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Stapled TransAnal Rectal Resection (STARR) With Contour® TranstarTM (STARR)

Primary Purpose

Obstructed Defecation Syndrome, Rectocele, Intussusception

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Stapled transanal rectum resection
Sponsored by
Cantonal Hospital of St. Gallen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstructed Defecation Syndrome focused on measuring Obstructed defecation syndrome, ODS, Rectocele, Intussusception, STARR

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Rectocele
  • Intussusception

Exclusion Criteria:

  • Non operability
  • inflammatory bowel disease

Sites / Locations

  • Department of Surgery, Cantonal Hospital St. Gallen

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Stapled transanal rectum resection

Arm Description

patients operated with stapled transanal rectum resection

Outcomes

Primary Outcome Measures

Quality of Life
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 Fecal Incontinence Quality of Life (FIQL) (Rockwood, Dis Colon Rectum (2000) 43:9)

Secondary Outcome Measures

Morbidity
Surgical complications after treatment according to Dindo (Ann Surg (2004) 240:205)
Hospitalization
Length of hospital stay (Date of release - Date of admission + 1)

Full Information

First Posted
May 5, 2008
Last Updated
October 1, 2012
Sponsor
Cantonal Hospital of St. Gallen
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1. Study Identification

Unique Protocol Identification Number
NCT00673400
Brief Title
Stapled TransAnal Rectal Resection (STARR) With Contour® TranstarTM
Acronym
STARR
Official Title
Morbidity and Functional Outcome of Stapled TransAnal Rectal Resection (STARR) With Contour® TranstarTM in Obstructed Defecation
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
November 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cantonal Hospital of St. Gallen

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The stapled transanal rectal resection (STARR procedure) is an effective treatment for obstructed defecation syndrome (ODS) caused by intussusception and rectocele. Recently a new technique has been developed using the new Contour® TranstarTM stapler, which was specifically designed to facilitate the STARR procedure. The investigators would like to evaluate the morbidity and quality of life.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructed Defecation Syndrome, Rectocele, Intussusception, SNS
Keywords
Obstructed defecation syndrome, ODS, Rectocele, Intussusception, STARR

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Stapled transanal rectum resection
Arm Type
Other
Arm Description
patients operated with stapled transanal rectum resection
Intervention Type
Procedure
Intervention Name(s)
Stapled transanal rectum resection
Intervention Description
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.
Primary Outcome Measure Information:
Title
Quality of Life
Description
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 Fecal Incontinence Quality of Life (FIQL) (Rockwood, Dis Colon Rectum (2000) 43:9)
Time Frame
6 months after intervention
Secondary Outcome Measure Information:
Title
Morbidity
Description
Surgical complications after treatment according to Dindo (Ann Surg (2004) 240:205)
Time Frame
1 year
Title
Hospitalization
Description
Length of hospital stay (Date of release - Date of admission + 1)
Time Frame
1 day to 1 year (until release from hospital)
Other Pre-specified Outcome Measures:
Title
Severity of Symptoms Score
Description
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)
Time Frame
before surgery - 6 weeks - 3 months - 6 months
Title
Obstructive Defecation Syndrome Score
Description
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)
Time Frame
before surgery - 6 weeks -3 months - 6 months
Title
SF36 Component Summary Scores
Description
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.
Time Frame
Before surgery - 6 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Rectocele Intussusception Exclusion Criteria: Non operability inflammatory bowel disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Franc Hetzer, MD
Organizational Affiliation
Cantonal Hospital St. Gallen, Department of Surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Surgery, Cantonal Hospital St. Gallen
City
St. Gallen
ZIP/Postal Code
9007
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
20485001
Citation
Wolff K, Marti L, Beutner U, Steffen T, Lange J, Hetzer FH. Functional outcome and quality of life after stapled transanal rectal resection for obstructed defecation syndrome. Dis Colon Rectum. 2010 Jun;53(6):881-8. doi: 10.1007/DCR.0b013e3181cdb445.
Results Reference
result
Links:
URL
http://www.surgery.ch
Description
Department of Surgery, Cantonal Hospital St. Gallen, Switzerland

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Stapled TransAnal Rectal Resection (STARR) With Contour® TranstarTM

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