An interventional study of laparoscopic ventral mesh rectopexy and Trans vaginal repair in Rectocele and Anterior Rectocele, sponsored by Mansoura University. Completed at 1 site in Egypt. Open to female participants aged 30 Years to 60 Years. Per ClinicalTrials.gov, last updated 2024-10-09.
Sponsored by Mansoura University · Not applicable, Interventional, and Treatment
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.
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.
50 studies on the registry are indexed under Rectocele; 9 are open to participants now.
This study's enrollment of 40 is below the median of 62 across 37 interventional studies indexed under Rectocele.
Browse Rectocele studies →Mansoura University is the lead sponsor of 1,119 studies on the registry; 183 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
performing laparoscopic ventral mesh rectopexy for group of patients to find out its efficacy
Procedure: laparoscopic ventral mesh rectopexy
performing trans vaginal repair for the 2nd group to find out its efficacy.
Procedure: Trans vaginal repair
performing ventral mesh rectopexy via laparoscopic surgery to correct the anterior rectocele.
Also known as: VMR, ventral mesh rectopexy
performing repair of the rectocele through the recto vaginal septum repair.
Also known as: TVR
Improvement of constipation
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.
Time frame: 6 month to 1 year
improvement of sexual function
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.
Time frame: 6 month to 1 year
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Apr 2021 to primary completion in Mar 2022, 11 months.
Of 16 interventional studies with no phase under Rectocele, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 38. This study's 11 months is below that.
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This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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