Introduction

Morcellation, a minimally invasive surgical technique used in gynecology, involves the removal of tissue or masses from the pelvic area. This approach has gained prominence due to its ability to reduce bleeding, minimize post-surgery pain, shorten recovery periods, and provide improved cosmetic results compared to traditional open surgery [1]. However, concerns arose with the adoption of uncontained power morcellation, which employs rapidly rotating blades to cut tissue into smaller pieces for removal through a port [2]. This technique posed risks of disseminating tissue fragments within the abdominal cavity, especially when dealing with undiagnosed sarcomas [3]. As a response to these concerns, the U.S. Food and Drug Administration (FDA) issued a safety warning in 2014, urging healthcare providers to discuss alternative treatment approaches with patients [4].

In light of the FDA’s warning, gynecological surgeons have explored safer alternatives such as contained transvaginal morcellation [5]. This method aims to maintain the benefits of minimally invasive surgery while reducing the risk of tissue dissemination. Previous studies have shown that there were few complications and good postoperative outcomes, even though there has been ongoing discussion about the duration of morcellation in these procedures [6, 7]. Since a significant portion of patients needed morcellation to complete their surgeries, transvaginal morcellation spared many patients from the potential complications associated with laparotomy [7]. These advancements highlight the convergence of innovation and patient well-being, offering women safer and more efficient surgical choices.

Several critical knowledge gaps persist in the understanding of transvaginal morcellation within an enclosed bag in gynecological surgeries. These gaps encompass various aspects, such as the optimal patient selection criteria, the potential impact of tissue characteristics on the procedure, and the long-term outcomes in terms of tumor recurrence and patient quality of life. Furthermore, the heterogeneity in study methodologies and patient populations has contributed to variations in reported outcomes, making it challenging to establish standardized protocols and guidelines for this technique. Filling these knowledge gaps is of paramount importance as it can lead to improved patient safety, more informed decision-making by clinicians, and the development of evidence-based practices in gynecological surgery. Addressing these gaps can also help mitigate potential risks associated with the procedure and enhance its overall effectiveness.

The primary aim of this study is to conduct a systematic and comprehensive review of the existing literature on transvaginal morcellation within an enclosed bag in gynecological surgeries. By synthesizing the available evidence, we seek to provide a thorough evaluation of the technique’s safety and efficacy across various surgical scenarios and patient populations. This review will critically analyze primary and secondary outcomes, including procedure duration, blood loss, reported adverse events, and long-term follow-up data. Through this investigation, we aim to identify areas of consensus and divergence in the current literature, offer insights into the factors influencing surgical outcomes, and highlight any potential concerns or areas for improvement. Ultimately, our study aims to contribute to the development of evidence-based guidelines for the use of transvaginal morcellation within an enclosed bag in gynecological surgeries, promoting safer and more effective minimally invasive approaches in the field.

Methods

We used a systematic review strategy to perform complete literature retrieval across several academic databases to explore scientific papers relevant to the outcomes of contained transvaginal morcellation. This review followed the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) 2020 standards, guaranteeing a robust and uniform methodology [8]. We submitted the research protocol for this systematic review to the International Prospective Registry of Systematic Reviews (PROSPERO) database (www.crd.york.ac.uk/prospero/) and assigned the PROSPERO ID: CRD42023437418. All working group members agreed on the study protocol before beginning the literature search.

Search strategy

An electronic search was conducted across five databases: Epistemonikos, Web of Science, Medline (through PubMed), Scopus, and Cochrane. In July 2023, a search was performed using a strategic combination of relevant terms to ensure effective results. The search strategy included the following terms: (morcellation OR morcellating OR morcellator OR morcellate OR morcellement OR Morcellation* OR Morcellator* OR “Tissue fragmentation”) AND (In-bag OR In-bag OR In-bag* OR within a bag OR enclose OR enclosed OR enclosed bag OR enclosure OR enclosing OR contained OR Intra-corporeal OR Intra-corporeal) AND (transvaginal OR vaginal OR intra-vaginal OR intra-vaginally OR intra-vaginal OR intra-vaginally).

The retrieved studies were carefully assessed based on their titles and abstracts, and only those that met the eligibility criteria were considered for the following stages, which involved extraction and quality assessment. The search for published work was conducted without imposing time restrictions or filters, aiming for inclusivity in the results without limitations based on publication date or predefined criteria. In addition, we conducted a manual search by reviewing the references of the included articles, and literature reviews for possible relevant studies.

Study selection

The collected articles were checked for potential duplicates. Following the removal of duplicates, the titles and abstracts were screened by four independent reviewers (RA, NB, MEM, and EM). Any discrepancies between the reviewers were resolved by carefully re-examining the article and discussing it until an agreement was achieved. If a resolution could not be reached, a supervisor (MA) was available to re-evaluate the distinctions and make a final decision regarding whether to include the study in the analysis.

Studies deemed relevant and any conflicts were subjected to full-text screening. Four reviewers (OA, EM, RA, and NB) obtained the full texts of studies that may have met the criteria and independently assessed them to decide if they should be included in the final analysis. The process for resolving disagreements during the full-text screening was similar to that used previously. The detailed search process and the selection of studies are elaborated in the accompanying PRISMA diagram (Fig. 1).

Fig. 1
figure 1

PRISMA 2020 flow diagram for new systematic reviews which included searches of databases and registers only

Full size image

Eligibility criteria

This review focused on adult patients who underwent gynecological surgeries involving transvaginal contained morcellation procedures. The selection criteria were not limited by language or study type, aiming to encompass a broad range of research perspectives. The inclusion criteria were all observational studies (prospective or retrospective cohort, case–control, cross-sectional, case series, or case study) and experimental studies (randomized controlled trials).

Our commitment to maintaining the rigor and significance of the assembled studies led us to exclude duplicate publications, reviews, editorial correspondence, book chapters, animal and laboratory experiments, and in vitro inquiries.

Data extraction

Four authors, RA, EM, NB, and MEM, conducted primary data extraction, each assigned to a specific portion of the studies. They entered the collected information into a pre-piloted Excel spreadsheet. To ensure data accuracy and consistency, a fifth (OA) author meticulously reviewed the completed extraction sheet, reconciled any discrepancies, and validated the precision of the data. The extracted information included details about the authors, publication years, countries of publication, study types, sample sizes, bag type, surgery indications, the type of surgical procedures, duration of the procedure, amount of blood loss, reported adverse events and the main findings of the included studies.

Critical appraisal tool and risk of bias assessment

Two authors (MEM and OA) conducted an assessment of the risk of bias in the eligible included studies. The National Institutes of Health (NIH) Quality Assessment Tool for Observational Cohort and Cross-sectional Studies was employed for this purpose [9]. The assessment involved rating studies on a scale of 0 for poor (0–4 out of 14 questions), for fair (5–10 out of 14 questions), and good (11–14 out of 14 questions). In cases where certain questions were not applicable (NA) or not reported (NR), these designations were used accordingly. The methodological quality of the included clinical trial was assessed by using the RoB2 tool [10]. Any discrepancies in their assessments were resolved through discussions among researchers until a consensus was reached.

Results

Summary of included studies

The electronic search yielded results from five different databases: Epistemonikos (67 hits), Web of Science (64 hits), MEDLINE through PubMed (47 hits), Scopus (30 hits), and Cochrane (five hits). After inclusion, exclusion, and deletion of duplicates, 22 articles were included in the final analysis [11,12,13,14,15,16,17,18,19,20,21,22,23,24,25,26,27,28,29,30,31,32]. The present study identified several published studies including clinical trials, retrospective studies, and case series. Table 1 summarizes the findings of these studies. The present study identified studies related to the safety and effectiveness of transvaginal morcellation within an enclosed bag in gynecological surgeries as well as the risk of tumor recurrence or dissemination. The overall quality of the studies ranged from fair to good, although one study exhibited poor methodology and was designated as having a high risk of bias. A comprehensive breakdown of the quality assessment results is presented in Table 2 and Fig. 2.

Table 1 Summary and baseline characteristics of the included studies
Full size table
Table 2 Quality-assessment tool for observational cohort and cross-sectional studies (NIH)
Full size table
Fig. 2
figure 2

The results of the RoB2 (Risk of Bias 2) Cochrane tool assessment for the included randomized trial conducted across five key domains

Full size image

Age and sample size

The age distribution of the participants in the included studies exhibited considerable variability, spanning a median age range of 35–61 years. This wide age range reflects the diverse demographic profiles of the studied patient population. Likewise, the sample sizes across these investigations exhibited substantial heterogeneity, with studies ranging from a single participant to as many as 1560 individuals. This wide variability in sample sizes highlights the diversity in study designs and varying degrees of statistical power across the included studies.

Bag type and histologic type/indications

Various bag types were utilized in the included studies, with seven studies using “Endo Catch/Endo Catch II,” five studies using the “Endoscopic specimen bag,” and four studies utilizing the “Specimen containment bag (Alexis Contained Extraction System, Applied Medical, Rancho Santa Margarita, CA, USA).” Other bag types employed across the studies included Ecosac, Lahey Bag, Anchor tissue retrieval system, and bowel bag (3M Steri-DrapeTM Isolation Bag 1003, St. Paul, MN, USA), 10- or 15 mm polyurethane specimen pouches (Covidien Surgical, Mansfield, MA, USA), and 32 × 41 cm nylon bags (4 L Espiner EcoSac morcellation, Espiner Medical) were deployed intra-abdominally. For larger uterine specimens, bigger bags without a frame (LapSac; Cook Medical, Bloomington, IN, USA) were used, although the placement and wrapping were more difficult and took much more time. In addition, some studies used a combination of a bag, Alexis’s ring, and stapler, whereas others did not specify the bag type used. These bag types were chosen based on the specific requirements of the procedures and preferences of the surgeons.

Surgical procedures

The primary surgical procedures performed in these studies included a wide range of indications, with some of the most common being abnormal uterine bleeding, pelvic pain, dysmenorrhea, and dyspareunia. These studies also addressed various histologic types, including leiomyomas (uterine fibroids) and malignancies such as endometrioid adenocarcinoma and carcinosarcoma. Among these, leiomyomas were the most commonly addressed histologic types, and some cases also involved adenomyosis. Furthermore, the studies explored other malignancies like serous adenocarcinoma, carcinosarcoma, and clear-cell adenocarcinoma. These studies demonstrated a varied spectrum of procedures and indications, underscoring the versatility of transvaginal morcellation within enclosed bags.

Duration of the procedure

The range of surgical procedure times varied widely, and the median surgical procedure time across these studies was approximately 120 min, with some studies reporting a range of 70–210 min. Notably, studies reported that the mean and median times for organ extraction and morcellation were approximately 13 and 16 min, respectively. A weak positive correlation was found between the duration of the procedure and the weight of the extraction tissue (Correlation Coefficient = 0.236). This suggests that longer procedure durations were associated with an increase in the weight of the extracted tissue. The overall trend suggests a reasonable duration for transvaginal morcellation within an enclosed bag, contingent on individual patient factors and surgeon experience. However, it is essential to consider individual patient factors, the complexity of the case, and the surgeon’s experience when assessing the suitability of this technique in practice.

Blood loss

Out of the 22 studies analyzed, 12 provided data on blood loss. These data were collected from various surgical procedures, such as total laparoscopic hysterectomy, subtotal hysterectomy, robotic-assisted hysterectomy, and laparoscopic myomectomy, with the majority involving laparoscopic surgeries. In the Ding 2022 [16] study, it was observed that patients undergoing minimally invasive surgery with vaginal in-bag morcellation had significantly lower estimated blood loss compared to patients undergoing abdominal hysterectomy (P < 0.001). In the Meurs 2017 [25] study, which observed surgical outcomes across different morcellation methods (Power Morcellation, Vaginal Morcellation, and Mini-laparotomy), no significant difference in estimated blood loss was found among power morcellation, manual vaginal morcellation, and mini-laparotomy in 297 patients. In this study, containment bags were utilized in the majority of patients across all techniques. Multivariate regression analysis revealed no significant differences in blood loss, length of stay, or complications among the techniques. blood loss is not a major concern for using morcellation bags when compared between morcellation techniques.

Malignancy risk

Among the 22 studies reviewed, 8 of them examined cases involving malignancy, while 3 of these studies were unsuspected malignancy. In the study conducted by Ding, which included a substantial cohort of 5683 low-risk benign patients, the incidence of malignancy was found to be remarkably low at just 0.33% [16]. Importantly, among the patients diagnosed with endometrial cancer in this study, three underwent in-bag manual morcellation, and none experienced relapse during a follow-up period spanning 32 months, ranging from 16 to 70 months. Similarly, in the Serur study [28]; which comprised 104 patients, 2 cases (1.92%) of occult malignancy were detected. Encouragingly, both individuals showed no signs of disease during follow-up periods of 28 and 36 months, respectively. Furthermore, in a separate study that involved unsuspected malignancy treated with power morcellation, no dissemination was observed. Even at the time of our current analysis, which is ≥ 2 years after the initial surgery, the patient remains free of recurrence.

Weight of the extracted tissue

The range of extraction tissue weights varied widely from as low as 70 g to as high as 950 g. The median values suggest that the typical weight of the extracted tissue was approximately 210 g [13] and 372 g [17]. However, it is important to note that there were substantial variations in the reported values. In Cohen 2019 [15], a standard deviation of 465 ± 208 was provided, indicating a considerable degree of variability in the weights of the extracted tissue within that specific study.

Reported adverse events

Ten studies have reported various adverse events. We have classified these adverse events based on their relatedness to the morcellation process (Table 3). Notably, among these ten studies, only three studies reported morcellation-related intraoperative complications. In Carrubba’s study conducted in 2020, it was observed that 5 patients (14.71%) required conversion to the abdominal route, highlighting the need for flexibility in surgical approaches. In addition, Serur’s 2016 study reported a conversion rate to an open surgical approach of 5.9% (7 out of 117 patients). Within this subgroup, one patient experienced a substantial estimated blood loss of 1200 mL during the procedure, which was attributed to bleeding from a broad ligament myoma. However, it is noteworthy that Serur’s study clarified that these complications were not directly attributable to the morcellation technique itself. In the study by Gil-Gimeno et al. in 2020 [22], complications were noted in two women. One case involved a posterior vaginal laceration during vaginal morcellation, while the other case included a bladder injury in a woman with a uterus weighing 1321 g. The latter incident was likely to have occurred during the initial bladder dissection rather than directly related to the morcellation procedure.

Table 3 Adverse events reported in the included studies
Full size table

Meanwhile, the remaining non-morcellation-related intraoperative or postoperative adverse events were reported in different seven studies (Table 3). Cohen et al. (2019) detailed intraoperative and postoperative issues, including pelvic abscess and skin-related problems. Dotson et al. (2018) found multiple postoperative complications, such as vaginal cuff separation and bladder infections. Favero et al. (2012, 2015) documented vesicovaginal fistulas requiring surgical repair. Meurs et al. (2017) reported diverse complications, including genitourinary tract injuries and infections. In addition, Wyman et al. (2012) noted one patient requiring secondary surgery postoperatively.

Discussion

The results from the comprehensive analysis of studies are reassuring about the usefulness of transvaginal morcellation within an enclosed bag in gynecological surgeries. The culmination of our research effort, comprising 22 carefully selected articles, has yielded valuable insights into the use of this technique. In the reviewed studies, various aspects were assessed, including the age and sample size of the participants, the type of bag used, histologic tissue type, surgical procedures, primary and secondary study outcomes, procedure duration, blood loss, and reported adverse effects. The primary focus of the analysis was to evaluate the safety and efficacy of transvaginal morcellation within an enclosed bag during gynecological surgeries. Furthermore, an examination was conducted to explore the potential for tumor recurrence and dissemination.

The reported blood loss varied, with minimum reported mean values ranging from 20 to 260 mL, as noted in the included studies. The median blood loss across these studies was approximately 110 mL, although some studies reported a range of 20–1200 mL. These findings suggest that blood loss can vary significantly among patients undergoing transvaginal morcellation within an enclosed bag. It is important to differentiate between blood loss occurring during the procedure and blood loss specifically due to the morcellation process. Factors such as the type of surgery, the size and condition of the uterus or fibroids, and the surgical technique employed may contribute to these variations. It is crucial for future studies to specifically assess blood loss attributable to morcellation and distinguish it from the overall blood loss that may be associated with other procedures of the operation.

Unfortunately, not all uterine cancers can be diagnosed preoperatively. Preoperative assessment of patient uterine masses or abnormal uterine bleeding must account for the limitations of endometrial biopsy and imaging studies in evaluating the possibility of uterine malignancy. Even in cases where benign indications are present, it is imperative to remain vigilant regarding the potential for unsuspected malignancy. In line with these facts, a cautious approach is recommended, particularly in instances involving bulky tumors, wherein power morcellation should be avoided in favor of manual morcellation [33]. Preoperative approaches to minimize the risk of inadvertently morcellating a malignant tumor include endometrial sampling, pelvic sonography, and MRI. Endometrial sampling detects endometrial carcinoma, while sonography is useful for the initial detection of fibroids but is limited in distinguishing benign from malignant masses [34, 35]. MRI offers detailed imaging of uterine masses, assessing tumor size, margins, and invasive growth, although it may struggle to differentiate leiomyosarcoma from benign leiomyoma [36]. Combining patients’ demographic information, medical history, and imaging techniques with serum tests and using advanced MRI sequences can enhance diagnostic accuracy and reduce the risk of morcellating malignant tumors [33].

While most of the included studies involving malignant indications or cases of unexpected malignancy, with a mean follow-up of 11.9 months, did not report tissue dissemination, it is worth noting that Dotson’s study did identify tumor spillage in 2 out of 52 cases (3.85%) involving malignancy [17]. In this context, the FDA recommends that patients be informed about the risk of occult cancer and the potential for laparoscopic power morcellators to disseminate cancer.

While the risk of dissemination appears low in most scenarios, meticulous attention to the choice of technique remains crucial to ensure patient safety and optimal outcomes. However, enclosed bag morcellation has potential advantages in terms of preventing the abdominal spread of tumor cells, compared to open morcellation, which can make it a useful option. Further studies should be conducted to assess the potential malignancy rate and the risk of tissue dissemination in cases of unsuspected malignancy.

Meanwhile, most studies indicated that no ruptures were observed in the bag. Only three articles reported bag ruptures [12, 15, 29]. Solima’s findings showed that approximately 33.33% (4 out of 12) of the EndoCatch bags had minimal ruptures. Cohen’s study examined the risk of spillage associated with different types of bags, and it found that the Endo Catch bag had the highest risk, with in vitro spillage observed in 32% (8 out of 25) bags. While Cohen Indicated that the bag’s leakage had no clinically significant impact. However, it is important to interpret these findings cautiously. Cohen et al. mentioned in their conclusion that they did not specifically assess the protective qualities of different specimen containment bags, nor did they account for potential variations in extraction methods. Therefore, it remains uncertain whether the observed leakage was solely attributable to the bag itself, the extraction technique used, or other unidentified factors. In light of these uncertainties, it should be noted that the studies reviewed did not explicitly investigate the bag’s integrity. Considering anatomic factors, it is reasonable to expect that vaginal morcellation could potentially lead to an increased risk of bag perforations.

While there may be variations in analgesia requirements between different morcellation methods included in the review, postoperative pain levels, as indicated by Visual Analog Scale (VAS) scores, generally remain comparable, suggesting that transvaginal morcellation does not lead to undue discomfort. The preservation of female sexual function is an important aspect, with one group showing no significant differences in postoperative sexual function scores, while another group did report some worsening. Furthermore, it is worth noting that associations between factors like uterine size, BMI, and the route of morcellation did not reveal any significant concerns in terms of safety. Notably, some studies have reported no complications or intraoperative issues related to transvaginal morcellation within an enclosed bag. It is important to note that the occurrence of adverse events varied among the studies, and the majority of patients did not experience complications.

This observation suggests that the overall safety profile of transvaginal morcellation within an enclosed bag is favorable when performed by experienced surgical teams. Nevertheless, it is important to consider the potential link between tumor weight and the occurrence of complications. Overall, the data highlight the variability in the weight of extraction tissue in gynecological surgeries. This variability could be influenced by factors such as the type of surgery, patient characteristics, the presence of pathology (e.g., fibroids or tumors), and the surgical technique employed (e.g., morcellation method). It is important for surgeons to consider these factors when planning and performing gynecological procedures involving tissue extraction to ensure the safety and effectiveness of the surgery. In addition, further analysis and comparisons, as indicated by the data point comparing abdominal and vaginal morcellation, may provide valuable insights into the factors affecting tissue weight and the choice of surgical approach.

Strengths and limitations

This is the first systematic review evaluating the outcomes of contained transvaginal morcellation in gynecological surgeries. Five different databases were used in the search and a large number of studies were reviewed for inclusion. Unfortunately, access to the EMBASE database was not obtained during the execution of our study, and as a result, it was not incorporated into our search strategy for identifying relevant studies. We included all available observational and experimental studies with variations in sample sizes, so our results combine case report data with larger studies. The quality of the included studies was assessed rigorously and studies’ overall quality ranged from fair to good. In addition, PRISMA 2020 standards were followed to ensure a consistent methodology.

The FDA encourages peer-reviewed scientific literature and prompt reporting of adverse events related to contained morcellation including the spread of unexpected cancer. All this information was assessed in our review, which may help in the improvement of contained morcellation procedures and the development of new techniques with lower risks.

A notable limitation in our study was the considerable heterogeneity observed in certain outcomes, which proved challenging to mitigate. This variability may, in part, be attributed to differences in surgical methods employed, which can vary not only between individual surgeons but also across various surgical cases. Another limitation is the lack of detailed reporting on whether the uterus was left in situ or removed in the included studies, which prevented a more granular analysis of outcomes based on this criterion. This highlights the need for more comprehensive data reporting in future research to better compare different surgical modalities. This inherent heterogeneity underscores the need for more standardized trials in the field of gynecological surgeries involving in-bag morcellation. Enhanced standardization would not only raise the quality of data but also reduce heterogeneity, enabling a more robust and well-founded analysis. A concerted effort to establish standardized protocols and guidelines for conducting such trials worldwide is imperative. By doing so, we can elevate the level of confidence in the safety and efficacy of in-bag morcellation, facilitating informed and evidence-based decisions in clinical practice.

Conclusion

The results of the collective analysis of various studies shed light on the safety and effectiveness of transvaginal morcellation within an enclosed bag in gynecological surgeries. Overall, the technique appears to offer several advantages, including reduced invasiveness, shorter operative times, and minimal blood loss, compared to traditional approaches such as abdominal hysterectomy. However, there are still concerns about the safety of the technique in cases of suspected or confirmed malignancy. In this regard, the risk of tumor recurrence or dissemination should also be assessed in conjunction with these findings and any available long-term follow-up data.