Clinical trial NCT03944720: Efficacy of Transvaginal Repair for Rectocele
Official title: Prospective Evaluation on the Efficacy of Transvaginal Repair for Rectocel
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Rectocele
Surgery
Lead sponsor: Consorci Sanitari de Terrassa
Sponsor class: OTHER
Collaborators: name: Hospital Universitari MútuaTerrassa
name: Heling HartZiekenhuis Lier
name: Hospital Clinico Universitario San Cecilio
First posted: 2019-05-09
Enrollment: 15
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with indication for rectocele surgical repair fulfilling the inclusion criteria

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.


Eligibility 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

Primary outcomes:
measure: Change in symptoms of obstructive defecation measured by the Altomare obstructed defecation syndrome (ODS) score
timeFrame: Baseline, 6 months and 12 months after surgery
measure: Change in symptoms of obstructive defecation measured by the KESS score
timeFrame: Baseline, 6 months and 12 months after surgery
Secondary outcomes:
measure: Changes in sexual function
timeFrame: Baseline, 6 months and 12 months after surgery
measure: Assessment of morbidity related to the surgical technique
timeFrame: Baseline, 6 months and 12 months after surgery
Other outcomes:
Locations:
city: Terrassa
country: Spain
facility: Consorci Sanitari de Terrassa
state: Barcelona
Study officials:
References: