Background
Vaginal mesh attachment can be one of the most time-consuming components of a minimally invasive sacrocolpopexy.
Objective
To assess the impact on the duration vaginal mesh attachment of using absorbable anchors compared to interrupted sutures for vaginal mesh attachment in robotic-assisted sacrocolpopexy.
Study Design
This was a single-masked, randomized clinical trial of women with pelvic organ prolapse that underwent a robotic-assisted sacrocolpopexy at 2 clinical sites. The participants were randomized to receive either interrupted delayed absorbable anchors or sutures during the vaginal mesh attachment portion of the surgery. The participants completed validated questionnaires at baseline and at 6 weeks, 6 months, and 12 months after the surgery. A certified examiner, masked to the attachment technique that was used, performed a clinical examination using the Pelvic Organ Prolapse Quantification system and also assessed for mesh exposure and the overall appearance of the vaginal walls using a 10-cm visual analog scale at each follow-up visit. The primary outcome was the vaginal mesh attachment time. The categorical variables were compared using chi-square or Fischer’s Exact test, whereas the continuous variables were compared using Student’s t-test or Mann-Whitney U test where appropriate. An intention-to-treat analysis was performed.
Results
Fifty-three participants were randomized, 26 to mesh attachment with anchor, 27 to mesh attachment with suture, and 81% (21/26) and 93% (25/27) had 12-month follow up respectively. There were no significant differences between the groups with regard to age ( P =.12), body mass index ( P =.23), stage of prolapse ( P =.97), or other preoperative factors. Mesh attachment interval time was faster in the anchor compared to suturing study arm (12.2±7.8 vs 21.2±5.2 minutes; P <.001), while sacrocolpopexy times (107.6±33.2 vs 109.8±21.2 minutes; P =.774) were not different. The ease of placement for the surgeon based on a visual analog scale ( P =.16), the appearance of the mesh attachment ( P =.07), and the overall satisfaction with the use of the specific attachment type ( P =.65) were similar for the arms. There was no difference in perioperative adverse events rates between arms and by 12 months follow-up there were no sacrocolpopexy mesh, anchor, or suture exposures. There was no difference in outcomes at 12 months including composite failure (10% vs 12%; P =.79), patient global impression of improvement (1.06 vs 1.19; P =.27), or patient pelvic pain (9.81 vs 9.67; P =.56).
Conclusion
In patients undergoing a robotic-assisted sacrocolpopexy, the anchor vaginal mesh attachment technique required significantly less time than suturing. There was no difference between techniques in complications, failure, surgeon, or patient-reported outcomes through 12 months of follow-up. Mesh attachment during sacrocolpopexy can be performed in less time by using the anchor technique, providing surgeons with an alternative surgical technique for this procedure.
A sacrocolpopexy (SCP) is a common surgical procedure that is used to treat symptomatic pelvic organ prolapse (POP). Recently, the use of minimally invasive (laparoscopic and robot assisted) SCPs is gaining popularity as it offers similar success rates with faster recovery times, less pain, less bleeding, and lower costs because of shorter hospitalization periods compared with more invasive procedures. The laparoscopic approach is limited by the technical challenge of suturing, which can make this portion of the surgery more time-consuming. Robotic surgery has several unique challenges including the absence of haptic feedback, the additional time required for setup, the additional training needed for surgeons, and increased operative times compared with more invasive vaginal approaches. The mean time to complete a robotic SCP ranges between 79–156 minutes, , with the attachment of the mesh with sutures (either interrupted or barbed) to the vagina being the most time-consuming portion (31–42 minutes). , Increased surgical times lead to increased procedural costs and potentially increased surgical adverse events associated with prolonged anesthesia and steep Trendelenburg positioning.
Why was this study conducted?
Vaginal mesh attachment can be one of the most time-consuming components of a robotic-assisted sacrocolpopexy. We conducted this study to compare the time to attach mesh to vagina using anchor vs suture during robotic-assisted sacrocolpopexy.
Key findings
In patients undergoing a minimally invasive sacrocolpopexy, the anchor vaginal mesh attachment technique was faster than suturing. There was no difference between techniques in sacrocolpopexy time, complications, surgical failure, surgeon, or patient-reported outcomes through 12 months of follow-up.
What does this add to what is known?
Vaginal mesh attachment during sacrocolpopexy can be performed in less time by using the anchor attachment technique instead of suturing, providing surgeons with an alternative surgical technique for this procedure.
Mesh attachment with absorbable anchors has been used successfully in laparoscopic incisional and ventral hernia repair, and has been associated with shorter operative times, less postoperative pain, similar rates of perioperative complications and hernia recurrence, and shorter hospital stays when compared with suturing. Absorbable anchors traditionally have several purchase depths with a standard purchase depth of 4.1 mm, and are made of polymers (such as violet-dyed absorbable synthetic polyester copolymer derived from lactic [PLA] and glycolic [PgA] acid) with similar properties as polydioxanone (PDS II) (Johnson & Johnson, New Brunswick NJ), which is a common suture material currently used in sacrocolpopexy vaginal mesh attachment.
The primary objective of this study was to assess the effect on the vaginal mesh attachment time when using absorbable anchors compared with interrupted sutures in a robotic-assisted SCP. We hypothesized that the use of an anchor device would decrease the vaginal mesh attachment times and would result in similar success rates, patient centered outcomes, and ease and satisfaction of use for the surgeon.
Materials and Methods
This is a prospective, randomized, single-blinded, 2 arms-parallel, clinical trial at 2 clinical sites to evaluate the effect of anchor vs interrupted suture on the length of vaginal mesh attachment in women undergoing SCP for symptomatic POP. The trial is registered with ClinicalTrials.gov ( NCT03378622 ) and was approved by the Institutional Review Board (#11460). Women undergoing a robotic-assisted laparoscopic SCP were recruited by the surgeons from the Kaiser Permanente San Diego Medical Center and received no compensation for their participation.
The inclusion criteria for participation in the trial included a participant of age greater than 21 years, a diagnosis of symptomatic POP and desiring surgical management with a minimally invasive SCP, and not pregnant or desiring future pregnancy. The exclusion criteria included a known adverse reaction to synthetic mesh or a history of mesh exposure, genitourinary or rectovaginal fistula or diverticular abscess, cervical intraepithelial neoplasia, cancer of the cervix, uterus or ovaries, unresolved chronic pelvic pain, or prior abdominal or pelvic radiation.
The 1:1 ratio of allocation to either of the attachment techniques was selected by a randomized computer-generated schedule with a block stratification based on the prolapse severity (stage 2/3, stage 4). The patients were masked to their allocation and the postoperative examiners were masked at the 6- and 12-month visits. The surgeon was, however, not masked to the allocation at the time of the surgery or at the 6-week postoperative appointment.
A total of 5 attending female pelvic medicine and reconstructive surgery surgeons enrolled the patients in this study and were assisted by 1 of 3 fellows during the majority of the cases. A total of 4 robotic ports and 2 laparoscopic assistant ports were placed. In patients with uterovaginal prolapse, a supracervical hysterectomy was performed beforeprior to SCP. Vaginal dissection was carried down to a minimum of 5 cm from the apex of the vagina on both the anterior and posterior vaginal walls. After the presacral dissection was completed, the randomization was performed to minimize the potential for postrandomization withdrawal. A Y-shaped, lightweight, wide-pore type 1 polypropylene mesh was introduced and attached to the anterior and posterior vagina per allocation. A permanent monofilament suture was used to attach the mesh to the anterior longitudinal ligament at S1–S2. Reperitonealization was performed with an absorbable suture to prevent exposure of the anchor, suture, or mesh intraperitoneally.
At least one of the co-investigating surgeons (S.A.M. or J.T.K.; each having completed more than 100 robotic-assisted SCPs and more than 5 years of postfellowship training) was present for the mesh attachment portion of each procedure to ensure proper execution of the study allocation. For the anchor mesh fixation arm, the study allowed the mesh to be secured to the vagina with up to 2 delayed absorbable monofilament sutures on both the anterior and the posterior vagina to stabilize the mesh and allow for ease of the anchor placement (the time required to place these sutures was included in the total mesh attachment interval). The anchoring device (Reliatack, Medtronic, Minneapolis, MN) articulating reloadable fixation device was inserted through a suprapubic and right-upper quadrant 5 mm laparoscopic accessory port (both ports are used as part of our traditional technique regardless of use of the anchoring device). The investigators believe that the articulating mechanism facilitated the placement of the posterior vaginal mesh attachment by allowing the anchors to be placed in a perpendicular plane, thereby minimizing misfiring or suboptimal attachment to the vagina. A minimum of 4 anchors were required by the protocol to attach the mesh to each side of the vagina, with the number used being based on the surgeon’s assessment of the appropriate fixation of the mesh ( Figure 1 ). The bedside surgeon (fellow or attending) performed the anchor attachment. If the anchors did not deploy properly or achieve adequate purchase into the vaginal tissue, they were removed from the abdomen with direct laparoscopic guidance.
For the suture mesh fixation arm, the mesh was secured to the vagina by using a minimum of 4 interrupted, delayed absorbable monofilament sutures on each side of the vagina, with the number used being based on the surgeon’s assessment of the appropriate fixation of the mesh. Knot tying was performed intracorporeally with 6 throws used per knot.
Preoperative demographic information (including age, body mass index, ethnicity, parity, diabetic status, tobacco use, and menopausal status) and Pelvic Organ Prolapse Quantification (POPQ) measurements were obtained and the POP stage assigned. A pre- and postoperative Pelvic Floor Impact Questionnaire (PFIQ7), Pelvic Floor Disability Index (PFDI-20), Pelvic Organ Prolapse Incontinence Sexual Questionnaire (PISQ-IR), and the postoperative pain visual analog scale (VAS) scores and the Patient Global Impression of Improvement (PGI-I) scores were also collected. Intraoperative data were collected and included the primary outcome variable (mesh attachment interval). The mesh attachment interval was defined as the period from when the first needle (including the stabilization stitches used for anchoring) or anchor was appropriately loaded on the primary needle driver or anchor device inside the patient’s body and introduced into the vaginal tissue to attach the mesh, to when the final anchor was placed or the last suture was cut. There was no upper boundary limit to the number of allowed passes or the number of sutures or anchors that could be used, as long as the minimum requirements were met. The security of the mesh attachment was determined by the clinical judgment of the attending surgeon. The console surgeon (fellow or attending) performed the suture attachment.
The number of sutures utilized per mesh attachment and the number of interrupted sutures placed to achieve adequate adherence, were recorded. In addition, data was collected on inability to use randomized technique, palpable mesh, anchor or suture, VAS scores for ease of placement, appearance of mesh attachment, global satisfaction with use of attachment type. The total surgery time (defined as the time from the initial incision to closure of the last incision) and SCP time (initial vesico-vaginal dissection to completion of reperitonealization) were measured. Intraoperative and postoperative adverse events such as hemorrhage, bleeding, nerve injury, infection, urinary retention, bowel injury, and bladder and urethral injury were assessed and tracked. At each postoperative visit (6 weeks, 6 months, and 12 months), subjective validated questionnaires were collected in addition to objective data collection, which included POPQ, vaginal assessments for mesh, anchor or suture exposure, and the appearance of the anterior, apex and posterior of the vagina. In addition, a query of electronic medical record was performed for additional hospitalization, emergency department, and ambulatory visits to assess for any additional adverse events. Composite failure was determined by the POPQ points Ba, C, or Bp>0 cm beyond the hymen, cervical descent into at least the lower half the vagina (defined as point C>-tvl/2), a “yes” answer greater than 1 for question 3 of the Pelvic Organ Prolapse Distress Inventory, and reoperation for prolapse.
The categorical variables were compared using chi-square or Fischer’s Exact test, whereas the continuous variables were compared using Student’s t-test or Mann-Whitney U test, where appropriate, based on the data distribution. Missing data from follow-up visits were excluded from the analysis of the endpoints. All of the statistical analysis was performed based on intention-to-treat. Statistical analysis was conducted using SPSS 24 (Chicago, IL). A statistical power calculation for the mesh attachment interval was performed using the PS Power and Sample Size program (PS version 3.1.2). Using suture mesh attachment time interval of 40±20 minutes , and seeking a 50% reduction in the time with the use of anchors with α=.05 and a power of 80%, 17 subjects would be required for each arm. By anticipating a dropout rate of up to laparoscopic 30%, we aimed to enroll 25 subjects in each arm. Although our study was powered to detect differences in the mesh attachment interval, it was not powered to detect differences in secondary or other outcomes.
Results
Between December 2017 and October 2018, 65 patients scheduled for robotic-assisted laparoscopic SCP at 2 sites were approached for participation. The 53 participants were randomized (CONSORT DIAGRAM is seen in Figure 2 ); 26 to mesh attachment with anchor, 27 to mesh attachment with suture. Only 11% of the patients were posthysterectomy and had a vaginal vault prolapse. Of the 26 participants assigned to the anchor arm, 1 underwent suture fixation of the vaginal mesh secondary to the intervention supplies being unavailable (the analysis was performed as intention-to-treat). Two participants had stage 4 POP, and one was allocated to the anchor and suture arm respectively. The demographics were similar between the two arms except for a higher median parity (3 vs 2; P =.008) in the suture arm and a more advanced median C point prolapse in the anchor arm (1 vs -1; P =.034) ( Table 1 ).
| Anchor ( n =26) | Suture ( n =27) | P Value | |
|---|---|---|---|
| Mean age (y) (SD) | 62.1 (8.6) | 59.3 (8.9) | .122 |
| Mean BMI (SD) | 26.7 (4.2) | 28.3 (5.0) | .226 |
| Race | .712 | ||
| White | 16 (61.5%) | 16 (59.2%) | |
| Hispanic | 9 (34.6%) | 8 (29.6%) | |
| Asian | 2 (7.7%) | 1 (3.7%) | |
| Black | 0 (0.0%) | 1 (3.7%) | |
| Median parity (range) | 2 (0–6) | 3 (1–6) | .008 |
| Baseline POPQ stage | |||
| Median Ba (range) | 2 (-3, 7) | 2 (-1, 6) | .968 |
| Median Bp (range) | -1(-4, 6) | -1 (-3, 3) | .732 |
| Median C (range) | 1 (-4, 6) | -1 (-5, 4) | .034 |
| Median greatest | 3 (2, 4) | 3 (2, 4) | .971 |
| stage (range) | |||
| Baseline POPQ by | .998 | ||
| Stage 1 | 0 (0%) | 0 (0%) | |
| Stage 2 | 4 (15.4%) | 4(14.8%) | |
| Stage 3 | 21(80.8%) | 22(81.5%) | |
| Stage 4 | 1(3.8%) | 1(3.7%) | |
| Diabetic | 6 (23.1%) | 2 (7.4%) | .111 |
| Current tobacco use | 0 (0%) | 0 (0%) | NA |
| Postmenopausal | 24 (92.3%) | 23 (85.2%) | .413 |
| Prior hysterectomy | 2 (7.7%) | 4 (14.8%) | .413 |
| Concomitant | |||
| Anterior repair | 0 (0%) | 3 (11.1%) | .08 |
| Posterior repair | 12 (46.2%) | 15 (55.6%) | .49 |
| Midurethral sling | 15 (57.7%) | 15 (55.6%) | .88 |
| Adnexal surgery | 22 (84.6%) | 24 (88.9%) | .25 |
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