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经单通道与传统腹腔镜胆囊切除术治疗后的生活质量评估:一项前瞻性随机研究。

Quality-of-life measures after single-access versus conventional laparoscopic cholecystectomy: a prospective randomized study.

机构信息

Department of Surgery, Mansoura University Hospital, Gihan El Sadat St., Dakahliya, Mansoura, Egypt.

出版信息

Surg Endosc. 2013 Jun;27(6):1896-906. doi: 10.1007/s00464-012-2625-5. Epub 2012 Dec 27.

Abstract

BACKGROUND

This study aimed to compare the short-term outcomes of single-access laparoscopic cholecystectomy (SALC) and conventional laparoscopic cholecystectomy (CLC).

METHODS

In a prospective study, patients with symptomatic cholelithiasis were randomized to SALC or CLC with follow-up at 1 week, 1 and 6 months. The primary end point of this study was to assess the total outcomes of quality of life using the EuroQoL EQ-5D questionnaire. The secondary end points were postoperative pain, analgesia requirement and duration of use, operative time, perioperative complications, estimated blood loss, hospital stay, cosmesis outcome, and number of days required to return to normal activities.

RESULTS

A total of 269 patients were prospectively randomized into two groups (125 in each group after excluding 19 patients for various reasons). The SALC procedure was done safely without intraoperative or major postoperative complications. In four SALC patients, an extra epigastric port was inserted to enhance exposure. There was no open conversion in either group. SALC patients reported better results among four of the EuroQoL EQ-5D dimensions (mobility, self-care, activity, and pain/discomfort) at 1 week after surgery, an improved pain profile at 4, 12, and 24 h, better cosmetic outcome at 1 and 6 months (P ≤ 0.01), shorter duration of need for analgesia (P ≤ 0.02), and earlier return to normal activities (P ≤ 0.026). Operative times, hospital stay, QOL at 1 and 6 months postoperatively, and estimated blood loss were similar for both procedures.

CONCLUSION

This study supports other studies that show that SALC is a feasible and promising alternative to traditional laparoscopic cholecystectomy in selected patients with better cosmesis, QOL, and improved postoperative pain results, and it can be performed with the existing laparoscopic instruments.

摘要

背景

本研究旨在比较单孔腹腔镜胆囊切除术(SALC)和传统腹腔镜胆囊切除术(CLC)的短期疗效。

方法

前瞻性研究中,将有症状性胆石症的患者随机分为 SALC 组或 CLC 组,分别于术后 1 周、1 个月和 6 个月进行随访。本研究的主要终点是使用欧洲五维健康量表(EQ-5D)问卷评估生活质量的综合结果。次要终点是术后疼痛、镇痛需求和使用时间、手术时间、围手术期并发症、估计出血量、住院时间、美容效果以及恢复正常活动所需的天数。

结果

共 269 例患者前瞻性随机分为两组(排除 19 例因各种原因不能手术的患者后,每组各 125 例)。SALC 手术安全完成,术中或术后无重大并发症。在 4 例 SALC 患者中,为增强显露而额外插入了一个上腹部切口。两组均无中转开腹。术后 1 周,SALC 组患者在 EQ-5D 的四个维度(活动、自理能力、疼痛/不适)的评分均优于 CLC 组(P≤0.01);术后 4、12、24 小时疼痛评分更低(P≤0.01);1 个月和 6 个月美容效果更好(P≤0.01);术后镇痛时间更短(P≤0.02);恢复正常活动时间更早(P≤0.026)。两组手术时间、住院时间、术后 1 个月和 6 个月的生活质量和估计出血量相似。

结论

本研究支持其他研究,表明 SALC 是一种可行且有前途的替代传统腹腔镜胆囊切除术的方法,尤其适用于美容效果、生活质量和术后疼痛改善更优的患者,且可使用现有的腹腔镜器械完成。

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