Department of Surgery, Kyoto University Hospital, Kyoto, Japan.
Department of Health Promotion and Human Behavior, Kyoto University Graduate School of Medicine/School of Public Health, Kyoto, Japan.
Cochrane Database Syst Rev. 2021 Sep 15;9(9):CD012998. doi: 10.1002/14651858.CD012998.pub2.
Gastric cancer is the fifth most common cancer diagnosed worldwide. Due to improved early detection rates of gastric cancer and technological advances in treatments, a significant improvement in survival rates has been achieved in people with cancer undergoing gastrectomy. Subsequently, there has been increasing emphasis on postgastrectomy syndrome (e.g. fullness, delayed emptying, and cold sweat, amongst others) and quality of life postsurgery. However, it is uncertain which types of reconstruction result in better outcomes postsurgery.
To assess the evidence on health-related quality of life and safety outcomes of Roux-en-Y and Billroth-I reconstructions after distal gastrectomy for people with gastric cancer.
We searched the Cochrane Library and the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, and Embase on 4 May 2021. We checked the reference lists of the included studies and contacted manufacturers and professionals in the field. There were no language restrictions.
Randomised controlled trials (RCTs) allocating participants to Roux-en-Y reconstruction or Billroth-I reconstruction after distal gastrectomy for gastric cancer.
Two review authors independently screened studies identified by the search for eligibility and extracted data. The primary outcomes were health-related quality of life after surgery and incidence of anastomotic leakage. The secondary outcomes included body weight loss, incidence of bile reflux, length of hospital stay, and overall morbidity. We used a random-effects model to conduct meta-analyses. We assessed risk of bias of the included studies in accordance with the Cochrane Handbook for Systematic Reviews of Interventions, and the certainty of the evidence using the GRADE approach.
We included eight RCTs (942 participants) in the review. One study included both cancer patients and benign disease patients such as stomach ulcers. Two studies compared Roux-en-Y, Billroth-I, and Billroth-II reconstructions, whilst the other studies compared Roux-en-Y and Billroth-I directly. For the primary outcomes, the evidence suggests that there may be little to no difference in health-related quality of life between Roux-en-Y and Billroth-I reconstruction (standardised mean difference 0.04, 95% confidence interval (CI) -0.11 to 0.18; I² = 0%; 6 studies; 695 participants; low-certainty evidence due to study limitations and imprecision). The evidence for the effect of Roux-en-Y versus Billroth-I reconstruction on the incidence of anastomotic leakage is very uncertain (risk ratio (RR) 0.63, 95% CI 0.16 to 2.53; I² = 0%; 5 studies; 711 participants; very low-certainty evidence). The incidence of anastomotic leakage was 0.6% and 1.4% in the Roux-en-Y and Billroth-I groups, respectively. For the secondary outcomes, the evidence suggests that Billroth-I reconstruction may result in little to no difference in loss of body weight compared to Roux-en-Y reconstruction (mean difference (MD) 0.41, 95% CI -0.77 to 1.59; I² = 0%; 4 studies; 541 participants; low-certainty evidence). Roux-en-Y reconstruction probably reduces the incidence of bile reflux compared to Billroth-I reconstruction (RR 0.40, 95% CI 0.25 to 0.63; I² = 22%; 4 studies; 399 participants; moderate-certainty evidence). Billroth-I reconstruction may shorten postoperative hospital stay, but the evidence for this outcome is very uncertain (MD 0.96, 95% CI 0.16 to 1.76; I² = 56%; 7 studies; 894 participants; very low-certainty evidence). Billroth-I reconstruction may reduce postoperative overall morbidity compared to Roux-en-Y reconstruction (RR 1.47, 95% CI 1.02 to 2.11; I² = 0%; 7 studies; 891 participants; low-certainty evidence).
AUTHORS' CONCLUSIONS: The evidence suggests that there is little to no difference between Roux-en-Y and Billroth-I reconstruction for the outcome health-related quality of life. The evidence for the effect of Roux-en-Y versus Billroth-I reconstruction on the incidence of anastomotic leakage is very uncertain as the incidence of this outcome was low. Although the certainty of evidence was low, we found some possibly clinically meaningful differences between Roux-en-Y and Billroth-I reconstruction for short-term outcomes. Roux-en-Y reconstruction probably reduces the incidence of bile reflux into the remnant stomach compared to Billroth-I reconstruction. Billroth-I reconstruction may shorten postoperative hospital stay compared to Roux-en-Y reconstruction, but the evidence is very uncertain. Billroth-I reconstruction may reduce postoperative overall morbidity compared to Roux-en-Y reconstruction. Future trials should include long-term follow-up of health-related quality of life and body weight loss.
胃癌是全球第五大常见癌症。由于胃癌早期检测率的提高和治疗技术的进步,接受胃切除术的癌症患者的生存率有了显著提高。因此,人们越来越关注胃切除术后的术后综合征(如饱胀、排空延迟和冷汗等)和术后生活质量。然而,尚不确定哪种重建类型会带来更好的术后结果。
评估 Roux-en-Y 和 Billroth-I 重建术在胃癌远端胃切除术后对患者健康相关生活质量和安全性结局的影响。
我们于 2021 年 5 月 4 日在 Cochrane 图书馆和 Cochrane 对照试验中心注册库(CENTRAL)、MEDLINE 和 Embase 上进行了检索。我们检查了纳入研究的参考文献,并联系了该领域的制造商和专业人士。无语言限制。
将参与者随机分配至 Roux-en-Y 重建术或 Billroth-I 重建术的随机对照试验(RCT),用于胃癌的远端胃切除术。
两位综述作者独立筛选了搜索到的研究,以确定其是否符合入选标准,并提取了数据。主要结局是术后健康相关生活质量和吻合口漏的发生率。次要结局包括体重减轻、胆汁反流发生率、住院时间和总体发病率。我们使用随机效应模型进行荟萃分析。我们根据 Cochrane 干预措施系统评价手册评估了纳入研究的偏倚风险,并使用 GRADE 方法评估了证据的确定性。
我们纳入了 8 项 RCT(942 名参与者)。一项研究同时包括了癌症患者和良性疾病患者,如胃溃疡。两项研究比较了 Roux-en-Y、Billroth-I 和 Billroth-II 重建术,而其他研究则直接比较了 Roux-en-Y 和 Billroth-I 重建术。对于主要结局,证据表明 Roux-en-Y 和 Billroth-I 重建术在健康相关生活质量方面可能没有差异(标准化均数差 0.04,95%置信区间(CI)-0.11 至 0.18;I²=0%;6 项研究;695 名参与者;由于研究局限性和不精确性,证据质量为低,证据确定性低)。Roux-en-Y 与 Billroth-I 重建术对吻合口漏发生率的影响证据非常不确定(风险比(RR)0.63,95%CI 0.16 至 2.53;I²=0%;5 项研究;711 名参与者;极低确定性证据)。吻合口漏的发生率分别为 Roux-en-Y 组的 0.6%和 Billroth-I 组的 1.4%。对于次要结局,证据表明 Billroth-I 重建术与 Roux-en-Y 重建术相比,体重减轻的发生率可能没有差异(平均差值(MD)0.41,95%CI-0.77 至 1.59;I²=0%;4 项研究;541 名参与者;低确定性证据)。Roux-en-Y 重建术可能比 Billroth-I 重建术减少胆汁反流的发生率(RR 0.40,95%CI 0.25 至 0.63;I²=22%;4 项研究;399 名参与者;中等确定性证据)。Billroth-I 重建术可能会缩短术后住院时间,但这一结果的证据非常不确定(MD 0.96,95%CI 0.16 至 1.76;I²=56%;7 项研究;894 名参与者;极低确定性证据)。Billroth-I 重建术与 Roux-en-Y 重建术相比,术后总体发病率可能降低(RR 1.47,95%CI 1.02 至 2.11;I²=0%;7 项研究;891 名参与者;低确定性证据)。
证据表明,Roux-en-Y 和 Billroth-I 重建术在健康相关生活质量方面的结果没有差异。Roux-en-Y 与 Billroth-I 重建术对吻合口漏发生率的影响证据非常不确定,因为该结局的发生率较低。尽管证据确定性较低,但我们发现 Roux-en-Y 和 Billroth-I 重建术在短期结局方面可能存在一些有临床意义的差异。Roux-en-Y 重建术可能比 Billroth-I 重建术减少胆汁反流到残胃的发生率。与 Roux-en-Y 重建术相比,Billroth-I 重建术可能会缩短术后住院时间,但证据非常不确定。与 Roux-en-Y 重建术相比,Billroth-I 重建术可能降低术后总体发病率。未来的试验应包括对健康相关生活质量和体重减轻的长期随访。