A Randomized Controlled Trial of Permanent vs Absorbable Suture for Uterosacral Ligament Suspension
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Cervical Cancer, Women's Studies |
| Therapuetic Areas: | Oncology, Reproductive |
| Healthy: | No |
| Age Range: | 18 - 99 |
| Updated: | 6/3/2018 |
| Start Date: | October 2016 |
| End Date: | November 2018 |
Uterosacral ligament suspension (USLS) is a commonly performed, vaginal surgery for the
correction of female pelvic organ prolapse. The original description of this procedure
included the use of permanent sutures. However, permanent suture use in this vaginal
application can result in some minor complication such as persistent vaginal spotting,
vaginal discharge and dyspareunia. Subsequent reports on this procedure have utilized
delayed-absorbable sutures in order to avoid these complications. Retrospective studies are
conflicting as to whether or not absorbable suture provides as durable an anatomic outcome as
permanent suture. There are currently no high-quality, prospective studies that have
evaluated outcomes of permanent and absorbable suture for uterosacral ligament suspension.
This study will recruit women scheduled to undergo USLS with or without other prolapse or
anti-incontinence procedures. Participants will be randomized 1:1 to permanent or absorbable
suture. Follow up will occur at 6 weeks and 12 months post-operatively. The primary outcome
will be Pelvic Organ Prolapse Quantification Exam (POP-Q) point C as measured at the 12 month
follow up visit. Subjects and assessors will be blinded.
correction of female pelvic organ prolapse. The original description of this procedure
included the use of permanent sutures. However, permanent suture use in this vaginal
application can result in some minor complication such as persistent vaginal spotting,
vaginal discharge and dyspareunia. Subsequent reports on this procedure have utilized
delayed-absorbable sutures in order to avoid these complications. Retrospective studies are
conflicting as to whether or not absorbable suture provides as durable an anatomic outcome as
permanent suture. There are currently no high-quality, prospective studies that have
evaluated outcomes of permanent and absorbable suture for uterosacral ligament suspension.
This study will recruit women scheduled to undergo USLS with or without other prolapse or
anti-incontinence procedures. Participants will be randomized 1:1 to permanent or absorbable
suture. Follow up will occur at 6 weeks and 12 months post-operatively. The primary outcome
will be Pelvic Organ Prolapse Quantification Exam (POP-Q) point C as measured at the 12 month
follow up visit. Subjects and assessors will be blinded.
Patient demographics, relevant histories, baseline physical exam including POP-Q and PFDI-20
data will be abstracted from the electronic medical record following enrollment. This
information will be placed into a secure database.
The randomization sequence will be generated by randomize.net, a web-based service that
provides comprehensive randomization services for randomized controlled trials. The sequence
will be randomized 1:1 with blocks of 4 and stratified by surgeon. Concealment will be
completely opaque as group allocation will not be revealed until the subject is enrolled on
the web-based service and the surgeon has elected to randomize the patient from an internet
connection in the operating room.
Subjects and assessors will be blinded to study group. The surgeons will, necessarily, not be
blinded. Subjects will only be informed of their assigned group upon request following
completion of the entire study.
USLS with the assigned suture and any scheduled concomitant prolapse and anti-incontinence
procedures will be performed. All procedures will be performed by one of two
fellowship-trained, Female Pelvic Medicine and Reconstructive Surgery board-certified
surgeons. USLS will be performed as initially described by Shull et al with two important
differences in technique. First, 2 sutures will be placed through the intermediate portion of
each uterosacral ligament instead of 3. Second, when absorbable suture (polydioxanone) is
used, the suture will be placed through the full thickness of the anterior and posterior
vaginal walls.
Follow up exams will occur at 6 weeks and 12 months post-operatively and will include a POP-Q
exam. The 6 week follow up visit will include the Patient Global Impression of Improvement
(PGI-I) and an additional survey. The 12 month follow up visit will include a the PGI-I,
PFDI-20 and an additional survey. All participants will also be assessed for any
suture-related complications, such as erosion or granulation tissue. Follow up exams will be
completed by one of two urogynecology nurse practitioners who will be blinded to the surgery
and suture choice. Both nurse practitioners have extensive experience in performing POP-Q
exams. The examiners will complete a follow up data abstraction form for each follow up
appointment (6 weeks and 12 months). Subjects will be provided with compensation following
completion of the 12-month follow up. This will be provided in the form of a $100 check.
The follow up clinic appointments at 6 weeks and 12 months are the times of usually scheduled
post-operative follow up for USLS procedures. Additionally, completion of the PFDI-20
questionnaire and a POP-Q exam constitute routine clinical care for these patients. As such,
there is no additional time commitment for subjects compared to routine clinical care.
data will be abstracted from the electronic medical record following enrollment. This
information will be placed into a secure database.
The randomization sequence will be generated by randomize.net, a web-based service that
provides comprehensive randomization services for randomized controlled trials. The sequence
will be randomized 1:1 with blocks of 4 and stratified by surgeon. Concealment will be
completely opaque as group allocation will not be revealed until the subject is enrolled on
the web-based service and the surgeon has elected to randomize the patient from an internet
connection in the operating room.
Subjects and assessors will be blinded to study group. The surgeons will, necessarily, not be
blinded. Subjects will only be informed of their assigned group upon request following
completion of the entire study.
USLS with the assigned suture and any scheduled concomitant prolapse and anti-incontinence
procedures will be performed. All procedures will be performed by one of two
fellowship-trained, Female Pelvic Medicine and Reconstructive Surgery board-certified
surgeons. USLS will be performed as initially described by Shull et al with two important
differences in technique. First, 2 sutures will be placed through the intermediate portion of
each uterosacral ligament instead of 3. Second, when absorbable suture (polydioxanone) is
used, the suture will be placed through the full thickness of the anterior and posterior
vaginal walls.
Follow up exams will occur at 6 weeks and 12 months post-operatively and will include a POP-Q
exam. The 6 week follow up visit will include the Patient Global Impression of Improvement
(PGI-I) and an additional survey. The 12 month follow up visit will include a the PGI-I,
PFDI-20 and an additional survey. All participants will also be assessed for any
suture-related complications, such as erosion or granulation tissue. Follow up exams will be
completed by one of two urogynecology nurse practitioners who will be blinded to the surgery
and suture choice. Both nurse practitioners have extensive experience in performing POP-Q
exams. The examiners will complete a follow up data abstraction form for each follow up
appointment (6 weeks and 12 months). Subjects will be provided with compensation following
completion of the 12-month follow up. This will be provided in the form of a $100 check.
The follow up clinic appointments at 6 weeks and 12 months are the times of usually scheduled
post-operative follow up for USLS procedures. Additionally, completion of the PFDI-20
questionnaire and a POP-Q exam constitute routine clinical care for these patients. As such,
there is no additional time commitment for subjects compared to routine clinical care.
Inclusion Criteria:
- Scheduled for uterosacral ligament suspension (USLS)
Exclusion Criteria:
- Non-English speaking
- Prisoner
- Cognitive impairment precluding informed consent
- Planned hysteropexy
We found this trial at
1
site
200 Hawkins Dr,
Iowa City, Iowa 52242
Iowa City, Iowa 52242
866-452-8507
Phone: 319-356-4839
University of Iowa Hospitals and Clinics University of Iowa Hospitals and Clinics—recognized as one of...
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