Pelvic Organ Prolapse Clinical Trial
Official title:
Pre-operative Bowel Preparation Prior to Minimally Invasive Sacral Colpopexy
Verified date | January 2018 |
Source | University of Pittsburgh |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Prior to surgery, gynecologists and urogynecologists have routinely prescribed preoperative
mechanical bowel preparations in attempts to decrease the risk of infection, while also
providing easier bowel manipulation and better visualization during surgery. However, many of
these proposed benefits have never been proven, and usage of bowel preparations amongst
surgeons remains highly variable. In both the general surgery and gynecology literature,
researchers have begun to question the need for the vigorous preparations.
Aside from surgical visualization, urogynecologists have additional concerns about how bowel
preparations may impact postoperative bowel function given up to half of women with pelvic
floor disorders have baseline constipation and straining is known to impact surgical
recovery. Many studies have addressed various postoperative fiber and laxative preparations
in attempts to improve postoperative bowel-related symptomatology, but none have specifically
looked at preoperative bowel preparations.
This study aims to determine if mechanical bowel preparation prior to minimally invasive
sacral colpopexy affects patients' postoperative recovery, specifically related to bowel
symptomatology; operative or post-operative complications; surgeons' perceptions of surgical
difficulty directly attributed to the bowel; and post-operative return of normal bowel
function.
Status | Completed |
Enrollment | 95 |
Est. completion date | August 2017 |
Est. primary completion date | August 2017 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Female - Age = 18 years - Planned laparoscopic or robotic-assisted sacral colpopexy Exclusion Criteria: - History of ulcerative colitis or Crohn's disease - Prior large or small bowel resection - Known diagnosis of gastroparesis - Prior pelvic radiation - History of abdominal or pelvic malignancy - Planned concurrent bowel surgery/anal sphincteroplasty/ rectovaginal fistula repair - Pregnancy - Known allergic reactions to components of the study products - Known renal insufficiency - Non-English speaking as the primary study questionnaires are all currently in English only |
Country | Name | City | State |
---|---|---|---|
United States | University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Halina M Zyczynski, MD |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | PAC-SYM | Bowel symptomatology and bowel-related discomfort will be assessed with the Patient Assessment of Constipation Symptom Questionnaire (PAC-SYM), a 12-item questionnaire covering three domains: abdominal, rectal, and stool. | 1 year | |
Secondary | Surgeon perception of bowel preparation | Immediately after completing the surgical case, surgeons will complete a 13-item surgeon questionnaire assessing degree of surgical difficulty and how it relates to the bowel. Operative time and consultations will also be recorded as objective measures of surgical difficulty. | 1 year | |
Secondary | Return of normal bowel function | A seven-day bowel diary will be obtained at baseline and in the first week after surgery. This log will include daily assessment of bowel frequency, type of bowel movement using the validated Bristol stool scale, degree of straining, and used of narcotics or laxatives. | 1 year | |
Secondary | Perioperative complications | Complications occurring in both groups will be recorded. These include, but are not limited to infections, bowel obstructions, visceral organ injuries, and readmissions. | 1 year |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT05420831 -
Comparison of Vaginal and Laparoscopic Apical Fixation Techniques for Pelvic Organ Prolapse Treatment
|
N/A | |
Active, not recruiting |
NCT05422209 -
The Influence of Simultaneous Posterior Colporrhaphy and Perineoplasty on the Efficiency and Safety of Mesh-augmented Sacrospinal Fixation (Apical Sling) in Advanced POP Repair.
|
N/A | |
Completed |
NCT05493735 -
Lidocaine for Pessary Check Pain Reduction
|
Phase 3 | |
Completed |
NCT06126328 -
Materna Prep Study Phase II
|
Phase 2 | |
Recruiting |
NCT05542836 -
EVeRLAST 2-Year Follow-Up
|
||
Recruiting |
NCT05918367 -
Multicenter Ventral Mesh Rectopexy Registry Collaborative
|
||
Recruiting |
NCT04172272 -
The Influence of TAP Block in the Control of Postoperative Pain After Laparotomy for Gynecological Procedures
|
N/A | |
Recruiting |
NCT04807920 -
BOTOX® at the Time of Prolapse Surgery for OAB
|
Phase 4 | |
Completed |
NCT06268782 -
The Effectiveness of an Online Exercise Program on Well-being of Postpartum Women
|
N/A | |
Recruiting |
NCT03146195 -
The 3D Reconstruction Research of Pelvic Organ Prolapse Disease
|
N/A | |
Recruiting |
NCT02919852 -
Laparoscopic Retrovesical Colpopectinopexia
|
N/A | |
Completed |
NCT02925585 -
Vaginal Tactile Imaging for Pelvic Floor Prolapse
|
||
Not yet recruiting |
NCT02536001 -
Prospective Randomized Study to Compare Results of Pelvic Organ Prolapse Repair With One Versus Two Vaginal Meshes
|
N/A | |
Recruiting |
NCT02113969 -
Conservative Management of Symptomatic Pelvic Organ Prolapse Using Vaginal Pessaries: Generation of a Standardized Management Protocol
|
N/A | |
Completed |
NCT02383199 -
Polypropylene Mesh in Prolapse Surgery
|
N/A | |
Terminated |
NCT01673360 -
Collection of Long Term Patient Outcomes Data Following Implantation of AMS Surgical Devices
|
N/A | |
Completed |
NCT01842464 -
Sacro-Spinous Ligaments Anterior Apical Anchoring
|
N/A | |
Withdrawn |
NCT01530191 -
Factors Affecting Perioperative Outcomes
|
N/A | |
Completed |
NCT01320631 -
Male Sexual Experience and Its Impact on Quality of Life Before and After Their Sexual Partners Undergo Polypropylene Mesh Augmented Pelvic Floor Reconstruction
|
N/A | |
Completed |
NCT00581412 -
Composite Graft Use in Abdominal Sacrocolpopexy Reduces Erosion Rates
|
N/A |