An interventional study of Stapled transanal rectum resection in Obstructed Defecation Syndrome, Rectocele and Intussusception, sponsored by Cantonal Hospital of St. Gallen. Completed at 1 site in Switzerland. Per ClinicalTrials.gov, last updated 2012-10-02.
Sponsored by Cantonal Hospital of St. Gallen · Not applicable, Interventional, and Treatment
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.
50 studies on the registry are indexed under Rectocele; 9 are open to participants now.
This study's enrollment of 52 is below the median of 62 across 37 interventional studies indexed under Rectocele.
Browse Rectocele studies →Cantonal Hospital of St. Gallen is the lead sponsor of 79 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
patients operated with stapled transanal rectum resection
Procedure: 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.
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)
Time frame: 6 months after intervention
Morbidity
Surgical complications after treatment according to Dindo (Ann Surg (2004) 240:205)
Time frame: 1 year
Hospitalization
Length of hospital stay (Date of release - Date of admission + 1)
Time frame: 1 day to 1 year (until release from hospital)
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)
Time frame: before surgery - 6 weeks - 3 months - 6 months
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)
Time frame: 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.
Time frame: Before surgery - 6 months
| Milestone | Stapled TransAnal Rectal Resection |
|---|---|
| Started | 52 |
| Completed | 52 |
| Not completed | 0 |
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)
| units on a scale | Before Surgery | 6 Months After Surgery |
|---|---|---|
| Lifestyle (LS) | 3.2 (2.4 to 3.6) | 3.7 (2.4 to 4.0) |
| Coping/behavior (C/P) | 2.8 (2.1 to 3.6) | 3.3 (2.2 to 4.0) |
| Depression/self-perception (D/S) | 3.3 (2.3 to 3.9) | 3.9 (3.1 to 4.1) |
| Embarrassment (E) | 3.3 (2.3 to 4.0) | 4.0 (3.7 to 4.0) |
Surgical complications after treatment according to Dindo (Ann Surg (2004) 240:205)
| participants | Stapled TransAnal Rectal Resection |
|---|---|
| overall | 6 |
| Urinay retention (Dindo IIIa) (within 30 days) | 1 |
| self limiting rectal bleeding (Dindo I)(6 weeks) | 2 |
| Pain from residual staple (Dindo IIIa)(6 weeks) | 2 |
| Perianal venous thrombosis (Dindo IIIa) (5 weeks) | 1 |
Length of hospital stay (Date of release - Date of admission + 1)
| days | Stapled TransAnal Rectal Resection |
|---|---|
| Hospitalization | 5 (2 to 29) |
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)
| units on a scale | Before Surgery | 6 Weeks After Surgery | 3 Months After Surgery | 6 Months After Surgery |
|---|---|---|---|---|
| Severity of Symptoms Score | 15 (13 to 17) | 4 (2 to 5) | 3 (2 to 5) | 3 (2 to 5) |
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)
| units on a scale | Before Surgery | 6 Weeks After Surgery | 3 Months After Surgery | 6 Months After Surgery |
|---|---|---|---|---|
| Obstructive Defecation Syndrome Score | 16 (14 to 18) | 5 (3 to 6) | 4 (3 to 5) | 5 (2 to 7) |
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.
| units on a scale | Before Surgery | 6 Months After Surgery |
|---|---|---|
| Physical component summary (PCS) | 51 (43 to 55) | 52 (35 to 55) |
| Mental component summary (MCS) | 39 (33 to 51) | 53 (40 to 58) |
Collected over 1 year. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Stapled TransAnal Rectal Resection | — | 0/52 (0%) | 4/52 (7.7%) |
| Event | Stapled TransAnal Rectal Resection |
|---|---|
| persisting pain due to residual staplesInjury, poisoning and procedural complications | 2/52 |
| thrombosisBlood and lymphatic system disorders | 1/52 |
| urinary retentionRenal and urinary disorders | 1/52 |
| Age, Categorical(Participants) | Stapled TransAnal Rectal Resection |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 29 |
| >=65 years | 23 |
| Age Continuous(years) | Stapled TransAnal Rectal Resection |
|---|---|
| Mean | 63.2 ± 12.9 |
| Sex: Female, Male(Participants) | Stapled TransAnal Rectal Resection |
|---|---|
| Female | 52 |
| Male | 0 |
| Region of Enrollment(participants) | Stapled TransAnal Rectal Resection |
|---|---|
| Switzerland | 52 |
The record gives a start of Jan 2008, a primary completion of Nov 2008 and a completion of Nov 2009. It does not say whether these dates are actual or estimated.
Results were first posted in Oct 2012, 3 years 11 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2012. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Cantonal Hospital of St. Gallen