Abstract
Purpose
Despite the advent of the ERAS Program, recovery after urogynecological surgery is still a highly debated topic in clinical practice. The majority of gynecologic surgeons, in fact, continue to advise patients to home rest and to avoid lifting heavy objects after surgery. The aim of the present study was to verify the impact of a moderate–high physical activity and recovery after surgery on anatomical results after LSC, with a 2-year follow-up (FU).
Methods
Two hundred and one consecutive patients with pelvic prolapse were retrospectively selected from our database among women who underwent, from October 2019 to February 2022, a laparoscopic sacral colpopexy. Three-six and 24 months follow-up were studied. At 3 months, patients completed the IPAQ-SF Questionnaire to assess physical activity. According to IPAQ-SF, patients were divided in two arms: Low and Moderate–High activity level.
Results
At 3 months follow-up, we obtained a high anatomic success rate in absences of statistical differences between populations, with a significative persistence of these results even at 6 and 24 months. No differences were found in terms of subjective success and vaginal mesh erosions at 3–6 months and 2-years follow-ups between patients despite differences in IPAQ-SF activity levels.
Conclusion
Our data highlight the need for urogynecologists, especially after LSC, to invest heavily in patient education and to shift away from the outdated concept of home rest after surgery.
Keywords: Sacral colpopexy, Pelvic organ prolapse, Laparoscopy, Recovery after surgery, ERAS, Rest, IPAQ, IPAQ-SF
What does this study add to the clinical work
| Our data highlights the need for urogynecologists, especially after LSC, to invest heavily in patient education and to shift away from the outdated concept of home rest after surgery. |
Introduction
Laparoscopic sacral colpopexy (LSC) is the gold standard technique for female pelvic organ prolapse (POP) of anterior and apical compartment and, if compared to a wide range of vaginal approaches, it showed more benefits in terms of objective success and recurrence rates [1].
Recovery after gynecological and POP surgery is still a highly debated topic in clinical practice. Gynaecologic surgeons have historically limited the physical activity of patients after surgery [2]. The reason is that increased patient movement and the consequent rise in abdominal pressure could determine instability of the recently traumatized pelvic floor. The majority of gynecologic surgeons continue to advise patients to avoid lifting heavy objects after surgery, with 60% recommending these limitations remain in place for at least 6 weeks following a minimally invasive laparoscopic hysterectomy [3].
Since 2014, there has been a significant shift away from the outdated concept of prolonged hospital or home rest, especially following urogynecological surgery, with the implementation of the ERAS (Enhanced Recovery After Surgery) Program, promoting early mobilization and revolutioning recovery protocols after surgery [4, 5].
Anyway, the concept of resuming unrestricted exercise may appear too radical to some experts in the field, and the long-term outcomes are not yet fully understood [3].
In the light of these observations, the aim of the present study was to verify the impact of a moderate–high physical activity and recovery after surgery on anatomical results after LSC, with a 2-years follow-up (FU).
Our primary endpoint was the incidence of anatomical failures; the secondary endpoints were subjective cute rate and the incidence of vaginal mesh erosions.
Materials and methods
This is a single center retrospective study conducted at the Pelvic Center of Pia Fondazione “G. Panico” of Tricase (LE), Italy.
Two hundred and forty-one consecutive patients with POP (POP-Q stage ≥ II) [6] were retrospectively selected from our database among women who underwent, from October 2019 to February 2022, a “two-meshes” [7, 8] LSC (Fig. 1).
Fig. 1.
Study flowchart according to STROBE
Of the 241 included subjects, 3 women were excluded and 238 completed the 3-months follow-up (FU), including, to assess their post-operative 12-weeks physical activity and recovery after surgery, the International Physical Activity Questionnaires—Short Form (IPAQ-SF) [9].
This questionnaire records the activity of four levels: (1) vigorous-intensity activity such as aerobics, (2) moderate-intensity activity such as leisure cycling, (3) walking, and (4) sitting. There are three levels of physical activity scored by IPAQ-SF: Low, Moderate and High [9].
Only 225 patients of 238 completed both the 6-months and the 2-years FU (Fig. 1).
According to the 3 months IPAQ-SF activity levels (Low-Moderate-High) [9], we retrospectively divided our FU evaluations in two arms, Low and Moderate-High activity (Low and M-H), as shown in Figs. 1 and 2.
Fig. 2.
Three-months IPAQ-SF levels after sacral colpopexy
All patients, after laparoscopic supracervical hysterectomy (LSH), vesico-vaginal and recto-vaginal preparation, underwent an anterior and posterior mesh fixation (Restorelle XL, Coloplast Corp., Minneapolis, MN, USA), as previously described [10].
No additional procedures for urinary incontinence or POP were practiced.
Inclusion criteria for the study were:
age ≤ 80 years;
physiologic or iatrogenic menopause;
no previous surgical procedures for POP;
POP-Q stage > II for anterior and/or apical compartment and ≥ III for posterior compartment;
no uterine size larger than conform 10 weeks gestation;
absence of defecatory dysfunctions
no uterine cervical dysplasia or endometrial disorders;
Defecatory dysfunctions were defined as any of the following patient reported symptoms: straining, splinting, constipation, as defined by the Rome III criteria [11], and/or dyschezia.
Preoperative workup included bimanual pelvic examination and ultrasound. In case of early endometrial and cervical cancer (exclusion criteria for the study), a staging magnetic resonance imaging or computed tomography was performed.
All the procedures were performed by the same surgeon (A.M.), expert [10, 12, 13] in laparoscopic pelvic surgery, assisted by a gynecological fellow.
At dismission, all patients were recommended, according to our surgical protocol, to quickly resume, from the day after dismission, a normal lifestyle, with a regular hydration, a balanced diet and a regular physical activity.
For each patient, baseline and FU diagnostic, clinical and surgical data were recorded. Anatomic surgical failure was defined by a POP-Q stage ≥ II at any site [6].
Post-operative complications were evaluated during the first 30 days after surgery according to Clavien–Dindo’s (CD Grade) classification [14].
Subjective cure rate was analyzed using the Patient Global Impression of Improvement (PGI-I) [15]. PGI-I responses of “very much better” and “much better” were considered “successful outcomes”.
All 225 retrospectively studied patients completed the 3–6–24 months PGI-I, the 3 months IPAQ-SF and filled, preoperatively and at 3–6–24-months follow-up, the Pelvic Organ Prolapse Distress Inventory—6 (POPDI-6) [16] and the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) [17].
As this was an observational analysis and clinical management of patients was not modified by the study, our local Ethics Committee considered the present study exempt from Institutional Review Board (IRB) approval. The study was conducted in accordance with the Declaration of Helsinki. Written informed consent was obtained from all the patients before the procedure, as part of our protocol for surgery.
Statistical analysis
Our study is the first ever comparing impact of IPAQ-SF activity levels on anatomical results after LSC. Anyway, despite no data were available in Literature, we considered a 20% difference on objective anatomical failure a clinical meaningful difference. In post hoc analysis, we calculated that a sample size of a minimum of 90 patients for arms would guarantee a power of at least 80% if assuming a 20% difference in objective anatomical failure (p < 0.05).
Once tested the non-normal distribution of the clinical variables with Kolmogorov–Smirnov test, we used nonparametric Mann–Whitney U and Wilcoxon test. Fisher’s exact test was used to analyze the differences between data expressed as percentage.
The results are shown as median and percentile range (25th– 75th) for continuous and as number and percentage for categorical variables.
All statistical analyses were performed using the Statistical Package for the Social Sciences, version 17.0 (SPSS Inc., Chicago, IL). Statistical significance was set at p (two-sided) < 0.05.
Results
Of the 241 included subjects, 238 completed the 3-months FU, including the IPAQ-SF questionnaire [9]. Only 225 patients of 238 completed also the 6-months and the 2-years FU (Fig. 1).
Figure 2 shows the 3-months IPAQ-SF levels after LSC. In particular, 127 women (56%) shown a Low activity level on IPAQ-SF, 90 patients (40%) a Moderate level and 8 patients (4%) a High level. We decided to create only two study arms according to 3-months IPAQ-SF: Low versus Moderate–High (Fig. 1).
Table 1 shows the baseline characteristics and perioperative outcomes of our populations that resulted not significantly different between the groups.
Table 1.
Baseline characteristics and perioperative outcomes according to 3-months IPAQ-SF levels
| LOW IPAQ-SF 127 pts | M-H IPAQ-SF 98 pts | p | |
|---|---|---|---|
| Age (year), median (range) | 67 (58–73) | 66 (57–73) | > 0.05 |
| BMI, median (range) | 25 (24–26) | 24 (23–26) | > 0.05 |
| Previous abdominal surgery, n (%) | 10/127 (8) | 8/98 (8) | > 0.05 |
| ASA score ≥ 2, n (%) | 4/127 (3) | 1/98 (1) | > 0.05 |
| POP-Q stage, median (range) | 3 (2–4) | 3 (2–4) | > 0.05 |
| POPDI-6, median (range) | 43 (35–54) | 46 (43–58) | > 0.05 |
| PISQ-12, median (range) | 42 (33–51) | 39 (31–50) | > 0.05 |
| Intraoperative complications, n (%) | 0/127 (0) | 1/98 (1) | > 0.05 |
| EBL (ml), median (range) | 50 (30–60) | 60 (20–70) | > 0.05 |
| Hospitalization (days), median (range) | 2 (2–3) | 2 (2–3) | > 0.05 |
| Postoperative complications, n (%) | 4/127 (3) | 3/98 (3) | > 0.05 |
Range, percentile range (25th–75th); BMI, body mass index; ASA score, American Society of Anesthesiologists score; POP-Q stage: Pelvic Organ Prolapse Quantification system scores; POPDI-6: “Pelvic Organ Prolapse Distress Inventory—6”; PISQ-12: “Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire—12”; EBL: estimated blood loss
Two-sided significance level set at p < 0.05
Intra- and post-operative complications were found not to be statistically different between populations.
A single patient in M-H group presented an intraoperative bladder injury, surgically resolved. We observed 2 urinary tract infection for group at 2–4 weeks from surgery, which were successfully treated with antibiotics (CD Grade 1). Two patients in Low group and one in M-H group presented fever at day 2 after surgery, resolved with Paracetamol 1000 mg (Table 1).
At 3 months FU, as shown in Table 2, we obtained a high anatomic success rate in absences of statistical differences between populations, with a significative persistence of these results even at 6 and 24 months.
Table 2.
Follow-up outcomes of sacral colpopexy patients according to 3-months IPAQ-SF levels
| LOW IPAQ-SF 127 pts | M-H IPAQ-SF 98 pts | P | ||
|---|---|---|---|---|
| 3 months FU | Anatomic failure, n (%) | 3/127 (2) | 1/98 (1) | > 0.05 |
| Anterior, n (%) | 1/127 (1) | 0/98 (0) | > 0.05 | |
| Apical, n (%) | 0/127 (0) | 0/98 (0) | > 0.05 | |
| Posterior, n (%) | 2/127 (1) | 1/98 (1) | > 0.05 | |
| Mesh erosion, n (%) | 0/127 (0) | 0/98 (0) | > 0.05 | |
| PGI-I successful outcomes, n (%) | 109/127 (86) | 87/98 (88) | > 0.05 | |
| POPDI-6, median (range) | 7 (6–11) | 8 (6–12) | > 0.05 * | |
| PISQ-12, median (range) | 71 (65–91) | 74 (69–94) | > 0.05 * | |
| De novo Defecatory dysfunctions, n (%) | 0/127 (0) | 2/98 (2) | > 0.05 | |
| 6 months FU | Anatomic failure, n (%) | 3/127 (2) | 1/98 (1) | > 0.05 |
| Anterior, n (%) | 1/127 (1) | 0/98 (0) | > 0.05 | |
| Apical, n (%) | 0/127 (0) | 0/98 (0) | > 0.05 | |
| Posterior, n (%) | 2/127 (1) | 1/98 (1) | > 0.05 | |
| Mesh erosion, n (%) | 0/127 (0) | 0/98 (0) | > 0.05 | |
| PGI-I successful outcomes, n (%) | 106/127 (83) | 83/98 (84) | > 0.05 | |
| POPDI-6, median (range) | 10 (8–14) | 11 (8–15) | > 0.05 * | |
| PISQ-12, median (range) | 68 (62–88) | 70 (65–91) | > 0.05 * | |
| De novo Defecatory dysfunctions, n (%) | 0/127 (0) | 0/98 (0) | > 0.05 | |
| 2 years FU | Anatomic failure, n (%) | 4/127 (3) | 2/98 (2) | > 0.05 |
| Anterior, n (%) | 1/127 (1) | 0/98 (0) | > 0.05 | |
| Apical, n (%) | 0/127 (0) | 0/98 (0) | > 0.05 | |
| Posterior, n (%) | 3/127 (2) | 2/98 (2) | > 0.05 | |
| Mesh erosion, n (%) | 1/127 (1) | 0/98 (0) | > 0.05 | |
| PGI-I successful outcomes, n (%) | 101/127 (80) | 80/98 (81) | > 0.05 | |
| POPDI-6, median (range) | 11 (8–15) | 13 (9–17) | > 0.05 * | |
| PISQ-12, median (range) | 66 (61–87) | 66 (62–88) | > 0.05 * | |
| De novo Defecatory dysfunctions, n (%) | 0/127 (0) | 0/98 (0) | > 0.05 |
Range, percentile range (25th–75th); *: p < 0.05 from baseline; Anatomic failure: POP-Q stage ≥ II at any site; POPDI-6: “Pelvic Organ Prolapse Distress Inventory—6”; PISQ-12: “Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire—12”
Two-sided significance level set at p < 0.05
Regarding anterior, apical and posterior anatomical results separately, in particular, we have not found differences between groups in terms of POP-Q stage > II at any site and at any FU time (Table 2). Specifically, at 2 years FU, we observed in Low group 1 patient with an anterior vaginal recurrence and 3 patients with a posterior recurrence and in M-H group 2 women with posterior anatomical failure (Table 2).
No statistical differences were, then, found, in terms of anatomical results, at 3–6 months and 2-years follow-ups between patients despite different IPAQ-SF activity levels.
We observed only 1 case of vaginal mesh erosion at 2 years in Low-IPAQ-SF arm, surgically resolved.
Regarding subjective results (successful outcomes rate in PGI-I, POPDI-6 and PISQ-12), as shown in Table 2, we observed a significative improvement in all questionnaires after surgery.
Despite the observed ameliorations at follow-ups, interestingly, POPDI-6 and PISQ-12 data at 3–6 and 24 months resulted, anyway, not statistically different between the studied populations (Table 2).
De novo defecatory dysfunctions were found only in two patients of M-H group at 3-months FU, with a spontaneous resolution, and without significant differences between populations, at any time of follow-up (Table 2).
Discussion
Our study is the first ever comparing impact of physical activity levels (studied with IPAQ-SF) on anatomical results after “two meshes” LSC.
We observed no statistical differences at 3, 6 and 24 months between patients with 3-months post-operative Low or M-H activity levels after LSC. From our data it is clear that any indication for home rest after LSC surgery should be avoided, reinforcing the ERAS Program indications of promoting early mobilization after surgery [4, 5].
Gynaecologic surgeons have historically limited the post-operative physical activity [2]. The reason lies in the assumption that increased patient movement and the consequent rise in abdominal pressure could determine instability of the recently traumatized pelvic floor. This concept originates from general surgery, where it is well established that postoperative hernias can develop when increased abdominal pressure places additional strain on the already weakened sutured fascia [18]. A recent survey highlighted that this longstanding concept remains highly relevant, as the majority of gynecologic surgeons continue to advise patients to avoid lifting heavy objects after surgery, with 60% recommending these limitations remain in place for at least 6 weeks following a minimally invasive laparoscopic hysterectomy. Approximately half of the surgeons set a weight limit of 4.5 kg, which is comparable to the weight of a gallon of milk or a typical women's purse [3].
In current medical practice, the focus has shifted toward early mobilization to address issues such as reduced hospital availability, increased handling costs, and patient dissatisfaction. The goal of modern medicine is to minimize these challenges by encouraging quicker recovery and reducing unnecessary delays. Since 2014, there has been a significant shift away from the outdated concept of prolonged hospital or home rest with the implementation of the ERAS (Enhanced Recovery After Surgery) program. This program promotes early mobilization and has revolutionized recovery protocols, aiming to enhance patient outcomes and overall satisfaction [4, 5].
Dutta et al. estimated the revolution implicated after the ERAS program with a main focus on the cost for the health institutions. The daily cost for a patient in a urogynecological unit after surgery was $533 in the PRE ERAS group, before the implementation of the ERAS program, and $210 in the POST ERAS group, after the implementation of the ERAS program [19].
At the era of the ERAS program key elements are patient education, preoperative optimization, avoiding preoperative fasting, carbohydrate loading, maintaining proper fluid balance during surgery, standardized anesthesia that minimizes opioid use, preventing postoperative pain and nausea, and encouraging early mobilization [20, 21]. The initial protocol was created in Europe for colorectal surgery and has subsequently been adapted for various other surgical specialties, including gynecology [22, 23]. Carter-Brooks et al. made a comparative study, analyzing 258 women to compare patients before ERAS time and after it. The study highlights the significant impact of early mobilization, as promoted by the ERAS program, on reducing hospital stay lengths. Importantly, this early mobilization strategy did not lead to a significant change in the complication rate. The rates of urinary tract infections, emergency department visits, unplanned office visits, and reoperations remained stable before and after ERAS implementation. The majority of patients reported a very good or excellent overall surgical experience (93.5%), effective pain control (86.7%), and felt well prepared for their surgery (89.6%) [24, 25].
Furthermore, the concept of restrictions on maximal lifting loads imposed nowadays seems to be illogical. It is showed that even a simple daily gesture, such as standing up, significantly increases intra-abdominal pressure to a level comparable to lifting approximately 6 kg (even more than the 4,5 kg limit imposed from the most surgeon [3] from the floor). The same could be said about coughing or defecating [26, 27].
Orthopedic surgery already made the “switch” of the concept noting that returning to activity earlier, can actually aid in the recovery of normal function [28].
Two studies pioneered in the field of lack of restrictions after urogynecological abdominal surgery. Mueller et al. conducted a multicenter, double-blind study where women were randomly assigned to either a liberal or restricted postoperative activity regimen following prolapse repair. Those in the liberal activity group were encouraged to resume normal activities, including running, lifting, and other strenuous exercises, while those in the restricted group were advised to limit physical activities and lifting. After 3 months, the women who resumed activities freely were just as satisfied as those with restrictions but experienced fewer prolapse and urinary symptoms post-surgery. Additionally, there were no significant differences in short-term anatomical outcomes between the two groups [29].
Similarly, O'Shea et al. led a trial including 123 women who underwent vaginal or laparoscopic apical reconstructive surgery for POP. Participants were randomly assigned to either standard activity restrictions or expedited postoperative activity. The main outcomes measured were the maximum anatomic support loss (SLmax) and the Pelvic Organ Prolapse Distress Inventory (POPDI) symptom score, both assessed 3 months after surgery. Results showed no significant difference in anatomical support loss or symptom scores between the two groups [30].
Our paper, however, unlike Mueller and O’Shea studies which evaluated heterogeneous surgical interventions such as sacral colpopexy plus vaginal approaches or vaginal suspension alone, analyzed exclusively “two mesh” [7, 8] LSC.
A reduction in movement after surgery may, furthermore, not be necessary and could potentially have unintended negative effects on the human body. According to Chong et al., in fact, the incidence and risk factors for venous thromboembolism (VTE) within 30 days after POP surgery increase significantly, highlighting the substantial risks associated with movement restrictions. Factors such as older age, higher BMI, longer operative time, and preoperative conditions further increased the likelihood of VTE, particularly in patients undergoing abdominal POP repairs [31].
Moreover, movement restrictions after pelvic surgery can lead to declines in cardiovascular function and muscle capacity, particularly if activity levels are significantly reduced. Within 2 to 4 weeks of decreased movement, maximal oxygen uptake (V̇O2max) can drop due to reduced stroke volume and blood volume. This results in decreased exercise performance and endurance. Additionally, reduced activity can lower muscle blood flow, vascular conductance, and oxidative enzyme activity, further impairing physical function.
However, maintaining some level of exercise intensity can help preserve V̇O2max and endurance, highlighting the importance of avoiding excessive movement restrictions post-surgery [32].
In the light of this literature, our data seem to reinforce the ERAS indication to patient education and encouraging early mobilization from the day after dismission [18, 19]. Short-term and long-term (2 years) objective and subjective outcome after LSC resulted statistically similar between patient with a Low and Moderate-High physical activity level in the first 3 months after laparoscopy.
There are strengths and limitations to our study. The main limitation include its single-center design. A multicenter long follow-up trial could better verify our data.
Regarding the strengths of our paper, the evaluation of a surgically homogeneous population with the study of only women undergoing LSC represents an important point in favor of this paper. The power of our sample size could be, moreover, considered another remarkable argument in favor of our results.
The systematic study of all women with validated Questionnaires (PGI-I, POPDI-6 and PISQ-12), moreover, made it possible to better verify the subjective improvement patient-related of our surgery.
In addition, our exclusion criteria enable to avoid bias related to the preoperative presence of defecatory dysfunctions, ensuring a more rigorous assessment of de novo defecatory disorders in the follow-up.
All the procedures were, finally, practiced by the same operator, avoiding any bias related to inter-surgeons learning curves, even if it limits generalizability of our data.
Conclusion
Our study is the first ever comparing impact of physical activity levels (studied with IPAQ-SF) on anatomical and subjective results after “two meshes” LSC.
The present paper highlights the need for urogynecologists practicing LSC to invest heavily in patient education and to shift away from the outdated concept of home rest after surgery.
Author contribution
AM: protocol development, manuscript writing, data analysis, patients’ enrollment; GP: data collection, patients’ enrollment and manuscript writing; AT: data analysis and manuscript editing; MCS: manuscript editing and data collection; GM: protocol development, data collection; MC: project development, manuscript editing; GS: protocol development, manuscript editing.
Funding
The authors declare that no funds, grants, or other support were received during the preparation of this manuscript.
Data availability
Not applicable.
Declarations
Conflicts of interest
None.
Footnotes
Publisher's Note
Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
Andrea Morciano and Giovanni Pecorella have equally contributed to the work.
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Data Availability Statement
Not applicable.