Clinical trial NCT03378622: Anchor for Robotic Sacrocolpopexy
Official title: The Use of Anchor Versus Suturing for Attachment of Vaginal Mesh in Minimally Invasive Sacrocolpopexy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Pelvic Organ Prolapse
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
Collaborators: name: University of California, San Diego
First posted: 2017-12-20
Enrollment: 53
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 1. PRIMARY OBJECTIVE: To assess the effect of absorbable anchor compared to suturing for mesh attachment to vagina in robotic assisted sacrocolpopexy on the length of surgery for this portion of the procedure.
2. SECONDARY OBJECTIVES:

   i. To assess intraoperative and ii. postoperative complication rates, iii. Intraoperative 10 cm visual analog scale (VAS), to subjectively assess surgeon satisfaction with the technique iv. post-operative Pelvic Organ Prolapse Quantification (POPQ) evaluation for anatomic failure and v. a VAS of the vaginal walls overall appearance

Detailed description: By applying a commonly used surgical technique of absorbable anchors to a new surgery, Sacrocolpopexy (SCP), operative time may be decreased while providing similar patient outcomes. Absorbable anchors have been validated in mesh fixation during laparoscopic surgical repair of hernias. This technique potentially takes less time than traditional suturing, thus decreasing cost and morbidity of anesthesia. The investigators hypothesis proposes that for women undergoing SCP at a large managed care organization, participants receiving anchor suture staples to attach the mesh to the vagina compared to participants receiving standard treatment will require 50% shorter surgical time for the mesh attachment portion of the surgery. The investigators secondary hypothesis is for women undergoing SCP at a large managed care organization, participants receiving anchor suture staples to attach the mesh to the vagina compared to participants receiving standard treatment will have similar rates of intra-operative and post-operative complications and surgical failure. On VAS, patients will not have different appearance of the vaginal walls. Surgeons will report higher satisfaction with the anchor technique.

Eligibility criteria: Inclusion Criteria:

* Age 21 or older
* Diagnosis of POP, defined as the descent of one or more of four different anatomic structures, a)the uterus(cervix), b)the apex of the vagina (in those status post hysterectomy) c) the anterior vaginal wall, or d) the posterior vaginal wall. This is defined on exam as the POPQ points Ba, C, or Bp \>0 cm beyond the hymen, uterine(cervix) descent into at least the lower half the vagina (defined as point c\> -tvl/2) or post hysterectomy vault into the lower 2/3 of the vagina. Bothersome bulge symptoms as indicated on question 3 of the Pelvic Floor Disorder Inventory (PFDI-20) form relating to 'sensation of bulging' or something 'falling out'
* Desire surgical treatment for POP with SCP
* Available for up to 6 months of follow up
* Not pregnant or desiring future pregnancy
* Written informed consent is obtained.

Exclusion Criteria:

* Known adverse reaction to synthetic mesh, or complications including but not limited to erosion, fistula, or abscess.
* Cervical intraepithelial neoplasia (cervical intraepithelial neoplasia (CIN) 2, CIN3, or cancer)
* Unresolved chronic pelvic pain
* Prior abdominal or pelvic radiation
* Contraindications to the surgical procedures including known horseshoe kidney, pelvic abscess or active diverticular abscess or diverticulitis

Primary outcomes:
measure: Mesh Attachment Time
timeFrame: Assessed at one time point, during the participants surgery.
Secondary outcomes:
measure: Perioperative Complications
timeFrame: Assessed at one time point, during the participants surgery.
measure: Postoperative Complications
timeFrame: Assessed at two time points, 6 weeks and 6 months postoperatively
measure: Surgeon Satisfaction
timeFrame: Assessed at one time point, during the participants surgery.
measure: Surgical Failure
timeFrame: Assessed at two time points, 6 weeks and 6 months postoperatively
measure: Vaginal wall appearance
timeFrame: Assessed at two time points, 6 weeks and 6 months postoperatively
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Kaiser Permanent San Diego
state: California
Study officials:
affiliation: Kaiser Permanente
name: Alexander A Berger
role: STUDY_DIRECTOR
affiliation: Kaiser Permanente
name: Shawn A Menefee, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Berger AA, Tan-Kim J, Menefee SA. Anchor vs suture for the attachment of vaginal mesh in a robotic-assisted sacrocolpopexy: a randomized clinical trial. Am J Obstet Gynecol. 2020 Aug;223(2):258.e1-258.e8. doi: 10.1016/j.ajog.2020.05.018. Epub 2020 May 13.