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新型曲线切割吻合器在外科治疗出口梗阻型便秘综合征中的应用:一项中期随机对照试验,临床结局得到改善。

Improved clinical outcomes with a new contour-curved stapler in the surgical treatment of obstructed defecation syndrome: a mid-term randomized controlled trial.

机构信息

Colorectal Surgery Unit, S. Stefano Hospital, Naples, Italy.

出版信息

Dis Colon Rectum. 2011 Jun;54(6):736-42. doi: 10.1007/DCR.0b013e31820ded31.

DOI:10.1007/DCR.0b013e31820ded31
PMID:21552059
Abstract

BACKGROUND

Stapled transanal rectal resection has become the primary surgical procedure for surgical treatment of obstructed defecation syndrome caused by rectocele or rectal intussusception. The procedure is generally performed with 2 circular staplers. Recently, a dedicated contour-curved stapler was developed.

OBJECTIVE

This study was designed to compare the effects of these stapler types on relief of symptoms.

DESIGN AND SETTING

A randomized controlled trial was conducted at a regional referral center in Naples, Italy.

PATIENTS

Patients with obstructed defecation syndrome and rectocele or rectal intussusception, treated from November 2005 through September 2007.

INTERVENTIONS

Participants were randomly assigned to undergo stapled transanal rectal resection with 2 circular staplers or the contour-curved stapler.

MAIN OUTCOME MEASURES

The primary end point was success rate at 24 months, defined by symptom improvement on an obstructed defecation syndrome scale. Secondary end points included success rate at 12 months, Agachan-Wexner constipation score, and rates of early and late complications at 12 and 24 months.

RESULTS

Of 198 patients evaluated, 63 patients (31.8%) satisfied criteria. Follow-up data were available for 61 patients: 30 patients (28 women) in the circular stapler group (mean age, 53; range, 41-75 years) and 31 (29 women) in the contour-curved stapler group (mean age, 55; range, 38-69 years). At 24-month follow-up, success was achieved in 21 patients (70.0%) with the circular staplers and in 27 (87.0%) with the contour-curved stapler (P = .10). Symptom scores improved significantly in both groups from baseline to 12 months (P < .0001). Improvement was maintained in the contour-curved stapler group: mean score, 5.0 (SD, 1.6) at 12 months and 5.5 (1.5) at 24 months (P = .20). In the circular stapler group, symptom scores worsened from 4.5 (1.5) at 12 months to 9.0 (1.3) at 24 months (P < .0001). At 24 months, the groups differed significantly in symptom scores (P < .0001) and constipation scores (P = .03). No significant differences were seen in duration of postoperative hospital stay or rate of early or late complications.

CONCLUSIONS

Stapled transanal rectal resection with either circular or contour-curved staplers can achieve relief of symptoms in patients with obstructed defecation syndrome. The contour-curved stapler appears to result in more stable clinical results over time.

摘要

背景

经肛门直肠吻合器切除术已成为治疗直肠前突或直肠套叠引起的出口梗阻型便秘的主要手术方法。该手术通常使用 2 个圆形吻合器进行。最近,开发了一种专用的曲线吻合器。

目的

本研究旨在比较这两种吻合器类型对症状缓解的影响。

设计、地点和患者:这是在意大利那不勒斯的一个区域转诊中心进行的随机对照试验。患者为 2005 年 11 月至 2007 年 9 月期间接受治疗的出口梗阻型便秘综合征伴直肠前突或直肠套叠患者。

干预措施

参与者被随机分配接受 2 个圆形吻合器或曲线吻合器的经肛门直肠吻合器切除术。

主要终点

24 个月时的成功率,定义为便秘症状量表上的症状改善。次要终点包括 12 个月时的成功率、Agachan-Wexner 便秘评分以及 12 个月和 24 个月时的早期和晚期并发症发生率。

结果

在 198 名评估的患者中,有 63 名患者(31.8%)符合标准。61 名患者获得随访数据:圆形吻合器组 30 名患者(28 名女性;平均年龄 53 岁;范围 41-75 岁)和曲线吻合器组 31 名患者(29 名女性;平均年龄 55 岁;范围 38-69 岁)。在 24 个月的随访中,圆形吻合器组 21 名患者(70.0%)和曲线吻合器组 27 名患者(87.0%)成功(P =.10)。两组患者的症状评分均从基线到 12 个月显著改善(P <.0001)。曲线吻合器组的改善得以维持:12 个月时平均评分为 5.0(标准差 1.6),24 个月时为 5.5(1.5)(P =.20)。在圆形吻合器组中,症状评分从 12 个月时的 4.5(1.5)恶化至 24 个月时的 9.0(1.3)(P <.0001)。24 个月时,两组患者的症状评分(P <.0001)和便秘评分(P =.03)差异显著。两组患者的术后住院时间、早期或晚期并发症发生率无显著差异。

结论

经肛门直肠吻合器切除术联合使用圆形或曲线吻合器均可缓解出口梗阻型便秘患者的症状。曲线吻合器在长期内似乎能产生更稳定的临床效果。

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