NCT01899209

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 8, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 15, 2013

Completed
17 days until next milestone

Study Start

First participant enrolled

August 1, 2013

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Last Updated

June 27, 2014

Status Verified

June 1, 2014

Enrollment Period

2 years

First QC Date

July 8, 2013

Last Update Submit

June 26, 2014

Conditions

Sensation of Inadequate DefecationRectal ProlapseRectocele

Keywords

Obstructed DefecationRectal rectoceleIntussusceptionSTARRVentral Rectopexy

Outcome Measures

Primary Outcomes (1)

  • Functional result

    comparison between Obstructed Defaecation Syndrome (ODS) score before and 12 months after surgery

    12 months

Secondary Outcomes (1)

  • Anatomical result

    12 months

Other Outcomes (1)

  • Quality of life and safety

    12 months

Study Arms (2)

Group A

EXPERIMENTAL

STARR

Procedure: STARR

Group B

EXPERIMENTAL

Laparoscopic ventral Rectopexy

Procedure: Laparoscopic Ventral Rectopexy

Interventions

STARRPROCEDURE
Group A
Laparoscopic Ventral RectopexyPROCEDURE
Group B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital

Bologna, Bologna, 40138, Italy

RECRUITING

MeSH Terms

Conditions

Rectal ProlapseRectoceleIntussusception

Condition Hierarchy (Ancestors)

Rectal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesPelvic Organ ProlapseProlapsePathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsHerniaIntestinal Obstruction

Central Study Contacts

Dajana Cuicchi, MD PhD

CONTACT

0516363236dajana.cuicchi@aosp.bo.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr Dajana Cuicchi

Study Record Dates

First Submitted

July 8, 2013

First Posted

July 15, 2013

Study Start

August 1, 2013

Primary Completion

August 1, 2015

Last Updated

June 27, 2014

Record last verified: 2014-06

Locations

IT(1)