探讨单孔腹腔镜手术(SPLS)与多孔腹腔镜手术(MPLS)在妇科良、恶性肿瘤治疗中的安全性、疗效及患者满意度等。

选择2017年11月至2018年9月，于四川大学华西第二医院接受SPLS或MPLS治疗的171例妇科良、恶性肿瘤患者为研究对象，进行前瞻性对照研究。根据患者接受的腹腔镜手术治疗方式，将其分别纳入SPLS组(n＝85，接受SPLS治疗)与MPLS组(n＝86，接受MPLS治疗)。收集2组患者一般临床资料，手术失败率、手术时间、术中出血量、术后视觉模拟评分法(VAS)评分、术后排气时间、住院时间与手术前、后血红蛋白(Hb)值等手术相关指标，以及围术期并发症发生率。于术后1、4、24周，采用《身体意象问卷》，包含《身体意象量表》(BIS)和《美容量表》(CS) 2个部分，对患者对自身身体意象的满意度，以及对手术切口瘢痕的患者满意度进行调查，并分别计算BIS评分与CS评分。采用成组t检验、重复测量资料的方差分析、Mann-Whitney U检验、χ²检验或Fisher确切概率法，对上述资料进行统计学比较。本研究遵循的程序符合2013年新修订的《世界医学协会赫尔辛基宣言》要求，并与所有受试者签署临床研究知情同意书。2组患者年龄、人体质量指数(BMI)、孕次、产次、腹部手术史、术前Hb值、手术方式构成比等一般临床资料分别比较，差异均无统计学意义(P>0.05)。

①SPLS组总体手术时间为170 min(120～230 min)，显著长于MPLS组的134 min(105～210 min)，差异有统计学意义(Z＝2.204、P＝0.028)，进一步对良、恶性肿瘤患者手术时间的分层分析结果显示，SPLS组良性肿瘤患者手术时间为160 min(115～197 min)，显著长于MPLS组的120 min(100～156 min)，差异有统计学意义(Z＝2.888、P＝0.004)；而2组恶性肿瘤患者手术时间比较，差异无统计学意义(P>0.05)。SPLS组术后12、24、36 h时VAS评分分别为3分(2～3分)、2分(2～3分)、1分(1～2分)，均显著低于MPLS组的3分(2～4分)、2分(2～4分)、2分(1～2分)，并且差异均有统计学意义(Z＝2.507、2.398、3.110，P＝0.012、0.016、0.002)。SPLS组围术期并发症发生率为4.7%(4/85)，显著低于MPLS组的14.0%(12/86)，并且差异有统计学意义(χ²＝4.310、P＝0.038)。2组患者术中出血量、术后排气时间、住院时间、手术失败率及手术前、后Hb值分别比较，差异均无统计学意义(P>0.05)。②SPLS组患者术后1、4、24周BIS评分分别为(18.2±1.5)分、(18.9±0.9)分与(19.4±0.9)分，MPLS组分别为(16.8±2.3)分、(16.9±2.2)分与(17.5±2.1)分。SPLS组患者术后1、4、24周CS评分分别为(19.8±2.9)分、(20.6±1.2)分与(22.6±1.4)，MPLS组分别为(18.2±2.1)分、(18.6±1.9)分与(19.2±1.9)分。2组患者术后不同时间BIS、CS评分，经重复测量资料的方差分析结果显示：对于BIS评分，不同处理措施与时间因素无交互效应(F_{处理×时间}＝2.205、P＝0.085)；对CS评分，不同处理措施与时间因素有交互相应(F_{处理×时间}＝9.609、P<0.001)。进一步固定时间因素进行分析的结果显示，SPLS组术后1、4、24周BIS、CS评分，均分别显著高于MPLS组，并且差异均有统计学意义(P<0.05)。进一步固定处理措施因素进行分析的结果显示，SPLS组术后24周BIS、CS评分，均显著高于组内术后1、4周，术后4周BIS、CS评分亦显著高于组内术后1周，并且差异均有统计学意义(P<0.05)；MPLS组术后24周BIS、CS评分，均显著高于组内术后1、4周，差异均有统计学意义(P<0.05)。

与MPLS相比，SPLS对妇科良、恶性肿瘤的治疗具有安全性、可行性，不增加患者术中出血量及围术期并发症发生率，可减轻其术后疼痛，增加其治疗满意度。由于本研究仅为单中心非随机对照试验，仍需要大样本、多中心、随机对照试验及对患者进行更长时间随访，对SPLS治疗妇科良、恶性肿瘤的疗效及患者满意度进一步研究、证实。

To explore the safety, efficacy and patients′ satisfaction of single-port laparoscopic surgery (SPLS) and multiple-port laparoscopic surgery (MPLS) in treatment of gynecologic benign and malignant neoplasms.

A total of 171 patients with gynecologic benign and malignant neoplasms in West China Second University Hospital, Sichuan University from November 2017 to September 2018 were selected as research subjects. This study was a prospective control trial. Patients who underwent SPLS were divided into SPLS group (n=85), and patients who underwent MPLS were divided into MPLS group (n=86). Data collection included preoperative baseline characteristics, operative information such as surgical failure rate, operative duration, intraoperative blood loss volume, postoperative visual analogue scale (VAS) score, postoperative exhaust time, postoperative pain score, length of hospital stay, hemoglobin (Hb) values before and after surgery, and incidence rate of perioperative complication, etc.. At 1, 4, and 24 weeks after surgery, the Body Image Questionnaire which included two parts: Body Image Scale (BIS) and Cosmetic Scale (CS), was used to investigate patients′ satisfaction of their own body image, the satisfaction of cosmetic effect of surgical incisions, and BIS score and CS score were calculated. Independent-samples t test, repeated measures ANOVA, Mann-Whitney U test, chi-square test and Fisher′s exact test were used to compare the above clinical data. This study was in line with World Medical Association Declaration of Helsinki revised in 2013, and clinical research informed contents were signed with all participants. There were no statistical differences between two groups in general clinical data, such as age, body mass index (BMI), gravidity, parity, history of abdominal surgery, preoperative Hb value, and composition ratio of surgical methods (P>0.05).

①The overall operation time in SPLS group was 170 min (120-230 min), which was significantly longer than that in MPLS group 134 min (105-210 min), and the difference was statistically significant (Z=-2.204, P=0.028). The results of stratified analysis of operation time by benign and malignant neoplasms showed that the operation time of patients with benign neoplasms in SPLS group was 160 min (115-197 min), which was significantly longer than that in MPLS group 120 min (100-156 min), and the difference was statistically significant (Z=-2.888, P=0.004); while there was no statistical difference in operation time of patients with malignant neoplasms between two groups (P>0.05). The VAS scores in SPLS group at 12, 24, and 36 h after surgery were 3 scores (2-3 scores), 2 scores (2-3 scores), and 1 score (1-2 scores), respectively, which were significantly lower than those of MPLS group 3 scores (2-4 scores), 2 scores (2-4 scores), and 2 scores (1-2 scores), and all the differences were statistically significant (Z=-2.507, -2.398, -3.110, P=0.012, 0.016, 0.002). The incidence rate of perioperative complication in SPLS group was 4.7% (4/85), which was significantly lower than that in MPLS group 14.0% (12/86), and the difference was statistically significant (χ²=4.310, P=0.038). There were no statistical differences between two groups in intraoperative blood loss, postoperative exhaust time, length of hospital stay, surgical failure rate, and Hb values before and after surgery (P>0.05). ②The BIS of patients in SPLS group were (18.2±1.5) scores, (18.9±0.9) scores and (19.4±0.9) scores at 1, 4, and 24 weeks after surgery, and (16.8±2.3) scores, (16.9±2.2) scores and (17.5±2.1) scores, respectively in MPLS group. The CS scores of patients in SPLS group were (19.8±2.9) scores, (20.6±1.2) scores and (22.6±1.4) scores at 1, 4, and 24 weeks after surgery, and (18.2±2.1) scores, (18.6±1.9) scores, and (19.2±1.9) scores, respectively in MPLS group. Repeated measures ANOVA analysis results showed that as for BIS score, the interaction between different treatment measures and time factors was not statistically significant (F_{treatment×time}=2.205, P=0.085), while as for CS score, the interaction between different treatment measures and time factors was statistically significant (F_{treatment×time}=9.609, P<0.001). Results of further analysis by fixing time factor showed that BIS and CS scores in SPLS group at 1, 4, and 24 weeks after surgery all were significantly higher than those in MPLS group, and all the differences were statistically significant (P<0.05). Results of further analysis by fixing the factor of treatment measures showed that as for SPLS group, BIS and CS scores at 24 weeks after surgery were significantly higher than those at 1 and 4 weeks after surgery, BIS and CS scores at 4 weeks after surgery were also significantly higher than those at 1 week after surgery, and all the differences were statistically significant (P<0.05); as for MPLS group, BIS and CS scores at 24 weeks after surgery were significantly higher than those at 1, 4 weeks after surgery, and the differences were statistically significant (P<0.05).

Compared with MPLS, SPLS is a safe and feasible approach for treatment of gynecologic benign and malignant neoplasms, it does not increase intraoperative blood loss or incidence rate of perioperative complication, at the same time, it can reduce postoperative pain in patients, and increases patients′ satisfaction with treatment. Since this study is just a single-center non-randomized controlled trial, large-sample size, multi-center, randomized controlled trials and longer follow-up are still needed to further confirm the efficacy and patients′ satisfaction of SPLS in treating patients with gynecologic benign and malignant neoplasms.