Department of Surgery and Pelvic Floor Center, Caritas-Krankenhaus St. Josef, Landshuter Str. 65, 93053, Regensburg, Germany.
Langenbecks Arch Surg. 2010 Jun;395(5):505-13. doi: 10.1007/s00423-009-0591-8. Epub 2010 Jun 13.
Internal rectal prolapse and rectocele are frequent clinical findings in patients with obstructed defecation syndrome (ODS). However, there is still no evidence whether stapled transanal rectal resection (STARR) provides a safe and effective surgical option. Therefore, the German STARR registry was initiated to assess safety, effectiveness, and quality of life.
The German STARR registry was designed as an interventional, prospective, multicenter audit. Primary outcomes include safety (morbidity and adverse events), effectiveness (ODS, symptom severity, and incontinence scores), and quality of life (PAC-QoL and EQ-5D) documented at baseline and at 6 and 12 months. Statistical evaluation was performed by an independent research organization of clinical epidemiology.
Complete data of 379 patients (78% females, mean age 57.8 years) were entered into the registry database. Mean operative time was 40 min, mean hospitalization was 5.5 days. A total of 103 complications and adverse events were reported in 80 patients (21.1%) including staple line complications (minor bleeding, infection, or partial dehiscence; 7.1%), major bleeding (2.9%), and postsurgical stenosis (2.1%). Comparisons of ODS and symptom severity scores (SSS) demonstrated a significant reduction in ODS score between baseline (mean 11.14) and 6 months (mean 6.43), which was maintained at 12 months (mean 6.45), and SSS at preoperative and at 6- and 12-month follow-up (13.02 vs. 7.34 vs. 6.59; paired t test, p < 0.001). Significant reduction in ODS symptoms was matched by an improvement in quality of life as judged by symptom-specific PAC-QoL and generic ED-5Q (utility and visual analog scale) scores and was not associated with an impairment of incontinence score following STARR (p > 0.05). However, 11 patients (2.9%) showed de novo incontinence, and new-onset symptoms of fecal urgency were observed in 25.3% of patients.
These data indicate that STARR is a safe and effective procedure. However, conclusions are limited due to the selection and reporting bias of a registry. The problem of fecal urgency needs cautious reassessment.
直肠内脱垂和直肠前突是便秘型排便障碍综合征（ODS）患者常见的临床发现。然而，目前仍缺乏关于经肛吻合器直肠切除术（STARR）是否为安全有效的手术选择的证据。因此，德国 STARR 注册研究旨在评估安全性、有效性和生活质量。
德国 STARR 注册研究设计为一项干预性、前瞻性、多中心审计。主要结局包括安全性（发病率和不良事件）、有效性（ODS、症状严重程度和失禁评分）以及在基线和 6 个月及 12 个月时的生活质量（PAC-QoL 和 EQ-5D），由一个独立的临床流行病学研究组织进行统计评估。
共纳入 379 例患者（78%为女性，平均年龄 57.8 岁）的完整数据，输入注册数据库。平均手术时间为 40 分钟，平均住院时间为 5.5 天。80 例（21.1%）患者报告了 103 例并发症和不良事件，包括吻合口并发症（少量出血、感染或部分裂开；7.1%）、大出血（2.9%）和术后狭窄（2.1%）。ODS 和症状严重程度评分（SSS）的比较显示，ODS 评分从基线（平均 11.14）到 6 个月（平均 6.43）显著降低，在 12 个月时仍保持在 6.45，SSS 在术前和 6 个月及 12 个月随访时也显著降低（13.02 vs. 7.34 vs. 6.59；配对 t 检验，p<0.001）。STARR 术后 ODS 症状的显著改善与生活质量的提高相匹配，这是通过特定于症状的 PAC-QoL 和通用 ED-5Q（效用和视觉模拟评分）评分来判断的，与 STARR 后失禁评分的损害无关（p>0.05）。然而，11 例（2.9%）患者出现新发失禁，25.3%的患者出现新发粪便急迫症状。
这些数据表明 STARR 是一种安全有效的手术方法。然而，由于注册研究的选择和报告偏倚，结论受到限制。粪便急迫的问题需要谨慎重新评估。
