Clinical trial NCT02856217: Impact of Tunneling During Minimally Invasive Sacrocolpopexy
Official title: Comparison of the Tunneling or Non-tunneling During Minimally Invasive Sacrocolpopexy in Terms of Lower Urinary Tract and Bowel Symptoms.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lower Urinary Tract Symptoms
Lower Gastrointestinal Tract Symptoms
Lead sponsor: The University of Texas Medical Branch, Galveston
Sponsor class: OTHER
First posted: 2016-08-04
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Pelvic organ prolapse occurs when the uterus or vaginal walls bulge into or beyond the vaginal introitus. Abdominal sacrocolpopexy is the most durable operation for advanced pelvic organ prolapse and serves as the criterion standard against which other operations are compared. Abdominal sacrocolpopexy involves attaching the vaginal apex to the sacral anterior longitudinal ligament reinforced with a graft, usually synthetic mesh. More than 225.000 surgeries are performed annually in the United States for pelvic organ prolapse. Abdominal sacrocolpopexy is considered the most durable pelvic organ prolapse surgery, but little is known about safety and long-term effectiveness.

Purpose of this study is to compare effect of tunneling or non-tunneling mesh placement on lower urinary tract symptoms and bowel symptoms in patients who underwent surgery with laparoscopic or robot-assisted sacrocolpopexy which is accepted surgical procedures for pelvic organ prolapse.

Detailed description: Pelvic organ prolapse represents a common female pelvic floor disorder that increases with age and has a serious impact on quality of life. It is estimated that 30% of women aged 50-89 years will seek consultation for pelvic floor disorders. The purpose of any surgical repair of pelvic organ prolapse is to restore pelvic anatomy, preserving urinary, intestinal, and sexual function, with the lowest rate of recurrences and complications.

In the history of surgical repair for pelvic organ prolapse vaginal or abdominal approach has been performed. In spite of decreased morbidity and shorter hospitalisation advantage with vaginal procedures, they have consistently lower long-term success rates compared to abdominal sacrocolpopexy. In contrast, the abdominal approach is considered the gold standard for surgical correction of vaginal vault prolapse, with reported long-term efficacy rates. However, the associated morbidity of open laparotomy has made this procedure less favourable. In an effort to overcome these drawbacks, a minimally invasive laparoscopic approach has been adopted. However, the rigidity of the laparoscopic instrumentation makes intracorporeal suturing and dissection in the narrow pelvis challenging. Robot-assisted technology, with its stereoscopic vision and the use of instruments which easily moved by wrist movement, offers an ergonomic platform that simplifies complex laparoscopic tasks and has been widely adopted by pelvic surgeons.

Most complications following sacrocolpopexy can occur with either an open or a minimally invasive approach, typically at similar rates. Bladder injury, postoperative voiding dysfunction and lower urinary tract symptoms may occur. Lower urinary tract symptoms may develop postoperatively for reason that are still not clearly understood. De nova lower urinary tract symptoms may appear after laparoscopic or robot-assisted sacrocolpopexy with a range from 0% to 27%. As with urinary system complication, bowel complications (bowel injury, bowel dysfunction) may occur intraoperatively and postoperatively. Constipation is the mostly reported with a range from 0% to 19%. Retroperitonealization of the mesh used in laparoscopic sacrocolpopexy or robot-assisted sacrocolpopexy is thought to reduce the risk of bowel injury, although some authors have noted a lack of bowel injuries when the mesh was left exposed to the peritoneum.

Eligibility criteria: Inclusion Criteria:

* Subject is female
* Subject is at least 18 years of age
* Subject is who can English speaking and reading
* Subject must have documented diagnosis of apical vaginal prolapse with leading edge of pelvic organ prolapse at or beyond the hymen. At or beyond the hymen is defined as Pelvic Organ Prolapse Quantification System (POP-Q) scores of C ≥ -1/2 total vaginal length (TVL)
* Subject reports a bothersome bulge they can see or feel per Pelvic Floor Distress Inventory Questionnaire - Short Form 20 (PFDI-20), question 3, response of 2 or higher (i.e., responses of "somewhat", "moderately", or "quite a bit")
* Subject or subject's legally authorized representative is willing to provide written informed consent
* Subject is willing and able to comply with the follow-up regimen

Exclusion Criteria:

* Subject is pregnant or intends to become pregnant during the study
* Subject has an active or chronic systemic infection including any gynecologic infection, untreated urinary tract infection (UTI) or tissue necrosis
* Subject has history of pelvic organ cancer (e.g. uterine, ovarian, bladder, or cervical)
* Subject has had prior or is currently undergoing radiation, laser therapy, or chemotherapy in the pelvic area
* Subject has taken systemic steroids (within the last month), or immunosuppressive or immunomodulatory treatment (within the last 3 months)
* Subject has systemic connective tissue disease (e.g. scleroderma, systemic lupus erythematosus (SLE), Marfan's syndrome, Ehlers Danlos, collagenosis, polymyositis or polymyalgia rheumatica)
* Subject has uncontrolled diabetes mellitus (DM)
* Subject has a known neurologic or medical condition affecting bladder function (e.g., multiple sclerosis, spinal cord injury or stroke with residual neurologic deficit)
* Subject is seeking obliterative vaginal surgery as treatment for pelvic organ prolapse (colpocleisis)
* Subject is currently participating in or plans to participate in another device or drug study during this study
* Subject has a known sensitivity to polypropylene
* Subject has had previous prolapse repair with mesh (abdominal or vaginal)
* Subject is planning to undergo a concomitant vaginal repair with use of mesh

Primary outcomes:
measure: Lower Urinary Tract Symptoms
timeFrame: Up to 1 year
Secondary outcomes:
measure: Pelvic Organ Prolapse
timeFrame: Up to 1 year
measure: Lower Gastrointestinal Tract Symptoms
timeFrame: Up to 1 year
measure: Surgical duration (time from skin incision to skin closure)
timeFrame: Postoperative 1.day
measure: Blood loss
timeFrame: Postoperative 1.day
measure: Intraoperative complications (conversion to open procedure or inadvertent structural lesions such as bladder, bowel, vessels, or solid organs)
timeFrame: Postoperative 1.day
measure: Postoperative complications (Clavien-Dindo classification)
timeFrame: Postoperative 7.day
measure: Sexual function
timeFrame: Up to 1 year
Other outcomes:
Locations:
Study officials:
affiliation: UTMB, Texas
name: Gokhan S Kilic, MD
role: PRINCIPAL_INVESTIGATOR
References:
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