JOURNAL ARTICLE
MULTICENTER STUDY
RANDOMIZED CONTROLLED TRIAL
RESEARCH SUPPORT, NON-U.S. GOV'T
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Laparoscopic versus open Burch colposuspension: a randomised controlled trial.

OBJECTIVE: To compare perioperative characteristics, short-term, and long-term outcomes for laparoscopic Burch colposuspension (LBC) and open Burch colposuspension (OBC) for the treatment of urinary stress incontinence.

DESIGN: Randomised surgical trial with single blinding.

SETTING: Three tertiary level teaching hospitals involving seven surgeons of varying skill levels.

POPULATION: Two hundred women with urodynamic stress incontinence (USI).

METHODS: The two groups were treated in identical fashion, except for the laparoscopic or open approach to surgery. Attempts were made to blind the subjects and the observers obtaining outcome data to treatment group. Analyses were adjusted for surgeon experience.

MAIN OUTCOME MEASURES: Absence of USI 6 months following surgery, postoperative pain, time spent in hospital, and time to return to activities of normal daily living.

RESULTS: There were no significant differences in objective and subjective measures of cure and in patient satisfaction at 6 months, 24 months, or 3-5 years of follow up between laparoscopic and open colposuspension groups. Laparoscopic colposuspension took longer time to perform (87 versus 42 minutes, P< 0.0001) but was associated with less blood loss (P = 0.03), less pain (P = 0.02), and quicker return to normal activities (P = 0.01).

CONCLUSION: LBC has significant advantages over traditional OBC, without any apparent compromise in short-term and long-term outcomes. To compare perioperative characteristics, short-term, and long-term outcomes for laparoscopic Burch colposuspension (LBC) and open Burch colposuspension (OBC) for the treatment of urinary stress incontinence. Randomised surgical trial with single blinding. Three tertiary level teaching hospitals involving seven surgeons of varying skill levels. Two hundred women with urodynamic stress incontinence (USI). The two groups were treated in identical fashion, except for the laparoscopic or open approach to surgery. Attempts were made to blind the subjects and the observers obtaining outcome data to treatment group. Analyses were adjusted for surgeon experience. Absence of USI 6 months following surgery, postoperative pain, time spent in hospital, and time to return to activities of normal daily living. There were no significant differences in objective and subjective measures of cure and in patient satisfaction at 6 months, 24 months, or 3-5 years of follow up between laparoscopic and open colposuspension groups. Laparoscopic colposuspension took longer time to perform (87 versus 42 minutes, P < 0.0001) but was associated with less blood loss (P= 0.03), less pain (P= 0.02), and quicker return to normal activities (P= 0.01). LBC has significant advantages over traditional OBC, without any apparent compromise in short-term and long-term outcomes.

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