Surgical Treatment of Obstructed Defecation Syndrome | NCT01899209

Studies
Surgical Treatment of Obstructed Defecation Syndrome

NCT01899209

Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Status

Unknown status

Last Update Posted

Jun 27, 2014Estimated

Enrollment

40Estimated

Phase

Not Applicable

Conditions

Sensation of Inadequate Defecation
Rectal Prolapse
Rectocele

Interventions

STARR
Laparoscopic Ventral Rectopexy

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2013

Primary Completion Date

Aug 2015Estimated

Completion Date

Not provided

First Submitted Date

Jul 8, 2013

First Submission Date that Met QC Criteria

Jul 11, 2013

First Posted Date

Jul 15, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 26, 2014

Last Update Posted Date

Jun 27, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dajana Cuicchi, Dr Dajana Cuicchi, IRCCS Azienda Ospedaliero-Universitaria di BolognaPrincipal Investigator

Lead Sponsor

IRCCS Azienda Ospedaliero-Universitaria di BolognaOTHER

Collaborators

Name	Class
University of Bologna	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group A	Experimental	STARR	Procedure: STARR
Group B	Experimental	Laparoscopic ventral Rectopexy	Procedure: Laparoscopic Ventral Rectopexy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
STARR	Procedure		Group A
Laparoscopic Ventral Rectopexy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Functional result	comparison between Obstructed Defaecation Syndrome (ODS) score before and 12 months after surgery	12 months

Secondary Outcomes

Measure	Description	Time Frame
Anatomical result	Comparison of clinical and radiological data before and 12 months after surgery	12 months

Other Outcomes

Measure	Description	Time Frame
Quality of life and safety	Comparison of Constipation-Related Quality of Life questionnaire (CRQoL) before and 12 months after surgery Comparison of morbidity and mortality rate between the two procedures	12 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients affected by Obstructed Defecation with ODS score >11
Symptomatic rectal Intussusception and/or defecographic finding of rectocele>2 cm
Failure of at least 6 months of medical therapy
Exclusion of neoplasm by rectosigmoidoscopy/colonoscopy

Exclusion Criteria:

Patients affected by complete rectal prolapse
Patients affected by slow transit constipation
Patients affected by anismus
Patients affected by pelvic organ prolapse
Patients with previous rectal or anal surgery

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Dajana Cuicchi, MD PhD	Contact	0516363236	0039	dajana.cuicchi@aosp.bo.it

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital	Recruiting	Bologna	Bologna	40138	Italy

Condition Browse Module

MeSH Terms

ID	Term
D012005	Rectal Prolapse
D020047	Rectocele
D007443	Intussusception

Ancestor Terms

ID	Term
D012002	Rectal Diseases
D007410	Intestinal Diseases
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided