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Completed

NCT Number: NCT06633172

Laparoscopic Ventral Mesh Rectopexy Versus Trans-vaginal Repair for Anterior Rectocele.

This study aims to compare the effect of laparoscopic ventral mesh rectopexy versus trans vaginal repair in management of anterior rectocele in females regarding functional outcomes.

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Key information

Age range

30 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Mansoura university

Al Mansurah, Dakahlia Governorate, 35516, Egypt

About this study

Rectocele is the protrusion of the anterior wall of the rectum into the vaginal lumen through the rectovaginal fascia and posterior vaginal wall. Symptomatic rectocele affects postmenopausal women and causes obstructed defecation Significant rectal emptying difficulties, straining at defecation, manually assisted defecation, the need for perineal or vaginal digitation, and local symptoms such as vaginal bulging and pelvic heaviness in 30-70% of cases have been described as symptoms of rectocele .

Constipation can be managed with dietary measures, laxatives, and biofeedback training , which can be beneficial for patients with modest symptoms. Surgical treatment is recommended if conservative treatment fails to alleviate symptoms . However, some patients may be left with constipation, fecal incontinence, incomplete bowel evacuation, or sexual dysfunction despite the correction of the anatomical defect. The selection of patients for surgical intervention for symptomatic rectocele remains a matter of debate.

There is still a controversy between abdominal approaches and the transanal, transperineal, and transvaginal approaches as the optimal surgical approach to treat complex rectocele. While the latter is preferred by gynecologists, the former has increased in popularity among colorectal surgeons, aided in part by the growing interest in minimally invasive surgery.

This study aimed to evaluate the outcome of LVMR in comparison with TVR of anterior rectocele regarding the improvement in constipation score and sexual-related quality of life, surgical outcomes and postoperative complications.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Female patients aged between 30 and 60 years, presented with symptomatic rectocele with failed conservative treatments.
  • anterior rectocele larger than 3 cm in size with retention of the contrast in the rectocele on defecography.
  • excessive straining, sense of incomplete evacuation, the need for digital manipulation during defecation, or dyspareunia.

Exclusion criteria

  • significant urinary manifestations due to anterior vaginal wall prolapse.
  • patients with recurrent rectocele
  • complete external rectal prolapse
  • isolated anismus
  • connective tissue disease
  • patients with slow-transit constipation
  • fecal incontinence (FI), or abnormal thyroid function.

Treatment and study plan

laparoscopic ventral mesh rectopexy

Procedure

performing ventral mesh rectopexy via laparoscopic surgery to correct the anterior rectocele.

Other names: VMR, ventral mesh rectopexy

Trans vaginal repair

Procedure

performing repair of the rectocele through the recto vaginal septum repair.

Other names: TVR

Primary outcomes

  1. Improvement of constipation

    Time frame: 6 month to 1 year

    The primary outcome of the study was the absolute decline in constipation score(Cleveland clinic constipation score). This score is composed of 8 questions. Score ranges from 0 to 32. The lowest score is 0 which means no constipation, while the highest is 32 which means worsening of the constipation. So, the decline in the score means improving of the constipation.

Secondary outcomes

  1. improvement of sexual function

    Time frame: 6 month to 1 year

    improvement in sexual function in the form of Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire(PISQ- 12). PISQ-12 score is composed of 3 domains with total score of 48. It ranges from 0 to 48. The higher the score, the better the sexual outcome.

    Other 2ry outcomes include: Operative time in minutes, time of wound healing in days and the postoperative complication in both groups.

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

Laparoscopic Ventral Mesh Rectopexy Versus Trans-vaginal Repair in Management of Anterior Rectocele; a Randomized Controlled Trial.

Acronym: RCT

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Oct 9, 2024
Registry last updated
Oct 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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