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Efficacy of Transvaginal Repair for Rectocele

NCT03944720 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 15

Last updated 2023-09-28

No results posted yet for this study

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

Sponsors & Collaborators

  • Hospital Universitari MútuaTerrassa

    collaborator UNKNOWN

  • Heling HartZiekenhuis Lier

    collaborator OTHER

  • Hospital Clinico Universitario San Cecilio

    collaborator OTHER

  • Consorci Sanitari de Terrassa

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-15
Primary Completion
2022-12-31
Completion
2022-12-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03944720 on ClinicalTrials.gov