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

Primary Purpose

Rectocele, Intussusception, Surgery

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
stapled transanal rectal resection
Anal compliance measure with Endoflip system
Sponsored by
University Hospital, Rouen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Rectocele focused on measuring rectocele, intussusception, surgery

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients >18 years old
  • Patient is not under any type of guardianship
  • Patient has a rectocele > 3 cm during defecography
  • Patient has persistent defecatory troubles despite medical treatment (laxatives for at least 1 month)
  • Patient received information and signed the consent form
  • Patients having social security coverage

Exclusion Criteria:

  • Patient has an asymptomatic rectocele
  • Patient with an enterocele at rest upon defecography, with opacification of the small bowel
  • Faecal incontinence
  • Anal sphincter insufficiency detected by rectal manometry
  • Patient with non-rehabilitated anorectal asynchrony
  • Patient has previously had rectal surgery or pelvic radiotherapy
  • Patient has a anal or rectal lesion, intestinal inflammatory disease
  • Anal or rectal tumor
  • Immunocompromised subjects
  • Positive pregnancy test, by urine
  • Psychological condition which would impair participation in the study
  • Coagulation disorders
  • Patients using anticoagulants
  • Participation in any other device or drug study within 30 days prior to enrollment.
  • Patient cannot read French
  • Patient is under any type of guardianship

Sites / Locations

  • UH RouenRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Surgery

Arm Description

Patient who undergone stapled transanal rectal resection for rectocele. Anal compliance will be evaluated before and starting the surgery using endoflip system

Outcomes

Primary Outcome Measures

Comparison of anal sphincter distensibility
Comparison of anal sphincter distensibility before and 3 months after surgery with cross-sectional area and intra-balloon pressure. The device used is Endoflip system

Secondary Outcome Measures

Comparison of Faecal Incontinence Quality-of-Life Index (FIQL) before and 3 months after surgery
Comparison of Faecal Incontinence Quality-of-Life Index (FIQL) before and 3 months after surgery
Comparison of radiological data (Anal ultrasound)
Comparison of radiological data (Anal ultrasound) before and 3 months after surgery Endo-rectal Brüel and Kjaer echographic probe will be used to compare radiological data (conventional endo-rectal echography)
Comparison of Cleveland Clinic Incontinence score (CCIS) before and 3 months after surgery
Comparison between Cleveland Clinic Incontinence score (CCIS)

Full Information

First Posted
January 27, 2014
Last Updated
December 6, 2016
Sponsor
University Hospital, Rouen
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1. Study Identification

Unique Protocol Identification Number
NCT02052063
Brief Title
Does the Stapled Transanal Rectal Resection (STARR Procedure) Has an Effect on Anal Compliance ?
Acronym
Compli-STARR
Official Title
Does the Stapled Transanal Rectal Resection (STARR Procedure) Has an Effect on Anal Compliance ?
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Unknown status
Study Start Date
September 2014 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Rouen

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectocele, Intussusception, Surgery, Sphincter Ani Incontinence
Keywords
rectocele, intussusception, surgery

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
28 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Surgery
Arm Type
Experimental
Arm Description
Patient who undergone stapled transanal rectal resection for rectocele. Anal compliance will be evaluated before and starting the surgery using endoflip system
Intervention Type
Device
Intervention Name(s)
stapled transanal rectal resection
Other Intervention Name(s)
transanal rectal resection using staple
Intervention Description
transanal rectal resection using staple will be done for rectocele
Intervention Type
Device
Intervention Name(s)
Anal compliance measure with Endoflip system
Intervention Description
Anal compliance will be measured using Endoflip system
Primary Outcome Measure Information:
Title
Comparison of anal sphincter distensibility
Description
Comparison of anal sphincter distensibility before and 3 months after surgery with cross-sectional area and intra-balloon pressure. The device used is Endoflip system
Time Frame
Month 3
Secondary Outcome Measure Information:
Title
Comparison of Faecal Incontinence Quality-of-Life Index (FIQL) before and 3 months after surgery
Description
Comparison of Faecal Incontinence Quality-of-Life Index (FIQL) before and 3 months after surgery
Time Frame
Month 3
Title
Comparison of radiological data (Anal ultrasound)
Description
Comparison of radiological data (Anal ultrasound) before and 3 months after surgery Endo-rectal Brüel and Kjaer echographic probe will be used to compare radiological data (conventional endo-rectal echography)
Time Frame
Month 3
Title
Comparison of Cleveland Clinic Incontinence score (CCIS) before and 3 months after surgery
Description
Comparison between Cleveland Clinic Incontinence score (CCIS)
Time Frame
Month 3

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients >18 years old Patient is not under any type of guardianship Patient has a rectocele > 3 cm during defecography Patient has persistent defecatory troubles despite medical treatment (laxatives for at least 1 month) Patient received information and signed the consent form Patients having social security coverage Exclusion Criteria: Patient has an asymptomatic rectocele Patient with an enterocele at rest upon defecography, with opacification of the small bowel Faecal incontinence Anal sphincter insufficiency detected by rectal manometry Patient with non-rehabilitated anorectal asynchrony Patient has previously had rectal surgery or pelvic radiotherapy Patient has a anal or rectal lesion, intestinal inflammatory disease Anal or rectal tumor Immunocompromised subjects Positive pregnancy test, by urine Psychological condition which would impair participation in the study Coagulation disorders Patients using anticoagulants Participation in any other device or drug study within 30 days prior to enrollment. Patient cannot read French Patient is under any type of guardianship
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Valérie BRIDOUX, MD
Phone
+3323288
Ext
8142
Email
valerie.bridoux@chu-rouen.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Julien BLOT
Phone
+3323288
Ext
8265
Email
julien.blot@chu-rouen.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Valérie BRIDOUX, MD
Organizational Affiliation
UH Rouen
Official's Role
Principal Investigator
Facility Information:
Facility Name
UH Rouen
City
Rouen
ZIP/Postal Code
76031
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Valérie BRIDOUX, MD
Phone
+3323288
Ext
8142
Email
valerie.bridoux@chu-rouen.fr
First Name & Middle Initial & Last Name & Degree
Valérie BRIDOUX, MD

12. IPD Sharing Statement

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