An observational study in Rectocele and Surgery, sponsored by Consorci Sanitari de Terrassa. Terminated at 1 site in Spain. Open to female participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2023-09-28.
Sponsored by Consorci Sanitari de Terrassa · Observational
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.
50 studies on the registry are indexed under Rectocele; 9 are open to participants now.
This study's enrollment of 15 is below the median of 113 across 13 observational studies indexed under Rectocele.
Browse Rectocele studies →Consorci Sanitari de Terrassa is the lead sponsor of 41 studies on the registry; 15 are open to participants now.
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Patients with indication for rectocele surgical repair fulfilling the inclusion criteria
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Symptoms of obstructed defecation associated to a rectocele with an indication for surgery according to the following criteria:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Time frame: 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.
Time frame: Baseline, 6 months and 12 months after surgery
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.
Time frame: 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
Time frame: Baseline, 6 months and 12 months after surgery
Plan to share: No — All data will be included in the same database and analyzed together
No publications or documents are linked to this record.
Ran from Jul 2019 to primary completion in Dec 2022, 41 months.
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This study is terminated, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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Consorci Sanitari de Terrassa