Transvaginal versus transabdominal specimen extraction in minimally invasive surgery: a systematic review and meta-analysis.

AIM: Natural orifice specimen extraction (NOSE) is an alternative to conventional transabdominal retrieval. We aimed to compare outcomes following transvaginal specimen extraction (TVSE) and transabdominal specimen extraction (TASE) in minimally invasive abdominal surgery. METHODS: An electronic database search of PubMed, Embase and CENTRAL was performed from inception until March 2023. Comparative studies evaluating TVSE versus TASE in adult female patients were included. Studies involving transanal NOSE, endoluminal surgery, or TVSE with concomitant hysterectomy were excluded. Weighted mean differences (WMD) and odds ratio were estimated for continuous and dichotomous outcomes respectively. Primary outcomes were postoperative day 1 (POD1) pain and length of stay (LOS). Secondary outcomes were operative time, rescue analgesia, morbidity, and cosmesis. A review of sexual, oncological, and technical outcomes was performed. RESULTS: Thirteen studies (2 randomised trials, 11 retrospective cohort studies), involving 1094 patients (TASE 583, TVSE 511), were included in the analysis. Seven studies involved colorectal disease and six assessed gynaecological conditions. TVSE resulted in significantly decreased POD1 pain (WMD 1.08, 95% CI: 0.49, 1.68) and shorter LOS (WMD 1.18 days, 95% CI: 0.14, 2.22), compared to TASE. Operative time was similar between both groups, with fewer patients requiring postoperative rescue analgesia with TVSE. Overall morbidity rates, as well as both wound-related and non-wound related complication rates were better with TVSE, while anastomotic morbidity rates were comparable. Cosmetic scores were higher with TVSE. TVSE did not result in worse sexual or oncological outcomes. CONCLUSION: TVSE may be feasible and beneficial compared to TASE when performed by proficient laparoscopic operators, using appropriate selection criteria. Continued evaluation with prospective studies is warranted.

Discharge within 24 h, transvaginal natural orifice transluminal endoscopic surgery- more suitable for ambulatory surgery in gynecology procedures: a retrospective study.

BACKGROUND: Natural orifice transluminal endoscopic surgery (NOTES) is an achievement in the field of minimally invasive surgery. However, the vantage point of vaginal natural orifice transluminal endoscopic surgery (vNOTES) in gynecologicalprocedures remains unclear. The main purpose of this study was to compare vNOTES with laparo-endoscopic single-site surgery, and to determine which procedure is more suitable for ambulatory surgery in gynecologic procedures. METHODS: This retrospective observational study was conducted at the Department of Gynecology, Chengdu Women's and Children's Central Hospital. The 207 enrolled patients had accepted vNOTES and laparo-endoscopic single-site surgery in gynecology procedures from February 2021 to March 2022. Surgically relevant information regarding patients who underwent ambulatory surgery was collected, and 64 females underwent vNOTES. RESULTS: Multiple outcomes were analyzed in 207 patients. The Wilcoxon Rank-Sum test showed that there were statistically significant differences between the vNOTES and laparo-endoscopic single-site surgery groups in terms of postoperative pain score (0 vs. 1 scores, p = 0.026), duration of anesthesia (90 vs. 101 min, p = 0.025), surgery time (65 vs. 80 min, p = 0.015), estimated blood loss (20 vs. 40 mL, p < 0.001), and intestinal exhaustion time (12.20 vs. 17.14 h, p < 0.001). Treatment with vNOTES resulted in convenience, both with respect to time savings and hemorrhage volume in surgery and with respect to the quality of the prognosis. CONCLUSION: These comprehensive data reveal the capacity of vNOTES to increase surgical efficiency. vNOTES in gynecological procedures may demonstrate sufficient feasibility and provide a new medical strategy compared with laparo-endoscopic single-site surgery for ambulatory surgery in gynecological procedures.

Outcomes of urethral meatal preservation ventral urethroplasty for female urethral stricture: a series of cases.

Objective: To present a series of cases with our initial experience and short-term outcomes of a modified vaginal mucosal flap urethroplasty. Methods: Patients diagnosed with urethral stricture and operated by the same operative technique between January 2012 and January 2018 were followed for at least 6 months. Uroflowmetry and clinical outcomes were evaluated. Results: Nineteen patients were included with an average age of 56.4 years, mean preoperative Qmax of 5.3 ml/s, and PVR of 101.4 mL. After 6 months of the procedure, the mean Qmax improved to 14.7 mL/s (p<0.05), PVR decreased to 47.3 mL (p<0.05), and 84.2% of all patients reported improvement in clinical self-reported symptoms. There was an improvement in symptoms such as voiding effort in 84.2% of patients, weak stream (89.5%), and recurrent urinary tract infection (85.7%). The success rate (absence of symptoms and normal Qmax with no significant PVR) of the procedure was 84.2%. Conclusion: The described technique was considered effective for the treatment of female urethra stricture, with a high clinical success rate and an objective improvement of Qmax and decrease in PVR after 6 months of the procedure.

Exploring the feasibility of indocyanine green fluorescence for intraoperative ureteral visualisation in robotic transvaginal natural orifice transluminal endoscopy surgery during endometriosis resection.

BACKGROUND: To assess the feasibility of use of indocyanine green (ICG) in identifying and minimising urinary tract injury during surgical resection of endometriosis through robotic transvaginal natural orifice transluminal endoscopy surgery (RvNOTES). METHODS: We conducted a retrospective case series in two academic tertiary care hospitals. We examined 53 patients who underwent RvNOTES hysterectomy with planned endometriosis resection. RESULTS: The study involved 53 patients undergoing RvNOTES with ICG fluorescence for endometriosis resection. Mean patient age was 37.98 ± 6.65 years. Operative time averaged 181.32 ± 53.94 min, with estimated blood loss at 45.57 ± 33.62 mL. Postoperative stay averaged 0.23 ± 0.47 days. No ICG-related complications occurred. CONCLUSION: No complications occurred with ICG fluorescence in RvNOTES. It appears to be a safe option for ureteral localisation and preservation. ICG fluorescence is widely used in diverse medical specialities for identifying ureters during complex surgeries. Larger studies are needed to firmly establish its advantages in intraoperative ureteral visualisation during RvNOTES for deep infiltrative endometriosis.

What is the applicability of tubal ligation with the vaginal natural orifice transluminal endoscopic surgery technique and its value in patient comfort?

OBJECTIVE: The aim of this study was to observe the feasibility of the tubal/adnexal approach using vaginal natural orifice transluminal endoscopic surgery and compare its contribution with surgeon ergonomics and postoperative patient comfort with that of conventional laparoscopy. METHODS: We completed this study retrospectively with 47 patients. Patients were followed at their postoperative first month. We analyzed the usability of the vaginal natural orifice transluminal endoscopic surgery method over conventional laparoscopy by comparing the demographics, surgical data, and postoperative findings collected between the two groups. RESULTS: Patients in the conventional laparoscopy group were older (39.1±3.3 years) than those in the vaginal natural orifice transluminal endoscopic surgery patient group (p=0.005). Pain intensity 24 h after surgery was lower in the vaginal natural orifice transluminal endoscopic surgery group (p=0.003), while sexual function and dyspareunia did not differ between the two groups in the first month. Patients in the vaginal natural orifice transluminal endoscopic surgery group were more relieved about painlessness and the comfort it brought than the conventional laparoscopy group (p=0.027, χ2=12.56). CONCLUSION: Patients subjected to the vaginal natural orifice transluminal endoscopic surgery procedure showed higher levels of satisfaction, less postoperative pain, and greater comfort than those subjected to conventional laparoscopy.

OHVIRA syndrome: clinical implications of a delayed diagnosis.

Obstructed Hemi Vagina with Ipsilateral Renal Agenesis (OHVIRA) syndrome is a rarely encountered müllerian duct anomaly. Delayed diagnosis is common due to normal onset of puberty and menstruation. We report a case of a woman in her early 20s with a background history of multiple emergency department visits, ward admissions and surgeries for chronic abdominal pain. She was reviewed at 1 month postlaparotomy for recurrent pelvic abscess and was finally diagnosed to have an OHVIRA syndrome, 11 years after her first clinical presentation. Excision of the vaginal septum completely resolved her symptoms. We are reporting this case to highlight the clinical implications resulting from the delayed diagnosis, to look into factors contributing to the delay and to highlight the importance of having a high index of suspicion to diagnose this unique condition.

Herlyn-Werner-Wunderlinch: An unusual presentation in a patient with Prader-Willi syndrome.

Herlyn-Werner-Wunderlich syndrome is an uncommon urogenital anomaly defined by uterus didelphys, obstructed hemi-vagina and unilateral renal anomalies. The most common clinical presentation is dysmenorrhoea following menarche, but it can also present as pain and an abdominal mass. Prader-Willi syndrome is a rare neuroendocrine genetic syndrome. Hypothalamic dysfunction is common and pituitary hormone deficiencies including hypogonadism are prevalent. We report the case of a 33-year-old female with Prader-Willi syndrome who was referred to the Gynaecology clinic due to vaginal bleeding and abdominal pain. Abdominal ultrasound revealed a haematometra and haematocolpos and computed tomography showed a uterus malformation and a right uterine cavity occupation (hematometra) as well as right kidney agenesis. Vaginoscopy and hysteroscopy were performed under general anaesthesia, finding a right bulging vaginal septum and a normal left cervix and hemiuterus. Septotomy was performed with complete haematometrocolpos drainage. The association of the two syndromes remains unclear.

Sexuality and quality of life of patients operated for Rokitansky syndrome Mayer Kuster Hauser.

INTRODUCTION: Rokitansky syndrome or Mayer Rokitansky Kuster Hauser (SRKMH) is a rare congenital malformation defined by uterovaginal aplasia. The aim of the treatment is to create a neovagina and restore sexual life. However, postoperative results in terms of sexual and overall quality of life of patients remain controversial. AIM: To evaluate the quality of life and sexuality of patients operated on for Rokitansky syndrome. METHODS: This was a retrospective and comparative study between two groups of patients. The first group consisted of patients who had undergone vaginoplasty as part of SRKMH. The second group was that of the controls. Control in terms of sexual function by the Ar FSFI (Arab FemaleSexualFunction Index) and quality of life by the SF36 (Short Forms Health Survey) were used in both groups. RESULTS: The average age of patients operated on for SRKMH was 22.53 years. Eighteen of these patients (60%) were sexually active at the time of the study. Patients operated on for SRKMH had a significantly lower Ar FSFI score compared to the control group. The two areas most affected were lubrication and pain. Likewise, patients who underwent vaginoplasty had a significantly lower SF 36 score compared to the control group. The psychological component was the most affected of the different components of quality of life. CONCLUSION: Sexual function and quality of life after vaginoplasty in the context of Rokitansky syndrome remains unsatisfactory despite the anatomical result.

Mid-term outcomes of laparoscopic vaginal stump?round (Kakinuma method) and stump?uterosacral (Shull method) ligament fixation for pelvic organ prolapse: a retrospective comparative study.

BACKGROUND: Laparoscopic sacrocolpopexy (LSC) and robot-assisted sacrocolpopexy (RSC) using mesh are popular approaches for treating pelvic organ prolapse (POP). However, it is not uncommon that native tissue repair (NTR) should be presented as an option to patients who are expected to have extensive intraperitoneal adhesion or patients for whom LSC or RSC is difficult owing to various risk factors. Laparoscopic vaginal stump-uterosacral ligament fixation (Shull method) has been introduced as a method for NTR in case of POP. However, effective repair using this surgical procedure may not be possible in severe POPs. To solve the problems of the Shull method, we devised the laparoscopic vaginal stump-round ligament fixation (Kakinuma method) in which the vaginal stump is fixed to the uterine round ligament, a histologically strong tissue positioned anatomically higher than the uterosacral ligament. This study aimed to retrospectively and clinically compare the two methods. METHODS: Of the 78 patients who underwent surgery for POP between January 2017 and June 2022 and postoperative follow-up for at least a year, 40 patients who underwent the Shull method (Shull group) and 38 who underwent the Kakinuma method (Kakinuma group) were retrospectively analyzed. RESULTS: No significant differences were observed between the two groups in patient background variables such as mean age, parity, body mass index, and POP-Q stage. The mean operative duration and mean blood loss in the Shull group were 140.5 ± 31.7 min and 91.3 ± 96.3 ml, respectively, whereas the respective values in the Kakinuma group were 112.2 ± 25.3 min and 31.4 ± 47.7 ml, respectively. Thus, compared with the Shull group, the operative duration was significantly shorter (P < 0.001) and blood loss was significantly less (P = 0.003) in the Kakinuma group. Recurrence was observed in six patients (15.0%) in the Shull group and two patients (5.3%) in the Kakinuma group. Hence, compared with the Shull group, recurrence was significantly less in the Kakinuma group (P = 0.015). No patients experienced perioperative complications in either group. CONCLUSIONS: The results suggest that the Kakinuma method can serve as a novel and viable NTR procedure for POP.

[Clinical analysis of 80 patients with oblique vaginal septum syndrome].

Objective: To investigate the clinical features, diagnosis and treatment of oblique vaginal septum syndrome (OVSS). Methods: The clinical data of 80 patients with OVSS admitted to The Second Hospital of Hebei Medical University from July 2005 to July 2023 were retrospectively analyzed. According to the classification system of OVSS proposed by Female Genital Anomalies Study Group, Chinese Obstetricians and Gynecologists Association in 2021, the patients were divided into four groups. The clinical manifestations, accompanied urinary system abnormalities, diagnosis and treatment methods and treatment outcomes were observed. Results: According to the above classification system, among the 80 patients with OVSS, 35 patients (44%, 35/80) were categorized as type Ⅰ, 33 patients (41%, 33/80) were categorized as type Ⅱ, 2 patients (3%, 2/80) were categorized as type Ⅲ and 10 patients (13%, 10/80) were categorized as type Ⅳ. The main onset symptom of patients was periodic abdominal pain (70%, 56/80), vaginal bleeding (20%, 16/80), dysuria or fecal impaction (15%, 12/80), vaginal mucopurulent discharge (10%, 8/80). The morbidity of combined urinary system abnormalities was 88% (70/80), and the most common urinary system abnormality was ipsilateral renal agenesis (81%, 65/80). Bilateral kidneys were normal in 13% (10/80) patients, and 6% (5/80) were combined with other urinary system abnormalities. A total of 74 patients underwent vaginal oblique septectomy or septum excision. Five of the 10 patients with type Ⅳ underwent hysterectomy on the cervical atresia side, 4 patients received hysteroscopy combined with cervicoplasty+oblique septotomy or septum excision, and one patient selected delayed menstruation. Two patients underwent laparoscopic resection of the dysplasia kidney and ectopic ureter which opening to the vagina. Eleven patients with endometriosis cyst, hydrosalpinx or empyema underwent laparoscopic surgery. Conclusions: The main symptom of type Ⅰ and Ⅳ patients is abdominal pain, while the main symptom of type Ⅱ and Ⅲ patients is bleeding. Magnetic resonance imaging (MRI) has advantages in the evaluation of complex OVSS, and MRI is recommended before operation to exclude other axial reproductive tract dysplasia and complex urinary system dysplasia. If there is leakage of urine, vaginal discharge or complex deformity, it is necessary to multidisciplinary discussion and formulate a reasonable surgical plan. The first treatment is related to the prognosis of patients especially children, and should be highly valued.

[Adolescent female reproductive system dysplasia: a clinical study of 356 cases].

Objective: To explore the age of onset and consultation, the main clinical manifestations, common types of combined malformations, the relationship of endometriosis, surgical prognosis and different types of proportion of adolescent female reproductive system dysplasia. Methods: The medical records of 356 patients (aged 10-19) with female reproductive system dysplasia in Women's Hospital, School of Medicine, Zhejiang University from January 2003 to August 2018 were collected and retrospectively analyzed. Results: (1) Among the 356 adolescent dysplasia patients, uterine dysplasia (23.6%, 84/356), oblique vaginal septum syndrome (OVSS; 22.5%, 80/356) and vaginal dysplasia (21.6%, 77/356) were the most frequent ones, followed by multi-sectional dysplasia (16.0%, 57/356), other types of developmental abnormalities like external genitaliaand urogenital fistula (13.5%, 48/356) and Mayer-Rokitansky-Küster-Hauser syndrome (MRKH syndrome; 2.8%, 10/356). (2) There were significant differences between the median age of onset and the age of consultation of patients with OVSS and other types of abnormalities except hymen atresia (both P<0.05). In contrast, there were no significant differences between the age of onset and the age of consultation of the patients of uterine dysplasia, vaginal dysplasia, hymen atresia, MRKH syndrome and multi-sectional dysplasia (all P>0.05). (3) The clinical manifestations were lack of specificity, and mainly abnormal finding was lower abdominal pain. (4) After admission, the majority of patients underwent comprehensive cardiopulmonary examination (71.3%, 254/356) and urinary system examination (63.5%, 226/356). Only 18.3% (65/356) of patients had completed abdominal organ examination, and 5.9% (21/356) skeletal system examination. About other systemic malformations, urological malformations were the most common (27.5%, 98/356), followed by anorectal malformation (0.6%, 2/356), heart malformations (0.3%, 1/356), and spinal malformations (0.3%, 1/356). 46.4% (84/181) of the surgical patients were diagnosed with combined endometriosis. Patients with obstructive genital tract malformations were more likely to combine with endometriosis than non-obstructive ones [50.3% (74/147) vs 29.4% (10/34); P<0.05]. However, there was no significant difference between the severity of endometriosis of those two kinds (P>0.05). (5) Totally 308 patients were followed up successfully with a median of 25.0 years old, and 20 cases were treated again; 12.0% (37/308) of them were suffering from menstrual disorder and 33.1% (102/308) of them with dysmenorrhea. Totally 130 patients had sexually active reported no sexual problems. Conclusions: Uterine dysplasia, OVSS and vaginal dysplasia are the most common syndromes in adolescent female reproductive system dysplasia along with frequent cases of coexisting urinary malformations and increasing risks of endometriosis. Meanwhile, the lack of specificity of clinical manifestations might delay the timely diagnosis and treatment after the onset of symptoms. Nonetheless, most patients could achieve good surgical outcomes.

A novel magnetic compression technique for establishment of a vesicovaginal fistula model in Beagle dogs.

Vesicovaginal fistula lacks a standard, established animal model, making surgical innovations for this condition challenging. Herein, we aimed to non-surgically establish vesicovaginal fistula using the magnetic compression technique, and the feasibility of this method was explored using eight female Beagle dogs as model animals. In these dogs, cylindrical daughter and parent magnets were implanted into the bladder and vagina, respectively, after anesthesia, and the positions of these magnets were adjusted under X-ray supervision to make them attract each other, thus forming the structure of daughter magnet-bladder wall-vaginal wall-parent magnet. Operation time and collateral damage were recorded. The experimental animals were euthanized 2 weeks postoperatively, and the vesicovaginal fistula gross specimens were obtained. The size of the fistula was measured. Vesicovaginal fistula was observed by naked eye and under a light microscope. Magnet placement was successful in all dogs, and remained in the established position for the reminder of the experiment. The average operation time was 14.38 min ± 1.66 min (range, 12-17 min). The dogs were generally in good condition postoperatively and were voiding normally, with no complications like bleeding and urine retention. The magnets were removed from the vagina after euthanasia. The vesicovaginal fistula was successfully established according to gross observation, and the fistula diameters were 4.50-6.24 mm. Histological observation revealed that the bladder mucosa and vaginal mucosa were in close contact on the internal surface of the fistula. Taken together, magnetic compression technique is a simple and feasible method to establish an animal model of vesicovaginal fistula using Beagle dogs. This model can help clinicians study new surgical techniques and practice innovative approaches for treating vesicovaginal fistula.

Laparoscopic-Assisted Transvaginal Cholecystectomy - the US Military Experience With Long-Term Follow Up.

Objectives: We present our initial clinical experience applying Natural Orifice Transluminal Endoscopic Surgical (NOTES) technique to perform cholecystectomy in ten patients at a military institution. Methods: A posterior colpotomy was created to accommodate a single site working port used to facilitate dissection and gallbladder mobilization under direct visualization via an infraumbilical port. The specimen was retrieved through the vagina and the colpotomy was closed with absorbable suture under direct visualization. Long-term follow up was performed over the phone to assess quality of life with 2 widely used health-related quality of life (HRQoL) surveys including RAND-36 Health Item Survey (Version 1.0),1 and the Female Sexual Function Index (FSFI).2. Results: Ten women underwent a laparoscopic-assisted transvaginal cholecystectomy (TVC) with 7 available for long-term follow-up. The average age was 28.9 years (20-37) and the indications for surgery included symptomatic cholelithiasis (9) and biliary dyskinesia (1). The mean operative time was 129 mins (95-180), and median blood loss was 34 ml (5-400). There were no conversions and the average length of stay was 9.98 hours (2.4-28.8). Pain (analogue scale 1-10) on postoperative day three was minimal (mean 2.3) and was limited to the infraumbilical incision. On average patients returned to work by postoperative day six and resumed normal daily activities at seven days. Immediate postoperative complications included one incident of postoperative urinary retention requiring bladder catheterization. One intra-operative cholangiogram was successfully performed due to elevated preoperative liver enzymes without significant findings. Long-term complications included one asymptomatic incisional hernia repair at the infraumbilical port site. The RAND-36 survey demonstrated an average physical and mental health summary score of 82.2 and 63.7 with an average general health score of 63.6. The average FSFI total score was 21.8. Conclusion: TVC is safe and effective. Implementation may improve operational readiness by returning service members to normal activities more expeditiously than conventional laparoscopy.

Vaginoplasty with Amnion Graft: Management of Mayer-Rokitansky-Kuster-Hauser Syndrome.

Mayer-Rokitansky-Kuster-Hauser syndrome also known as mullerian agenesis is a rare congenital condition in which there is absence of uterus along with upper vagina. Patient usually presents with primary amenorrhea with or without cyclical lower abdominal pain but have normal secondary sexual characters. Modified McIndoe Vaginoplasty with amnion graft is the commonest surgery performed worldwide. A 23 year old girl with normal secondary sexual characters presented with primary amenorrhea with cyclical lower abdominal pain; on examination blind vagina was present. Vaginoplasty with amnion graft was done and vaginal mould was placed. Vaginal dilatation with Hegar's dilator was done weekly until 6 weeks. She is under regular follow-up at present and advised for regular manual dilation at home. McIndoe Vaginoplasty with amnion graft is a simple yet rewarding procedure especially in low resource countries like ours, with good success rate and with minimal postoperative complications. Keywords: Amnion graft; Mayer-Rokitansky-Kuster-Hauser Syndrome; Modified McIndoe Vaginoplasty; Primary amenorrhea; Secondary sexual characters.

Complications of obliterative versus reconstructive vaginal surgery for pelvic organ prolapse in octogenarians: A retrospective cohort study.

AIMS: Women of advanced age may choose between restorative or obliterative surgery for surgical management of pelvic organ prolapse. Obliterative surgery is traditionally reserved for a subset of older women with more severe medical comorbidities, since obliterative approaches are generally considered to be less morbid and older individuals have higher rates of perioperative complications than younger cohorts. This study compared perioperative complications amongst octogenarians undergoing obliterative versus reconstructive approaches. This data will help to inform perioperative counselling as previous studies have not been powered to evaluate complications in this population. METHODS: The National Surgical Quality Improvement Program database was used to identify patients that had Pelvic organ prolapse surgery between 2012 and 2021, aged 80 years or older. Single-compartment procedures, vaginal mesh procedures, and oncologic surgery were excluded. The primary outcome was any complication within the first 30 days excluding urinary tract infection (UTI). UTI, readmission, and severe complications were secondary outcomes. RESULTS: Of the 4149 patients identified, 2514 (60.6%) underwent reconstructive surgery and 1635 (39.4%) underwent obliterative surgery. Patients undergoing reconstructive surgery were more likely to have an American Society of Anesthesiologists (ASA) class of 1 or 2 (46.1% vs. 31.3%, p = 0.002) and were less likely to be on antihypertensive medication (72.0% vs. 75.8%, p = 0.006). Further, there was an increased length of stay (1.47 ± 1.84 vs. 1.03 ± 1.31 days, p < 0.001) in hospital for reconstructive surgery which was more often performed as an inpatient (45.7% vs. 37.9%, p < 0.001). There was no difference in the primary outcome: any complication excluding UTIs. However, UTI was more common in the reconstructive group (aOR 0.48; 95% confidence interval 0.34-0.0). The rate of serious complications (Clavien-Dindo Class IV) was low overall and not different between reconstructive and obliterative approaches (1.3% vs. 1.0%, respectively). CONCLUSIONS: Both vaginal reconstructive and obliterative approaches have low complication rates in octogenarians, with only UTI rate being different between cohorts. When choosing surgical approach, we suggest a case-based, patient center discussion on the anatomic outcomes, durability and patient satisfaction.

Two-Year Preclinical Evaluation of Long-Term Absorbable Poly-4-hydroxybutyrate Scaffold for Surgical Correction of Pelvic Organ Prolapse.

INTRODUCTION AND HYPOTHESIS: Fully absorbable implants may be an alternative to permanent meshes in the correction pf pelvic organ prolapse (POP) as they may reduce adverse events by promoting tissue regeneration and collagen metabolism. This study was aimed at evaluating the long-term host and biomechanical response to a fully absorbable poly-4-hydroxybutyrate (P4HB) scaffold in comparison with polypropylene (PP) mesh. METHODS: Poly-4-hydroxybutyrate scaffold (n = 16) and PP mesh (n = 16) were surgically implanted in the posterior vaginal wall of parous female Dohne Merino sheep. Vaginal explants were evaluated in terms of gross necropsy, host response (immune response, collagen deposition, tissue regeneration), biomechanics, and degradation of P4HB at 12 and 24 months post-implantation. RESULTS: Gross necropsy revealed no infection or fluid collection using P4HB or PP. At 12 months, exposures were observed with both P4HB (3 out of 8) and PP (4 out of 8), whereas at 24 months, exposures were observed only with PP (4 out of 8). The tensile stiffness of the P4HB explants was maintained over time despite complete absorption of P4HB. The collagen amount of the vaginal tissue after P4HB implantation increased over time and was significantly higher than PP at 24 months. P4HB scaffolds exhibited significantly lower myofibroblast differentiation than PP meshes at 24 months. CONCLUSIONS: The P4HB scaffold allowed for gradual load transfer to the vaginal wall and resulted in mechanically self-sufficient tissue. P4HB scaffold had a more favorable host response than PP mesh, with higher collagen content, lower myofibroblastic differentiation, and no exposures at 24 months. P4HB scaffolds have potential as an alternative to permanent implants in treating POP.

Mobility analysis of a posterior sacrospinous fixation using a finite element model of the pelvic system.

INTRODUCTION AND HYPOTHESIS: In order to improve the knowledge POP physiopathology and POP repair, a generic biomechanical model of the female pelvic system has been developed. In the literature, no study has currently evaluated apical prolapse repair by posterior sacrospinous ligament fixation using a generic model nor a patient-specific model that personalize the management of POP and predict surgical outcomes based on the patient's pre-operative Magnetic Resonance Imaging. The aim of our study was to analyze the influence of a right and/or left sacrospinous ligament fixation and the distance between the anchorage area and the ischial spine on the pelvic organ mobility using a generic and a patient-specific Finite Element model (FEM) of the female pelvic system during posterior sacrospinous ligament fixation (SSF). METHODS: Firstly, we used a generic 3D FEM of the female pelvic system previously made by our team that allowed us to simulate the mobility of the pelvic system. To create a patient-specific 3D FEM of the female pelvic system, we used a preoperative dynamic pelvic MRI of a 68 years old woman with a symptomatic stage III apical prolapse and cystocele. With these 2 models, a SSF was simulated. A right and/or left SSF and different distances between the anchorage area and the ischial spine (1 cm, 2 cm and 3 cm.) were compared. Outcomes measures were the pelvic organ displacement using the pubococcygeal line during maximal strain: Ba point for the most posterior and inferior aspect of the bladder base, C point the cervix's or the vaginal apex and Bp point for the anterior aspect of the anorectal junction. RESULTS: Overall, pelvic organ mobility decreased regardless of surgical technique and model. According to the generic model, C point was displaced by 14.1 mm and 11.5 mm, Ba point by 12.7 mm, and 12 mm and Bp point by 10.6 mm and 9.9 mm after left and bilateral posterior SSF, respectively. C point was displaced by 15.4 mm and 11.6 mm and Ba point by 12.5 mm and 13.1mm when the suture on the sacrospinous ligament was performed at 1 cm and 3 cm from the ischial spine respectively (bilateral posterior SSF configuration). According to the patient-specific model, the displacement of Ba point could not be analyzed because of a significative and asymmetric organ displacement of the bladder. C point was displaced by 4.74 mm and 2.12 mm, and Bp point by 5.30 mm and 3.24 mm after left and bilateral posterior SSF respectively. C point was displaced by 4.80 mm and 4.85 mm and Bp point by 5.35 mm and 5.38 mm when the suture on the left sacrospinous ligament was performed at 1 cm and 3 cm from the ischial spine, respectively. CONCLUSION: According to the generic model from our study, the apex appeared to be less mobile in bilateral SSF. The anchorage area on the sacrospinous ligament seems to have little effect on the pelvic organ mobilities. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04551859.