Study Preview
Study Title and Description
Is obesity a risk factor for failure and complications after surgery for incontinence and prolapse in women?
Key Questions Addressed
2 | Sling Adverse Events |
Primary Publication Information
Title | Is obesity a risk factor for failure and complications after surgery for incontinence and prolapse in women? |
Author | Haverkorn RM., Williams BJ., Kubricht WS., Gomelsky A. |
Country | Department of Urology, University of Texas Southwestern, Dallas, Texas, USA. |
Year | 2011 |
Numbers |
Pubmed ID: 21247603 1256 (internal) |
Secondary Publication Information
There are currently no secondary publications defined for this study.
Extraction Form: Sling Adverse Events
Arms
Number | Title | Description | Comments |
---|---|---|---|
1 | Fascial PVS, BMI less than 30 | ||
2 | Fascial PVS, BMI 30 or greater | ||
3 | Cadaveric PVS, BMI less than 30 | ||
4 | Cadaveric PVS, BMI 30 or greater | ||
5 | Transobturator synthetic, BMI less than 30 | ||
6 | Transobturator synthetic, BMI 30 or greater |
Question... Follow Up | Answer | Follow-up Answer | |
---|---|---|---|
Study Type | Retrospective nonrandom (2+ slings analyzed separately) | ||
Study Country | US | ||
Sling Category | Retropubic biologic | ||
Obturator synthetic | |||
Pubovaginal (bladder neck) | |||
Multicenter? | Yes | ||
Institution Type | Academic hospital | ||
No. of Surgeons Performing the Procedures | Unclear/Not reported | ||
Surgeons' Training | Urology | ||
Residents or Fellows Performing the Surgery? | Unclear/Not reported | ||
Adverse Event Ascertainment | Active | ||
Was the Clavien-Dindo Classification of Surgical Complications system used? | No / Not reported | ||
Was a data safety monitoring board used? | No / Not reported | ||
Study Sponsor/Funding | Not reported | ||
Comments (overall study) | This is a retrospective cohort study of 3 procedures for SUI: Autologous rectus fascia, acellular porcine dermis and TOT. They ensambled 6 groups (3 procedures and BMI <or>30). Minimum follow up was 12 months. In terms of AEs they did not find increase complications in obese women. Table 6 summarizes all AEs. Unfortunately they do not report the crude numbers but rather percentages. |
Results & Comparisons
No Results found.
Adverse Events
Arm or Total | Title | Description | Follow-up time | In-hospital or After discharge | Is event serious? | Reported definition of serious event | Number affected | Number at risk (analyzed) | Difference between 2 slings (eg, OR/RR or %, with 95% CI) | Reported P value between slings | Comments |
---|---|---|---|---|---|---|---|---|---|---|---|
Fascial PVS, BMI less than 30 | Total perioperative complications | Data are given in percentages | 12 months | In-hospital | no | 2.1 (%) | 94 | ||||
Fascial PVS, BMI 30 or greater | 12 months | In-hospital | no | 3 | 66 | ||||||
Cadaveric PVS, BMI less than 30 | 12 months | In-hospital | no | 3.2 | 157 | ||||||
Cadaveric PVS, BMI 30 or greater | 12 months | In-hospital | no | 4.4 | 114 | ||||||
Transobturator synthetic, BMI less than 30 | 12 months | In-hospital | no | 3.7 | 161 | ||||||
Transobturator synthetic, BMI 30 or greater | 12 months | In-hospital | no | 2.6 | 117 | ||||||
Total | |||||||||||
Fascial PVS, BMI less than 30 | Total perioperative complications lasting less than 30 days | All complications resolved by day 30 | 1 month | Both | no | 13.8 | 94 | ||||
Fascial PVS, BMI 30 or greater | 1 month | Both | no | 22.7 | 66 | ||||||
Cadaveric PVS, BMI less than 30 | 1 month | Both | no | 15.3 | 157 | ||||||
Cadaveric PVS, BMI 30 or greater | 1 month | Both | no | 17.5 | 114 | ||||||
Transobturator synthetic, BMI less than 30 | 1 month | Both | no | 9.3 | 161 | ||||||
Transobturator synthetic, BMI 30 or greater | 1 month | Both | no | 6 | 117 | ||||||
Total | |||||||||||
Fascial PVS, BMI less than 30 | Urinary Retention lasting less than 30 days | Urinary retention resolved by day 30 | 1 month | both | no | 3.2 | 94 | ||||
Fascial PVS, BMI 30 or greater | 1 month | both | no | 3.0 | 66 | ||||||
Cadaveric PVS, BMI less than 30 | 1 month | both | no | 3.8 | 157 | ||||||
Cadaveric PVS, BMI 30 or greater | 1 month | both | no | 4.4 | 114 | ||||||
Transobturator synthetic, BMI less than 30 | 1 month | both | no | 3.7 | 161 | ||||||
Transobturator synthetic, BMI 30 or greater | 1 month | both | no | 1.7 | 117 | ||||||
Total | |||||||||||
Fascial PVS, BMI less than 30 | Abdominal wound complications resolved by day 30 | 1 month | both | no | 5.3 | 94 | |||||
Fascial PVS, BMI 30 or greater | 1 month | both | no | 12.1 | 66 | ||||||
Cadaveric PVS, BMI less than 30 | 1 month | both | no | 1.3 | 157 | ||||||
Cadaveric PVS, BMI 30 or greater | 1 month | both | no | 3.5 | 114 | ||||||
Transobturator synthetic, BMI less than 30 | 1 month | both | no | 0.6 | 161 | ||||||
Transobturator synthetic, BMI 30 or greater | 1 month | both | no | 0 | 117 | ||||||
Total | |||||||||||
Fascial PVS, BMI less than 30 | Delayed vaginal healing/extrusion | Delayed vaginal healing/extrusion resolved by day 30 | 1 month | both | no | 3.2 | 94 | ||||
Fascial PVS, BMI 30 or greater | 1 month | both | no | 4.5 | 66 | ||||||
Cadaveric PVS, BMI less than 30 | 1 month | both | no | 7.0 | 157 | ||||||
Cadaveric PVS, BMI 30 or greater | 1 month | both | no | 7.9 | 114 | ||||||
Transobturator synthetic, BMI less than 30 | 1 month | both | no | 5.0 | 161 | ||||||
Transobturator synthetic, BMI 30 or greater | 1 month | both | no | 1.7 | 117 | ||||||
Total | |||||||||||
Fascial PVS, BMI less than 30 | Total complications lasting 30 days or more | Total complications | 12 months | After discharge | no | 14.9 | 94 | ||||
Fascial PVS, BMI 30 or greater | 12 months | After discharge | no | 7.6 | 66 | ||||||
Cadaveric PVS, BMI less than 30 | 12 months | After discharge | no | 9.6 | 157 | ||||||
Cadaveric PVS, BMI 30 or greater | 12 months | After discharge | no | 7.9 | 114 | ||||||
Transobturator synthetic, BMI less than 30 | 12 months | After discharge | no | 5.0 | 161 | ||||||
Transobturator synthetic, BMI 30 or greater | 12 months | After discharge | no | 1.7 | 117 | ||||||
Total | |||||||||||
Fascial PVS, BMI less than 30 | Urinary retention/Positional voiding lasting 30 days or more | 12 months | After discharge | no | 14.9 | 94 | |||||
Fascial PVS, BMI 30 or greater | 12 months | After discharge | no | 1.5 | 66 | ||||||
Cadaveric PVS, BMI less than 30 | 12 months | After discharge | no | 6.4 | 157 | ||||||
Cadaveric PVS, BMI 30 or greater | 12 months | After discharge | no | 3.5 | 114 | ||||||
Transobturator synthetic, BMI less than 30 | 12 months | After discharge | no | 3.1 | 161 | ||||||
Transobturator synthetic, BMI 30 or greater | 12 months | After discharge | no | 0 | 117 | ||||||
Total | |||||||||||
Fascial PVS, BMI less than 30 | Pain, other (new or different after surgery) | Dyspareunia lasting 30 days or longer | 12 months | After discharge | no | 0 | 94 | ||||
Fascial PVS, BMI 30 or greater | 12 months | After discharge | no | 1.5 | 66 | ||||||
Cadaveric PVS, BMI less than 30 | 12 months | After discharge | no | 2.5 | 157 | ||||||
Cadaveric PVS, BMI 30 or greater | 12 months | After discharge | no | 2.6 | 114 | ||||||
Transobturator synthetic, BMI less than 30 | 12 months | After discharge | no | 0 | 161 | ||||||
Transobturator synthetic, BMI 30 or greater | 12 months | After discharge | no | 0 | 117 | ||||||
Total | |||||||||||
Fascial PVS, BMI less than 30 | Total non-urological complications | Unspecified | 12 months | ? | no | 2.1 | 94 | ||||
Fascial PVS, BMI 30 or greater | 12 months | ? | no | 1.5 | 66 | ||||||
Cadaveric PVS, BMI less than 30 | 12 months | ? | no | 3.2 | 157 | ||||||
Cadaveric PVS, BMI 30 or greater | 12 months | ? | no | 0.9 | 114 | ||||||
Transobturator synthetic, BMI less than 30 | 12 months | ? | no | 1.2 | 161 | ||||||
Transobturator synthetic, BMI 30 or greater | 12 months | ? | no | 1.7 | 117 | ||||||
Total | |||||||||||
Fascial PVS, BMI less than 30 | Total hospital readmissions | Hospital readmissions | 12 months | After discharge | no | 6.4 | 94 | ||||
Fascial PVS, BMI 30 or greater | 12 months | After discharge | no | 3.0 | 66 | ||||||
Cadaveric PVS, BMI less than 30 | 12 months | After discharge | no | 1.3 | 157 | ||||||
Cadaveric PVS, BMI 30 or greater | 12 months | After discharge | no | 0 | 114 | ||||||
Transobturator synthetic, BMI less than 30 | 12 months | After discharge | no | 1.2 | 161 | ||||||
Transobturator synthetic, BMI 30 or greater | 12 months | After discharge | no | 1.7 | 117 | ||||||
Total | |||||||||||
Fascial PVS, BMI less than 30 | Total reoperations | Total reoperations | 12 months | Both | no | 13.8 | 94 | ||||
Fascial PVS, BMI 30 or greater | 12 months | Both | no | 3 | 66 | ||||||
Cadaveric PVS, BMI less than 30 | 12 months | Both | no | 1.3 | 157 | ||||||
Cadaveric PVS, BMI 30 or greater | 12 months | Both | no | 0 | 114 | ||||||
Transobturator synthetic, BMI less than 30 | 12 months | Both | no | 1.2 | 161 | ||||||
Transobturator synthetic, BMI 30 or greater | 12 months | Both | no | 1.7 | 117 | ||||||
Total | |||||||||||
Fascial PVS, BMI less than 30 | Obstruction requiring reoperation | Urethrolysis/sling incision | 12 months | Both | no | 7.4 | 94 | ||||
Fascial PVS, BMI 30 or greater | 12 months | Both | no | 0 | 66 | ||||||
Cadaveric PVS, BMI less than 30 | 12 months | Both | no | 0.6 | 157 | ||||||
Cadaveric PVS, BMI 30 or greater | 12 months | Both | no | 0.9 | 114 | ||||||
Transobturator synthetic, BMI less than 30 | 12 months | Both | no | 1.2 | 161 | ||||||
Transobturator synthetic, BMI 30 or greater | 12 months | Both | no | 0 | 117 | ||||||
Total |