腹腔镜结直肠手术中腹内压升高对急性胃肠损伤影响的前瞻性研究

Effect of elevated intra-abdominal pressure on acute gastrointestinal injury in laparoscopic colorectalsurgery： a prospective study

目的探讨腹腔镜结直肠手术中c0：气腹压力升高对急性胃肠损伤（AGI）的影响。方法选取2014年1-6月上海交通大学医学院附属瑞金医院行腹腔镜结直肠手术的66例结直肠癌患者进行前瞻性研究，采用随机、双盲对照法，通过随机数将入组患者随机分为3组，分别为10mrnHg（1mmHg=0．133kPa）组、12mmHg组和15mmHg组。3组患者术中c02气腹压力分别设定为10mmHg、12mmHg和15mmHg。主要观察指标：记录患者术中情况、术后恢复情况、检测患者IL-6及TNF-α水平。正态分布的计量资料以x±s表示，组间比较采用单因素方差分析。非正态分布的计量资料以M（Qn）表示，采用非参数检验。计数资料以频数和百分比表示，组间比较采用，检验。结果筛选出符合研究条件的患者66例，3组各22例。研究过程中11例患者退出（10mmHg组3例、12mmHg组3例、15mmHg组5例）。3组患者术后6h内拔除鼻胃管的患者分别为19、18、14例，3组比较，差异无统计学意义（X^2=3．55，P〉0．05）。3组患者中分别有0、1、2例发生术后非AGI早期腹腔内并发症，3组比较，差异无统计学意义（r=5．82，P〉0．05），且均经保守治疗后治愈，无短期内再手术。15例患者出现AGI，其中AGII级8例，AGIⅡ级7例。10mmHg组、12mmHg组、15mmHg组患者AGI发生比例分别6／19、3／19、6／17，AGI严重程度AGII、Ⅱ级分别为2例和4例、2例和1例、4例和2例，3组比较，差异均无统计学意义（X^2=2．04，2．00，P〉0．05）。10mmHg组、12mmHg组、15mmHg组患者术后肠麻痹发生比例分别为4／19、3／19、4／17，肠蠕动恢复时间分别为（37±25）h、（26±16）h、（33±12）h，首次肛门排气或排便时间分别为31．3h（16．8h，45．6h）、40．8h（20．9h，64．5h）、31．9h（20．8h，51．0h），耐受半流质饮食时间分别为142．3h（118．9h，144．9h）、137．4h（118．7h，143．4h）、139．5h（119．1h，145．5h），术后呕吐各1例，术后腹泻分别为5、3、4例，术后住院时间分别为8d（8d，9d）、8d（8d，9d）、8d（8d，10d），3组比较，差异均无统计学意义（X^2=0．46，F=1．64,X^2=1．22，1．27，0．ol，0．76，0．90，P〉0．05）。10mmHg组、12mmHg组、15mmHg组患者术前血清IL-6水平分别为2．0ng／L（2．0ng／L，2．7ng／L）、2．8．g／L（2．0．g／L，5．9ng／L）、2．1ng/L（2．0ng／L，3．0．g／L），术后1d血清IL-6水平分别为分别为10．7．g／L（7．5ng／L，17．7ng／L）、11．3ng/L（5．4．g／L，14．5．g／L）、9．4ng／L（6．7．g／L，18．2ng／L），各组术前和术后比较，差异均有统计学意义（Z=-3．93，-3．46，-4．12，P〈0．05）；但3组患者术后血清IL-6水平比较，差异无统计学意义（X^2=0．43，P〉0．05）。3组患者IL-6水平增加幅度比较，差异无统计学意义（X^2=2．65，P〉0．05）。10mmHg组、12mmHg组、15mmHg组患者术前血清TNF-α水平分别为9．5ng／L（7．4ng／L，10．7ng／L）、9．4ng／L（8．5ng／L，13．4ng／L）、8．5ng／L（7．8．g／L，9．5ng／L），术后血清TNF-d水平分别为9．0ng／L（8．5ng／L，12．5．g／L）、10．3ng／L（7．8ng／L，12．0ng／L）、8．2ng／L（6．4ng／L，12．2ng／L），各组术前和术后比较，差异均无统计学意义（Z=-1．10，-0．02，-0．68，P〉0．05）；3组患者术后血清TNF-α水平比较，差异无统计学意义（X^2=2．61，P〉0．05）。11例发生术后肠麻痹患者术后血清IL-6水平为10．7ng／L（6．8，14．7ng／L），44例未发生肠麻痹患者血清IL-6水平为10．6ng／L（6．9ng／L，18．1ng／L），两者比较，差异无统计学意义（z=-0．03，P〉0．05）。结论腹腔镜结直肠手术后AGI的发生与术中腹内压力升高无关。临床试验注册：在中国临床试验注册中心注册，注册号为ChiCTR-TRC-13003292。

Objective To investigate the effect of elevated CO2 intra-abdominal pressure on acute gastro- intestinal injury （AGI） during laparoscopic colorectal surgery. Methods The clinical data of 66 patients who underwent laparoscopic colorectal surgery at the Ruijin Hospital of Shanghai Jiaotong University School of Medicine from January 2014 to June 2014 were prospectively analyzed. A double blind, randomized, controlled study was performed in the 66 patients who were allocated into the 10 mmHg group （ 1 mmHg = 0. 133 kPa） , 12 mmHg group and 15 mmHg group based on a random number table and setting value of intraoperative CO2 intra-abdominal pressure （10 mmHg, 12 mmHg and 15 mmHg）. The main observation indicators such as intraoperative conditions and postoperative recovery were recorded and the levels of serum IL-6 and TNF-α were detected. Measurement data with normal distribution were presented as x ± s, and comparison among groups was analyzed using the one- way ANOVA. Non-normal distribution data were described as M （Qn） and analyzed by the nonparametric test, count data were presented as the frequency and percentage, and comparison among groups was analyzed using the chi-square test. Results Sixty-six patients were screened for eligibility, and were allocated into the 10 mmHg group, 12mmHg group and 15mmHg group （22 patients in each group） , and 11 patients dropped out of the study （3 in the 10 mmHg group, 3 in the 12 mmHg group and 5 in the 15 mmHg group）. The number of patients with nasogastric tube removal within postoperative hour 6 in the 3 groups were 19, 18 and 14, with no significant difference among the 3 groups （X： = 3.55, P 〉 0.05）. There were 0, 1 and 2 patients in the 3 groups complicated with postoperative early abdominal complications without AGI, showing no significant difference among the 3 groups （X^2=5.82, P 〉 O. 05 ）, and they were cured by the conservative treatment without reoperation in the short term. Fifteen patients had AGI, including 8 with grade I of AGI and 7 with grade I of AGI. The incidence ratio of AGI and number of patients with grade I and grade 11 of AGI were 6/19, 2 and 4 in the 10 mmHg group, 3/19, 2 and 1 in the 12 mmHg group and 6/17, 4 and 2 in the 15 mmHg group, respectively, with no significant difference among the 3 groups （X^2 = 2. 04, 2. 00, P 〉 0.05 ）. The incidence ratio of postoperative intestinal paralysis, time of intestinal peristalsis recovery, time to anal exsufflation or defecation, tolerant time for semi-fluid diet intake, number of patients with postoperative vomiting, number of patients with postoperative diarrhea and duration of hospital stay were 4/19, （37 ±25） hours, 31.3 hours（ 16.8 hours, 45.6 hours）, 142.3 hours（ll8.9 hours, 144.9 hours）, 1, 5, 8 days（8 days, 9 days） in the 10 mmHg group, 3/19, （26 ± 16）hours, 40.8 hours（20.9 hours, 64.5 hours）, 137.4 hours（ll8.7 hours, 143.4 hours）, 1, 3, 8 days （8 days, 9 days） in the 12 mmHg group and 4/17, （33 ± 12） hours, 31.9 hours（20.8 hours, 51.0 hours）, 139.5 hours （119.1 hours, 145.5 hours） , 1,4, 8 days（8 days, 10 days） in the 15 mmHg group, respectively, showing no significant difference among the 3 groups （X：^2= 0. 46, F = 1.64, X^2 = 1.22, 1.27, 0. 01, 0. 76, 0. 90, P〉0.05）. The levels of serum IL-6 in the 10 mmHg group, 12 mmHg group and 15 mmHg group were 2.0 ng/L （2.0 ng/L, 2.7 ng/L）, 2.8 ng/L（2.0 ng/L, 5.9 ng/L） and 2.1 ng/L（2.0 ng/L, 3.0 ng/L） before operation and 10.7 ng/L（7.5 ng/L, 17.7 ng/L）, 11.3 ng/L（5.4 ng/L, 14.5 ng/L） and 9.4 ng/L（6.7 ng/L, 18.2 ng/L） at postoperative day 1, respeetively, with significant differences between pre- and post-operative levels of serum IL-6 among the 3 groups （Z = - 3. 93, - 3. 46, - 4. 12, P 〈 0.05 ）, with no significant differences in the postoperative levels and increasing range of serum IL-6 among the 3 groups （X^2 = 0. 43, 2. 65, P 〉 0.05 ）. The pre- and post-operative levels of serum TNF-α in the 10 mmHg group, 12 mmHg group and 15 mmHg group were 9.5 ng/L（7.4 ng/L, 10.7 rig/L）, 9.4 ng/L（8.5 ng/L, 13.4 ng/L）, 8.5 ng/L（7.8 ng/L, 9.5 ng/L） and 9.0 ng/L（8.5 ng/L, 12.5 ng/L）, 10.3 ng/L（7.8 ng/L, 12.0 ng/L）, 8.2 ng/L（6.4 ng/L, 12.2 ng/L）, respectively, with no significant differences in the pre- and post-operative levels of serum TNF-oL among the 3 groups （Z =- 1.10, -0. 02, -0. 68, P 〉0.05）, and with no significant difference in the postoperative levels of serum TNF-α among the 3 groups （X2= 2.61, P 〉 O. 05）. The levels of serum IL-6 were 10.7 ng/L（6.8 ng/L, 14.7 ng/L）in 11 patients with postoperative intestinal paralysis and 10.6 ng/L（6.9 ng/L, 18. 1 ng/L） in 44 patients without postoperative intestinal paralysis, with no significant difference （ Z = - 0. 03, P 〉 0.05 ）. Conclusion There is no correlation between elevated CO2 intra-abdominal pressure and AGI after laparoscopic colorectal surgery. Registry： This study was registered with the Chinese Clinical Trial Registry with the registry number of ChiCTR-TRC-13003292.