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Stapled TransAnal Rectal Resection (STARR) With Contour® TranstarTM

NCT ID: NCT00673400

Last Updated: 2012-10-02

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2009-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Obstructed Defecation Syndrome Rectocele Intussusception SNS

Keywords

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Obstructed defecation syndrome ODS Rectocele Intussusception STARR

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Stapled transanal rectum resection

patients operated with stapled transanal rectum resection

Group Type OTHER

Stapled transanal rectum resection

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Rectocele
* Intussusception

Exclusion Criteria

* Non operability
* inflammatory bowel disease
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cantonal Hospital of St. Gallen

OTHER

Sponsor Role lead

Responsible Party

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F. Hetzer

Leitender Arzt

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Franc Hetzer, MD

Role: PRINCIPAL_INVESTIGATOR

Cantonal Hospital St. Gallen, Department of Surgery

Locations

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Department of Surgery, Cantonal Hospital St. Gallen

Sankt Gallen, , Switzerland

Site Status

Countries

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Switzerland

References

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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.

Reference Type RESULT
PMID: 20485001 (View on PubMed)

Other Identifiers

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STARR

Identifier Type: -

Identifier Source: org_study_id