Stapled TransAnal Rectal Resection (STARR) With Contour® TranstarTM - Full Text View

Sponsored by:	Cantonal Hospital of St. Gallen
Information provided by:	Cantonal Hospital of St. Gallen
ClinicalTrials.gov Identifier:	NCT00673400

Purpose

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.We like to evaluate the morbidity and the quality of life.

Condition	Intervention
Obstructed Defecation Syndrome Rectocele Intussusception	Procedure: Stapled transanal rectum resection

MedlinePlus related topics: Pelvic Support Problems

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Morbidity and Functional Outcome of Stapled TransAnal Rectal Resection (STARR) With Contour® TranstarTM in Obstructed Defecation

Further study details as provided by Cantonal Hospital of St. Gallen:

Primary Outcome Measures:

Quality of life [ Time Frame: before intervention and 6 months after intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Morbidity [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Hospitalization [ Time Frame: Length of hospital stay ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	January 2008
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1	Procedure: Stapled transanal rectum resection Contour Transtar-STR5G (Ethicon EndoSurgery Inc., Cincinnati, OH).The circularanaldilator is fixed to perianalskin.Rectal intussusception is evidenced with aswab.The firststitch is placed superficial on top of the intussuscetion.The procedure is performed 5to6 times counterclockwise.A final stitch for first radialcut at3 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 dilatator and moved counter clockwise with 4to6firings to complete the resection. Additional stitches across the stapleline to assure haemostasis.

Arms

Assigned Interventions

1

Procedure: Stapled transanal rectum resection

Contour Transtar-STR5G (Ethicon EndoSurgery Inc., Cincinnati, OH).The circularanaldilator is fixed to perianalskin.Rectal intussusception is evidenced with aswab.The firststitch is placed superficial on top of the intussuscetion.The procedure is performed 5to6 times counterclockwise.A final stitch for first radialcut at3 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 dilatator and moved counter clockwise with 4to6firings to complete the resection. Additional stitches across the stapleline to assure haemostasis.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Rectocele
Intussusception

Exclusion Criteria:

Non operability
inflammatory bowel disease

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00673400

Contacts

Contact: Franc Hetzer, MD	41-71-494-1339	franc.hetzer@kssg.ch
Contact: Katja Wolff, MD	41-71-494-1111	katja.wolff@kssg.ch

Locations

Switzerland
Department of Surgery, Cantonal Hospital St. Gallen	Recruiting
St. Gallen, Switzerland, 9007
Principal Investigator: Franc Hetzer, MD

Sponsors and Collaborators

Cantonal Hospital of St. Gallen

Investigators

Principal Investigator:

Franc Hetzer, MD

Cantonal Hospital St. Gallen, Department of Surgery

More Information

Department of Surgery, Cantonal Hospital St. Gallen, Switzerland This link exits the ClinicalTrials.gov site

Responsible Party:	Cantonal Hospital of St. Gallen ( Franc Hetzer )
Study ID Numbers:	STARR
Study First Received:	May 5, 2008
Last Updated:	May 6, 2008
ClinicalTrials.gov Identifier:	NCT00673400
Health Authority:	Switzerland: Ethikkommission

Keywords provided by Cantonal Hospital of St. Gallen:

Obstructed defecation syndrome
ODS
Rectocele
Intussusception
STARR

Study placed in the following topic categories:

Intestinal Obstruction
Rectocele
Digestive System Diseases
Gastrointestinal Diseases

Intussusception
Intestinal Diseases
Rectal Diseases

Additional relevant MeSH terms:

Pathologic Processes
Disease
Syndrome

ClinicalTrials.gov processed this record on January 16, 2009