Clinical Trials Logo

Rectocele clinical trials

View clinical trials related to Rectocele.

Filter by:
  • Recruiting  
  • Page 1 ·  Next »

NCT ID: NCT06117670 Recruiting - Clinical trials for Pelvic Organ Prolapse

Gamma-irradiated Amniotic Membrane Graft in Posterior Colporrhaphy

Start date: November 1, 2023
Phase: Phase 3
Study type: Interventional

The goal of this clinical trial is to test the benefit of using gamma-irradiated amniotic membrane as a graft in surgical repair for women with posterior vaginal wall defects. The main question it aims to answer is: • Is posterior colporrhaphy using gamma-irradiated amniotic membrane as a graft effective? Participants will undergo posterior colporrhaphy, which will be modified by adding gamma-irradiated amniotic membrane as a graft during the repair.

NCT ID: NCT05918367 Recruiting - Surgery Clinical Trials

Multicenter Ventral Mesh Rectopexy Registry Collaborative

M2R2
Start date: September 25, 2023
Phase:
Study type: Observational [Patient Registry]

The goal of this multicenter observational study is to collect data prospectively of patients with pelvic organ prolapse undergoing ventral mesh rectopexy (as well as rectoceles, entero-/sigmoidoceles/ intussusception/ rectal prolapse or combined) by laparoscopy or robotic surgery and to evaluate the longterm functional outcomes. Secondly complications (mesh erosions, recurrence, reoperations) are evaluated. Following main questions will be analysed - other can follow in consultation with the collaborative 1. Is VMR the technique of choice for treatment of rectoceles? Functional results - recurrence - mesh related complications 2. Has a perineal descent an impact on the functional outcome of ventral mesh rectopexy perfored for external rectal prolaps, internal rectal prolaps, rectocele, enterocele, sigmoidcele or combined pelvic organ prolapse?

NCT ID: NCT05037422 Recruiting - Rectocele; Female Clinical Trials

Long-term Results of the Stapled Transanal Rectal Resection (STARR) Operation Proposed in the Treatment of a Rectocele

STARRLOC
Start date: October 16, 2021
Phase:
Study type: Observational

Rectal static disorders, including the rectocele, represent a frequent functional pathology which affects the quality of life of affected patients. Among vaginal treatments, the STARR technique corresponds to rectal resection by transanal approach using a stapler. The American Gastroenterology Association (AGA) has concluded that service to patients is insufficient. The technical and functional results published are mostly short-term studies. The investigators seek to assess the technical and functional results of Operation STARR, based on a series of consecutive expert center cases, to confirm or refute the conclusions of the AGA recommendations.

NCT ID: NCT04817150 Recruiting - Rectal Prolapse Clinical Trials

3D vs 2D-laparoscopy for Rectocele and Rectal Prolapse Correction: a Prospective, Randomized, Single Center Study

LARC
Start date: March 10, 2021
Phase: N/A
Study type: Interventional

The aim is to compare proximate and remote results of 3D and conventional 2D laparoscopic interventions in terms of efficacy and safety in treatment of symptomatic rectocele and rectal prolapse. This is a prospective randomized comparative study in parallel groups conducted in single Colorectal unit. Inclusion criteria: female patients with stage 3 rectocele (3-4 POP-Q [pelvic organ prolapse quantification] grade) and/or full-thickness rectal prolapse. Intervention - laparoscopic ventral rectopexy. The primary outcome is objective cure rate of pelvic prolapse. Secondary outcomes include obstructive defecation and incontinence symptoms according to Wexner and Cleveland Clinic scales, and satisfaction according to Patient Global Impression of Improvement questionnaire. Operative times, intraoperative blood loss, length of hospital stay, postop pain severity, urinary incontinence, as well as surgical and mesh complications are also assessed. The specific point of interest in this study is surgeon's tiredness after the operation assessed with Profile of Mood States questionnaire.

NCT ID: NCT04564677 Recruiting - Rectal Prolapse Clinical Trials

A Study Evaluating the Clinical Outcome of a Modified d'Hoore Technique for Laparoscopic Ventral Mesh Rectopexy

POP-01
Start date: February 8, 2021
Phase:
Study type: Observational

The purpose of this observational study is to evaluate the clinical outcome of a modified d'Hoore technique for laparoscopic ventral mesh rectopexy in patients with primary rectal prolapse, rectocele and/or enterocele.The goal of the study will be achieved by reporting the peri- and postoperative complications ((serious) adverse events), recurrences and re-interventions. Pre-operative to postoperative changes in pain, functional outcome and quality of life will be evaluated as well.

NCT ID: NCT04547816 Recruiting - Clinical trials for Functional Constipation

Efficacy of Conservative Treatment of Functional Defecatory Disorders in Females With Pelvic Organ Prolapse

Start date: July 1, 2020
Phase: Phase 3
Study type: Interventional

This study is planned to evaluate the efficacy of complex conservative treatment (including tibial neuromodulation, biofeedback therapy, special pelvic floor training and diet modification) in women with pelvic organ prolapse

NCT ID: NCT04009694 Recruiting - Clinical trials for Pelvic Organ Prolapse

Does a High BMI Affect Supervised Pelvic Floor Muscle Training for Improving Symptoms in Women With Various Stages of Pelvic Organ Prolapse?

Start date: September 1, 2018
Phase: N/A
Study type: Interventional

The trial design is a quasi-experimental cohort trial that includes women referred for pelvic organ prolapse specific physiotherapy. Candidates will be selected via a convenience sampling method from four physiotherapy outpatient departments at a NHS trust within Greater Manchester. The data collection occurred in January-June 2019 and ethical approval was granted by School Research Ethics, University of Salford. Treatment aims to ensure there is respect for their autonomy, treatment is fair (Justice), no harm is done to the participant (nonmaleficence) and treatment benefits the participants (beneficence). Participants are required to complete a consent form prior to their initial session. To ensure methodological quality, the STROBE guidelines will be followed to make certain all apt information required is reported to allow for replication of the intervention. The trial aims to include (n=60) women with a diagnosed pelvic organ prolapse. They are required to complete 16 weeks of supervised pelvic floor exercises with a specialist physiotherapist as documented within the most recent NICE guidelines. The outcome measures used will be the Pelvic Organ Prolapse symptom score (POPSS) and this will be documented before and after the 16 week period. Along side the POPSS, the patients body mass index and severity of pelvic organ prolapse will also be recorded and the results of this will be correlated post trial using the relevant data analysis testing methods.

NCT ID: NCT02052063 Recruiting - Surgery Clinical Trials

Does the Stapled Transanal Rectal Resection (STARR Procedure) Has an Effect on Anal Compliance ?

Compli-STARR
Start date: September 2014
Phase: N/A
Study type: Interventional

The stapled transanal rectal resection (STARR) has recently been recommended for patients with obstructed defecation syndrome (ODS) caused by rectocele and rectal wall intussusception. The aim of STARR is to correct the mechanical outlet obstruction using a stapler device for endorectal resection of the distal rectum. This technique significantly improves constipation. However, there are several reports of new-onset faecal incontinence after STARR and urgency has been identified as the major side-effect of this procedure. Although this technique has become an important surgical option in the treatment of obstructive defaecation syndrome, its impact on continence can be problematic and objective data about parameters that predict its result are not yet available One study evaluated the anal function after surgery in 30 patients. In this study, urgency or incontinence was complained by 26% of patients. No sonographically demonstrable sphincter fragmentations were noticed in the endoanal exam performed at the follow-up. No significant difference was observed in anorectal manometry. Even if data are not statistically significant, resting and squeezing pressures are lower in those patients not satisfied. Currently, anal canal pressure measurements using ano-rectal manometry are the most common means of assessment of sphincter function. Some studies have been looking at the concept of distending sphincter regions as a better measure of its performance. The functional lumen imaging probe (FLIP) is a novel technique which has the ability to provide real-time images of the function of human gastrointestinal sphincter during distension. This distensibility technique provides an important new way of studying the anal canal and hence may have a role in testing sphincter competence in patients with disorders after STARR procedure. Twenty-eight patients will be enrolled in this study over a period of 36 months. Preoperative assessment will include - clinical examination - the Wexner Incontinence Score and the Faecal Incontinence Quality-of-Life Index (FIQL) to rate anal incontinence - video defecography, anorectal manometry, anal ultrasound (AUS) and measure of anal sphincter distensibility using endoFLIP Follow-up evaluation will scheduled for 3 months after surgery, and will include symptom evaluation (using the same standard questionnaires for incontinence), clinical examination and investigation using anal ultrasound and endoFLIP. If we demonstrate that this surgical technique can cause anal lesions with decreased sphincter competence, this may lead to a modification of the surgical technique especially in patients at risk of developing postoperative anal incontinence.

NCT ID: NCT01899209 Recruiting - Rectal Prolapse Clinical Trials

Surgical Treatment of Obstructed Defecation Syndrome

PRO-REST
Start date: August 2013
Phase: N/A
Study type: Interventional

Obstructed Defecation is a profoundly disabling condition. Many different surgical procedures has been introduced to treat patients affected by this disease. The most used are STARR and ventral rectopexy. Because of the heterogenity of studies and overall the lack of comparison trials, there is no accepted standard surgical treatment.PRO-REST aimed to compare these two procedures (STARR and Ventral Rectopexy) evaluating functional and anatomical results.

NCT ID: NCT00988975 Recruiting - Rectocele Clinical Trials

Trial to Determine Which of Two Surgical Techniques Works Better to Correct Vaginal Bulging

Start date: September 2009
Phase: N/A
Study type: Interventional

Women with vaginal bulging who are undergoing laparoscopic sacrocolpopexy at Clarian Health are eligible to enroll in this study. Two different methods of correcting rectocele at the time of sacrocolpopexy will be compared for surgical outcome, surgical complications, and patient satisfaction with intercourse and bowel function. One of the surgical methods uses an additional graft material and one surgical method does not. It is hypothesized that the method which uses an additional graft material to strengthen the patient's tissues will have a better outcome.