Sheen Aali J, Pilkington J James, Baltatzis Minas, Tyurkylmaz Ahmed, Stathakis Panagiotis, Jamdar Saurabh, Siriwardena Ajith K
Department of Surgery, Manchester University Foundation NHS trust, M13 9WL, Manchester, UK.
Department of Biomedicine, Manchester Metropolitan University, Manchester, UK.
BMC Surg. 2018 Jul 11;18(1):46. doi: 10.1186/s12893-018-0378-3.
Minimally invasive incisional hernia repair has been established as a safe and efficient surgical option in most centres worldwide. Laparoscopic technique includes the placement of an intraperitoneal onlay mesh with fixation achieved using spiral tacks or sutures. An additional step is the closure of the fascial defect depending upon its size. Key outcomes in the evaluation of ventral abdominal hernia surgery include postoperative pain, the presence of infection, seroma formation and hernia recurrence. TACKoMESH is a randomised controlled trial that will provide important information on the laparoscopic repair of an incisional hernia; 1) with fascial closure, 2) with an IPOM mesh and 3) comparing the use of an articulating mesh-fixation device that deploys absorbable tacks with a straight-arm mesh-fixation device that deploys non-absorbable tacks.
A prospective, single-centre, double-blinded randomised trial, TACKoMESH, will establish whether the use of absorbable compared to non-absorbable tacks in adult patients undergoing elective incisional hernia repair produces a lower rate of pain both immediately and long-term. Eligible and consenting patients will be randomized to surgery with one of two tack-fixation devices and followed up for a minimum one year. Secondary outcomes to be explored include wound infection, seroma formation, hernia recurrence, length of postoperative hospital stay, reoperation rate, operation time, health related quality of life and time to return to normal daily activity.
With ongoing debate around the best management of incisional hernia, continued trials that will add substance are both necessary and important. Laparoscopic techniques have become established in reducing hospital stay and rates of infection and report improvement in some patient centered outcomes whilst achieving similarly low rates of recurrence as open surgical techniques. The laparoscopic method with tack fixation has developed a reputation for its tendency to cause post-operative pain. Novel additions to technique, such as intraoperative-sutured closure of a fascial defect, and developments in surgical technology, such as the evolution of composite mesh design and mesh-fixation devices, have brought about new considerations for patient and surgeon. This study will evaluate the efficacy of several new technical considerations in the setting of elective laparoscopic incisional hernia repair.
Name of registry - ClinicalTrials.gov Registration number: NCT03434301 . Retrospectively registered on 15th February 2018.
在全球大多数医疗中心，微创切口疝修补术已被确立为一种安全有效的手术选择。腹腔镜技术包括放置腹膜内补片，并使用螺旋钉或缝线进行固定。根据筋膜缺损大小，还需进行额外的筋膜缺损闭合步骤。腹前壁疝手术评估的关键结果包括术后疼痛、感染情况、血清肿形成和疝复发。TACKoMESH是一项随机对照试验，将提供关于切口疝腹腔镜修补术的重要信息：1）进行筋膜闭合；2）使用腹膜内补片修补术（IPOM）补片；3）比较使用可部署可吸收钉的关节式补片固定装置与使用不可吸收钉的直臂式补片固定装置。
一项前瞻性、单中心、双盲随机试验TACKoMESH，将确定在接受择期切口疝修补术的成年患者中，使用可吸收钉与不可吸收钉相比，是否能在近期和长期产生更低的疼痛发生率。符合条件并同意参与的患者将被随机分配接受两种钉固定装置之一的手术，并随访至少一年。有待探索的次要结果包括伤口感染、血清肿形成、疝复发、术后住院时间、再次手术率、手术时间、健康相关生活质量以及恢复正常日常活动的时间。
围绕切口疝的最佳治疗方法仍在持续争论，继续开展有实质意义的试验既必要又重要。腹腔镜技术在缩短住院时间和降低感染率方面已得到确立，并且在一些以患者为中心的结果方面有所改善，同时疝复发率与开放手术技术相当。采用钉固定的腹腔镜方法因易导致术后疼痛而闻名。技术上的新进展，如术中缝合筋膜缺损，以及手术技术的发展，如复合补片设计和补片固定装置的演变，给患者和外科医生带来了新的思考。本研究将评估在择期腹腔镜切口疝修补术中几种新技术考量的疗效。
注册机构名称 - ClinicalTrials.gov 注册号：NCT03434301。于2018年2月15日进行回顾性注册。
