Abstract
Background:
The incidence of pelvic organ prolapse (POP) is high, and laparoscopic sacralcolpopexy (LSC) is considered the gold standard procedure for central pelvic defects. However, surgery can lead to postoperative stress response, postoperative pain, and discomfort related to catheters, thus affecting patients’ postoperative recovery. Numerous studies have shown that enhanced recovery after surgery (ERAS) protocols can alleviate stress response to varying degrees in gynecological surgical patients and improve postoperative recovery quality and satisfaction. However, the effectiveness of ERAS in LSC remains unclear.
Methods:
The clinical data of 38 patients with POP in the Department of Gynecology and Obstetrics of Renmin Hospital of Wuhan University from March 2022 to March 2023 were collected, including 19 patients in the ERAS group and 19 patients in the control group. The primary outcomes were postoperative hospital length of stay (LOS) and hospitalization costs. Secondary outcomes were 30-day readmission rate, postoperative complications, postoperative nausea and vomiting incidence, and VAS pain scores.
Results:
Compared with the control group, postoperative LOS was significantly shorter in the ERAS group (113.195 vs. 148.563 hours, p = 0.003). The hospitalization costs were also significantly lower in the ERAS group (41398.25 vs. 45548.04 yuan, p = 0.023). No 30-day readmission or reoperation occurred in either group. PONV occurred in one patient (5.26%) in the ERAS group and in eight patients (42.11%) in the control group. Compared with the control group, the ERAS group had earlier and shorter the first postoperative exhaust time and first postoperative off-bed activity time (p < 0.05). The overall rate of postoperative complications in the ERAS group was lower than that in the control group. The results of the POP quantification (POP-Q) score and the patient global impression of improvement (PGI-I) questionnaire conducted 30 days post-surgery indicate that both groups exhibited similar improvements in prolapse symptoms following the procedure. No significant differences were found between the two groups in the Visual Analogue Scale scores and the Quality of Postoperative Rehabilitation Scale scores.
Conclusions:
The implementation of the ERAS protocol for LSC provides significant advantages compared to traditional gynecological perioperative management. In this small study, improvements were observed in postoperative recovery time, a reduction in length of hospital stay, and lower hospital costs. We did not observe any increase in complications or risks in this small group of patients. Therefore, the ERAS protocol for LSC should be considered for widespread clinical use.
Introduction
Pelvic organ prolapse (POP) is the abnormal position and dysfunction of pelvic organs caused by the abnormality of pelvic floor muscles and fascia tissue. Urination, defecation, and sexual dysfunction affect the quality of life of patients to varying degrees. 1 The incidence of POP is high, and the lifetime risk of gynecological surgery due to POP is as high as 19% in the female population. 2 Based on data from a study of U.S. women, the number of women experiencing POP is expected to increase by about 50 percent by 2050. 3 The prevalence of POP has made it a global health concern. As the world’s population continues to age, the number of elderly women affected by this condition is expected to rise, leading to an increase in medical and socioeconomic burdens. Surgical intervention is the primary mode of treatment for POP, with a lifetime risk of gynecological surgery due to POP estimated to be as high as 19% in the female population. 2 Laparoscopic sacralcolpopexy (LSC) is a therapeutic surgical procedure for POP by holding the uterus and/or vagina in the correct anatomical position using a synthetic mesh, and it represents the gold standard in advanced prolapse repair. 4 This procedure also can be performed after a hysterectomy to treat uterine prolapse and provide long-term support for the vagina. 5 However, it is important to note that a majority of patients undergoing LSC surgery are middle-aged and elderly individuals, and the costs associated with LSC are high. 6 Hence, it is imperative to explore strategies aimed at minimizing surgery-related complications and reducing associated costs for patients. Such efforts not only align with the principle of patient-centered treatment but also hold significant importance for the advancement of LSC.
Enhanced recovery after surgery (ERAS) has been widely used in various surgical departments in clinical practice. As a patient-centered perioperative model, ERAS has multiple clinical advantages, including reduced surgical stress response, accelerated postoperative recovery, shortened postoperative hospital stay, and improved overall satisfaction. 7 Previous studies have confirmed the feasibility and safety of the ERAS program in gynecology. 7 However, there are few reports on the implementation of ERAS in LSC in China, and more clinical evidence is needed.
Herein, we retrospectively analyzed the clinical data of 38 patients with POP who underwent LSC in the Department of Gynecology and Obstetrics of Renmin Hospital of Wuhan University from March 2022 to March 2023, explored the promoting effect of the ERAS measures on postoperative rehabilitation, and provided evidence for establishing a disease-specific gynecological ERAS program for POP patients.
Methods
Patient recruitment
The research protocol was reviewed by the Clinical Research Ethics Committee of Renmin Hospital of Wuhan University (No. WDRY2022-K045) and registered in the China Clinical Trial Registration Center (https://www.chictr.org.cn/) before implementation. This study collected the clinical data of 38 patients with POP who underwent LSC in the Department of Gynecology and Obstetrics of Renmin Hospital of Wuhan University from March 2022 to March 2023, including 19 patients receiving accelerated ERAS treatment (ERAS group) and 19 patients accepting routine surgical treatment (control group). The inclusion criteria were as follows: (1) Age ≤75 years old; (2) severe POP, conservative treatment is ineffective and LSC is proposed; (3) American Society of Anesthesiologists (ASA) grade I–II; (4) had no clear contraindication to laparoscopic surgery; (5) Provided written informed consent.
Exclusion criteria: (1) Combined with gynecological malignancies; (2) Acute infection period, mental illness, and other surgical contraindications; (3) Contraindications to NSAIDs (renal insufficiency, peptic ulcer, history of NSAIDs allergy, history of aspirin asthma); (4) Refusal to sign the written informed consent.
The patients in the control group received the standard gynecological care program, and the patients in the ERAS group received the gynecological ERAS program. The primary outcomes were postoperative length of stay and total hospitalization costs. The secondary outcomes were 30-day readmission rate, postoperative complications, PONV incidence, and VAS pain scores. All patients were re-examined on the 30th day after discharge.
Study design and participants
Details about the specific implementation of ERAS are shown in Table 1. In brief, our ERAS program for patients with POP consists of three components: preoperative, intraoperative, and postoperative interventions. Key measures that distinguished the ERAS group from the control group preoperatively: no mechanical bowel preparation was used, shorter duration of preoperative fasting and water deprivation, and avoidance of sedative drugs. Key measures that distinguished the ERAS group from the control group intraoperatively: use of short-acting, low-emetogenic anesthetic drugs; use appropriate heat preservation measures for patients whose operation time exceeds 30 minutes; and control and limit intraoperative fluid intake within 2000 mL. Key measures that distinguished the postoperative ERAS group from the control group: postoperative multimodal antiemetic therapy, avoidance of nasogastric tube placement, minimization of drain placement, multimodal analgesia based on NSAIDs, chewing gum, early postoperative feeding, shorter duration of indwelling urinary catheter, earlier bed mobility, and earlier discharge.
Enhanced Recovery Protocol for Laparoscopic Sacralcolpopexy
Visual Analogue Scale (VAS, 0–10 scale) scores were used to assess patients’ pain at 2 hours, 12 hours, 24 hours, and 48 hours postoperatively, with 1–3 being mild, 4–6 being moderate, and 7–9 being severe. The Quality of Postoperative Rehabilitation Rating Scale (QoR-15) was used to assess patients’ quality of life on postoperative days 3, 7, and 30, respectively. The patient global impression of improvement (PGI-I) score 8 was used to assess the degree of goal attainment after treatment at the postoperative 30 outpatient follow-up and was classified into 7 levels, very favorable is 7, favorable is 6, slightly favorable is 5, no change is 4, slightly poor is 3, poor is 2, and very poor is 1.
Statistical analysis
SPSS 22.0 software (SPSS Inc., Chicago, IL, USA) was used for statistical analysis. The Shapiro–Wilk test was used to determine the normality of the distribution of continuous variables. Student’s t test and the Mann–Whitney test were used to analyze the normal distribution data and non-normal distribution data, respectively. Categorical variables were assessed by the chi-square test or Fisher’s exact test. p < 0.05 indicated a statistically significant difference.
Result
Patient sociodemographic and clinical characteristics
A total of 38 patients diagnosed with POP and treated with LSC were recruited. All patients underwent outpatient follow-up 30 days after the procedure. A total of 38 patients (19 in the ERAS group and 19 in the control group) were included in the final analysis. Patients in both groups were systematically evaluated preoperatively, and there were no statistically significant differences in the preoperative general conditions (age, BMI, years of menopause, and number of births) and POP-Q scores between the two groups (Tables 2 and 3).
The Preoperative General Conditions in Two Groups (
POP-Q Scores between the Two Groups before Surgery [M(Q1,Q3)]
Primary outcome measures
The postoperative hospital stay was significantly shorter in the ERAS group (113.195 ± 23.25 hours) than in the control group (148.563 ± 40.99 hours) (p = 0.003). The hospitalization cost was (41398.25 ± 5972.095 yuan) in the ERAS group and (45548.04 ± 4744.485 yuan) in the control group (Table 4). The implementation of the ERAS protocol significantly reduced the hospitalization cost of patients (p = 0.023) (Table 4).
Primary Outcomes and Secondary Outcomes between ERAS Group and Control Group
Secondary outcome measures
The statistics of postoperative complications are shown in Table 4. No mortality or 30-day readmission was found in both groups. There was one patient with fever and two patients with acute urinary retention (residual urine >100 mL) in the control group, and there was no statistical significance of these two complications in the ERAS group (p > 0.05); the two patients with acute urinary retention had symptoms of incomplete urination before surgery. These two patients were given a new urinary catheter for 3 days, and after the catheter was removed again, all urination was normal and the residual urine was less than 100 mL. PONV occurred in one patient (5.26%) in the ERAS group and eight patients (42.11%) in the control group, with statistically significant differences (p < 0.007).
Other ERAS-related indicators
Intraoperative fluid rehydration, intraoperative bleeding, and operative time were not statistically different in the ERAS and control groups (p > 0.05) (Table 5). The ERAS group had a shorter first postoperative venting time and first postoperative off-bed activity time, and the difference was statistically significant compared with the control group (p < 0.05) (Table 5). There was no statistically significant difference in the overall satisfaction rate of improvement of prolapse symptoms (PGI-I) (Table 5) and POP-Q staging (Table 6) at 30 days postoperatively between the two groups of patients. This shows that the application of ERAS can guarantee the therapeutic effect while reducing the hospitalization cost, shortening the length of hospitalization, and improving the comfort of patients during the perioperative period.
Key Measures on ERAS Protocol for LSC
Comparison of POP-Q Scores between the Two Groups at 30 Days after Operation
There was no statistical difference in pain assessment between the two groups of patients at 2 hours, 12 hours, day1, and day 2 postoperatively (Table 7). There was no statistical difference in the QoR-15 scores on postoperative days 3, 7, and 30 between the two groups of patients (Table 8).
Postoperative Pain Assessment of Two Groups of Patients (VAS0-10)
QoR-15 Scores of Patients in the Two Groups [M(Q1,Q3)]
Discussion
ERAS is a multimodal perioperative care program. 9 This approach incorporates various essential components with the goal of minimizing surgical stress and promoting faster patient recovery. The concept of ERAS was introduced in Europe in the 1990s and has shown successful results in colorectal surgery.10,11 It is now widely accepted by various surgical specialties and is recommended by clinical practice guidelines.12–14 The ERAS concept encompasses the treatment of patients before, during, and after surgery. It aims to optimize perioperative measures, reduce patient stress response, maintain normal physiological functions, minimize complications, hasten patient recovery, and shorten postoperative hospital stays. 15 The patient is at the center of the ERAS concept, with individualized plans formulated and all measures based on humanitarian principles. 16 POP has a high incidence and is commonly seen in older women, and surgery is the primary treatment for severe POP. 17 LSC has become the gold standard procedure for mid-pelvic defects and has gradually replaced the open vaginal sacral fixation. 18 However, the surgical procedure inevitably disrupts the body’s integrity to some extent, causing postoperative stress, postoperative pain, and catheter-related discomfort, thus affecting the patient’s postoperative recovery. A large number of studies have shown that the ERAS program can alleviate the stress response of patients undergoing gynecological surgery to varying degrees and improve the quality and satisfaction of postoperative rehabilitation.13,19,20 In line with the concept of ERAS, we implemented various measures to improve the perioperative care of patients with severe POP who underwent laparoscopic sacral colpopexy (LSC). The outcome was satisfactory, and this approach significantly advanced the standardization of treatment for patients with POP.
Based on the analysis of clinical effect indicators, it is evident that the ERAS group had a better recovery of intestinal function compared to the control group. This could be attributed to various factors such as the absence of rectal enema in the ERAS group, appropriate fasting time before the operation, chewing gum after the operation, and early postoperative feeding. Early feeding has been shown to be effective in promoting the recovery of intestinal function. Although preoperative mechanical bowel preparation is commonly used, it has been found to be ineffective in reducing the occurrence of surgical site infection and anastomotic leakage.13,19,20 However, it can lead to negative side effects such as anxiety, dehydration, and electrolyte imbalance in patients. 21 Research has shown that extended periods of fasting and water deprivation can cause patients to feel thirsty and hungry, ultimately leading to insulin resistance. This can impede the patient’s recovery process. 22 The results of our study indicate that implementing several preoperative measures in the ERAS group is both safe and effective for patients undergoing POP surgery. However, there was no significant difference in the first exhaust time between the two groups postoperation, which may be attributed to individual differences within the groups.
The ERAS program recommends controlling fluid intake during and after surgery to prevent complications such as pulmonary and gastrointestinal edema caused by excessive infusion. 23 It is also important to maintain body temperature during surgery to prevent stress-induced hormone imbalances and related complications. 23 Most patients with POP are middle-aged and elderly people, and more attention should be paid to preventing postoperative deep vein thrombosis complications. Therefore, patients in the ERAS group were advised to wear elastic stockings after surgery. In this study, the incidence of complications in the ERAS group was lower than that in the control group, which may be related to the optimization of perioperative management in the ERAS group, such as controlling fluid infusion, keeping warm during the operation, and early oral intake. Multimodal antiemetic therapy in the ERAS group reduced the functional rate of postoperative PONV. Indwelling urinary catheter can affect patients’ postoperative activities, prolong hospital stay, and increase the risk of urinary system infection. Therefore, in this study, the ERAS group was required to remove the urinary catheter within 24 hours. The results showed that early removal of the urinary catheter did not increase the incidence of postoperative urinary retention, but it was beneficial for patients to get out of bed early and reduce the discomfort of patients. In our case series study, patients in the ERAS group were encouraged to walk around on the first day after surgery, which was associated with a shorter postoperative hospital stay and better recovery. Under the same discharge indications, the shorter postoperative hospital stay in the ERAS group meant that patients in the ERAS group recovered faster than those in the control group. The total length of hospital stay in the ERAS group was shorter than that in the control group, which could theoretically reduce hospitalization costs and speed up bed turnover. By comparing hospitalization expenses, we found that the hospitalization expenses of the ERAS group were lower than those of the control group, which reduced the economic burden of patients and had certain economic and social benefits. Notably, although patients in the ERAS group used multimodal analgesia, there was no statistical difference in postoperative VAS pain scores between the two groups. The reasons for this are, on the one hand, because the patients included in this study were middle-aged and elderly, and aging decreases pain sensitivity to pain intensity, 24 which leads to relatively low VAS pain scores in the control group, then the results of using multimodal analgesia are less significant; on the contrary, the inclusion of cases in this study was limited, and further more realistic and reliable results may need to be obtained through a large sample and multicenter study.
Our study has certain limitations. Firstly, it is a single-center retrospective study, and therefore, the generalizability of the results may be limited. To establish the validity and reliability of the findings, it is essential to conduct a large-sample, multicenter study. Additionally, it is crucial for hospitals to develop their own tailored implementation plan while promoting and implementing ERAS.
In summary, the implementation of ERAS ensures medical safety and medical effects, improves medical efficiency and has high application value.
Footnotes
Acknowledgment
The authors would like to thank all the professors and teachers at the Department of Gynecology and Obstetrics.
Precis
The implementation of the ERAS protocol for LSC can improve postoperative recovery time, shorten hospital stays, and reduce hospitalization costs without increasing perioperative complications or risks.
Author Disclosure Statement
No competing financial interests exist.
Funding Information
This work was financially supported by the National Key R&D Program of China: The Establishment of Comprehensive Network for the PFD Prevention, Rehabilitation, Pelvic Floor Surgery and Related Complications (2021YFC2701300; 2021YFC2701302); National Natural Science Foundation of China (82571874, 82371639, 81971364); Hubei Provincial Key Research and Development Program (2022BCA045).
