单孔内镜入路腹腔镜手术在良性附件手术中的效果：一项随机对照试验的研究方案
Effect of laparoscopy by single-port endoscopic access in benign adnexal surgery: study protocol for a randomized controlled trial.
作者信息
Schmitt Andy, Crochet Patrice, Baumstark Karine, Tourette Claire, Poizac Sabine, Pivano Audrey, Boubli Léon, Cravello Ludovic, Agostini Aubert
机构信息
Pôle de gynécologie-obstétrique et reproduction, Gynepôle, AP-HM Hôpital de la Conception, 147 bd Baille, 13005, Marseille, France.
Clinical Research Platform, Assistance Publique des Hôpitaux de Marseille, Aix-Marseille University, Marseille, France.
出版信息
Trials. 2018 Jan 15;19(1):38. doi: 10.1186/s13063-017-2429-y.
BACKGROUND
Laparoscopic surgery has become the preferred surgical approach due to a reduction in postoperative pain, better recovery, shorter hospitalization, and improved esthetic outcomes. Laparoscopic surgery with single-port laparoscopy (SPL) is a laparoscopic surgery technique that is based on making a single parietal incision using a single trocar specifically designed to allow introduction of several instruments. The level of evidence regarding the advantages of SPL in terms of postoperative pain has remained low despite several randomized studies. Adult patients exhibiting a surgical indication for an a priori benign ovarian pathology or for prophylactic purposes that can be performed by laparoscopy will be randomized to receive conventional laparoscopy (CL) or SPL. The aim of our study is to evaluate whether SPL offers advantages over CL in benign adnexal surgery.
METHODS
The patients will be evaluated preoperatively to confirm their eligibility. The perioperative data up to 24 h after the intervention, as well as the postoperative data at day 7 and at one month from the intervention will be collected. The primary outcome for the study will be the postoperative pain at 24 h ± 2 h after the intervention. The pain will be assessed by a numeric rating scale of 0-10. Other outcomes will also be assessed, such as pain at other times, the consumption of analgesics, the operative time, perioperative bleeding, the number of additional trocars in the two groups, the incidence of laparoconversion, the esthetic criteria of the scar at one month, the incidence of complications, and the quality of life at one month.
DISCUSSION
If our hypothesis is confirmed, this study will provide evidence that the use of SPL can decrease postoperative pain in adnexal surgery. The standard surgical treatment of this condition would thus be modified.
TRIAL REGISTRATION
ClinicalTrials.gov, NCT02739724 . Registered on 12 April 2016.
背景
由于术后疼痛减轻、恢复更好、住院时间缩短以及美观效果改善，腹腔镜手术已成为首选的手术方式。单孔腹腔镜手术（SPL）是一种腹腔镜手术技术，其基于使用专门设计的单孔穿刺器进行单个腹壁切口，该穿刺器允许引入多种器械。尽管有多项随机研究，但关于SPL在术后疼痛方面优势的证据水平仍然较低。表现出可通过腹腔镜进行的先验性良性卵巢病变手术指征或预防性手术指征的成年患者将被随机分组，分别接受传统腹腔镜手术（CL）或SPL。我们研究的目的是评估在良性附件手术中SPL是否比CL更具优势。
方法
将对患者进行术前评估以确认其符合条件。收集干预后24小时内的围手术期数据以及干预后第7天和第1个月的术后数据。该研究的主要结局将是干预后24小时±2小时的术后疼痛。疼痛将通过0至10的数字评分量表进行评估。还将评估其他结局，例如其他时间的疼痛、镇痛药的使用、手术时间、围手术期出血、两组中额外穿刺器的数量、中转开腹的发生率、1个月时瘢痕的美观标准、并发症的发生率以及1个月时的生活质量。
讨论
如果我们的假设得到证实，本研究将提供证据表明使用SPL可减少附件手术中的术后疼痛。因此，这种疾病的标准手术治疗方法将得到改进。
试验注册
ClinicalTrials.gov，NCT02739724。于2016年4月12日注册。
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