Stapled TransAnal Rectal Resection (STARR) With Contour® TranstarTM

Study Overview
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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.

Official Title
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Morbidity and Functional Outcome of Stapled TransAnal Rectal Resection (STARR) With Contour® TranstarTM in Obstructed Defecation

Conditions
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Obstructed Defecation Syndrome, Rectocele, Intussusception, SNS

Intervention / Treatment
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* Procedure: Stapled transanal rectum resection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Rectocele Intussusception Exclusion Criteria: Non operability inflammatory bowel disease
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Stapled transanal rectum resection<br>patients operated with stapled transanal rectum resection | Procedure: Stapled transanal rectum resection<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morbidity | Surgical complications after treatment according to Dindo (Ann Surg (2004) 240:205) | 1 year | 
| Hospitalization | Length of hospital stay (Date of release - Date of admission + 1) | 1 day to 1 year (until release from hospital) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obstructed defecation syndrome, ODS, Rectocele, Intussusception, STARR