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临床试验/NCT03944720
NCT03944720终止不适用

Prospective Evaluation on the Efficacy of Transvaginal Repair for Rectocel

Consorci Sanitari de Terrassa1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2019年7月15日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
15
试验地点
1
主要终点
Change in symptoms of obstructive defecation measured by the KESS score

研究概览

简要总结

Patients with rectoceles may present a variety of symptoms such as pelvic pressure, obstructive defecation or discomfort during sexual intercourse. The main symptom of the patient probably ends up conditioning if the patient is referred to a gynaecologist or a colorectal surgeon.

Different surgical techniques have been described to repair the rectocele. The posterior colporrhaphy is the preferred approach for most gynaecologists, while the transanal repair is the most common approach for the majority of colorectal surgeons. However, the small number of prospective studies, the inconsistent inclusion criteria and the variability of the outcome measures make difficult to know what the ideal surgical approach for a rectocele repair would be. Gynaecologists usually do not assess defecatory function before a rectocele repair, and studies focused on obstructive defecation include patients with other co-existing pathologies (rectal prolapse, rectal intussusception, enterocele) that may influence the success of the repair. Moreover, functional disorders such as the paradoxical contraction of the external anal sphincter or the puborectalis muscle are not systematically reported. On the other hand, many surgeons have questioned the transvaginal approach because it has been reported that patients may present dyspareunia after the surgery, although it is not systematically evaluated.

The hypothesis of the investigators is that the transvaginal approach for rectocele repair is an effective treatment for symptoms of obstructive defecation and is not associated with sexual dysfunction when the plication of the puborectalis muscle is not performed.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Older than 18 year old
  • Symptoms of obstructed defecation associated to a rectocele with an indication for surgery according to the following criteria:
  • Symptoms of obstructed defecation according to Rome III criteria: straining, sensation of incomplete evacuation, sensation of anorectal obstruction/blockage, and/or manual manoeuvres to facilitate defecation at least in 25% of defecations for the last 3 months
  • Incomplete emptying of the rectocele on a defecography
  • Failure of conservative treatment including dietary advice and laxatives, with persisting symptoms of obstructive defecation
  • Recto-rectal intussusception may coexist on defecography (grade I and II of Oxford Prolapse Grading System)
  • Non-obstructive enterocele may coexist on defecography (type A enterocele: the small bowel descends to puboccoccygeal line (PCL) during straining and returns to PCL at the end of the straining attempt without compressing the rectal ampulla or compressing it from above with no obstruction)
  • Absence of anal sphincter dyssynergia on anorectal manometry, or successful rehabilitation after biofeedback in the case of previous dyssynergia
  • Ability to understand the surgical procedure and the questionnaires of the study
  • Written informed consent

排除标准

  • Anal sphincter dyssynergia
  • Coexisting recto-anal intussusception on defecography or external rectal prolapse (grades III, IV and V Oxford Prolapse Grading System)
  • Coexisting enterocele compressing/obstructing the rectum on defecography (type B enterocele: the enterocele descends beyond the PCL to the perineum through the rectovaginal space to compress the rectal ampulla at the end of the evacuation process; type C enterocele (obstructive): the enterocele descends beyond the PCL to the perineum through the rectovaginal space to compress the rectal ampulla at the beginning of the evacuation process)
  • Slow transit constipation associated to obstructed defecation
  • Severe psychiatric disorder
  • Refusal to provide written informed consent

结局指标

主要结局

Change in symptoms of obstructive defecation measured by the KESS score

时间窗: Baseline, 6 months and 12 months after surgery

Assessment of the efficacy of the transvaginal approach for rectocele repair to improve symptoms of obstructive defecation according to the KESS score. The KESS (Knowles-Eccersley-Scott-Symptom) score is a validated questionnaire to assist in diagnosing constipation and in discriminating among pathophysiologic subgroups, consisting of eleven questions. Each question has four to five possible answers which are scored on an unweighted linear integer scale to produce a range between zero and three, or zero and four points. Lower scores represent symptom-free states and higher scores, increased symptom severity. The KESS score is the sum of all points, with a maximum possible of 39 points.

Change in symptoms of obstructive defecation measured by the Altomare obstructed defecation syndrome (ODS) score

时间窗: Baseline, 6 months and 12 months after surgery

Assessment of the efficacy of the transvaginal approach for rectocele repair to improve symptoms of obstructive defecation according to the Altomare ODS score. The Altomare ODS score is a validated questionnaire to assess the severity of the obstructed defecation syndrome, consisting of eight 3- o 4-point Likert-scaled symptom items. Each of the items has four or five possible answers with scores ranging from zero (symptom free) to three or four points (more severe symptom). The ODS score is the sum of all points, with a maximum possible of 31 points.

次要结局

  • Changes in sexual function(Baseline, 6 months and 12 months after surgery)
  • Assessment of morbidity related to the surgical technique(Baseline, 6 months and 12 months after surgery)

研究者

发起方
Consorci Sanitari de Terrassa
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yolanda Ribas

Principal investigator

Consorci Sanitari de Terrassa

研究点 (1)

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