- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00673400
Stapled TransAnal Rectal Resection (STARR) With Contour® TranstarTM (STARR)
Morbidity and Functional Outcome of Stapled TransAnal Rectal Resection (STARR) With Contour® TranstarTM in Obstructed Defecation
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
St. Gallen, Switzerland, 9007
- Department of Surgery, Cantonal Hospital St. Gallen
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Rectocele
- Intussusception
Exclusion Criteria:
- Non operability
- inflammatory bowel disease
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Stapled transanal rectum resection
patients operated with stapled transanal rectum resection
|
Contour Transtar-STR5G (Ethicon EndoSurgery Inc., Cincinnati, OH).The circular anal dilator is fixed to perianal skin.Rectal intussusception is evidenced with a swab.The first stitch is placed superficial on top of the intussusception.
The procedure is performed 5to6 times counterclockwise.A final stitch for first radial cut at 3 o'clock.The device is introduced into the rectum.
This cut opens the prolapse.
Check with a finger the vagina.
The device is then closed and fired.
After replacing the cartridge, the device is introduced in the rectum, placed parallel to the circular anal dilator and moved counter clockwise with 4to6firings to complete the resection.
Additional stitches across the staple line to assure haemostasis.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quality of Life
Time Frame: 6 months after intervention
|
Quality of life is measured by Fecal incontinence quality of life (FIQL) Possible range of score 0 - 4 (Depression/Self perception 4.4) 0 = worst condition
|
6 months after intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Morbidity
Time Frame: 1 year
|
Surgical complications after treatment according to Dindo (Ann Surg (2004) 240:205)
|
1 year
|
Hospitalization
Time Frame: 1 day to 1 year (until release from hospital)
|
Length of hospital stay (Date of release - Date of admission + 1)
|
1 day to 1 year (until release from hospital)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Severity of Symptoms Score
Time Frame: before surgery - 6 weeks - 3 months - 6 months
|
Score based on the severity of 9 symptoms of bowel movement (physician administered) (0 - 36, no symptoms = 0) Dis Colon Rectum 39:681 (DOI: 10.1007/BF02056950) |
before surgery - 6 weeks - 3 months - 6 months
|
Obstructive Defecation Syndrome Score
Time Frame: before surgery - 6 weeks -3 months - 6 months
|
Score based on severity or frequency of 9 symptoms of obstructive defecation (physician administered) (0 - 40, no symptoms = 0) Dis Colon Rectum 51:348(DOI: 10.1007/s10350-007-9115-1) |
before surgery - 6 weeks -3 months - 6 months
|
SF36 Component Summary Scores
Time Frame: Before surgery - 6 months
|
Quality of life short form 36 version 2(SF36v2) standard form PCS: physical component summary score (range 1 to 81, with 81 being the best) MCS: mental component summary score (range -9 to 82, with 82 being the best) A score of 50 correlates with the result of a healthy standard US population (score transformation to a mean of 50 and a standard deviation of 10) Ware JE, Kosinski M, Dewey JE. How to Score Version 2 of the SF-36® Health Survey. Lincoln, RI: QualityMetric Incorporated, 2000. |
Before surgery - 6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Franc Hetzer, MD, Cantonal Hospital St. Gallen, Department of Surgery
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STARR
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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