Early Safety and Efficiency Outcomes of a Novel Standardized Interdisciplinary Procedure of Combined Laparoscopic Resection Rectopexy with Laparoscopic Sacrocolpopexy to Treat Obstructive Defecation Syndrome in Women with Pelvic Organ Prolapse

doi:10.21203/rs.3.rs-2232934/v1

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Research Article

Early Safety and Efficiency Outcomes of a Novel Standardized Interdisciplinary Procedure of Combined Laparoscopic Resection Rectopexy with Laparoscopic Sacrocolpopexy to Treat Obstructive Defecation Syndrome in Women with Pelvic Organ Prolapse

https://doi.org/10.21203/rs.3.rs-2232934/v1

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Purpose

Obstructive defecation syndrome (ODS) defines a disturbed defecation process frequently associated with pelvic organ prolapse (POP) in women. It substantially compromises quality of life. Conservative treatment options are limited. Surgical interventions are characterized by a variety of individual approaches. This study standardized laparoscopic resection rectopexy (L-RRP) combined with laparoscopic sacrocolpopexy (L-SCP) in an interdisciplinary setting. Additionally, offering both synthetic mesh (SM) and biological mesh (BM) material for L-SCP is a novel treatment alternative, particularly for premenopausal women.

Methods

Women with ODS combined with POP underwent surgery using an interdisciplinary approach. The primary endpoint was postoperative morbidity and mortality measured by the Clavien-Dindo classification (CDC). Further endpoints were improvement in bowel evacuation, POP, and urinary incontinence at a median follow-up period of > 12 months.

Results

Of a total of 44 patients, 36 patients were treated with L-RRP combined with L-SCP (28 patients with SM, 8 patients with BM). CDC grades and the frequency of postoperative complications were low. Clinical outcomes for ODS, bowel dysfunction, and fecal control improved significantly. Anatomical outcome for POP was significantly better with 28 (78%) patients having POP-Q stage 0 after surgery. 17 patients (47%) had urinary incontinence before surgery, which was restored in 14 patients (82%). No de-novo urinary incontinence appeared.

Conclusion

The interdisciplinary surgical approach with L-RRP and L-SCP is safe, feasible, and effective in treating women with ODS and POP. The use of a biomesh was established as an effective alternative to the SM and offers an additional and new uterine-preserving option.

Obstructed defecation syndrome

pelvic organ prolapse

resection rectopexy

sacrocolpopexy

mesh

biological mesh

Novel standardized interdisciplinary surgical approach for laparoscopic resection rectopexy and sacropexy in women with obstructed defecation syndrome and pelvic organ prolapse.

Obstructive defecation syndrome (ODS) defines a disturbed defecation process caused by the protrusion of the lower rectum (rectocele) or the telescoping within the rectum (intussusception) (1–3). The patients have to exert pressure frequently and strongly to evacuate the rectum and manual manipulation may be required (4). The unsuccessful attempts to defecate are associated with a feeling of incomplete rectal voiding. ODS affects approximately 10–25% of the population and is mainly related to female sex (5). The condition is frequently associated with POP and almost 20% of the women require surgery during their lifetime (6,7).

Individual aspects, such as pregnancy, childbirth, connective tissue disorders, the physiological descending of the pelvic floor at an older age, and pelvine surgical interventions further contribute to the condition (5,8,9). Almost 60% of the female population develop POP during their lifetime and 1/3 of them have bowel dysfunction presenting as constipation and ODS (10,11). The women experience extreme frustration due to their disturbed defecation, compromising their quality of life substantially. Conservative treatment options such as dietary modifications, sufficient fluid intake, laxative medication, physical exercise, pelvic floor training, pelvic floor biofeedback therapy, and pessary treatment are limited and do not achieve the desired long-term effect (12,13).

The surgical treatment aims at the anatomic reconstruction of the bowel and pelvic floor (14,15) and has been characterized by individual approaches. By ignoring the complexity of the underlying condition, the desired results are often missed (oder besseres Wort ?) (13,16). A standardized treatment option for evidence-based advice to women with ODS and POP is missing (17–20). Furthermore, there is only insufficient data on interdisciplinary approaches. Of the 40 registered clinical trials evaluating this medical condition none includes an interdisciplinary surgical approach or offers a biological mesh material.

This pilot study standardizes an interdisciplinary surgical approach of combining laparoscopic resection rectopexy (L-RRP) with laparoscopic sacrocolpopexy (L-SCP) for women with ODS and POP. Additionally, as a novel treatment option, an absorbable biological mesh (BM) for L-SCP is offered to avoid mesh erosion and migration and to preserve the uterus in cases of a planned pregnancy.

In the period February 2020 and August 2021, a total of 44 women with ODS and POP presented at our tertiary center pelvic floor unit, consisting of the Departments of Visceral Surgery, Gynecology, and Urology. 36 patients were scheduled for combined L-RRP with pelvic floor reconstruction. Inclusion criteria were women with ODS and POP over 18 years of age and being eligible for laparoscopic surgery. Informed consent for the planned procedure, the mesh material used, the data collection, and the publication of the results was obtained from all patients before surgery (Fig. 1).

All patients underwent preoperative and postoperative urogynecological and surgical examinations at the outpatient clinics. These examinations included taking the medical history of clinical symptoms, pelvic organ prolapse (POP) according to the POP quantification system (POP-Q), the subjective symptom questionnaires for the defecation disorder (Altomare score, modified Longo score, rectal toxicity score, and Wexner incontinence score WIS) (21–25).

Magnetic resonance image defecography (MRI-D) (Fig. 2) as well as presentation to our pelvic floor board were obligatory before surgery. Women who wished to preserve their uterus or who declined the use of synthetic mesh (SM) material for the L-SCP were offered a biological mesh (BM). The patients´ anesthesiologic operability was assessed using the ASA score (American Society of Anesthesiologists, ASA) (26).

The primary study outcome parameters were the safety and efficacy of the combined laparoscopic procedure. The primary endpoint was postoperative morbidity and mortality measured using the Clavien-Dindo classification (CDC) as a measure of the safety of the procedure (27). The secondary outcome parameters were clinical and anatomical outcomes as measured by the aforementioned scores. All scores are routinely collected before the surgery and at follow-up examinations at 6 and 12 months after surgery, and every 12 months thereafter. The 12 months values were used for statistical analysis.

Surgical procedure

For the laparoscopic procedure, after induction of general anesthesia, patients were maintained in dorsal lithotomy position and head-down position of 18°. CO₂ pneumoperitoneum was established according to institutional standards, and trocars were placed. The procedure began with the preparation of the rectum down to the pelvic floor by opening the retrorectal Waldeyer space and the rectovaginal space to ensure the mobilization of the rectocele and the rectal intussusception. An anterior rectal resection was performed in cases of elongation or functional kinking of the sigmoid and rectum (Fig. 3A and B). Suture rectopexy fixed the rectum to the sacral vertebrae at the left side of the promontory with nonabsorbable sutures grasping the perirectal peritoneal tissue. The apical fixation of the middle pelvic organ compartment was performed unilaterally in analogy to the previously published cervicosacropexy and vaginosacropexy technique, as well as hysteropexy respectively, as published previously (Fig. 3C) (28,29).

The synthetic mesh material (SM) consisted of polyvinylidene-fluoride (DynaMesh VASA, FEG Textiltechnik mbH Aachen, Germany). In selected cases a biological mesh (BM) substituted the SM. We used either the Biodesign® Rectopexy Graft derived from small-intestinal submucosa and remodeled into an avascularized tissue (Cook Biotech Incorporated, USA) or the Phasix™ mesh, a knitted monofilament mesh scaffold by using poly-4-hydroxybutyrate from biologically derived, resorbable material (Becton, Dickinson and Company, USA). A pelvine peritoneoplasty covered the mesh material and obliterated the small pelvis and the Douglas pouch. The procedure is summarized in the attached video file (Video 1). The surgical procedure is summarized in a video file (www.youtu.be!A3F_SxdOINE).

Data management and statistical analysis

The necessary clinical data were collected preoperatively, during the hospital stay, and during the follow-up examinations. All scores were documented on paper and transferred to a data bank. Data were analyzed using the SPSS statistical package, version 29.0.0.1. (IBM Corp., Armonk, NY, USA). Quantitative variables are described as means (± standard deviation) and were compared using the Kruskal–Wallis H test and Mann–Whitney U test. Qualitative variables are summarized using count, percentage, median, and interquartile range and were compared using the Fisher’s exact test. A two-sided p value of < 0.05 was considered statistically significant. Because no adjustments for multiple testing were performed, the analyses were exploratory.

Ethical approval

This retrospective study was registered and approved by the Ethical Committee of the Aerztekammer Nordrhein in Düsseldorf, Germany (Registration No.: 2022-070).

Of the 44 women with ODS and POP treated with surgery eight patients were excluded from further analysis because the pelvic floor was reconstructed transvaginally. In total, 36 patients were operated on in the interdisciplinary manner combining L-RRP with L-SCP as described above. The median follow-up period was 19 months (12–32 months) with 33 patients to be analyzed at 12 months. For L-SCP a SM was used in 28 patients and a BM was used in 8 patients. The decision was based on patients’ preference and in cases planning for future pregnancies. One patient in the SM group was lost to follow-up. In two patients of the SM group the 12 months data were incomplete and were marked as missing values for statistical analysis of the follow-up (Fig. 1).

Patients´ characteristics

Patients’ median age was 57.5 years (range: 26–83 years), and the mean body mass index (BMI, kg/m²) was 23 (18–35) with no statistically significant differences between the two subgroups, SM and BM. The ASA score ranged from ASA I (n = 2) to ASA III (n = 12), with most of the patients having ASA II (n = 22). The BM group consisted only of patients with ASA I (n = 1) and ASA II (n = 7), whereas in the SM group, 12 patients had ASA III. The difference was statistically significant (p = 0.029). Table 1 summarizes the baseline clinical characteristics of the operated patients.

Surgical outcome

All patients were operated laparoscopically with no conversion to open surgery. Operating time averaged 263 minutes (min; range: 165–418 min) and postoperative hospital stay was 8.2 days (range: 4–15 days), with no differences between the subgroups (Table 2). In 19 of the 36 patients (52%), a concomitant anterior/posterior colporrhaphy was added to the combined laparoscopic surgical procedure. The details are listed in Table 2, as well.

Morbidity and Mortality

In total, 5 patients experienced postoperative complications, one of them in the BM group. Most of the complications were mild (CDC 1–3a). Superficial wound infection (CDC 1) in one patient required no further treatment. One Urinary tract infection, diarrhea in one patient, and one lung embolism 5 days after surgery, all of which could be treated with medication (all CDC 2). One patient in the SM group developed an anastomotic leakage and required surgical revision with a temporary loop ileostomy (CDC 3b). The procedure was easier due to a previously placed Ghost stoma, a silicone loop marking a suitable ileum loop during the primary operation (30). Further recovery was uneventful, and the patient was discharged on day 10 (for further details see Table 3).

Clinical and Functional Outcome after Surgery

Obstructed defecation syndrome (ODS)

All patients enrolled had ODS, which was classified clinically by using scores before and after surgery. The Altomare score (maximum 30 points) averaged 10 points preoperatively and dropped to 5 points at 12 months (p = 0.006) (Fig. 4). Between the two subgroups the difference of the scores after surgery was significant for the SM group (p = 0.023), but not for the BM group (p = 0.074). The categorial analysis showed an improvement for the BM group, which did not reach significance due to the small sample size.

The mean results in the modified Longo score (maximum 24 points) reached 12 points preoperatively and 7 points after 12 months (p = 0.003) (Fig. 4). The results in the mesh subgroups showed the same result, as for the Altomare score. In the SM group the results differed (p = 0.015), whereas the analysis of the BM subgroup was not statistically significant (p = 0.09).

Some patients had bowel dysfunction symptoms, such as diarrhea, meteorism, and pain upon defecation, which was measured using the rectal toxicity score (maximum 32 points). In the total cohort, 15 points were measured preoperatively and 7 points 12 months (p < 0.01) (Fig. 4). Both subgroups were statistically lower after surgery, with higher values for the SM group (15 and 10 points before and after surgery, respectively; p = 0.004) than for the BM group (8 and 5 points before and after surgery, respectively; p = 0.04).

The Wexner incontinence score (WIS) as a parameter for the control of flatus and stool improved after surgery. The WIS documented 7 points preoperatively and 4 points at 12 months (p = 0.035) (Fig. 4). The results differed significantly between the subgroups. In the SM group, the median was 9 and 2 points before and after surgery, respectively (p = 0.01). In the BM group, the values were 7 and 3 points before and after surgery (p = 0.5).

Pelvic organ prolapse (POP)

Postoperative anatomical results were compared with preoperative evaluation by using the POP-Q score. Before surgery, 13 (36%) patients had POP-Q stage 1 and 23 (64%) patients had POP-Q stages 2–3. Postoperatively, 28 (78%) patients had POP-Q stage 0. Of these 7 patients (19%) with POP-Q stage 1, 5 patients had improved from higher grade POP-Q. One (3%) patient had POP-Q stage 2 relapse after 6 months due to insufficient fixation of the BM; the patient underwent laparoscopic apical refixation with an SM. The difference between these results was statistically significant (p < 0.001, Fig. 5).

Urinary incontinence symptoms

Of all 36 patients who underwent L-RRP and L-SCP, 17 (47%) patients suffered from urinary incontinence before surgery (mixed urinary incontinence). Postoperatively continence was restored in 14 patients (82%). No de-novo stress or urgency urinary incontinence symptoms appeared. The results were statistically significant (p < 0.001, Fig. 5). In the subgroup analysis the results after the use of a SM were significantly different (p < 0.001), whereas the difference in the BM group could not be shown due to the low number of patients (p = 1).

To date, the treatment of ODS with POP has been characterized by individual approaches. Sufficient data on standardized treatment options and particularly a combined interdisciplinary approach for evidence-based advice to women with ODS and POP is missing (17–20) (31,32).

This study is the first to establish an interdisciplinary laparoscopic surgical approach, combining a resection rectopexy (with anastomosis and without protective stoma) and a sacrocolpopexy in one surgical procedure as a standard treatment option for women with ODS and POP. All affected women with that defined medical condition received this laparoscopic combined surgical procedure in our setting.

Both, anatomical and functional outcomes were evaluated after surgery in this novel interdisciplinary setting at our institution. The procedure proved to be easy to establish and to be technically feasible and safe. The morbidity was low - with only one surgical re-intervention in the SM group because of an anastomotic leakage requiring subsequent protective stoma. The synthetic mesh was not adjacent to the leakage and remained intraabdominally. No further complications occurred within a mean of 19 months after surgery.

Excellent functional outcomes for ODS were achieved in a significant lowering of the assessed scores. Additional bowel discomforting symptoms, as diarrhea and meteorism as well as fecal incontinence were also improved as a positive side effect. Furthermore, excellent anatomical outcomes were obtained after this surgical procedure with a significant lowering of the POP-Q scores. The improvement of urinary incontinence was observed in 82% of patients with no postoperative de-novo incontinence.

At the moment, 40 registered clinical trials are evaluating the medical condition of either ODS and/or POP with none of these trials including an interdisciplinary surgical approach. Neither do they offer an alternative mesh material considering the known risk of a synthetic mesh (33). Because of multiple synthetic mesh associated complications like infections, erosion, and migration with serious consequences e.g., a lifelong diverting stoma years after surgery the use of SMs for transvaginal POP surgery was restricted in the United States by the Food and Drug Administration (FDA) (20,33–36). In addition to standardizing surgical care for patients with ODS with POP, an alternative to SMs must also be offered. The use of a BM for these conditions is an interesting alternative reducing and eliminating the risks of synthetic material. It has already proved its efficacy with excellent results in laparoscopic ventral mesh rectopexy (17,18,36–40). Although BMs are currently not recommended for L-SCP in urogynecological surgery according to the German guidelines for POP, the underlying scientific evidence is scarce and the biological and resorbable mesh material has been improved since then. Even though the risk of recurrence after mesh degradation may be associated with the use of a BM the lifelong risk after using synthetic material, particularly in surgery of younger women, must also be considered (19).

For the first time, this study offered a biological mesh material for apical fixation as an alternative to the synthetic mesh in selected cases, as in a later planned pregnancy and if required by the patient.

The results after surgery with this new option were convincing and did not differ significantly from the results with the synthetic material. The morbidity was even lower, than in the SM group, highlighting the reduced risks for infection, erosion, and migration as the major benefits, particularly in combination with a simultaneous colorectal resection (L-RRP). Thus, the early safety and functional results of the L-SCP were excellent.

A drawback of the study is the small number of patients in the group with the biological material not allowing to draw definitive conclusions. Furthermore, the decision to implant a BM was patient driven and thus inherits a selection bias. Additionally, the follow-up period of 12 months for the total cohort is still too short to propagate our procedure as a standard alternative for SM. Nevertheless, the safety and efficacy of a BM in this study proved to be an additional uterus-preserving treatment option, particularly for younger women of child-bearing age and in times of FDA warnings and the need for a more conscious implantation of synthetic materials. As a next step, a prospective randomized pilot study has already been designed to prove the concept, which will then be followed by a larger multicenter trial with long-term follow-up aspects.

In conclusion, this study is the first known trial combining an interdisciplinary laparoscopic resection rectopexy with sacrocolpopexy as a standard treatment option for women with ODS and POP, additionally offering either a synthetic or biological mesh for simultaneous apical fixation. This surgical approach is safe and feasible and early follow-up results are promising.

Authors´ contribution

Sebastian Ludwig: project and protocol development, data collection and analysis, manuscript writing and editing

Joshy Madukkakuzhy: protocol development, data collection and analysis, manuscript writing

Alberto Vega Hernandez: data collection and analysis, manuscript writing and editing

Jakob Otten: data collection and analysis

Christoph Ulrici: protocol development and data collection

Leonidas Karapanos: project development

Claudia Rudroff: project and protocol development, data collection and analysis, manuscript writing and editing

Funding

There was no funding of this study.

Consent to participate

Informed consent was obtained from all individual participants included in the study.

Consent to publish

The authors affirm that human research participants provided informed consent for publication of the images in Figures 2 and 3.

Acknowledgments

The Authors thank Mrs. Desire Paul and Mrs. Elvira Brovkova for their efforts in the outpatient ward. Our special thanks goes to Mrs. Carina Heider for her continuous help in data monitoring and maintaining contact with the study patients.

Conflict of interests

Sebastian Ludwig receives honoraria for speaking at symposia from the FEG Textiltechnik mbH Aachen, Germany. The other authors declare that they have no conflict of interest with this study.

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Table 1. Patient’s characteristics of the 36 patients with obstructive defecation syndrome (ODS) and pelvic organ prolapse (POP) operated with combined laparoscopic resection rectopexy (L-RRP) and sacrocolpopexy (L-SCP). P-Values showed a significant difference between the two subgroups for the ASA classification.

	all patients (n= 36)	biomesh (n= 8)	synthetic mesh (n= 28)	*p-value*
Age, y, median (IQR)	57.5 (26 – 83)	47 (26 – 77)	59 (37 – 83)	0.189
ASA, n (%)				0.029
1	2 (5.6%)	1 (2.8%)	1 (2.8%)
2	22 (61.1%)	7 (19.4%)	15 (41.7%)
3 4	12 (33.3%) 0	0 0	12 (33.3%) 0
BMI (kg/m²), median (IQR)	23 (18 – 35)	23.5 (20 – 31)	23 (18 – 35)	0.646
Distributions are presented as median and interquartile range (IQR) for continuous, and total number and percentages (%) for binary data

Table 2. Surgical outcome of the patients including operating time and duration of hospital stay. P-Values show no difference between the two subgroups. The surgical procedure was further stratified into the different apical fixations to the vaginal stump (sacrocolpopexy, SColP), to the cervical stump (sacrocervicopexy, SCerP), and to the uterus (sacrohysteropexy, SHP). Furthermore, cases with an additional colporrhaphia (+Col) are listed below.

	all patients (n= 36)	biomesh (n= 8)	synthetic mesh (n= 28)	*p-value*
Operation time in min, median/IQR	263 (165 – 418)	245 (165 – 331)	264 (177 – 418)	0.253
Duration of hospital stay in days, Mean/range	8.2 (4-15)	8.4 (5-11)	8.2 (4-15)	0.671
Surgical Procedure
RRP + SColP	11 (30.6%)	3 (8.3%)	8 (22.2%)
RRP + SCerP	3 (8.3%)	0	3 (8.3%)
RRP + SHP	2 (5.6%)	2 (5.6%)	0
RRP + SColP + Col	5 (13.9%)	0	4 (11.1%)
RRP + SCerP + Col	12 (33.3%)	1 (2.8%)	11 (30.6%)
RRP + SHP + Col	3 (8.3%)	2 (5.6%)	1 (2.8%)
Distributions are presented as median and interquartile range (IQR) for continuous, and total number and percentages (%) for binary data

Table 3. Patient’s morbidity and mortality according to the Clavien Dindo Classification (CDC) was listed and further stratified into minor complications (CDC 1-3a) and major complications (CDC 3b-5). Furthermore, the individual complications were counted and classified clinically.

	all patients (n= 36)	biomesh (n= 8)	synthetic mesh (n= 28)	*p-value*
Overall morbidity, n (%)	5 (13.89)	1 (2.8%)	4 (11.1%)	0.170
Minor (CDC 1 – 3a), n (%)	3 (8.3%)	1 (2.8%)	2 (5.6%)
Major (CDC 3b – 5), n (%)	2 (5.6%)	0	2 (5.6%)

Mortality, n (%)	0	0	0

Anastomotic Leakage	1 (2.8%)	0	1 (2.8%)
Lung embolism	1 (2.8%)	0	1 (2.8%)
Wound infection	1 (2.8%)	1 (2.8%)	0
Gastrointestinal	1 (2.8%)	0	1 (2.8%)
Urologic	1 (2.8%)	0	1 (2.8%)
Distributions are presented as median and interquartile range (IQR) for continuous, and total number and percentages (%) for binary data

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Early Safety and Efficiency Outcomes of a Novel Standardized Interdisciplinary Procedure of Combined Laparoscopic Resection Rectopexy with Laparoscopic Sacrocolpopexy to Treat Obstructive Defecation Syndrome in Women with Pelvic Organ Prolapse

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