Wijerathne Sujith, Agarwal Narendra, Ramzy Ahmad, Lomanto Davide
Minimally Invasive Surgical Centre, Department of Surgery, National University Health System, Singapore, Singapore,
Surg Endosc. 2014 Nov;28(11):3053-8. doi: 10.1007/s00464-014-3578-7. Epub 2014 Jun 6.
The success of laparoscopic surgery is due to the less surgical trauma, including less operative pain, complications and better cosmetics. Objective of our study was to compare in two blind randomized groups of patients, the surgical outcome of total extra-peritoneal (TEP) inguinal hernia repair using either single-port or conventional surgical technique. We will report our interim results in the first group of 50 patients.
Our study is a prospective, randomized, controlled clinical trial conducted from August 2011 to June 2013. Fifty patients aged between 21 and 80 years undergoing surgery for unilateral inguinal hernia were randomised into two groups: conventional laparoscopic TEP inguinal hernia repair versus single-port TEP repair. Clinical data on patient demographics, surgical technique and findings, postoperative complications and pain scores were collected. Primary endpoint is the postoperative pain while secondary endpoints are recurrence, chronic pain, postoperative hospital stay and complications.
Out of the 50 patients, 26 underwent single-port hernia TEP repair and 24 had conventional 3-port TEP hernia repair after randomization. Mean operative time was 51.7 (±13.4) min in the multiport group and 59.3 (±14.9) min in the single-port group, respectively (P = 0.064). Mean hospital stay was 19.7 (±4.8) h in the conventional group and 22.1 (±4.5) h in the single-port group (P = 0.079). No statistically significant differences were observed between the two groups for postoperative complications, and no recurrence reported at 11 months follow-up. There was no significant difference in the pain scores (visual analog scale) between the two groups at regular intervals post surgery.
The outcomes after laparoscopic TEP inguinal hernia repair with a single-port device are comparable to the standard three-port technique.
腹腔镜手术的成功得益于较小的手术创伤,包括手术疼痛减轻、并发症减少以及美容效果更佳。我们研究的目的是在两个盲法随机分组的患者群体中,比较使用单孔或传统手术技术进行完全腹膜外(TEP)腹股沟疝修补术的手术结果。我们将报告第一组50例患者的中期结果。
我们的研究是一项前瞻性、随机、对照临床试验,于2011年8月至2013年6月进行。50例年龄在21至80岁之间接受单侧腹股沟疝手术的患者被随机分为两组:传统腹腔镜TEP腹股沟疝修补术与单孔TEP修补术。收集了患者人口统计学、手术技术和发现、术后并发症及疼痛评分等临床数据。主要终点是术后疼痛,次要终点是复发、慢性疼痛、术后住院时间和并发症。
50例患者中,随机分组后26例行单孔疝TEP修补术,24例行传统三孔TEP疝修补术。多端口组的平均手术时间分别为51.7(±13.4)分钟,单端口组为59.3(±14.9)分钟(P = 0.064)。传统组的平均住院时间为19.7(±4.8)小时,单端口组为22.1(±4.5)小时(P = 0.079)。两组术后并发症无统计学显著差异,11个月随访时未报告复发。术后定期两组疼痛评分(视觉模拟量表)无显著差异。
使用单孔装置进行腹腔镜TEP腹股沟疝修补术后的结果与标准三孔技术相当。