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Clinical Trials/NCT06330857
NCT06330857CompletedNot Applicable

Evaluation of Anatomy and Symptoms After Surgery With a Novel Anterior Rectopexy in a Cohort With Combined Pelvic Defects.

Sahlgrenska University Hospital0 sites25 target enrollmentStarted: May 28, 2002Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
25
Primary Endpoint
Recurrence

Study Overview

Brief 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).

Detailed 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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Symptoms of obstructed defecation, more than one posterior pelvic organ prolapse, undergone conservative treatment

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Recurrence

Time Frame: One year

Clinical and radiological assesment of relapse of prolapse

Bowel function

Time Frame: Over ten years

Questionnaire regarding fecal incontinence and obstructed defecation

Bowel related quality of life

Time Frame: Over ten years

Questionnaire regarding bowel related quality of life

Secondary Outcomes

  • Hospital days(days)
  • Operative time(minutes)
  • Conversions to open surgery(Numbers)
  • Postoperative complications(30 days)
  • Peroperative complications(surgery)

Investigators

Sponsor
Sahlgrenska University Hospital
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Bjarne Melvas

Consultant

Sahlgrenska University Hospital

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