Dataset Information

Cosmetic Appearance of Port-site Scars 1 Year After Laparoscopic Versus Robotic Sacrocolpopexy: A Supplementary Study of the ACCESS Clinical Trial.

ABSTRACT: To prospectively measure trocar site appearances 1 year after surgery in women participants in the Abdominal Colpopexy: Comparison of Endoscopic Surgical Strategies Trial, a 2-center randomized surgical trial (NCT01124916).Supplementary analysis of a surgical trial that randomized women to robotic or laparoscopic sacrocolpopexy (Canadian Task Force classification I).Operative trial.Women undergoing clinically indicated sacrocolpopexy for symptomatic stage ?II pelvic organ prolapse were randomized to laparoscopic abdominal sacrocolpopexy (LASC) or robotic abdominal sacrocolpopexy (RASC). Trocar skin incision closure was standardized by using Dermabond (Ethicon, Somerville, NJ).Photographs of all incision sites were taken at baseline (immediately), 6 weeks, 6 months, and 1 year after surgery. Study coordinators scored each incision with the validated Stony Brook Evaluation Scale (SBES), a 5-point wound evaluation scale. We calculated the average of all scars scores per case to determine the percent of optimal wound healing (0%-100%) for each case as well as the proportion of cases meeting 100% wound repair scoring. Wound repair scores across groups were tested with the Wilcoxon rank sum test. The overall proportion of cases in each group meeting "optimal" wound recovery (scores of 100%) was tested with the Fisher exact test. Seventy-eight women with a mean age of 59 years (range, 26-79 years) were randomized to LASC (n = 38) or RASC (n = 40). We did not detect significant differences in baseline characteristics or rates of dropout between the 2 study groups (5 in LASC and 7 in RASC, p = .60). Pain in the initial postoperative period was higher in the robotic arm although groups were similar at 2 weeks. Nearly all cases (75/78) contributed wound repair data (36 laparoscopic and 39 robotic). Laparoscopic surgeries require significantly fewer incisions (median = 4; range, 4-6) than robotic surgeries (median = 5; range, 4-6; p < .001). SBES scores at 6 weeks were not different for LASC and RASC (p = .426). By 6 months, the scores were better in the LASC group (84.8% ± 8.8% vs 78.5% ± 7.2%, p = .031), and this finding remained at 1 year (93.4% ± 7.2% vs 85.9% ± 8.8%, p = .001). The proportion of cases with optimal wound repair (score of 100%) was higher in the laparoscopic arm at 1 year after surgery (12/27 vs 4/33, p = .008).Women were randomized to robotic assisted laparoscopy or laparoscopy.Wound appearance using the SBES was better in the LASC group, suggesting that there may be alterations in the mechanism for wound initiation and/or healing based on the minimally invasive route used for sacrocolpopexy.

SUBMITTER: Mueller ER

PROVIDER: S-EPMC5007204 | biostudies-literature | 2016 Sep-Oct

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Cosmetic Appearance of Port-site Scars 1 Year After Laparoscopic Versus Robotic Sacrocolpopexy: A Supplementary Study of the ACCESS Clinical Trial.

Mueller Elizabeth Rose ER Kenton Kimberly K Anger Jennifer T JT Bresee Catherine C Tarnay Christopher C

Journal of minimally invasive gynecology 20160512 6

<h4>Study objective</h4>To prospectively measure trocar site appearances 1 year after surgery in women participants in the Abdominal Colpopexy: Comparison of Endoscopic Surgical Strategies Trial, a 2-center randomized surgical trial (NCT01124916).<h4>Design</h4>Supplementary analysis of a surgical trial that randomized women to robotic or laparoscopic sacrocolpopexy (Canadian Task Force classification I).<h4>Setting</h4>Operative trial.<h4>Patients</h4>Women undergoing clinically indicated sacro ...[more]

PMID: 27180224

Similar Datasets

Project description:Sacrocolpopexy has been dubbed the “gold standard” repair for apical pelvic organ prolapse (POP). This study sought to determine a genetic cause for sacrocolpopexy failure by comparing genotypes from 10 women who suffered from early POP reoccurance after sacrocolpopexy surgery, versus 40 randomly selected women with long term success after the same procedure. We objectively defined early overt failure after robotic-assisted laparoscopic sacrocolpopexy as having a pelvic organ prolapse quantification system examination (POP-Q) of stage III or IV occurring in more than one compartment within six months after surgery. All medical records identified during this process were then reviewed by a panel of urogynecology attendings and fellows to select patients who were truly clinical outliers. By this method we identified 10 patients (cases) who experienced early overt surgical failure. We also randomly selected 40 controls from our research database which includes greater than 500 patients who underwent robotic-assisted laparoscopic sacrocolpopexy during the same time period and had been objectively and subjectively assessed for ≥ 12 months with surgical success at ≥ 12 months that did not undergo prolapse re-operation or re-treatment. Demographics and peri-operative details were compared between cases and controls. Exclusion criteria for controls included use of other graft material besides polypropylene mesh, prior surgery for prolapse involving graft material, and conversion to laparotomy. DNA from the 10 cases and 40 controls was isolated from buccal swabs and genotyped on a single nucleotide polymorphism (SNP) array that contains 250,000 markers (NspI 250K SNP array, Affymetrix, Santa Clara, CA). All women in this study identified as Caucasian. All subjects provided written informed consent to study participation and data release. This was a case-control study approved by the Institutional Review Board at the Atlantic Health System in Morristown New Jersey (R11-10-004).

Project description:Sacrocolpopexy has been dubbed the âgold standardâ repair for apical pelvic organ prolapse (POP). This study sought to determine a genetic cause for sacrocolpopexy failure by comparing genotypes from 10 women who suffered from early POP reoccurance after sacrocolpopexy surgery, versus 40 randomly selected women with long term success after the same procedure. We objectively defined early overt failure after robotic-assisted laparoscopic sacrocolpopexy as having a pelvic organ prolapse quantification system examination (POP-Q) of stage III or IV occurring in more than one compartment within six months after surgery. All medical records identified during this process were then reviewed by a panel of urogynecology attendings and fellows to select patients who were truly clinical outliers. By this method we identified 10 patients (cases) who experienced early overt surgical failure. We also randomly selected 40 controls from our research database which includes greater than 500 patients who underwent robotic-assisted laparoscopic sacrocolpopexy during the same time period and had been objectively and subjectively assessed for â¥ 12 months with surgical success at â¥ 12 months that did not undergo prolapse re-operation or re-treatment. Demographics and peri-operative details were compared between cases and controls. Exclusion criteria for controls included use of other graft material besides polypropylene mesh, prior surgery for prolapse involving graft material, and conversion to laparotomy. DNA from the 10 cases and 40 controls was isolated from buccal swabs and genotyped on a single nucleotide polymorphism (SNP) array that contains 250,000 markers (NspI 250K SNP array, Affymetrix, Santa Clara, CA). All women in this study identified as Caucasian. All subjects provided written informed consent to study participation and data release. This was a case-control study approved by the Institutional Review Board at the Atlantic Health System in Morristown New Jersey (R11-10-004). This case-control study compared single genotypes of 10 cases to 40 controls. All subjects were identified as Caucasian. Cases were women who experienced early overt POP recurrence after robotic sacrocolpopexy, and controls were randomly selected women with long term success after the same procedure.

Project description:BackgroundSacrocolpopexy is the gold standard procedure for treating pelvic organ prolapse (POP) patients with apical defects. Different surgical approaches have emerged and been utilized successively, including traditional laparoscopy, single-hole laparoscopy, robotic laparoscopy, vaginal-assisted laparoscopy, and transvaginal approaches. Robotic sacrocolpopexy (RSC) has attracted increasing attention as an emerging surgical technique and has unique advantages, such as a "simulated wrist" mechanical arm and high-definition three-dimensional (3D) visual field, which has gradually begun to be utilized in the clinical setting.MethodsWe followed the Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) reporting checklist, and a systematic literature search was conducted on six databases from their inception to 1st March 2020. We evaluated patients with POP who underwent RSC or laparoscopic sacrocolpopexy (LSC), outcomes (including perioperative outcomes: blood loss, operating times, blood transfusion, and hospital stay), surgery-related complications, as well as cure and recurrence rates.ResultsA total of 49 articles were available, including 3,014 patients, among which 18 were comparative studies on LSC vs. RSC, and 31 were non-comparative single-arm studies on RSC. For RSC, median operative time was 226 [90-604] minutes, estimated blood loss was 56 [5-1,500] mL, and hospital stay was 1.55 [1-16] days. Intraoperative complications and postoperative complications occurred in 74 (2.7%) and 360 (13.0%) patients, respectively. Of 2,768 RSC patients, 40 had been converted from a robot-assisted approach to other approaches, and 134 of 1,852 patients (7.2%) have recurrent prolapses of any compartment. Compared to LSC, RSC was associated with significantly lower blood loss and lower conversion rate. However, more operative time was observed in RSC. No significant differences were observed in perioperative transfusion, intraoperative and postoperative complications, or objective recurrence between RSC and LSC.ConclusionsRSC's application seems to contribute some advantages compared to conventional laparoscopic surgery, although both approaches appear to promote equivalent clinical outcomes. Notably, heterogeneity among studies might have affected the outcome of the study. Consequently, high-quality and large-sample randomized trials comparing both techniques are necessitated.

Dataset Information

Cosmetic Appearance of Port-site Scars 1 Year After Laparoscopic Versus Robotic Sacrocolpopexy: A Supplementary Study of the ACCESS Clinical Trial.

Publications

Cosmetic Appearance of Port-site Scars 1 Year After Laparoscopic Versus Robotic Sacrocolpopexy: A Supplementary Study of the ACCESS Clinical Trial.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets