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Efficacy of Transvaginal Repair for Rectocele

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ClinicalTrials.gov Identifier: NCT03944720
Recruitment Status : Recruiting
First Posted : May 9, 2019
Last Update Posted : August 23, 2021
Sponsor:
Collaborators:
Hospital Universitari MútuaTerrassa
Heling HartZiekenhuis Lier
Hospital Clinico Universitario San Cecilio
Information provided by (Responsible Party):
Yolanda Ribas, Consorci Sanitari de Terrassa

Brief Summary:

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.


Condition or disease
Rectocele Surgery

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 24 Months
Official Title: Prospective Evaluation on the Efficacy of Transvaginal Repair for Rectocel
Actual Study Start Date : July 15, 2019
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Change in symptoms of obstructive defecation measured by the Altomare obstructed defecation syndrome (ODS) score [ Time Frame: 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.

  2. Change in symptoms of obstructive defecation measured by the KESS score [ Time Frame: 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.


Secondary Outcome Measures :
  1. Changes in sexual function [ Time Frame: Baseline, 6 months and 12 months after surgery ]
    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.

  2. Assessment of morbidity related to the surgical technique [ Time Frame: Baseline, 6 months and 12 months after surgery ]
    Description of the morbidity that may be related to any surgical technique



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Only females may present with anterior rectocele
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with indication for rectocele surgical repair fulfilling the inclusion criteria
Criteria

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:

    1. 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
    2. Incomplete emptying of the rectocele on a defecography
    3. Failure of conservative treatment including dietary advice and laxatives, with persisting symptoms of obstructive defecation
    4. Recto-rectal intussusception may coexist on defecography (grade I and II of Oxford Prolapse Grading System)
    5. 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)
    6. 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03944720


Contacts
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Contact: Yolanda Ribas, MD PhD +347839388 yribas@cst.cat

Locations
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Spain
Consorci Sanitari de Terrassa Recruiting
Terrassa, Barcelona, Spain, 08227
Contact: Yolanda Ribas, MD, PhD    0034 937839388    yribas@cat.cat   
Principal Investigator: Yolanda Ribas, MD, PhD         
Sponsors and Collaborators
Consorci Sanitari de Terrassa
Hospital Universitari MútuaTerrassa
Heling HartZiekenhuis Lier
Hospital Clinico Universitario San Cecilio
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Responsible Party: Yolanda Ribas, Principal investigator, Consorci Sanitari de Terrassa
ClinicalTrials.gov Identifier: NCT03944720    
Other Study ID Numbers: 02-18-102-024
First Posted: May 9, 2019    Key Record Dates
Last Update Posted: August 23, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: All data will be included in the same database and analyzed together

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Rectocele
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Hernia
Pathological Conditions, Anatomical