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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stapled transanal rectum resection | Other | patients operated with stapled transanal rectum resection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stapled transanal rectum resection | 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. |
| 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
| 6 months after intervention |
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Severity of Symptoms Score | 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) | before surgery - 6 weeks - 3 months - 6 months |
| Obstructive Defecation Syndrome Score |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Franc Hetzer, MD | Cantonal Hospital St. Gallen, Department of Surgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Surgery, Cantonal Hospital St. Gallen | Sankt Gallen | 9007 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20485001 | Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Stapled TransAnal Rectal Resection | patients were operated by stapled transanal rectal resection |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Stapled TransAnal Rectal Resection | patients were operated by stapled transanal rectal resection |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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
| Participating in the FIQL survey was voluntarily. Some patients did not participate at all, some did not answer all questions. Patients answering >=50% of questions of a domain were counted as participants | Posted | Median | Inter-Quartile Range | units on a scale | 6 months after intervention |
|
1 year
Grading of adverse events according to Accordion/Dindo Scale see also secondary outcome: morbidity (Ann Surg (2004) 240:205)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Stapled TransAnal Rectal Resection | patients were operated by stapled transanal rectal resection |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| persisting pain due to residual staples | Injury, poisoning and procedural complications | Dindo Scale | Systematic Assessment | Dindo grade IIIa: intervention without general anesthesia |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ulrich Beutner PhD | Cantonal Hospital St. Gallen, Department of Surgery | +41 71 494 1111 | ulrich.beutner@kssg.ch |
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| ID | Term |
|---|---|
| D020047 | Rectocele |
| D007443 | Intussusception |
| ID | Term |
|---|---|
| D012002 | Rectal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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|
| 1 day to 1 year (until release from hospital) |
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) |
| before surgery - 6 weeks -3 months - 6 months |
| SF36 Component Summary Scores | 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. | Before surgery - 6 months |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
outcome measured within one month before surgery
|
|
|
| Secondary | Morbidity | Surgical complications after treatment according to Dindo (Ann Surg (2004) 240:205) | Posted | Number | participants | 1 year |
|
|
|
| Secondary | Hospitalization | Length of hospital stay (Date of release - Date of admission + 1) | Posted | Median | Full Range | days | 1 day to 1 year (until release from hospital) |
|
|
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| Other Pre-specified | Severity of Symptoms Score | 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) | Posted | Median | Inter-Quartile Range | units on a scale | before surgery - 6 weeks - 3 months - 6 months |
|
|
|
|
| Other Pre-specified | Obstructive Defecation Syndrome Score | 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) | Posted | Median | Inter-Quartile Range | units on a scale | before surgery - 6 weeks -3 months - 6 months |
|
|
|
|
| Other Pre-specified | SF36 Component Summary Scores | 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. | Posted | Median | Inter-Quartile Range | units on a scale | Before surgery - 6 months |
|
|
|
|
| 0 |
| 52 |
| 4 |
| 52 |
|
| thrombosis | Blood and lymphatic system disorders | Dindo Scale | Systematic Assessment | perianal venous thrombosis 5 weeks postoperatively Dindo grade IIIb: incision under general anesthesia |
|
| urinary retention | Renal and urinary disorders | Dindo Scale | Systematic Assessment | Dindo grade IIIa: intervention without general anesthesia |
|
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| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007415 | Intestinal Obstruction |
| <0.0000001 |
| 95 |
| No |
| Superiority or Other |
| Wilcoxon (Mann-Whitney) | two-sided, paired test, exact method | <0.0000001 | 95 | No | Superiority or Other |
| <0.0000001 |
| 95 |
| No |
| Superiority or Other |
| Wilcoxon (Mann-Whitney) | two-sided, paired test, exact method | <0.0000001 | 95 | No | Superiority or Other |
Mental component summary (MCS)
| Wilcoxon (Mann-Whitney) |
matched pair test, two-sided, exact method |
| 0.010 |
based on 28 pairwise matches |
| 95 |
| No |
| Superiority or Other |