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Surgical Treatment of Obstructed Defecation Syndrome (PRO-REST)

S

Scientific Institute for Research Hospitalization and Healthcare (IRCCS)

Status

Unknown

Conditions

Rectal Prolapse
Sensation of Inadequate Defecation
Rectocele

Treatments

Procedure: STARR
Procedure: Laparoscopic Ventral Rectopexy

Study type

Interventional

Funder types

Other

Identifiers

NCT01899209
PRO-REST

Details and patient eligibility

About

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.

Enrollment

40 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

40 participants in 2 patient groups

Group A
Experimental group
Description:
STARR
Treatment:
Procedure: STARR
Group B
Experimental group
Description:
Laparoscopic ventral Rectopexy
Treatment:
Procedure: Laparoscopic Ventral Rectopexy

Trial contacts and locations

1

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Central trial contact

Dajana Cuicchi, MD PhD

Data sourced from clinicaltrials.gov

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