Clinical Trials Logo

Clinical Trial Summary

Several pelvic prolapses can render defecation difficulties and they are often treated with different surgical techniques. This study will evaluate a novel variation of a laparoscopic technique used to treat rectal prolapse that is modified to treat multiple pelvic prolapses. 25 women with symptoms of obstructed defecation and multiple pelvic prolapses are assessed before and after surgery with clinical examination, defecography and a questionnaire for bowel function and quality of life. Follow up was scheduled after three and twelve months and at long term (minimum ten years).


Clinical Trial Description

Patients and Methods Patients From 2002 to 2008, referred patients with symptoms of obstructed defecation (=OD) and diagnosed with multiple posterior pelvic organ prolapse (=PPOP) (protocol below) were considered for inclusion in the study. More than one defect (internal-or external rectal prolapse, Enterocele (EC) or Rectocele (RC)) was denoted as multiple PPOP. Patients were evaluated with clinical examination, defecography and a questionnaire that evaluated bowel function and bowel-related quality of life (QoL). Patients who did not respond to conservative treatment (diet advice, oral bulking agents, rectal enemas and/or bio-feedback) were offered inclusion in the study. Patients with anismus were excluded after evaluation with a combination of defecography (see below) and manometry. Surgical procedure Pneumoperitoneum was established with Verres needle. Two 12 mm trocars are placed at the umbilicus and two cm above the symphysis. Two 5 mm trocars are placed in the right and left iliac fossa. The procedure starts with an incision exposing the promontory which continues down along the right peritoneal reflection (Fig 9). A limited dissection of the promontory and a shallow unilateral incision was employed to avoid damage to the superior hypogastric plexus and the hypogastric nerves. The rectovaginal space was opened down to the pelvic floor, exposing the pelvic floor muscles. A T-shaped Vypro-mesh was inserted into the rectovaginal space and sutured to the pelvic floor muscles lateral to the vagina and to the distal vagina with a non-absorbable suture (EthibondR,). Two additional sutures fixated the mesh to the sacrouterine ligaments, closing the rectovaginal space and elevating the pouch of Douglas. Staples were used to anchor the mesh to the promontory as well as the mesorectum to the mesh, preventing rectal intussusception. The peritoneal defect was closed with a running, absorbable suture. Bowel Function Questionnaire The symptom load was evaluated with Linkoping Bowel function Questionnaire (LBQ). It is a quantitative bowel function questionnaire that evaluates four domains: fecal incontinence, constipation, OD and bowel-related quality of life. Symptom load is graded in four levels. Questions considered most relevant for each category of OD, incontinence and QoL were used for the longitudinal analyses. Defecography The defecography used plain X-ray and pictures/film were recorded at rest and during straining with the patient situated on a commode. Preparations included oral, rectal and vaginal contrast. Examination of the investigation was made by two senior radiologists and the following protocol was used for evaluation: Rectal prolapse Oxford grading system 1-5 for intususception and external prolapse. Enterocele Grade1 EC reaching below cervix, but not distal to half of the vaginal length. Grade 2 EC reaching below half of the vaginal length, but not below the sphincter plane. Grade 3 EC protruding below the sphincter plane and out of the anal canal. Rectocele A protrusion beyond the imaginary line between the sphincter and the rectum over or equal to 2 cm in depth. Anismus The inability to open the anal canal during evacuation of rectal contrast without an anatomical reason. The puborectal function is evaluated separately regardless of signs of anismus with assessment of the anorectal angle. The following protocol was used at follow-up visits: 3 months: Recording of per -and postoperative complications. Review of medical records and visit at the outpatient clinic. 12 months: 1. Clinical examination by one surgeon and one gynaecologist 2. Defecography 3. Bowel function questionnaire (LBQ) Since defecographic evaluation was not always available due to technical failure and/or patient related factors, the evaluation protocol was adjusted according to the reliability of the clinical examination. Clinical evaluation of EC and internal prolapse (IRP) is difficult and unreliable. However, clinical evaluation of RC (> 2cm), is considered reliable. Therefore, clinical evaluation was considered sufficient for evaluation of rectocele, but not for enterocele or internal prolapse. The following protocol was used: Rectal prolapse and RC: Clinical evaluation and defecography. If defecography was not evaluable, clinical evaluation was considered sufficient. IRP and EC: Clinical evaluation and defecography. If defecography was not evaluable, clinical evaluation was considered insufficient. Long term: During 2020, LBQ was sent to all patients who were alive achieving a minimum of 10 years follow-up; patients who did not respond were contacted via telephone. Median follow-up was 16 years (10-18 years) ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06330857
Study type Interventional
Source Sahlgrenska University Hospital, Sweden
Contact
Status Active, not recruiting
Phase N/A
Start date May 28, 2002
Completion date April 1, 2025

See also
  Status Clinical Trial Phase
Recruiting NCT03825575 - Sacral Neuromodulation as Treatment for Fecal Incontinence N/A
Completed NCT00605826 - A Randomized, Blinded, Multicenter Study to Evaluate NASHA/Dx for the Treatment of Fecal Incontinence N/A
Withdrawn NCT02208258 - Efficacy, Safety, and Performance Study of a Novel Device Designed to Manage Fecal Incontinence in Hospitalized Bedridden Patients With Liquid to Semi-formed Stool. N/A
Completed NCT01957969 - French Post-Inscription Study on Sacral Neuromodulation in the Treatment of Fecal Incontinence N/A
Completed NCT01939821 - A Pilot Study to Evaluate Educational Programs to Improve Fecal Incontinence Care in Nursing Homes N/A
Completed NCT01710579 - Normal Values in Ano-rectal 3D High Resolution Manometry N/A
Recruiting NCT00530933 - Tibial Nerve Stimulation for Faecal Incontinence N/A
Completed NCT00565136 - Evaluation of Outcomes of Restoring Pelvic Floor Support With TOPAS in Women With Moderate Fecal Incontinence Symptoms Phase 1/Phase 2
Withdrawn NCT00522691 - Efficacy of Sacral Nerve Stimulation Before Definitive Implantation N/A
Completed NCT00677508 - Development of an Instrument to Measure Quality of Life in Children With Chronic Constipation and Soiling
Completed NCT05032534 - Examination of a New Irrigation System for Transanal Irrigation in Children With Fecal Incontinence N/A
Completed NCT05058326 - Severity of Fecal Incontinence and Manometric Values Using the Anopress® Device in Women
Completed NCT03746834 - NASHA/Dx as a Perianal Implant for the Treatment of Persistent Fecal Incontience After Anorectal Malformation Phase 4
Completed NCT00124904 - Biofeedback for Fecal Incontinence N/A
Completed NCT03028636 - LIBERATE - PRO: Eclipseâ„¢ System Registry
Completed NCT04097288 - Effects of Single Dose Citalopram and Reboxetine on Urethral and Anal Closure Function on Healthy Female Subjects Phase 1
Completed NCT05621629 - Management of FI After Surgery of ARM
Withdrawn NCT04138602 - BTL Emsella Chair Versus Sham for the Treatment of Fecal Incontinence N/A
Completed NCT03252951 - Physical Therapy for Anal Incontinence N/A
Completed NCT04478799 - Transcutaneous Posterior Nerve Stimulation inTreatment of Fecal Incontience N/A