Laparoscopic cholecystectomy is widely regarded as the gold standard for the surgical management of symptomatic cholelithiasis and acute cholecystitis, owing to its well-established advantages over open cholecystectomy, including reduced postoperative pain, shorter hospital stay, and faster recovery [1]. Despite these benefits, gallbladder retrieval remains a technically challenging and often time-consuming step. Although numerous techniques have been proposed to facilitate safe extraction, difficulties persist, and surgeons frequently need to enlarge the port site to remove the specimen. Such enlargement increases the risk of bleeding, hematoma formation, and surgical site infection, and also predisposes the patient to incisional hernia development [2]. Port-site herniation is a recognized complication following laparoscopic surgery. Severe consequences, such as bowel obstruction due to incarceration through a fascial defect, may occur. Reports of Richter’s hernia at trocar sites highlight this risk, with an incidence ranging from 0.2% to 3% [3]. Gallbladder perforation during laparoscopic cholecystectomy is another common intraoperative event that may lead to the loss of gallstones and spillage of bile. The resulting complications may include intra-abdominal or subcutaneous abscesses, fistula formation, liver abscess, staphylococcal bacteraemia, granuloma formation, bowel obstruction, and port-site hernia [4]. Port-site infections, though generally superficial, tend to occur more frequently at the extraction site and usually respond to local treatment. These infections are largely attributable to contamination during specimen retrieval [5]. To minimize such contamination, the infected or potentially infected gallbladder should be extracted using an endobag to prevent wound infection, avoid spillage of bile or malignant cells, and reduce contamination of both the peritoneal cavity and the port-site tract [6]. Using an endobag also helps prevent the intra-abdominal dissemination of gallstones, which may otherwise lead to delayed complications. There are documented cases where spilled stones were recovered years later from port-site sinuses, underscoring the importance of protected retrieval [7,8]. In the present study, a sterile female condom is used as an indigenous, low-cost endobag. The objective is to identify a more effective and practical method for routine gallbladder extraction by comparing outcomes between endobag-assisted extraction and direct extraction through a 10-mm port, evaluating both advantages and potential complications.

Study Design and Setting A prospective randomized comparative study was performed at the Department of Surgery, Sir Sayajirao Gaekwad Hospital & Medical College, Baroda, from December 2018 to September 2019. Sample Size Sixty patients undergoing elective laparoscopic cholecystectomy were included. Two additional patients were excluded due to conversion to open cholecystectomy. Inclusion Criteria • Age >18 years • Diagnosed with symptomatic cholelithiasis • Fit for general anesthesia Exclusion Criteria • Age <18 years • Suspected gallbladder malignancy • Obstructive jaundice • Conversion to open surgery • Uncontrolled comorbidities Randomization Participants were randomly allocated into two equal groups using a sealed-envelope lottery technique: • Group A: Direct extraction through the port • Group B: Retrieval using an indigenous sterile female-condom endobag Surgical Technique The standard four-port laparoscopic cholecystectomy technique was used in all cases [15–17]. After dissection and clipping of the cystic duct and artery, the gallbladder was separated from the liver bed. In Group A, the gallbladder was extracted directly through the umbilical port, sometimes requiring fascial enlargement. In Group B, a sterile female condom was introduced through the umbilical port as an endobag. The gallbladder was placed inside, secured, and retrieved without contamination. Outcome: The primary outcomes assessed in this study included the incidence of bile and stone spillage during gallbladder extraction, the total operative time required for the procedure, and the occurrence of postoperative complications such as port-site infection and port-site hernia. In addition, the duration of postoperative hospital stay was evaluated to compare overall recovery between the study groups. These parameters were systematically recorded and analyzed to determine the efficacy and safety of the extraction Statistical Analysis Data were analyzed using MedCalc v17.9.5. A p-value <0.05 was considered statistically significant.

A total of 62 patients were initially enrolled in the study. Two cases required conversion to open cholecystectomy—one due to common bile duct (CBD) injury and the other due to intractable bleeding. Therefore, 60 patients were included in the final analysis, comprising 45 women (60%) and 15 men (40%). Table 1. Age wise distribution of study participants Age (Years) Group A (n=30) % Group B (n=30) % 18–20 0 0 1 3.333 21–30 5 16.667 3 10 31–40 9 30 8 26.667 41–50 8 26.667 5 16.667 51–60 6 20 8 26.667 61–70 2 6.667 4 13.333 71–80 0 0 1 3.333 Mean Age 43.63 — 47.13 — Mean ± 2SD 43.63 ± 11.861 — 47.13 ± 14.925 — Table 1 presents the age-wise distribution of study participants in both groups. Most participants in Group A were between 31–40 years (30%) and 41–50 years (26.67%), while Group B also showed higher representation in the 31–40 years (26.67%) and 51–60 years (26.67%) age brackets. Younger (18–20 years) and older (71–80 years) age groups were minimally represented. The mean age was slightly higher in Group B (47.13 years) compared to Group A (43.63 years), with wider variability reflected in the mean ± 2SD values. Table 2. Comparison of Average Operative Time and Hospital Stay Between Groups Parameter Group A (Direct Extraction) Group B (Endobag Extraction) Average Operative Time (minutes) 69.2 88.93 Operative Time (Mean ± 2SD) 69.2 ± 7.47 88.93 ± 11.52 Average Hospital Stay (days) 2.9 2.7666 Hospital Stay (Mean ± 2SD) 2.9 ± 0.83 2.7666 ± 0.84 Table 2 summarises the comparison of average operative time and hospital stay between the two groups. The mean operative time was substantially lower in Group A (69.2 minutes) compared to Group B (88.93 minutes), with corresponding variability shown by the mean ± 2SD values. In contrast, the average duration of hospital stay was similar between the groups, measuring 2.9 days in Group A and 2.77 days in Group B, with comparable standard deviation ranges. Overall, the use of an endobag increased operative time but did not prolong postoperative hospital stay. Table 3 provides a comparative overview of intraoperative and postoperative complications observed in both groups. In Group A, bile spillage (13.33%), stone spillage (3.33%), and gallbladder perforation (13.33%) were recorded, whereas none of these complications occurred in Group B. No bile duct or visceral injuries were reported in either group. Perforation of the indigenous endobag occurred only in Group B (10%). Postoperatively, port-site infection was more frequent in Group A (13.33%) compared to Group B (3.33%), while no cases of bile leak, intraperitoneal sepsis, or port-site hernia were observed in either group. Overall, the findings indicate a higher complication rate in the direct-extraction group compared to the endobag group. Table 3. Comparison of Intraoperative and Postoperative Complications Complication Type Specific Complication Group A (n = 30) Group B (n = 30) Intraoperative Complications Bile spillage 4 (13.33%) 0 Stone spillage 1 (3.33%) 0 Gallbladder perforation 4 (13.33%) 0 Bile duct injury 0 0 Visceral injury 0 0 Perforation of indigenous endobag 0 3 (10%) Postoperative Complications Bile leak 0 0 Intraperitoneal sepsis 0 0 Port-site infection 4 (13.33%) 1 (3.33%) Port-site hernia 0 0 In Group A, 60% of patients had multiple stones and 30% had a single stone, while in Group B, 80% had multiple stones and 20% had a single stone; the difference was not statistically significant (p = 0.465). Rates of gallbladder empyema and mucocele were also comparable between groups. Two patients in Group A (6.67%) required extension of the port-site incision, whereas none in Group B required extension. Most patients in both groups did not require drainage, and when placed, drains were removed by the second postoperative day. Intraoperative contamination occurred only in Group A, with bile spillage in 13.33% and stone spillage in 3.33% of patients, representing a significant difference compared to Group B (p = 0.0074). Port-site spillage was similarly confined to Group A (13.33%). Postoperative port-site infections were more common in Group A (13.33%) than Group B (3.33%), though the difference was not statistically significant (p = 0.5072). All infections responded to conservative management, and only one culture grew Klebsiella sensitive to ceftriaxone. No port-site hernia was observed in either group.

In the present study, the mean postoperative hospital stay was comparable between the two groups, measuring 2.9 days in Group A and 2.76 days in Group B, with no statistically significant difference. The duration of hospitalization was influenced partly by drain placement, as patients with drains typically remained admitted longer—an observation consistent with prior studies indicating prolonged hospital stay among drained patients [9-11]. The findings of Singh DP et al., who reported a mean hospital stay of 1.96–2.08 days based on criteria of drain removal and symptomatic improvement, as well as reports by Nusral TZ et al. and Riskin DJ et al. demonstrating delayed discharge in drained groups, support the trends observed in our study. Similarly, Stevens KA et al. documented a mean stay of 2.6 days, further aligning with the present results [9-11]. The operative time was longer in Group B (88.93 minutes) compared to Group A (69.2 minutes), with maximum durations of 120 and 86 minutes respectively. These findings correspond with previously published data, including the work of Kirshtein B et al., who noted differences in operative time between drained and undrained cases, and the results reported by Makama and Ameh [12-13]. The slightly prolonged operative time in the endobag group may be attributable to specimen handling and bag deployment. Drain removal followed standard criteria in both groups, based on non-bilious, serous fluid and decreasing output volumes. The difference between the two groups was statistically insignificant. Previous literature similarly reports early drain removal, with Singh DP et al. documenting removal within two postoperative days in most cases [9]. Although some authors suggest drains may help reduce postoperative nausea and vomiting [14], others report no statistically significant advantage [15]. The use of an indigenous endobag markedly reduced intra-abdominal contamination. No stone or bile spillage was observed in Group B, whereas Group A demonstrated bile spillage in 13.33% and stone spillage in 3.33% of cases—a statistically significant difference (p = 0.0074). These results support previous findings indicating that endobag use minimizes intraoperative and postoperative morbidity associated with gallbladder perforation and spillage [16-21]. Historical studies, including large series by Rice, Diez, and Schäfer, similarly show that uncontrolled spillage occurs frequently during laparoscopic cholecystectomy and may lead to complications if not contained [16-18]. Port-site spillage was also confined to Group A (13.33%), reflecting the protective effect of the endobag. In terms of postoperative complications, port-site infection occurred more frequently in Group A (13.33%) than in Group B (3.33%); however, this difference was not statistically significant (p = 0.5072). These infection rates are consistent with other studies reporting port-site infection rates ranging from 2% to 6% following laparoscopic cholecystectomy [9,22-25]. All infections observed in our study responded to conservative management, with only one culture yielding Klebsiella species sensitive to ceftriaxone, while all other cultures were sterile. Port-site hernia did not occur in either group during the 3-month follow-up. This finding aligns with reported incidences ranging from 0.38% to 5.4% in previous studies [7,26-27], and may be attributed to meticulous port-site closure and avoidance of undue fascial stretching. There were no cases of postoperative bleeding, peritonitis, ileus, or mortality in either group. Furthermore, both groups demonstrated comparable cosmetic outcomes and overall procedural cost. Collectively, the findings of this study reaffirm the value of an indigenous sterile female-condom endobag as an economical, practical, and effective alternative for gallbladder retrieval, significantly reducing intraoperative and port-site contamination without adding morbidity.

The indigenous sterile female-condom endobag represents a safe, effective, and cost-efficient alternative to commercially available specimen retrieval systems. Its use minimizes intraoperative contamination by preventing bile and stone spillage, significantly reduces the incidence of port-site infection, and eliminates the need for port enlargement during specimen extraction. Moreover, it does not contribute to prolonged operative time or extended hospital stay. Considering these advantages, routine incorporation of this indigenous endobag during laparoscopic cholecystectomy is recommended to reduce postoperative morbidity.

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