Reanalysis of a randomized trial of 3 techniques of anterior colporrhaphy using clinically relevant definitions of success

Objective The purpose of this study was to reanalyze the results of a previously published trial that compared 3 methods of anterior colporrhaphy according to the clinically relevant definitions of success. Study Design A secondary analysis of a trial of 114 subjects who underwent surgery for anteri...

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Published in	American journal of obstetrics and gynecology Vol. 205; no. 1; pp. 69.e1 - 69.e8
Main Authors	Chmielewski, Lauren, MD, Walters, Mark D., MD, Weber, Anne M., MD, MS, Barber, Matthew D., MD, MHS
Format	Journal Article Conference Proceeding
Language	English
Published	New York, NY Mosby, Inc 01.07.2011 Elsevier
Subjects	Aged anterior colporrhaphy Biological and medical sciences cystocele Female Gynecologic Surgical Procedures - methods Gynecology. Andrology. Obstetrics Humans Medical sciences Middle Aged Obstetrics and Gynecology outcome measure pelvic organ prolapse Pelvic Organ Prolapse - surgery Polyglactin 910 - therapeutic use Recurrence Treatment Outcome treatment success Vagina - surgery anterior colporrhaphy outcome measure treatment success cystocele pelvic organ prolapse Randomization Colporrhaphy Gynecology Anterior Definition Clinical trial Technique Obstetrics
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Abstract	Objective The purpose of this study was to reanalyze the results of a previously published trial that compared 3 methods of anterior colporrhaphy according to the clinically relevant definitions of success. Study Design A secondary analysis of a trial of 114 subjects who underwent surgery for anterior pelvic organ prolapse who were assigned randomly to standard anterior colporrhaphy, ultralateral colporrhaphy, or anterior colporrhaphy plus polyglactin 910 mesh from 1996−1999. For the current analysis, success was defined as (1) no prolapse beyond the hymen, (2) the absence of prolapse symptoms (visual analog scale ≤2), and (3) the absence of retreatment. Results Eighty-eight percent of the women met our definition of success at 1 year. One subject (1%) underwent surgery for recurrence 29 months after surgery. No differences among the 3 groups were noted for any outcomes. Conclusion Reanalysis of a trial of 3 methods of anterior colporrhaphy revealed considerably better success with the use of clinically relevant outcome criteria compared with strict anatomic criteria.
AbstractList	The purpose of this study was to reanalyze the results of a previously published trial that compared 3 methods of anterior colporrhaphy according to the clinically relevant definitions of success. A secondary analysis of a trial of 114 subjects who underwent surgery for anterior pelvic organ prolapse who were assigned randomly to standard anterior colporrhaphy, ultralateral colporrhaphy, or anterior colporrhaphy plus polyglactin 910 mesh from 1996−1999. For the current analysis, success was defined as (1) no prolapse beyond the hymen, (2) the absence of prolapse symptoms (visual analog scale ≤2), and (3) the absence of retreatment. Eighty-eight percent of the women met our definition of success at 1 year. One subject (1%) underwent surgery for recurrence 29 months after surgery. No differences among the 3 groups were noted for any outcomes. Reanalysis of a trial of 3 methods of anterior colporrhaphy revealed considerably better success with the use of clinically relevant outcome criteria compared with strict anatomic criteria. Objective The purpose of this study was to reanalyze the results of a previously published trial that compared 3 methods of anterior colporrhaphy according to the clinically relevant definitions of success. Study Design A secondary analysis of a trial of 114 subjects who underwent surgery for anterior pelvic organ prolapse who were assigned randomly to standard anterior colporrhaphy, ultralateral colporrhaphy, or anterior colporrhaphy plus polyglactin 910 mesh from 1996−1999. For the current analysis, success was defined as (1) no prolapse beyond the hymen, (2) the absence of prolapse symptoms (visual analog scale ≤2), and (3) the absence of retreatment. Results Eighty-eight percent of the women met our definition of success at 1 year. One subject (1%) underwent surgery for recurrence 29 months after surgery. No differences among the 3 groups were noted for any outcomes. Conclusion Reanalysis of a trial of 3 methods of anterior colporrhaphy revealed considerably better success with the use of clinically relevant outcome criteria compared with strict anatomic criteria. The purpose of this study was to reanalyze the results of a previously published trial that compared 3 methods of anterior colporrhaphy according to the clinically relevant definitions of success. A secondary analysis of a trial of 114 subjects who underwent surgery for anterior pelvic organ prolapse who were assigned randomly to standard anterior colporrhaphy, ultralateral colporrhaphy, or anterior colporrhaphy plus polyglactin 910 mesh from 1996-1999. For the current analysis, success was defined as (1) no prolapse beyond the hymen, (2) the absence of prolapse symptoms (visual analog scale ≤ 2), and (3) the absence of retreatment. Eighty-eight percent of the women met our definition of success at 1 year. One subject (1%) underwent surgery for recurrence 29 months after surgery. No differences among the 3 groups were noted for any outcomes. Reanalysis of a trial of 3 methods of anterior colporrhaphy revealed considerably better success with the use of clinically relevant outcome criteria compared with strict anatomic criteria. OBJECTIVEThe purpose of this study was to reanalyze the results of a previously published trial that compared 3 methods of anterior colporrhaphy according to the clinically relevant definitions of success.STUDY DESIGNA secondary analysis of a trial of 114 subjects who underwent surgery for anterior pelvic organ prolapse who were assigned randomly to standard anterior colporrhaphy, ultralateral colporrhaphy, or anterior colporrhaphy plus polyglactin 910 mesh from 1996-1999. For the current analysis, success was defined as (1) no prolapse beyond the hymen, (2) the absence of prolapse symptoms (visual analog scale ≤ 2), and (3) the absence of retreatment.RESULTSEighty-eight percent of the women met our definition of success at 1 year. One subject (1%) underwent surgery for recurrence 29 months after surgery. No differences among the 3 groups were noted for any outcomes.CONCLUSIONReanalysis of a trial of 3 methods of anterior colporrhaphy revealed considerably better success with the use of clinically relevant outcome criteria compared with strict anatomic criteria.
Author	Barber, Matthew D., MD, MHS Walters, Mark D., MD Weber, Anne M., MD, MS Chmielewski, Lauren, MD
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Keywords	anterior colporrhaphy outcome measure treatment success cystocele pelvic organ prolapse Randomization Colporrhaphy Gynecology Anterior Definition Clinical trial Technique Obstetrics
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Snippet	Objective The purpose of this study was to reanalyze the results of a previously published trial that compared 3 methods of anterior colporrhaphy according to... The purpose of this study was to reanalyze the results of a previously published trial that compared 3 methods of anterior colporrhaphy according to the... OBJECTIVEThe purpose of this study was to reanalyze the results of a previously published trial that compared 3 methods of anterior colporrhaphy according to...
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SubjectTerms	Aged anterior colporrhaphy Biological and medical sciences cystocele Female Gynecologic Surgical Procedures - methods Gynecology. Andrology. Obstetrics Humans Medical sciences Middle Aged Obstetrics and Gynecology outcome measure pelvic organ prolapse Pelvic Organ Prolapse - surgery Polyglactin 910 - therapeutic use Recurrence Treatment Outcome treatment success Vagina - surgery
Title	Reanalysis of a randomized trial of 3 techniques of anterior colporrhaphy using clinically relevant definitions of success
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