General Surgery, Faculty of Medicine, Zagazig University, Zagazig, Egypt.
Surg Endosc. 2023 Aug;37(8):6145-6152. doi: 10.1007/s00464-023-10092-z. Epub 2023 May 5.
Colonic anastomotic leak and fistula following anterior resection surgery for rectal cancer are associated with high mortality rates. The incidence of occurrence varies from 2 to 25% and it is difficult to accurately calculate the incidence of fistula and leak post anterior resection, as most of them are asymptomatic. Endoscopic management of fistula and leak has become the first line of management after conservative management in many gastrointestinal surgical centers with the advantages of being less invasive, shorter length of post-operative hospital stay, effective and rapid recovery in comparison to revision surgery. Effective endoscopic management for colonic fistula or leak depends on the clinical status of the patient and fistula characters (time-to-occur and size and site of defect), and device availability.
This prospective randomized controlled clinical trial included all patients who developed the manifestations of low output recurrent colonic fistula or leak after colonic anterior resection for rectal cancer at Zagazig University Hospital between (December 2020 and August 2022). Sample size was 78 patients divided into two equal groups. Endoscopic group (EG): included 39 patients who underwent endoscopic management. Surgical group (SG): included 39 patients who underwent surgical management.
The investigators randomized eligible 78 patients into two groups: 39 patients in SG and 39 patients in EG. The median size of the fistula or leak was nine (range: 7-14) mm in EG, versus ten (range: 7-12) mm in SG. Clipping and Endo-stitch device were used in 24 patients versus 15 patients, respectively, in EG while primary repair with ileostomy, and resection & anastomosis were used in 15 patients versus 24 patients, respectively, in SG. Recurrence, abdominal collection, and mortality were the post procedure's complications with incidence of occurrence of 10.3, 7.7 and 0%, respectively, in EG versus 20.5, 20.5 and 2.6%, respectively, in SG. Excellent, good, and poor were the parameters for quality of life with incidence of occurrence of 43.6, 54.6 and 0%, respectively, in EG versus 28.2, 33.3 and 38.5%, respectively, in SG. Median hospital stay was one (range: 1-2) day in endoscopic group, and seven (range: 6-8) days in SG.
Endoscopic intervention may offer a successful modality in managing low output recurrent colonic fistula or leak after anterior resection for rectal cancer that did not respond to conservative measures in stable patients.
gov ID: NCT05659446.
直肠癌前切除术术后吻合口漏和瘘管与高死亡率相关。其发生率为 2%至 25%，由于大多数瘘管和漏口是无症状的，因此很难准确计算前切除术后瘘管和漏口的发生率。在许多胃肠外科中心，内镜治疗瘘管和漏口已成为保守治疗后一线治疗方法，与 revision surgery 相比，内镜治疗具有创伤小、术后住院时间短、有效且恢复迅速的优点。有效的结肠瘘或漏口内镜治疗取决于患者的临床状况和瘘口特征（发生时间、大小和缺陷部位）以及器械可用性。
这项前瞻性随机对照临床试验纳入了 2020 年 12 月至 2022 年 8 月期间在 Zagazig 大学医院因直肠前切除术后出现低位复发性结肠瘘或漏的所有患者。样本量为 78 例，分为两组相等。内镜组（EG）：包括 39 例接受内镜治疗的患者。手术组（SG）：包括 39 例接受手术治疗的患者。
研究人员将符合条件的 78 例患者随机分为两组：SG 组 39 例，EG 组 39 例。EG 组瘘管或漏口的中位大小为 9（范围：7-14）mm，SG 组为 10（范围：7-12）mm。夹闭和内镜缝合器分别用于 24 例患者，而原发性修复伴回肠造口术和切除吻合术分别用于 15 例患者，SG 组。在 EG 组中，术后并发症为复发、腹腔积血和死亡率，发生率分别为 10.3%、7.7%和 0%，而在 SG 组中，发生率分别为 20.5%、20.5%和 2.6%。EG 组生活质量参数分别为优秀、良好和差，发生率分别为 43.6%、54.6%和 0%，SG 组分别为 28.2%、33.3%和 38.5%。内镜组的中位住院时间为 1（范围：1-2）天，SG 组为 7（范围：6-8）天。
在稳定患者中，内镜干预可能为直肠前切除术后低位复发性结肠瘘或漏管提供一种成功的治疗方法，这些患者对保守治疗无反应。
gov ID：NCT05659446。
