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Lack of recruitment in participating centers
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| Name | Class |
|---|---|
| Hospital Mutua de Terrassa | OTHER |
| Heling HartZiekenhuis Lier | OTHER |
| Hospital Clinico Universitario San Cecilio | OTHER |
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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.
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| Measure | Description | Time Frame |
|---|---|---|
| Change in symptoms of obstructive defecation measured by the Altomare obstructed defecation syndrome (ODS) score | 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. | Baseline, 6 months and 12 months after surgery |
| Change in symptoms of obstructive defecation measured by the KESS score | 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. | Baseline, 6 months and 12 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in sexual function | To assess changes in the Female Sexual Function Index (FSFI) questionnaire. The FSFI score is a validated 19-item questionnaire to measure the sexual functioning in women, including six domains: desire, subjective arousal, lubrication, orgasm, satisfaction and pain. Domain scoring is as follows: desire 2-10, arousal 0-20, lubrication 0-20, orgasm 0-15, satisfaction 2-15, pain 0-15. Lower scores represent worse sexual functioning. |
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Inclusion Criteria:
Women
Older than 18 year old
Symptoms of obstructed defecation associated to a rectocele with an indication for surgery according to the following criteria:
Ability to understand the surgical procedure and the questionnaires of the study
Written informed consent
Exclusion Criteria:
Only females may present with anterior rectocele
Patients with indication for rectocele surgical repair fulfilling the inclusion criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Consorci Sanitari de Terrassa | Terrassa | Barcelona | 08227 | Spain |
All data will be included in the same database and analyzed together
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| ID | Term |
|---|---|
| D020047 | Rectocele |
| ID | Term |
|---|---|
| D012002 | Rectal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| Baseline, 6 months and 12 months after surgery |
| Assessment of morbidity related to the surgical technique | Description of the morbidity that may be related to any surgical technique | Baseline, 6 months and 12 months after surgery |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |