Ibañez N, Abrisqueta J, Luján J, Hernández Q, Parrilla P
Colorectal Unit, Department of General Surgery, Virgen de la Arrixaca University Clinical Hospital, University of Murcia, Murcia, Spain.
Departamento de Cirugía General, Unidad Colorrectal, Hospital Universitario Virgen de la Arrixaca, IMIB, Ctra. Madrid-Cartagena, 30120, El Palmar, Murcia, Spain.
Int J Colorectal Dis. 2017 Sep;32(9):1349-1356. doi: 10.1007/s00384-017-2840-6. Epub 2017 Jun 21.
It is believed that loosing ileocecal valve is well tolerated in patients who do not have short bowel syndrome or Crohn disease. From the hypothesis of colonic peristalsis and transit is regulated by that ileocecal valvular mechanism, we try to find out if the creation of a new pseudo-valvular mechanism as antiperistaltic anastomosis could be considered after right hemicolectomy can cause any short- or long-term changes in gastrointestinal habits.
The purpose of the study at primary endpoint is to compare early (occurring within 30 days of surgery) and late (occurring during the follow-up) postoperative complications between both groups The purpose of the study at secondary endpoint is to compare intraoperative and postoperative events between experimental and control groups in terms of operating time, first oral tolerance day, first flatus and faeces, length of hospital stay and orocecal transit; comparing rates of gastrointestinal life quality and comparing mortality rates between both groups.
The ISOVANTI trial is a randomized controlled single-centre trial comparing isoperistaltic versus antiperistaltic side-to-side anastomosis after right laparoscopic hemicolectomy. It is designed as a parallel group superiority trial.
It is unknown if a pseudo-valvular mechanism as antiperistaltic anastomosis can be considered has short- or long-term consequences in gastrointestinal habit. Considering the impact that ileocolic anastomosis configuration could have on the restitution of bowel transit after right hemicolectomy, we think it is indicated and necessary a randomized trial comparing iso- and antiperistaltic modalities.
NCT02309931.
人们认为，对于没有短肠综合征或克罗恩病的患者，回盲瓣切除耐受性良好。基于结肠蠕动和转运受回盲瓣机制调节的假说，我们试图探究在右半结肠切除术后创建一种新的假瓣膜机制（即抗蠕动吻合术）是否会引起胃肠道习惯的任何短期或长期变化。
该研究的主要终点目的是比较两组之间的早期（术后30天内发生）和晚期（随访期间发生）术后并发症。该研究的次要终点目的是比较实验组和对照组在手术时间、首次口服耐受日、首次排气和排便、住院时间和口盲传输方面的术中及术后事件；比较两组胃肠道生活质量的发生率并比较死亡率。
ISOVANTI试验是一项随机对照单中心试验，比较右腹腔镜半结肠切除术后顺蠕动与抗蠕动侧侧吻合术。它被设计为平行组优势试验。
作为抗蠕动吻合术的假瓣膜机制是否会对胃肠道习惯产生短期或长期影响尚不清楚。考虑到回结肠吻合术构型对右半结肠切除术后肠道转运恢复的影响，我们认为进行一项比较顺蠕动和抗蠕动方式的随机试验是有必要的。
NCT02309931。
