A Phase 4 interventional study of STARR and Biofeedback in Gastric Outlet Obstruction, Rectocele and Intussusception, sponsored by Ethicon Endo-Surgery (Europe) GmbH. Completed at 9 sites in 3 countries. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-12-18.
Sponsored by Ethicon Endo-Surgery (Europe) GmbH (part of Johnson & Johnson) · Phase 4, Interventional, and Treatment
This study aimed to evaluate the safety and symptomatic outcomes achieved with Stapled Transanal Rectal Resection (STARR) compared to biofeedback training in patients with obstructed defecation syndrome (ODS).
38 studies on the registry are indexed under Gastric Outlet Obstruction; 14 are open to participants now.
This study's enrollment of 121 is above the median of 69 across 28 interventional studies indexed under Gastric Outlet Obstruction.
Browse Gastric Outlet Obstruction studies →Ethicon Endo-Surgery (Europe) GmbH is the lead sponsor of 5 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Evidence of external sphincter injury associated with incontinence.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
STARR
Device: STARR
Biofeedback
Behavioral: Biofeedback
Stapled Trans-Anal Rectal Resection for the treatment of ODS
electromyographic-based treatment sessions
ODS total score
Time frame: 12 months
PAC-QoL score
Time frame: 12 months
This study is completed, as verified in Dec 2013. You cannot join it, but the record below documents what was studied.
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