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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2014 by University Hospital, Rouen
Sponsor:
Information provided by (Responsible Party):
University Hospital, Rouen
ClinicalTrials.gov Identifier:
NCT02052063
First received: January 27, 2014
Last updated: January 30, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Rectocele
Intussusception
Surgery
Sphincter Ani Incontinence
Device: stapled transanal rectal resection
Device: Anal compliance measure with Endoflip system

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Does the Stapled Transanal Rectal Resection (STARR Procedure) Has an Effect on Anal Compliance ?

Resource links provided by NLM:


Further study details as provided by University Hospital, Rouen:

Primary Outcome Measures:
  • Comparison of anal sphincter distensibility [ Time Frame: Month 3 ] [ Designated as safety issue: Yes ]

    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 [ Time Frame: Month 3 ] [ Designated as safety issue: No ]
    Comparison of Faecal Incontinence Quality-of-Life Index (FIQL) before and 3 months after surgery

  • Comparison of radiological data (Anal ultrasound) [ Time Frame: Month 3 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Month 3 ] [ Designated as safety issue: No ]
    Comparison between Cleveland Clinic Incontinence score (CCIS)


Estimated Enrollment: 28
Study Start Date: March 2014
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Surgery
Patient who undergone stapled transanal rectal resection for rectocele. Anal compliance will be evaluated before and starting the surgery using endoflip system
Device: stapled transanal rectal resection
transanal rectal resection using staple will be done for rectocele
Other Name: transanal rectal resection using staple
Device: Anal compliance measure with Endoflip system
Anal compliance will be measured using Endoflip system

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02052063

Contacts
Contact: Valérie BRIDOUX, MD +3323288 ext 8142 valerie.bridoux@chu-rouen.fr
Contact: Julien BLOT +3323288 ext 8265 julien.blot@chu-rouen.fr

Locations
France
UH Rouen Not yet recruiting
Rouen, France, 76031
Contact: Valérie BRIDOUX, MD    +3323288 ext 8142    valerie.bridoux@chu-rouen.fr   
Principal Investigator: Valérie BRIDOUX, MD         
Sponsors and Collaborators
University Hospital, Rouen
Investigators
Principal Investigator: Valérie BRIDOUX, MD UH Rouen
  More Information

No publications provided

Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT02052063     History of Changes
Other Study ID Numbers: 2013/132/HP
Study First Received: January 27, 2014
Last Updated: January 30, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Keywords provided by University Hospital, Rouen:
rectocele
intussusception
surgery

Additional relevant MeSH terms:
Intussusception
Rectocele
Intestinal Obstruction
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on July 24, 2014