46] An RFID system is unique as it can both count and detect sponges. Similar to the barcoding system, the RFID tag for each sponge can be identified when scanned by a handheld scanner and like the RF system, RFID does not require visual proximity.[47] At the moment, no single technology is superior to the other. Unfortunately, owing to the infrequency of retained sponges, it is believed that randomization of >100,000 patients would be needed to reliably detect a significant reduction in retained surgical sponges using one or more of these methods.[48] Till such a study is possible, a safe working culture, open communication, teamwork, and an accurate sponge count, remain our best defence against this often unpredictable complication of modern surgery.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.