Mesh safety in pelvic surgery: Our experience and outcome of biological mesh used in laparoscopic ventral mesh rectopexy

INTRODUCTION

The aim of this study was to investigate the outcomes of LVMR using a biologic mesh in a district general hospital in an era where there is concern regarding the placement of pelvic mesh. We assessed the outcome of the procedure in relation to complications, bowel function and recurrences of symptoms following surgery.

Over the last few years there have been concerns about the usage of meshes in pelvic surgery, especially since serious complications have been recorded in urogynaecology procedures where trans-vaginal placement of mesh in women was used to treat pelvic organ prolapse. This led many countries to scrutinise the use of mesh. This was particularly the case in the United Kingdom with the Scottish Government being the first to halt the use of trans-vaginal mesh in 2014[3]. However the incidence of meshrelated complications, and particularly mesh erosion, after LVMRs is low, especially when a biological mesh is used[4]. This was shown by Balla[4] in their review of literature where they demonstrated that the synthetic and the biological mesh-related erosion rates were 1.87% and 0.22%, respectively.

To assess the safety of the mesh and the outcome of the procedure.

Laparoscopic ventral mesh rectopexy (LVMR) has recently become the preferred treatment for full thickness rectal prolapse, and it has been also widely used in the treatment of rectoceles, enteroceles and rectal intussusception with associated symptoms of obstructive defecation with or without faecal incontinence[1]. The procedure has good short term and long term results with minimum morbidity rates and low recurrence rates[2], particularly when compared to the perineal surgical approach used for treatment of rectal prolapse[2]. In addition, due to reduced postoperative complications, a shorter length of hospital stay is an advantage[1,2].

MATERIALS AND METHODS

Laparoscopic ventral mesh rectopexy is becoming one of the leading treatment options for the elective repair of rectal prolapse around the world[6,7]. Perineal procedures are still performed especially for elderly patients and those with associated significant comorbidity who are not candidates for transabdominal laparoscopic procedures[8,9].However, there are recent studies that demonstrate that LVMRs would be safe for selected elderly patients as well[10]. In our series, there were 5 elderly patients over 80 that had a successful procedure with a good outcome.

The functional outcomes for these patients were calculated using the Wexner scoring system for constipation and incontinence before and after surgery. All patients had a follow-up appointment in the clinic 3 mo after surgery and further follow-up 6-12 mo later. We also reviewed the notes on average 18.3 ± 4.2 mo after the procedure.Clinical outcomes of surgery and any complications resulting from surgery were recorded in the Pelvic Floor Society hosted national database.

子程序上電初始化把程序全部復位，其作用在于使系統(tǒng)做好工作準備，降低程序死循環(huán)的可能性，增加系統(tǒng)可靠性[4-5]。

Surgical technique

At University Hospital Wishaw all LVMR procedures from June 2012 to August 2018 were performed by the same colorectal surgeon. After creating pneumoperitoneum and inserting the working ports (12 mm port on the right iliac fossa, 5 mm supra umbilical port and a 5 mm port in the right abdomen, the pelvic peritoneum at sacral promontory was opened using hook diathermy and continued distally and anteriorly down to the level of the levator muscles, while preserving the lateral ligaments and the hypogastric and sacral nerves. The biological porcine skin mesh that was used for all cases (permacol 4 × 18 cm long and 1 mm thick) was sutured as distally as possible onto the anterior rectal wall using interrupted seromuscular nonabsorbable sutures (2-0 Ethibond, Ethicon Endosurgery, Raritan, NJ, United States) and the upper part of the mesh was fixated to the sacral promontory using 4-5 spiral attachments (Pro-TackFixation Device, Medtronic, Dublin, Ireland). Also, the gap between vagina and mesh was closed in women using 2.0 PDS (Figure 1).

The peritoneum was closed over the mesh with a continuous suture (V-lock 180, 15 cm). Perioperative care was conducted per the enhanced recovery after surgery protocol. A urinary catheter was inserted after the patient was anesthetised and was removed on the first post-operative day.

Statistical analysis

It is evident that our study demonstrates a significant improvement of patients’symptoms of obstructive defecation. The median post-operative Wexner score for constipation was 3 (IQR: 1-6) compared to the median pre-operative score which was 14.5 (IQR: 10.5-18.5), demonstrating a significant improvement (0.01). These results are comparable to the results of Franceschilli[18] who demonstrated that the mean Wexner score for constipation improved from 18.4 ± 11.6 to 5.4 ± 4.1 (= 0.04).Comparing the average pre-operative Wexner score for incontinence (11, IQR: 7-15) to the median post-operative score for incontinence (2, IQR: 0-5), there was also a significant improvement demonstrated (0.01).

RESULTS

A total of 86 patients underwent LVMR from June 2012 to August 2018. Eighty-two(95%) were female and 4 (5%) were male with a median age of 57 years (IQR: 47-70).The median hospital stay was 1 d (IQR: 1-2). The first follow-up of the patients was at 3 mo, and the second one was 6-12 mo after surgery.

The pre-operative Wexner scores were calculated during the first visit to the clinic,usually 6-9 mo prior to surgery, while the post operative Wexner scores for constipation and incontinence were calculated on forms filled in during the consecutive follow-up appointment with the patient and in some cases over a telephone conversation with the patient by one of the surgical team members. Out of the 86 patients, pre-operative data were obtained for 86 patients, while post-operative Wexner score was obtained for 80 patients, since 6 of them did not return the forms.For these 80 patients the median post-operative Wexner score for constipation was 3(IQR: 1-6), which was significantly improved compared to the median pre-operative score for constipation which was 14.5 (IQR: 10.5-18.5) (0.01). Again, comparing the median pre-operative Wexner score for incontinence, which was 11 (IQR: 7-15), to the median post-operative score for faecal incontinence, which was 2 (IQR: 0-5), there was also a significant improvement demonstrated (0.01) (Table 2).

All the procedures were completed laparoscopically, and there was no surgery related mortality recorded. No mesh related infection or erosion was recorded,although there was 1 case of diskitis that had to be treated with antibiotics after seen in the clinic for a follow-up. One of the patients developed an incarcerated femoral hernia post-surgery, which was seen intraoperatively but not repaired since the patient was not consented for that procedure, and it was repaired on day 2. Out of the 86 patients, 3 (3.4%) had issues with chronic pelvic pain after the procedure. Two of the patients complained of a foreign body sensation/irritation in rectum and were found to have a suture protruding through the rectum that was removed in clinic, which was followed by immediate relief of their symptoms. Out of the 86 patients, 4 (4.6%) of them came back with a recurrence of symptoms, 3 (2.3%) of which had a posterior prolapse recurrence and 2 of which eventually underwent a modified Delorme’s procedure.

Overall recurrence at 12 mo was estimated with the Kaplan-Meier method as 1.4%(95%CI: 0.3%#4.0%), 7% (95%CI: 6.1%#15.5%) at 2 years and 11% (95%CI: 6.7%#16.8%)at 3 years (Figure 2).

DISCUSSION

This is a retrospective study of 86 consecutive patients that underwent LVMR from June 2012 to August 2018 in University Hospital of Wishaw. For 40 of them obstructive defecation was the main symptom, for 38 it was both obstructive defecation and faecal incontinence, 5 (5.8%) presented with pain and bleeding related to full thickness rectal prolapsed and 3 with mainly symptoms of faecal incontinence. All patients had a full history and physical examination, and a lower gastrointestinal endoscopic assessment.All, except those with obvious full thickness rectal prolapse, underwent a defecating proctogram, while 9 of them (10%) had anorectal physiology studies. Seven (0.08%)patients with not so clear symptoms and findings required an examination of the anorectum under general anaesthesia prior to the procedure. A detailed obstetric and pelvic surgery history was taken for women, and following formal development of Pelvic Floor multidisciplinary, all the patients were discussed on a monthly basis at the pelvic floor multidisciplinary team (Table 1).

When LVMRs are compared to resectional and posterior rectopexies, the functional results are better, especially since there is no interference with the sacral nerves and therefore fewer issues with slow transit constipation[11]. Other surgical procedures such as stapled transanal rectal resection can be used for rectal intussusception and obstructive defecation secondary to rectoceles as an alternative surgical approach to laparoscopic ventral mesh rectopexy[12]. However, this procedures has been associated with higher morbidity rates including pain, haemorrhage and sepsis[13].

Over the past years there has been a major concern over the use of mesh in pelvic surgery, but in our series of patients so far there were no mesh related complications,such as mesh erosion or infection. This is likely due to the consistent use of biological mesh in all of our cases, and our findings therefore come in agreement with previous studies’ findings that the mesh related complications are far less when using a biologic mesh instead of a synthetic one[4]. Although our directly obtained data of follow-up were for 1 year after surgery, the fact that there was only one colorectal surgeon that provides such surgery in Lanarkshire combined with the absence of re-referrals of previously operated patients for symptoms related to mesh complication, indirectly suggests that there was no mesh complication over a period of 5 years. Balla[4]have shown after reviewing the literature that using a biological mesh is a safer option than using a synthetic one, especially since the synthetic and the biological meshrelated erosion rates were 1.87% and 0.22%, respectively.

Although there was an initial concern that using biological mesh might be associated with higher recurrence rate, it has been demonstrated that there was no difference in recurrence when using a biological mesh compared to a synthetic one[11]. It has also been suggested that biological mesh should be preferred in patients with a high risk of fistula formation, such as those with diverticular disease, Crohn's disease, previous pelvic irradiation and steroid use[12]. Additionally, in another study,Mercer-Jones[13] suggested it could be prudent to use a biological mesh in young adolescents or women of child-bearing age regardless of the higher cost.

Complications were observed in the current study. Lumbosacral discitis near the site of mesh fixation to the sacral promontory was observed in 1 patient. This is a rare but serious complication with patients typically presenting 1-3 mo after the initial operation with severe lower back pain, fever and malaise[14]. In this case, magnetic resonance imaging confirmed the diagnosis, and broad spectrum antibiotics were given as they are the treatment of choice[14,15]. Although an uncommon complication,it should always be considered for patients that present with lower back pain after an LVMR[14,15]. Two patients presented with rectal symptoms of discharge and discomfort and were found to have ethibond suture erosion into their rectum. This is likely related to the suturing technique or the material itself, although there is no report of this complication in the literature so far[16]. In both patients, symptoms improved dramatically after transanal removal of sutures at outpatient/endoscopy room.

In conclusion, our study adds more evidence to support that LVMR using biological mesh is a safe and effective procedure for the treatment of rectal prolapse and that it significantly improves bowel symptoms of obstructive defecation and faecal incontinence in patients with not only full thickness prolapse but also internal rectal prolapse and rectoceles[6,7,17,19]. In our study there were no mesh related complications, and this result correlates with the low biological mesh complication rate reported in other studies[4,13]. Our recurrence rates are in line with the ones reported in the literature[16], and although we acknowledge that the direct follow-up period was short, the absence of re-referral of those previously operated patients over the period of 5 years would indirectly suggest the safety of the mesh over longer periods.However, our continued effort is to follow this group of patients more directly and continue to assess formally their quality of life in the near future.

此外，對于延伸組分除只按碳數(shù)進行歸類外(處理方式1)，一般還將苯、甲苯、環(huán)己烷、甲基環(huán)己烷等組分進行單獨定量分析(處理方式2)，兩個實際天然氣樣品按照數(shù)據(jù)處理方式2獲得的結(jié)果見表2。

總體思路是推進公共服務(wù)領(lǐng)域的供給側(cè)結(jié)構(gòu)性改革，增強基本公共服務(wù)供給的均等化程度，增加非基本公共服務(wù)供給的多元化水平，更好地解決人民日益增長的美好生活需要與不平衡不充分發(fā)展之間的矛盾。結(jié)合本文的實證檢驗結(jié)論，對如何推進公共服務(wù)領(lǐng)域的供給側(cè)結(jié)構(gòu)性改革，提出以下政策建議：

In our study, we had 4 patients that had a recurrence of their symptoms (4.6%). A systematic review of the literature by Samaranayake[17] has demonstrated that across various studies with median follow-up ranging from 3 to 106 mo the recurrence rates varied from 0%-15.4%. Our Kaplan Meier analysis revealed a 2 year recurrence rate of 7%, which can be compared to other studies like McLean[5] who demonstrated a recurrence rate of 9.74% (95%CI: 6.1%#15.5%) at 2 years.

Pre-operative and post-operative Wexner score values for constipation and incontinence were inserted in tables. The median and interquartile range (IQR) values were calculated, and comparison and analysis between pre-operative and postoperative values were performed using the Wilcoxon signed rank test. Complication and recurrence rates were evaluated and analysed using the Kaplan-Meier method. Avalue < 0.05 was considered as significant. Libreoffice Calc 6.2.8 was used for the calculations (The Document Foundation).

2. D動詞辨析。tell告訴，講述，強調(diào)一個人說；say說，強調(diào)說的內(nèi)容；talk不及物動詞，談話，多和介詞搭配使用；speak演講，發(fā)言，說某種語言。聯(lián)系下文，可知此處指的是面對面和你談?wù)撐业南敕?，故選D。

There was an overall improvement of the daily life activity for the majority of patients, which correlates with the results of other studies[4,17,18]. McLean[5]demonstrated patient satisfaction levels of 93% at 5 years, Consten[19] showed that both rates of faecal incontinence and obstructed defecation decreased significantly after LVR compared to the preoperative incidence.

CONCLUSION

對照組中出現(xiàn)不良事件患者共8例，不良事件發(fā)生率為18.18%；再住院患者為10例，再住院率為22.72%；觀察組中出現(xiàn)不良事件患者共3例，不良事件發(fā)生率為6.82%，再住院患者2例，再住院率為4.55%。觀察組患者的不良事件發(fā)生率及在住院率均低于對照組，差異有統(tǒng)計學意義（P＜0.05）。

Over the last few years there have been concerns about the usage of meshes in pelvic surgery, especially since serious complications have been recorded in urogynaecology procedures.

To show that the incidence of mesh-related complications, and particularly mesh erosion, after LVMRs is low, especially when a biological mesh is used. We also wanted to investigate whether there is a significant improvement in function and quality of life outcomes.

另一方面，陰離子表面活性劑溶于水能電離出Na+和陰離子基團，其中Na+能夠通過煤中原生孔裂隙進入煤體，發(fā)生離子交換，置換出煤中Ca2+、 Mg2+，另外，煤表面雖然帶負電荷，但由于煤表面存在著或多或少的缺陷，使得煤表面電荷分布不對稱，仍存在正電荷，因此煤需要將溶液中電離出的陰離子基團吸附到?jīng)]有被反離子所占的位點，以使煤表面能趨于穩(wěn)定，吸附過程示意圖如圖7所示。從煤樣的SEM圖譜(圖2)可以看出，原煤樣結(jié)構(gòu)較為均勻致密，而浸泡后的煤樣礦物顆粒的連接處有明顯的孔隙產(chǎn)生，表明煤體與有機/酸復合溶液之間不斷進行著離子交換、顆粒運移等化學反應(yīng)。

Questionnaires for the calculation of Wexner scores for constipation and incontinence were completed by 86 patients who underwent LVMR with Permacol (Biological)mesh from 2012 to 2018 at University Hospital Wishaw. The patients were followed up in the clinic 12 mo after surgery. Statistical analysis of the result included the calculation of median and interquartile range (IQR) values and comparison and analysis between pre-operative and post-operative values. Complication and recurrence rates were evaluated and analysed using the Kaplan-Meier method.

The median Wexner scores for constipation pre-operatively and post-operatively were 14.5 (IQR 10.5-18.5) and 3 (IQR: 1-6), respectively, while the median Wexner score for faecal incontinence was 11 (IQR: 7-15) and 2 (IQR: 0-5), respectively (0.01). There were 4 (4.6%) recurrences, 2 cases with erosion of a suture through the rectum and 1 patient that returned with diskitis. There were no mesh complications or mortalities.

從單個功率合成器仿真結(jié)果來看,這種新型的徑向波導空間功率合成結(jié)構(gòu)工作帶寬能夠覆蓋22 GHz～27 GHz,電磁場沿軸心對稱分布,24路輸入端口,每路插入損耗均在(14±0.2)dB內(nèi),相位本一致,呈現(xiàn)了良好幅度及相位一致性;從背靠背功率分配/合成器仿真結(jié)果來看,電場結(jié)構(gòu)規(guī)律分布,在22 GHz～27 GHz范圍內(nèi),相位具有良好周期性變化規(guī)律,最大插入損耗約為0.25 dB,回波損耗小于15 dB,整體損耗較小,駐波特性優(yōu)良。

In our results, it is demonstrated that LVMR using a biological mesh is both safe and effective for the treatment of rectal prolapse and that it fundamentally improves bowel symptoms of obstructive defecation and faecal incontinence in patients with internal rectal prolapse and symptomatic rectoceles.

Since we acknowledge that the direct follow-up period was short, we will continue our efforts to follow up our patients and formally assess their quality of life again in the near future.