Transvaginal Surgery: Do Women Want It?

Introduction

Minimally invasive surgery became the standard of care for many abdominal surgeries in the early 1990s. The current widespread use of minimally invasive procedures was largely a patient-driven process; patients embraced these techniques with the prospect of better recovery and fewer complications. Natural orifice translumenal endoscopic surgery (NOTES^®; American Society for Gastrointestinal Endoscopy [Oak Brook, IL] and Society of American Gastrointestinal and Endoscopic Surgeons [Los Angeles, CA]) is a new method of minimally invasive surgery that has the potential to leave the patient with no incisions in his or her abdominal wall by using a transgastric, transrectal, or transvaginal (TV) approach. Surgeons are investigating the possibility of TV access to the abdominal cavity for several common abdominal procedures, such as cholecystectomy and appendectomy. The TV approach could result in a decreased risk of infection, fewer wound complications, less postoperative pain, and better cosmetic results. ¹ The TV point of access has been used in women for a variety of gynecological procedures but may have personal and potentially social implications when used routinely for other intraabdominal procedures.

A few TV abdominal procedures were performed beginning in the early 1900s, but NOTES did not start gaining popularity until the 2000s. ² Beginning in 2001, surgeons reported using the TV access for abdominal exploration during laparoscopic procedures and later for cholecystectomy during a vaginal hysterectomy.^3,4 Since then, many surgeries have been performed across the world using TV or transgastric approaches, yielding encouraging results, including decreased postoperative pain, decreased infection risk, and decreased rates of hernia development. Women who have undergone TV surgeries have been surveyed in various studies, and reports show no dyspareunia and no change in quality of life afterward. All the women were satisfied with their surgeries, and many even began sexual activities within 3 weeks following surgery.^5–10 However, TV NOTES has not been embraced as warmly by the public as other minimally invasive techniques, so we conducted a survey on women's perspectives in order to better understand why that is the case. The results of this survey will serve to inform physicians, other healthcare professionals, and industry partners regarding public acceptance of NOTES, which will (1) aid discussions with patients concerning surgical options and (2) determine the need for furthering NOTES development.

Materials and Methods

Female patients waiting to be seen at several Wexner Medical Center (Columbus, OH) general, gastrointestinal, and bariatric surgery clinics were asked to complete a survey. Participants were also given a brief verbal and written summary regarding the two techniques to aid in answering the survey questions (Appendix A). The survey was administered by research personnel after explaining and answering all questions regarding the TV NOTES and laparoscopic procedures. The survey consisted of 10 questions regarding laparoscopic surgery and TV NOTES and used a 5-point Likert response scale (Appendix B).

To simplify the presentation and to answer our research question in an unbiased and straightforward manner, women who answered “strongly disagree,” “disagree,” and “neither agree nor disagree” were aggregated as having given a “No” response to that question, and women who answered “agree” or “strongly agree” were considered to having given a “Yes” response. Demographic, social, and medical history data were also collected from the participant or from her medical record, such as level of education, number and type of deliveries, relationship status, menopause status, sexual activity, age, weight, ethnicity, comorbidities, reason for visit, and previous surgeries (Appendix B). Women's ages were sorted into three groups: <36, 36–55, and >55 years of age. Logistic regression analysis on dichotomized responses was used to investigate interactions of effects.

For each demographic characteristic and dichotomized potential surgery concern, the proportion of respondents in each of the “concern” categories was first compared with each other with regard to whether or not they would choose TV NOTES over standard laparoscopic surgery using Fisher's exact test of binomial proportions for contingency tables. An association was considered statistically significant for a two-sided P value of <.05.

A comprehensive logistic regression model with multiple effects was built to explore the interactions among demographic variables and concerns of women in the study, as well as to investigate how various factors jointly affected the outcome. All demographic variables, responses to potential surgery concerns, and all two-factor interactions (such as age×cosmesis) were included in the model to determine the likelihood of choosing NOTES over standard laparoscopic surgery. A stepwise model selection procedure was first carried out, which adjusted for all other significant factors, to determine which factors affected a patient's preference for NOTES. As the model developed, each term was added to the model one at a time based on lowest P value if the P value was <.20. Terms were removed if the P value ever became >.25 as the model grew. Additionally, to further validate our model selection, we performed an all-subset-model-selection, where we used the AIC (Akaike Information Criterion) as the selection criterion to choose the most plausible model. After comparing all 31 possible models, we found that the parameters (as well as odds ratios) in our original model remained fairly stable with no change of signs for any individual model term. The model presented in this article had the lowest AIC.

To then test for validity and internal consistency of survey responses, we devised a nonsymmetrically weighted kappa statistic to measure the agreement of two subtly different questions: “would you consider transvaginal NOTES” versus “would you choose a transvaginal procedure.” We assigned nonsymmetric weights to each of the four possible outcomes to identify whether our respondents were giving logical responses. We weighted those who “would consider and would choose transvaginal NOTES” and “would not consider and would not choose,” as well as “would consider but would not choose,” as 1, and we weighted the category of “would not consider but would choose” as 0, for obvious reasons. ¹¹

The statistical analyses described above were carried out using SAS^® version 9.3 software (SAS Institute, Cary, NC) and the R statistical computing package.

Results

Completed surveys were obtained from 142 women who visited Ohio State University general surgery clinics. Among the respondents, 23% (n=32) were under 36 years of age, 44% (n=62) were between 36 and 55 years of age, and 33% (n=46) were above 55 years of age. About half of the women were postmenopausal. The majority (85%) described themselves as white, and less than half had started college. About 82% of women had at least one child, 69% had at least one vaginal birth, and 18% had at least one cesarean section. About half (49%) of respondents were married, and 68% were sexually active. Eighty-five percent of women had undergone previous abdominal surgery, and the majority (86%) had not heard of NOTES before this study (Table 1).

More than 60% of subjects ≥36 years of age would preferentially choose NOTES (P=.024). A patient's menopausal status, level of sexual activity, and relationship status also trended toward significance in determining preference for TV NOTES. About half (48%) of pre- and perimenopausal women chose NOTES, whereas 65% of postmenopausal women chose NOTES (P=.056). Fifty-one percent of women who were sexually active chose NOTES as compared with 67% of non-sexually active women (P=.13). Eighteen (43%) single women chose NOTES compared with 40 (59%) married women. Age was found to be a statistically significant explanatory variable in determining whether a patient would choose TV NOTES. The other demographic characteristics, such as race, education background, previous surgeries, parity, and reason for visit to clinic, were not found to be statistically significant factors associated with a patient's choice of NOTES or standard laparoscopic surgery (Table 1).

After a 10-minute education period, patients were asked to respond to a survey eliciting their main concerns about surgery in general and a TV procedure (Appendix B). Seventy-one percent were concerned about the risk of infection, 51% about hernia risk, 59% about abdominal adhesions, 61% about organ injury, and 69% about postoperative pain. More specifically focusing on TV NOTES, 66% of women were concerned about postprocedural cosmesis, 62% were worried about recovery time, and 46% were worried about abstinence from sexual activity (Table 2).

Concern for postsurgical cosmesis, recovery time, and surgeon's familiarity with the procedure influenced a woman's preference for NOTES. Patients concerned with abdominal scarring from laparoscopic surgery were more likely to choose TV NOTES over the standard laparoscopic procedure. Sixty-six percent who were concerned about cosmesis would choose NOTES compared with only 49% of those who were unconcerned (P=.060). Sixty-two percent of women concerned about recovery time would choose NOTES, and only 43% unconcerned about recovery time would choose NOTES (P=.058). Those who were concerned about the length of time for recovery postsurgery were more likely to choose the TV NOTES procedure over standard laparoscopic surgery (Table 2).

We also found that although many respondents felt that the concerns listed on the survey were important, many of these concerns did not affect whether or not they would choose TV NOTES in a statistically significant manner. More than half (55%) of respondents would choose NOTES, regardless of whether they rated risk of infection as a significant concern. Risk of hernia, abdominal adhesions, organ injury, and postsurgical pain were also not significant influences on whether a woman would choose NOTES. Similarly, the potential disadvantages of a TV procedure did not influence a respondent's choice of TV or standard laparoscopic procedure, such as the need for sexual abstinence, risk for infertility, and risk for dyspareunia (Table 2).

In the multivariate analysis, we found that age and concerns for cosmesis, hernias, adhesions, and abstinence, as well as the interaction between age and concern for cosmesis (age×cosmesis), play important roles in predicting preference for NOTES over standard laparoscopic surgery. The coefficient for each term and the corresponding P values are given in Table 3. Each of the parameters was compared with a reference level (either “disagree” for most parameters or “age ≤35 years” for the age parameter. The interpretation of this regression model follows the rule that a positive coefficient renders the corresponding effect level more likely to favor NOTES, whereas a negative coefficient favors not choosing NOTES. Therefore, in the 36–55-year-old age group, being concerned about cosmesis and/or adhesions favors “choosing NOTES,” whereas being concerned about hernia and/or abstinence favors “not choosing NOTES.”

In a study of interactions between variables, we found a significant association between age and cosmesis. There is a much bigger difference between the groups who would and would not choose NOTES if they also felt that cosmesis was a significant concern. The odds ratios between “concerned about cosmesis” and “unconcerned” toward choosing a NOTES procedure, as predicted by the model, are 0.753, 8.110, and 4.074 for the age groups ≤35, 36–55, and ≥56 years old, respectively. Even though the univariate analysis shows that those who were concerned about cosmesis were more likely to choose NOTES, after analyzing the interaction between age and concern for cosmesis, we see that this positive relationship between concern for cosmesis and preference for NOTES only exists in the older age groups (36–55 and ≥56 years of age). The difference between the number of women who felt that cosmesis was a concern and would choose NOTES and the number who felt that cosmesis was a concern but would not choose NOTES was much less striking for the women <36 years of age (46% versus 54%) than for women ≥36 years of age (72% versus 28%).

As described in Materials and Methods, we also devised a weighted kappa statistic to test whether our survey respondents were selecting their responses in a logical and thoughtful manner. We found a weighted kappa value to be 0.7522, with 95% confidence interval (0.5563, 0.9482). In addition, we also found that only seven respondents (5.04%) answered unreasonably (i.e., those who claimed they would not consider TV NOTES but would choose to have the procedure). This shows that the agreement between answers to these two questions is fairly good, which validates the responses to the questionnaire.

Our results showed that 55.7% of women surveyed would choose a TV NOTES procedure over the standard laparoscopic procedure for a routine abdominal surgery. However, there were variations to this proportion, depending on the demographic characteristics and major concerns of the patients.

Discussion

Women have a generally positive perception of TV NOTES. They do have many concerns with surgery, but this does not affect their opinion of surgery technique. Age is a major factor in identifying whether or not a woman would choose TV NOTES surgery, especially when associated with a woman's concern about postsurgical cosmesis. In addition, concerns for adhesions made a woman more likely to choose TV NOTES, whereas concerns for hernia and abstinence made a woman less likely to choose TV NOTES.

Past studies presented somewhat conflicting results. Some studies showed that a majority of those surveyed would choose NOTES cholecystectomy over laparoscopic surgery, whereas others showed that participants were neutral or even unhappy about the prospect of NOTES.^12–14 In addition, it is difficult to determine if these respondents were provided with complete information regarding the potential risks and benefits because, as far as we can tell, several surveys were conducted remotely or otherwise explained more briefly than ours.^2,15–20 We aimed to rectify this by standing by to answer any questions about the procedures before administering the survey.

The 2008 study conducted by Varadarajulu et al. ²¹ in Alabama found that 78% of adults would choose a NOTES procedure over laparoscopic cholecystectomy. However, 81% of women expressed preference for the transgastric approach over the TV or transrectal approaches. ²¹ In a 2009 study conducted by Peterson et al. ¹⁵ at the University of California, San Diego, 100 women were given a 10-question survey about their opinions on TV surgery. The study claimed that 68% of patients would choose NOTES cholecystectomy over laparoscopic surgery. However, the survey only asked women if they would consider a TV NOTES procedure and did not address their preferences. ¹⁵ On the other hand, the 2009 study (published in 2010) by Strickland et al. ²⁰ in Australia found contrary results. The study surveyed 300 Australian women and found that 75% were neutral or unhappy about a NOTES procedure and would choose a laparoscopic cholecystectomy instead. ²⁰

We therefore aimed to identify the perceptions of women in the Midwestern United States with regard to TV NOTES. Our results showed that 55.7% of women surveyed would choose a TV NOTES procedure over the standard laparoscopic procedure for an abdominal surgery, although this depended on the demographic characteristics and major concerns of the women.

In the 2011 study (published in 2012) at the Mayo Clinic by Bingener et al., ² results from 409 women showed that 41% would consider a TV approach for a cholecystectomy, 43% for an appendectomy, and 59% for a tubal ligation. This study also looked at the relationship between choice of NOTES and age, education, number of children, and number of previous TV surgeries. Researchers found that only age had a predictive value in women's choice of NOTES or standard laparoscopic surgery. ² Our study found a similar result regarding age: women older than 36 years of age were more likely to choose TV NOTES over the standard laparoscopic procedure.

In addition, we also found a likely interaction between concern for cosmesis and age. Most likely because of a small number of participants in each of the three categories, this interaction is not statistically significant with P<.05, but does show an apparent trend. There is a striking difference in the proportion of women who are concerned about cosmesis and would choose NOTES in each of the three age groups. Women who felt that cosmesis was a concern were much more likely to choose NOTES, especially if they were in the 36–55- or ≥56-year-old age groups. This likely means that women ≤35 years of age do not rank cosmesis as a particularly important factor and are considering many other concerns when deciding on a type of surgery. Future studies will need to be done to elucidate these concerns. One explanation for the largest odds ratio in the 36–55-year-old age group (8.110) could be that these women are more likely to be finished with childbirth so they are unconcerned about factors such as dyspareunia and risk for infertility, and yet they are still young enough to worry about cosmesis. Therefore, we see that concern for cosmesis is a large influence on whether or not a woman in the 36–55-year-old age range chooses NOTES.

Overall, a woman's preference for TV NOTES was influenced by her major concerns regarding the surgery. The potential for improved cosmesis and reduced adhesion risk are positive factors in persuading a woman to choose NOTES. Similarly, after controlling for all other factors, we found abstinence and hernia risk to be significant negative influences. It is thus important to address these concerns when presenting women with an option for surgery. Although infertility and dyspareunia were major concerns for many respondents, these concerns were not associated with an aversion to TV surgery. Therefore, most patients were confident in surgeons' ability to prevent infection or dyspareunia with TV surgeries. Through these findings we are better able to understand women's opinions and can more directly address them when offering their options for surgery.

With future studies we may want to further validate our results by reducing bias. Contrasting results regarding women's positive or negative perceptions of TV NOTES may have to do with whether or not they actually have to undergo a surgery. There may be some responder bias where, at first glance, this new surgery technique may be welcomed by women because of the potential benefits, but if women were to think about it longer and/or have to undergo the surgery, they may change their attitudes. This may contribute to the slow progression of TV procedures in the past 8 years, even though many studies have reported positive perceptions. Other limitations include selection bias because all of our respondents were women being seen at surgery clinics in Ohio, although this population is likely representative of surgical candidates for TV NOTES. There are also limitations to our conclusions from the questionnaire we designed. This questionnaire has not been tested or validated in another study, although we did assess for internal consistency via an agreement measure between Questions 10 and 11. Further limitations in our study include the use of a lenient P value (<.20) for selection of factors into our multivariate regression model. This was done to explore the possibility of a comprehensive model, and the P values for each term in the final model are listed in Table 3 to allow the reader to form his or her own opinions on the significance of each term.

Despite an overall positive response and even preference for TV NOTES in many studies, including ours, TV NOTES has been slow to become a standard procedure or option. As such, does our research need to move away from questions regarding perceived risks and delve into more personal, and possibly more important, social and cultural factors that complicate the issue of perception? In understanding what the perceptions are, we must study the “why.” If we do not, then the disconnect between the slow adoption of TV NOTES despite its positive perceptions cannot be understood. As more and more TV NOTES procedures are done around the world, further data can be collected regarding the benefits and risks of these new techniques and help the medical community make more informed decisions about recommending a certain surgical technique to patients. Our study shows that women are at least open to the idea of TV NOTES; further research showing the benefits of the TV point of access will determine the rate at which TV NOTES becomes widely accepted for abdominal surgery.