NCT00673400

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2008

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 5, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 7, 2008

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
2.9 years until next milestone

Results Posted

Study results publicly available

October 2, 2012

Completed
Last Updated

October 2, 2012

Status Verified

October 1, 2012

Enrollment Period

10 months

First QC Date

May 5, 2008

Results QC Date

July 16, 2012

Last Update Submit

October 1, 2012

Conditions

Obstructed Defecation SyndromeRectoceleIntussusceptionSNS

Keywords

Obstructed defecation syndromeODSRectoceleIntussusceptionSTARR

Outcome Measures

Primary Outcomes (1)

  • 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)

    6 months after intervention

Secondary Outcomes (2)

  • Morbidity

    1 year

  • Hospitalization

    1 day to 1 year (until release from hospital)

Other Outcomes (3)

  • Severity of Symptoms Score

    before surgery - 6 weeks - 3 months - 6 months

  • Obstructive Defecation Syndrome Score

    before surgery - 6 weeks -3 months - 6 months

  • SF36 Component Summary Scores

    Before surgery - 6 months

Study Arms (1)

Stapled transanal rectum resection

OTHER

patients operated with stapled transanal rectum resection

Procedure: Stapled transanal rectum resection

Interventions

Stapled transanal rectum resectionPROCEDURE

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.

Stapled transanal rectum resection

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Rectocele
  • Intussusception

You may not qualify if:

  • Non operability
  • inflammatory bowel disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Surgery, Cantonal Hospital St. Gallen

Sankt Gallen, 9007, Switzerland

Location

Related Publications (1)

  • 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.

    PMID: 20485001RESULT

MeSH Terms

Conditions

RectoceleIntussusception

Condition Hierarchy (Ancestors)

Rectal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsIntestinal Obstruction

Results Point of Contact

Title
Ulrich Beutner PhD
Organization
Cantonal Hospital St. Gallen, Department of Surgery
ulrich.beutner@kssg.ch
+41 71 494 1111

Study Officials

  • Franc Hetzer, MD

    Cantonal Hospital St. Gallen, Department of Surgery

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Leitender Arzt

Study Record Dates

First Submitted

May 5, 2008

First Posted

May 7, 2008

Study Start

January 1, 2008

Primary Completion

November 1, 2008

Study Completion

November 1, 2009

Last Updated

October 2, 2012

Results First Posted

October 2, 2012

Record last verified: 2012-10

Locations

CH(1)