Efficacy of Transvaginal Repair for Rectocele

Surgery Clinical Trial

Official title:

Prospective Evaluation on the Efficacy of Transvaginal Repair for Rectocel

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03944720
• Other study ID #: 02-18-102-024
• Status: Terminated
• Start date: July 15, 2019
• Est. completion date: December 31, 2022

Study information

• Verified date: September 2023
• Source: Consorci Sanitari de Terrassa
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Rectocele
• Surgery

Locations

Country	Name	City	State
Spain	Consorci Sanitari de Terrassa	Terrassa	Barcelona

Sponsors (4)

Lead Sponsor	Collaborator
Consorci Sanitari de Terrassa	Heling HartZiekenhuis Lier, Hospital Clinico Universitario San Cecilio, Hospital Universitari MútuaTerrassa

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Secondary	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.	Baseline, 6 months and 12 months after surgery
Secondary	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