Evaluation of the clinical efficacy and safety of TST33 mega hemorrhoidectomy for severe prolapsed hemorrhoids

lNTRODUCTlON

The patients in the two groups were given routine preoperative preparation, improved preoperative examination, and fasted on the day of operation. All patients were given intraspinal anesthesia, and the left lateral position was used for the operation.

《淮南子·道應(yīng)訓(xùn)》中的記錄和《列子·說(shuō)符》中的內(nèi)容大體一致，只是多了老子的一句評(píng)價(jià)“故老子曰：‘大智若愚，大巧若拙’”。而這段耳熟能詳?shù)倪x千里馬的故事要告訴我們的無(wú)非是要重視事物內(nèi)在的本質(zhì)，也就是原文中說(shuō)的千里馬“其內(nèi)”(即神韻)，而忽略“其外”。劉勰引用這個(gè)故事，就是為了說(shuō)明在文學(xué)創(chuàng)作時(shí)也應(yīng)該注重內(nèi)在的本質(zhì)，不能一味注重大文體的創(chuàng)作而忽略了小文體的存在。

MATERlALS AND METHODS

General information

A total of 204 patients with severe prolapsed hemorrhoids that were admitted to the anorectal department of our hospital from April 2018 to June 2020 were selected and randomly divided into Group A and Group B, with 102 cases in each group, by a single-blind, randomized and controlled clinical research scheme. Inclusion criteria: (1) The age range of patients is 19 to 65 years; (2) The diagnostic criteria for patients with severe prolapsed hemorrhoids refer to the criteria in the Chinese Guidelines for the Diagnosis and Treatment of Hemorrhoids (2020)[3]; (3) Non-circular hemorrhoids Suspended for more than half a year, reaching Ⅲ and Ⅳ degree; (4) Conservative treatment for more than 3 mo is not effective; and (5) The research plan obtains the informed consent of patients and their families. The exclusion criteria were as follows: (1) Patients with a rectal tumor; (2) Patients with a perianal abscess, or anal fistula formation; (3) Patients with liver and kidney function diseases; (4)Patients with coagulation diseases; (5) Patients with a history of drug use or addiction; and (6) Patients with mental or psychological diseases.

Surgical methods

The symptoms are more serious and the hemorrhoids generally need to be pushed back with the hand after prolapse, so severe prolapsed hemorrhoids require surgical treatment[1,2]. The procedure for prolapse and hemorrhoids (PPH) can lift and pull the anal cushion by circular resection of the rectal mucosa approximately 2-3 cm above the tooth line and anastomosis. The advantage is that the shortterm therapeutic effect is still acceptable, but the PPH is prone to various complications after surgery,the recurrence rate is high, and the long-term curative effect is poor. The use of tissue-selecting therapy staplers (TSTs) has been reported, but reports are rare. To some extent, this operation reduces the disadvantages of the PPH caused by circular resection, but because of selective resection, the use of TSTs does not change the high recurrence rate after PPH. The TST33 mega stapler has an open window,and the resection tissue boundary is open, so more pathological hemorrhoids are able to be resected.Under the premise of solving PPH complications, the use of TSTs also improves the postoperative recurrence rate to a certain extent[3]. To further summarize and analyze the surgical treatment methods for patients with severe prolapsed hemorrhoids, this study compared the effect of TST33 mega staplers to provide a basis for clinical practice, which is reported as follows.

For patients undergoing TST33 mega stapler hemorrhoid mucosal resection surgery, the appropriate anal mirror was selected (single opening, double opening or three opening anal mirror).The anal mirror was inserted and the inner tube was removed to expose the hemorrhoid tissue to be removed, and sutured with “0” silk sutures at the distance of 2.5-5 cm from the dentate line. Sutures were only placed in the mucosa and submucosa, a needle was placed in each opening suture, and a continuous bag was used. Sutures were only placed in the mucosa and submucosa, a needle was placed in each opening suture, and a continuous bag was used. The tail wing of the stapler was opened counterclockwise. After the head and body of the stapler were completely loosened, the head of the stapler was inserted into the anal expander. The two ends of the purse line were tightened and knotted around the central rod. The suture was exported from the symmetrical side hole of the stapler body through the suture export rod. Moderate traction was performed, the stapler was screwed clockwise,and the traction rectal tissue was pulled into the stapler nail slot. At this time, the feel knob was resistant, and the pointer of the stapler indicator window was displayed in the firing range. For female patients, surgeons paid attention to whether the posterior wall of the vagina was sutured. The stapler was hit, completing the cutting and anastomosis. For a fixed wait time of 30 s, the stapler was spun counterclockwise with a loose 3/4 circle tail, and removed. Observation of anastomotic stoma was performed if there was active bleeding Line 8' sutures were used for hemostasis. The 'cat ear' in the middle of the anastomosis was ligated with “0” silk thread. External hemorrhoid stripping to the teeth near the line parallel low ligation was performed.

All study participants, or their legal guardian, provided informed written consent prior to study enrollment.

All authors report no conflict of interest.

Observation indices and evaluation criteria

The operation time, intraoperative blood loss, hospitalization time, cure rate, pain degree, anal edema degree, anal Wexner score and surgical complications were compared between the two groups.

The criteria for healing[5] were postoperative defecation or standing for a long time and no hemorrhoid prolapse when coughing, tired, and loaded was defined as a cure.

Hemorrhoids are common diseases in the anorectal system. On the one hand, the occurrence of hemorrhoids is related to varicose veins. Hemorrhoids are caused by venous congestion of the rectal submucosal and anal skin hemorrhoids[8-10]. Subnuclear prolapse aggravates venous congestion, and venous congestion aggravates the development of hemorrhoids, forming a vicious cycle. Anastomotic hemorrhoid mucosal circumcision is a traditional surgical treatment, but it has been reported that the operation has more postoperative complications and patients are prone to recurrence, mainly because the stapler used in the operation does not have enough space to remove larger amounts of rectal mucosa, resulting in incomplete resection, so the long-term effect is not good. At the same time,prolapsed hemorrhoids will lead to their own rectal elongation, expansion, volume increase, rectal muscle thinning or disappearance of pathological changes, which cannot be effectively removed and easily lead to recurrence[11,12].

The visual analogue scale (VAS) was used to evaluate the degree of pain[5], with 0 indicating no pain,and 10 indicating the most pain. The pain scores at 12 h, 24 h, 48 h, 72 h and 96 h postoperatively were observed.

Observe the edema around the anal margin on the 1

and 7

postoperative day. Degree I: no edema of the anal margin; degree II: mild edema of the anal margin occupies less than 1/4 circle of the perianal;degree III: edema of the anal margin occupies more than 1/4 circle of the perianal, and ≤ 1/2 circle;degree IV: Anal marginal edema occupies more than 1/2 circle perianal.

Tao L and Wei J design the study; Ding XF drafted the manuscript, Ji L and Tao L collected the data; Tao L and Ji L analyzed and interpreted data, Tao L and Wei J revised the manuscript.

Anal Wexner score[7] evaluates the patient’s preoperative and postoperative anal function, mainly from the patient’s stool frequency, defecation difficulty, incomplete defecation feeling, the time required for each defecation, whether defecation requires assistance, and defecation Unsuccessful times/24 h,duration of constipation, a total score of 32 points, the higher the score, the worse the anal defecation function of patients.

Statistical analysis

In this study, measurement indices such as operation time, intraoperative blood loss and hospitalization time were tested by normal distribution, which were in accordance with the approximate normal distribution or normal distribution and are expressed as mean ± SD. The

-test was used for comparisons between the two groups. Non-counting data are represented by percentages, and the

test was used for comparisons. The Mann-Whitney

test was used for comparisons of grade counting data between the groups. Professional SPSS 21.0 software for data processing was used, with the test level α = 0.05.

（2）簽證變更需一月一清，及時(shí)閉合。工程變更也是問(wèn)題頻發(fā)。通常，建設(shè)項(xiàng)目預(yù)算精準(zhǔn)，嚴(yán)格控制材料的供應(yīng)，項(xiàng)目結(jié)構(gòu)規(guī)范，隱蔽設(shè)備不多的情況下，工程項(xiàng)目的成本公開透明，施工單位利潤(rùn)可觀。工程變更就成為弄虛作假的高發(fā)地，虛開工程變更或直接偽造工程變更。

RESULTS

Baseline data comparison of patients in the A and B groups

The baseline data for age, height, weight, course of disease, sex, prolapse of hemorrhoids, constipation,bleeding and pain were compared between Group A and Group B, and the difference was not statistically significant (

＞ 0.05, Table 1).

Comparison of surgery-related indicators between Group A and Group B

The operation time, intraoperative blood loss and hospitalization time in Group A were significantly lower than those in Group B (

＜ 0.05, Table 2).

Comparison of cure rate between Group A and Group B

The cure rate of Group A was 98.04%, compared with the cure rate of 95.10% for Group B, and the difference was not statistically significant (

＞ 0.05, Table 3).

Postoperative VAS scores for Group A and Group B

The VAS scores of patients in group A at 12 h and 24 h after operation were lower than those in group B,and the difference was statistically significant (

＜ 0.05). There was no significant difference between group A and group B at 48 h, 72 h, and 96 h after operation (

＞ 0.05), as shown in Table 4.

Comparison of postoperative perianal edema between Group A and Group B

One day postoperatively, the degree of perianal edema in Group A was compared with that in Group B,and the difference was not statistically significant (

＞ 0.05). Seven days postoperatively, the degree of perianal edema in Group A was significantly lower than that in Group B (

＜ 0.05, Table 5).

Comparison of the anal Wexner score between the two groups

Comparisons of preoperative, postoperative, 1 mo, 3 mo, and 6 mo, anal Wexner scores were made between the two groups, and the difference was not statistically significant (

＞ 0.05). The Wexner scores of the two groups at 1 mo, 3 mo and 6 mo postoperatively were significantly lower than the scores preoperatively (

＜ 0.05, Table 6).

本研究所納入的臨床試驗(yàn)普遍質(zhì)量較低，缺乏高質(zhì)量、標(biāo)準(zhǔn)化的RCT。由于各研究間針刺所選穴位不同、服用的西藥和中成藥不同，且各研究間所納入患者的病情嚴(yán)重程度不一等因素的影響，造成分析過(guò)程中各研究間存在較大異質(zhì)性。在治療前后NIH-CPSI評(píng)分變化量與白細(xì)胞降低有效率作為結(jié)局指標(biāo)的分析中，由于納入的相關(guān)分析較少，得出的結(jié)果可能可靠性不強(qiáng)。故在今后要多進(jìn)行相關(guān)的臨床研究，尤其是與中藥湯劑、中藥坐浴和微波治療等方面的對(duì)比研究，且要進(jìn)行高質(zhì)量、標(biāo)準(zhǔn)化的RCT；盡量多注重治療后隨訪的結(jié)果，為針刺治療CP遠(yuǎn)期療效提供可靠證據(jù)。

Comparison of the complication rate between two groups

The postoperative complication rate of Group A was 2.94% lower than that of Group B (11.76%), which was statistically significant (

＜ 0.05, Table 7).

DlSCUSSlON

我們使用(6)式通過(guò)OLS回歸估算資本產(chǎn)出彈性α。然后代入(3)式即可得出安徽全要素生產(chǎn)率的增長(zhǎng)率。在估算之前，為避免偽回歸，需要對(duì)數(shù)據(jù)的平穩(wěn)性進(jìn)行檢驗(yàn)。

Selective supraclavicular mucosal resection was improved on the basis of traditional surgical suspension and devascularization. The mucosal and submucous tissues above the supraclavicular nucleus were selectively resected, and the normal mucosal tissues between the supraclavicular nuclei were retained, so the trauma to the patients was decreased. This study found that the operation time,intraoperative blood loss and hospitalization time in Group A were lower than those in Group B,suggesting that the use of TST33 mega stapler hemorrhoid mucosal resection in the treatment of severe prolapsed hemorrhoids has reduced trauma and shorter hospitalization times, which is basically consistent with the conclusions of previous studies[13,14]. TST33 mega stapler hemorrhoid mucosal resection surgery has a large window vision, and the operation is smoother. The large window has no resection limitation, and the resection range is greater, which can fully allow for the “pulling” effect but also protect normal tissue. At the same time, the operation height is reduced. The operation height ofthe PPH is 4 cm, and the operation height of the TST33 mega stapler is 2.5-3.5 cm. This height can partially remove hemorrhoid tissue and reduce the recurrence rate to a certain extent. In this study, the postoperative complication rate of Group A was 2.94% lower than that of Group B (11.76%), suggesting that TST33 mega stapler hemorrhoid mucosal resection can reduce the incidence of surgical complications in patients with severe prolapsed hemorrhoids.

This study also showed that the VAS scores at 12 h and 24 h after the operation in Group A were lower than those in Group B, suggesting that TST33 mega stapler mucosal resection for severe prolapsed hemorrhoids could significantly reduce postoperative pain. There are many influencing factors for postoperative pain. TST33 mega stapler hemorrhoid mucosal resection surgery is performedabove the dentate line, where the dominant nerve is mainly the visceral nerve, which is not sensitive to pain. There is less resected rectal mucosa, so the postoperative pain is relatively reduced[15]. This study also found that 7 d after the operation, the degree of perianal edema in Group A was lower than that in Group B, suggesting that TST33 mega stapler hemorrhoid mucosal resection in the treatment of severe prolapsed hemorrhoids for postoperative perianal edema was reduced to some extent, and two surgical methods for the treatment of severe prolapsed hemorrhoids can improve anal function. TST33 mega stapler hemorrhoid mucosal resection reduces the number of anastomotic nails implanted and reduces the anal bulge, thus protecting anal contraction defecation functions[16,17].

In the process of the operation, we believe that attention should be given to the following aspects.First, the appearance of a “cat ear” between anastomotic stomas after TST operation is very common.Ligation with “0” silk thread is a simple, safe and reliable method. Second, surgeons should check whether there is bleeding in the anastomotic stoma carefully before removing the anal mirror, and the bleeding tendency should be removed to stop bleeding by “8” sutures to strengthen the anastomotic stoma. Third, the size of the resected tissue should be evaluated before the operation and the height and mode of the purse suture should be adjusted according to the need to play an individualized treatment role. Fourth, the height of the purse-string should be appropriately lowered. Choose 2.5 cm-3.5 cm on the tooth line, and remove part of the internal hemorrhoid tissue, which has a certain value for improving the postoperative curative effect[18-20].

This study analyzed the advantages of TST33 mega stapler hemorrhoid mucosal resection in the treatment of severe prolapsed hemorrhoids and showed the reduced incidence of postoperative complications, which was in line with the patient-oriented treatment concept of modern surgery and provided a certain basis for the clinical operation in the treatment of severe prolapsed hemorrhoids.However, due to the small number of cases included in this study, the lack of a large sample with a long-term follow-up and survey, the long-term efficacy and recurrence need to be further evaluated by increasing the sample size, improving the corresponding observation index, and carrying out prospective studies with in-depth analysis.

實(shí)驗(yàn)方法：將已經(jīng)收集好的石蠟包埋的組織標(biāo)本，逐個(gè)放置于切片機(jī)上，將蠟塊與刀刃的位置和角度調(diào)好之后，制成5μm，邊緣整齊平整的組織切片2張，而且卵巢癌患者蠟塊要求每個(gè)組織切片中均含有瘤巢。免疫組化的操作步驟按照說(shuō)明書進(jìn)行烤片脫水、脫蠟、水化-高溫高壓抗原熱修復(fù)-滴加一抗-4°C冰箱中保存過(guò)夜-放入PBS緩沖液中清洗后滴加二抗-DBA染色-蘇木精復(fù)染、分化返藍(lán)——脫水、封片。其中一抗中抗EGR-1抗體稀釋濃度為1：100；抗HER-2抗體稀釋濃度為 1：150。

CONCLUSlON

In summary, TST33 mega stapler hemorrhoid mucosal resection in the treatment of patients with severe prolapsed hemorrhoids yielded satisfactory results, less postoperative pain, perianal edema recovery block, and fewer complications.

炳發(fā)呀！我今年是十九歲了，我難道一點(diǎn)兒不知道嗎？每次看到天上的月亮圓了，花園里的花開了，想起我們的青春年少……

ARTlCLE HlGHLlGHTS

FOOTNOTES

1.切實(shí)保障中小企業(yè)的發(fā)展。政府部門需要加強(qiáng)立法，通過(guò)相關(guān)的法律規(guī)定來(lái)推動(dòng)中小企業(yè)的有序發(fā)展，為中小企業(yè)提供良好的環(huán)境。從整個(gè)中小企業(yè)的發(fā)展以及社會(huì)經(jīng)濟(jì)發(fā)展的方向，重視中小企業(yè)的發(fā)展，加強(qiáng)中小企業(yè)的規(guī)范，對(duì)中小企業(yè)的管理模式進(jìn)行科學(xué)有效地設(shè)計(jì)，密切關(guān)注中小企業(yè)的發(fā)展方向，包括中小企業(yè)的資金運(yùn)用以及中小企業(yè)的戰(zhàn)略決策等，逐步推動(dòng)中小企業(yè)產(chǎn)業(yè)結(jié)構(gòu)的升級(jí)。

Special Project of Diagnosis and Treatment Technology for Key Clinical Diseases in Suzhou, No.LCZX202022; and Changshu Municipal Science and Technology Bureau Supporting Project, No. CS201925.

This study was approved by the Changshu Hospital Affiliated to Nanjing University of Chinese Medicine.

The PPH was used for the treatment of hemorrhoids, and a PPH stapler was used for the treatment of internal hemorrhoids. External hemorrhoid stripping to the teeth near the line parallel low ligation was performed.

The patients in the two groups could go to the recovery unit after anesthesia recovery, and their diet gradually changed from a half-stream diet to an ordinary diet. The total infusion volume was controlled within 500 mL 6 h after the operation to reduce the incidence of urinary retention. Antibiotics were routinely used for 5 d after the operation, and dressing treatment was performed after sitting in the bath.

No additional data are available.

The authors have read the CONSORT 2010 statement, and the manuscript was checked according to the CONSORT 2010 statement.

This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BYNC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is noncommercial. See: https://creativecommons.org/Licenses/by-nc/4.0/

傳統(tǒng)數(shù)理統(tǒng)計(jì)的內(nèi)容包括哪些呢？雖然不同的教科書在編排上有所不同，但大同小異，主要包括：樣本及抽樣分布（隨機(jī)樣本、直方圖、統(tǒng)計(jì)量、抽樣分布）、參數(shù)估計(jì)（參數(shù)的點(diǎn)估計(jì)、估計(jì)量的評(píng)選標(biāo)準(zhǔn)、參數(shù)的區(qū)間估計(jì)、正態(tài)總體均值與方差的區(qū)間估計(jì)、置信區(qū)間）、假設(shè)檢驗(yàn)（正態(tài)總體均值與方差的假設(shè)檢驗(yàn)、分布擬合檢驗(yàn)）、方差分析和回歸分析（單因素試驗(yàn)的方差分析、一元回歸分析）．

China

Liu Tao 0000-0002-6962-7122; Jun Wei 0000-0002-7216-0375; Xu-Feng Ding 0000-0002-2858-375X; Li-Jiang Ji 0000-0003-4416-8334.

某深埋隧洞工程全長(zhǎng)50 km多，最大埋深超過(guò)2 200 m，屬于無(wú)壓洞，隧洞洞徑5.3 m。采用TBM與鉆爆法相結(jié)合的施工方案。隧洞自南向北穿越多個(gè)地質(zhì)構(gòu)造單元，圍巖巖性復(fù)雜多變，主要包括志留系、泥盆系、石炭系砂巖、變質(zhì)砂巖、凝灰?guī)r、凝灰質(zhì)砂巖以及華力西期花崗巖，少量為奧陶系灰?guī)r和第三系泥巖，除第三系泥巖為軟巖外，其余屬硬巖類。

Wang JL

A

β2-MG是由淋巴細(xì)胞或者其他有核細(xì)胞分泌一種內(nèi)源性低分子量血清蛋白質(zhì)。血清中的99.9%的β2-MG會(huì)被近曲小管細(xì)胞重吸收和降解，不再向血液中反流，以此保持β2-MG在體內(nèi)的恒定。但當(dāng)近曲小管輕度受損時(shí)，尿液中β2-MG會(huì)顯著增加[7]，可見人體腎臟的損傷程度與β2-MG具有明顯的對(duì)應(yīng)關(guān)系。

Wang JL

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