BJOG : an international journal of obstetrics and gynaecology · 2004
A randomised trial comparing open Burch colposuspension using sutures with laparoscopic colposuspension using mesh and staples in women with stress urinary incontinence.
Клиническое исследованиеСравнительное исследованиеСтатьяМногоцентровое исследованиеРандомизированное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Ankardal Maud, Ekerydh Anne, Crafoord Kristina, Milsom Ian, Stjerndahl Jan-Henrik, Engh Marie Ellström
Аннотация
OBJECTIVE: To compare open Burch colposuspension using sutures with laparoscopic colposuspension using mesh and staples in women with stress urinary incontinence.
DESIGN: Multicentre, prospective randomised trial.
SETTING: Departments of Obstetrics and Gynaecology, Sahlgrenska University Hospital, Göteborg, Borås County Hospital and Orebro University Hospital, Sweden.
POPULATION: Women with genuine stress urinary incontinence or mixed incontinence with a predominantly stress component were included, and were randomised to either open colposuspension (n= 120) or laparoscopic colposuspension (n= 120).
METHODS: Women were randomised to open colposuspension with sutures or laparoscopic colposuspension with polypropylene mesh and staples. Anaesthesia/operation time, blood loss, complications and other related surgical parameters were compared.
MAIN OUTCOME MEASURES: Objective and subjective cure rates from 48-hour frequency-volume chart, a 48-hour pad test and a subjective assessment of the woman's incontinence and quality of life performed one year after surgery.
RESULTS: Objective and subjective cure rates were higher after open compared with laparoscopic colposuspension (P < 0.001). Quality of life was improved following surgery in both groups (P < 0.0001) and the improvement was significantly greater in the open colposuspension group (P < 0.05) with regard to physical activity. Performing an open colposuspension was less time consuming (P < 0.0001), resulted in more blood loss (P < 0.0001), longer catheterisation time (P < 0.01), greater risk of urinary retention (P < 0.01) and a longer hospital stay (P < 0.0001) compared with performing a laparoscopic colposuspension. The rate of serious complications was low in both groups.
CONCLUSION: Open colposuspension had a higher objective and subjective cure rate one year after surgery but with a greater blood loss, greater risk of urinary retention and a longer hospital stay than laparoscopic colposuspension.
DESIGN: Multicentre, prospective randomised trial.
SETTING: Departments of Obstetrics and Gynaecology, Sahlgrenska University Hospital, Göteborg, Borås County Hospital and Orebro University Hospital, Sweden.
POPULATION: Women with genuine stress urinary incontinence or mixed incontinence with a predominantly stress component were included, and were randomised to either open colposuspension (n= 120) or laparoscopic colposuspension (n= 120).
METHODS: Women were randomised to open colposuspension with sutures or laparoscopic colposuspension with polypropylene mesh and staples. Anaesthesia/operation time, blood loss, complications and other related surgical parameters were compared.
MAIN OUTCOME MEASURES: Objective and subjective cure rates from 48-hour frequency-volume chart, a 48-hour pad test and a subjective assessment of the woman's incontinence and quality of life performed one year after surgery.
RESULTS: Objective and subjective cure rates were higher after open compared with laparoscopic colposuspension (P < 0.001). Quality of life was improved following surgery in both groups (P < 0.0001) and the improvement was significantly greater in the open colposuspension group (P < 0.05) with regard to physical activity. Performing an open colposuspension was less time consuming (P < 0.0001), resulted in more blood loss (P < 0.0001), longer catheterisation time (P < 0.01), greater risk of urinary retention (P < 0.01) and a longer hospital stay (P < 0.0001) compared with performing a laparoscopic colposuspension. The rate of serious complications was low in both groups.
CONCLUSION: Open colposuspension had a higher objective and subjective cure rate one year after surgery but with a greater blood loss, greater risk of urinary retention and a longer hospital stay than laparoscopic colposuspension.