RectoceleNCT03944720
Efficacy of Transvaginal Repair for Rectocele
An observational study of Rectocele and Surgery, run by Consorci Sanitari de Terrassa at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years, women only
- How many people
- 15 participants
- Where
- 1 siteSpain
- Study dates
- 15 Jul 2019to 31 Dec 2022
- How long will I take part?
- 24 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with indication for rectocele surgical repair fulfilling the inclusion criteria
Who may be able to join
- Women
- 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
Show all 11Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Evaluation on the Efficacy of Transvaginal Repair for Rectocel
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.
- Medical subject headings
- Rectocele
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline, 6 months and 12 months after surgery
Secondary outcomes (2)
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.
Measured: 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
Measured: Baseline, 6 months and 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2019
- Study start15 Jul 2019
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Why it stopped: Lack of recruitment in participating centers
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RectoceleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- Consorci Sanitari de Terrassa
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Mutua de Terrassa, Heling HartZiekenhuis Lier, Hospital Clinico Universitario San Cecilio
- Responsible party
- Principal investigator, Yolanda Ribas, Consorci Sanitari de Terrassa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03944720
- Sponsor's protocol ID
- 02-18-102-024
- Status last verified
- Sep 2023
- First submitted
- 3 May 2019
- Last updated
- 28 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All data will be included in the same database and analyzed together
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation on the Efficacy of Transvaginal Repair for Rectocel
- ClinicalTrials.gov ID
- NCT03944720
- Acronym / sponsor ID
- 02-18-102-024
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Lack of recruitment in participating centers
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Consorci Sanitari de TerrassaUniversity, hospital or other
- Collaborators
- Hospital Mutua de Terrassa, Heling HartZiekenhuis Lier, Hospital Clinico Universitario San Cecilio
- Study start
- 15 Jul 2019 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 9 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with indication for rectocele surgical repair fulfilling the inclusion criteria
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
2 secondary outcomes
Changes in sexual function
Time frame: Baseline, 6 months and 12 months after surgery
Assessment of morbidity related to the surgical technique
Time frame: Baseline, 6 months and 12 months after surgery
Results and safety
The study was stopped early (reason given: Lack of recruitment in participating centers). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- Individual participant dataSharing planned: No. All data will be included in the same database and analyzed together
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rectocele and Surgery, run by Consorci Sanitari de Terrassa at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Lack of recruitment in participating centers). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2023.