Intussusception, Obstructed Defecation Syndrome, Rectocele, SNS
Conditions
Keywords
Obstructed defecation syndrome, ODS, Rectocele, Intussusception, STARR
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.
Interventions
PROCEDUREStapled 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.
Sponsors
Cantonal Hospital of St. Gallen
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Rectocele * Intussusception
Exclusion criteria
* Non operability * inflammatory bowel disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life | 6 months after intervention | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Morbidity | 1 year | Surgical complications after treatment according to Dindo (Ann Surg (2004) 240:205) |
| Hospitalization | 1 day to 1 year (until release from hospital) | Length of hospital stay (Date of release - Date of admission + 1) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Severity of Symptoms Score | before surgery - 6 weeks - 3 months - 6 months | 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) |
| Obstructive Defecation Syndrome Score | before surgery - 6 weeks -3 months - 6 months | 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) |
| SF36 Component Summary Scores | Before surgery - 6 months | 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. |
Countries
Switzerland
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Stapled TransAnal Rectal Resection patients were operated by stapled transanal rectal resection | 52 |
| Total | 52 |
Baseline characteristics
| Characteristic | Stapled TransAnal Rectal Resection |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 23 Participants |
| Age, Categorical Between 18 and 65 years | 29 Participants |
| Age Continuous | 63.2 years STANDARD_DEVIATION 12.9 |
| Region of Enrollment Switzerland | 52 participants |
| Sex: Female, Male Female | 52 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 4 / 52 |
| serious Total, serious adverse events | 0 / 52 |
Outcome results
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 * Fecal Incontinence Quality of Life (FIQL) (Rockwood, Dis Colon Rectum (2000) 43:9)
Time frame: 6 months after intervention
Population: 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
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Before Surgery | Quality of Life | Lifestyle (LS) | 3.2 units on a scale |
| Before Surgery | Quality of Life | Embarrassment (E) | 3.3 units on a scale |
| Before Surgery | Quality of Life | Coping/behavior (C/P) | 2.8 units on a scale |
| Before Surgery | Quality of Life | Depression/self-perception (D/S) | 3.3 units on a scale |
| 6 Months After Surgery | Quality of Life | Embarrassment (E) | 4.0 units on a scale |
| 6 Months After Surgery | Quality of Life | Lifestyle (LS) | 3.7 units on a scale |
| 6 Months After Surgery | Quality of Life | Depression/self-perception (D/S) | 3.9 units on a scale |
| 6 Months After Surgery | Quality of Life | Coping/behavior (C/P) | 3.3 units on a scale |
Comparison: Lifestyle (LS)p-value: 0.134Wilcoxon (Mann-Whitney)
Comparison: Coping/behavior (C/B)p-value: 0.088Wilcoxon (Mann-Whitney)
Comparison: Depression/self-perception (D/S)p-value: 0.0012Wilcoxon (Mann-Whitney)
Comparison: Embarrassment (E)p-value: 0.0074Wilcoxon (Mann-Whitney)
Secondary
Hospitalization
Length of hospital stay (Date of release - Date of admission + 1)
Time frame: 1 day to 1 year (until release from hospital)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Before Surgery | Hospitalization | 5 days |
Secondary
Morbidity
Surgical complications after treatment according to Dindo (Ann Surg (2004) 240:205)
Time frame: 1 year
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Before Surgery | Morbidity | Urinay retention (Dindo IIIa) (within 30 days) | 1 participants |
| Before Surgery | Morbidity | self limiting rectal bleeding (Dindo I)(6 weeks) | 2 participants |
| Before Surgery | Morbidity | Pain from residual staple (Dindo IIIa)(6 weeks) | 2 participants |
| Before Surgery | Morbidity | Perianal venous thrombosis (Dindo IIIa) (5 weeks) | 1 participants |
| Before Surgery | Morbidity | overall | 6 participants |
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)
Time frame: before surgery - 6 weeks -3 months - 6 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Before Surgery | Obstructive Defecation Syndrome Score | 16 units on a scale |
| 6 Months After Surgery | Obstructive Defecation Syndrome Score | 5 units on a scale |
| 3 Months After Surgery | Obstructive Defecation Syndrome Score | 4 units on a scale |
| 6 Months After Surgery | Obstructive Defecation Syndrome Score | 5 units on a scale |
p-value: <1e-7Wilcoxon (Mann-Whitney)
p-value: <1e-7Wilcoxon (Mann-Whitney)
p-value: <1e-7Wilcoxon (Mann-Whitney)
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)
Time frame: before surgery - 6 weeks - 3 months - 6 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Before Surgery | Severity of Symptoms Score | 15 units on a scale |
| 6 Months After Surgery | Severity of Symptoms Score | 4 units on a scale |
| 3 Months After Surgery | Severity of Symptoms Score | 3 units on a scale |
| 6 Months After Surgery | Severity of Symptoms Score | 3 units on a scale |
p-value: <1e-7Wilcoxon (Mann-Whitney)
p-value: <1e-7Wilcoxon (Mann-Whitney)
p-value: <1e-7Wilcoxon (Mann-Whitney)
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.
Time frame: Before surgery - 6 months
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Before Surgery | SF36 Component Summary Scores | Physical component summary (PCS) | 51 units on a scale |
| Before Surgery | SF36 Component Summary Scores | Mental component summary (MCS) | 39 units on a scale |
| 6 Months After Surgery | SF36 Component Summary Scores | Physical component summary (PCS) | 52 units on a scale |
| 6 Months After Surgery | SF36 Component Summary Scores | Mental component summary (MCS) | 53 units on a scale |
Comparison: Physical component summary (PCS)p-value: 0.65Wilcoxon (Mann-Whitney)
Comparison: Mental component summary (MCS)p-value: 0.01Wilcoxon (Mann-Whitney)