Clinical trial NCT06633172: Laparoscopic Ventral Mesh Rectopexy Versus Trans-vaginal Repair for Anterior Rectocele.
Official title: Laparoscopic Ventral Mesh Rectopexy Versus Trans-vaginal Repair in Management of Anterior Rectocele; a Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rectocele
Anterior Rectocele
Keywords: transvaginal repair
ventral mesh rectopexy
laparoscopic
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2024-10-09
Enrollment: 40
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Improvement of constipation
timeFrame: 6 month to 1 year
Secondary outcomes:
measure: improvement of sexual function
timeFrame: 6 month to 1 year
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura university
state: Dakahlia
Study officials:
affiliation: Mansoura University Hospital
name: Ahmad Sakr, Phd
role: PRINCIPAL_INVESTIGATOR
References: