Efficacy of Transvaginal Repair for Rectocele

NCT03944720 | Terminated

• 1 other identifier: 02-18-102-024
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Rectocele; Surgery

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• Changes in sexual function

  Baseline, 6 months and 12 months after surgery

• Assessment of morbidity related to the surgical technique

  Baseline, 6 months and 12 months after surgery

Eligibility Criteria

• Age: 18 Years - 85 Years
• Gender Eligibility Details: Only females may present with anterior rectocele
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with indication for rectocele surgical repair fulfilling the inclusion criteria

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Consorci Sanitari de Terrassa: lead
• Hospital Universitari MútuaTerrassa: collaborator
• Heling HartZiekenhuis Lier: collaborator
• Hospital Clinico Universitario San Cecilio: collaborator

Study Sites (1)

Consorci Sanitari de Terrassa

Terrassa, Barcelona, 08227, Spain

Location

MeSH Terms

Conditions

Rectocele

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: May 3, 2019
• First Posted: May 9, 2019
• Study Start: July 15, 2019
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: September 28, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)