A Multicentric Randomized Trial to Evaluate the ROle of Uterine MANipulator on Laparoscopic/Robotic HYsterectomy for the Treatment of Early-Stage Endometrial Cancer: The ROMANHY Trial

ObjectiveThis prospective randomized trial aimed to assess the impact of the uterine manipulator in terms of lymph vascular space invasion (LVSI) in patients undergoing minimally invasive staging for early-stage endometrial cancer.MethodsIn this multicentric randomized trial, enrolled patients were randomly allocated in two groups according to the no use (arm A) or the use (arm B) of the uterine manipulator. Inclusion criteria were G1-G2 early-stage endometrial cancer at preoperative evaluation. The variables collected included baseline demographic characteristics, perioperative data, final pathology report, adjuvant treatment, and follow-up.ResultsIn the study, 154 patients (76 in arm A and 78 in arm B) were finally included. No significant differences were recorded regarding the baseline characteristics. A statistically significant difference was found in operative time for the laparoscopic staging (p=0.005), while no differences were reported for the robotic procedures (p=0.419). The estimated blood loss was significantly lower in arm A (p=0.030). No statistically significant differences were recorded between the two study groups in terms of peritoneal cytology, LVSI (p=0.501), and pattern of LVSI (p=0.790). No differences were detected in terms of overall survival and disease-free survival (p=0.996 and p=0.480, respectively). Similarly, no differences were recorded in the number of recurrences, 6 (7.9%) in arm A and 4 (5.2%) in arm B (p=0.486). The use of the uterine manipulator had no impact on DFS both at univariable and multivariable analyses.ConclusionsThe intrauterine manipulator does not affect the LVSI in early-stage endometrial cancer patients undergoing laparoscopic/robotic staging.Clinical Trial Registrationhttps://clinicaltrials.gov, identifier (NCT: 02762214)

A novel approach to minimally invasive hysterectomy without the use of a uterine manipulator: Kamran’s TLH

Background Hysterectomy remains one of the most common major gynaecological procedures, with total laparoscopic hysterectomy (TLH) now established as the technique of choice over conventional open approaches. This approach depends on the use of a uterine manipulator to facilitate uterine retraction and colpotomy. This study describes a novel approach in performing total laparoscopic hysterectomy without the use of uterine manipulator or vaginal tubes and reports the intra- and postoperative outcome of this technique. Methods A single-centre retrospective analysis of patients who underwent TLH without uterine manipulator or vaginal tube “Kamran’s TLH” for benign conditions was performed from January 2017 to October 2019. Data collected included patients’ demographics, intraoperative finding and postoperative course. Results A total of eighty-six hysterectomies were performed utilizing the Kamran’s TLH (KTLH) approach. Mean age was 52.2 (± 11) years old and BMI was 28.2 (± 7). TLH with bilateral salpingo-oophorectomy was performed in 63 (73.3%) patients and TLH with preservation of ovaries in 23 (26.7%) patients. Mean operative time was 64.7 (± 27.9) min and estimated bloods loss was 46.2 (± 54.6) ml. No intraoperative complications were recorded and there was no conversion to open surgery. Only one patient required readmission and surgery for vaginal vault dehiscence during their postoperative course. Conclusion Uterine manipulator is a key component in performing laparoscopic hysterectomy. However, our approach demonstrated that TLH can be safely performed without the use of any uterine or vaginal manipulation.

The outcomes of ‘8’suture suspension laparoscopic radical hysterectomy for early-stage cervical carcinoma.

e17519 Background: The mainly causes may due to the use of uterine manipulator and unprotected vaginal incision. To avoid these disadvantages, we modified the procedures by using ‘8’ suture suspension of the uterine instead of the uterine manipulator and vagino-purse-string suture before cutting of the vaginal. The aim of this study is to evaluate surgical data and oncological outcome of LRH without uterine manipulator based‘8’suture suspension method for early-stage cervical cancer. Methods: Patients with cervical cancers who underwent‘8’ suture suspension LRH in our center between January 2018 to August 2020 were retrospective analyzed. Without the use of uterine manipulator, a 2-0 absorbable suture was used to make an‘8’suture at the fundus of the uterine, and then make a coil. Another suture was passed through the coil to manipulate the uterus towards suitable directions. When separating the rectovaginal space, a needle with suture was pierced into the abdominal cavity from the abdominal wall above the pubic symphysis and passed through the coil to pull the uterus upwards and forwards, which was remove when separating the vesicovaginal space. Before cutting of the vaginal, a vagino-purse-string suture was made to prevent the tumor exposure in the abdominal cavity. Surgical data, postoperative complications, relapse rate and disease-free survival rate were evaluated. All operations were performed by the same surgical team. Results: A total of 48 cervical cancer patients were included in this study. Eight patients were stage IA2, 37 patients were stage IB and 3 patients were stage IIA1. There were 37 patients with squamous carcinoma while 11 with adenocarcinomas. The mean operative time was 199min (ranged from 120 to 290min). The median time of hospital stay after surgery was 7 days (ranged from 4 to 17 days). The mean blood loss volume was 40ml (ranged from 5 to 200 ml). The mean of number of removed lymph nodes are 30. The median time of removing urinary tube was 18 days (ranged from 12 to 25 days). The median time of postoperative exhaust time was 3 days(ranged from 2 to 4 days). There were no intraoperative complications, while postoperative complications were observed in 4 patients with fever. The median follow- up times were 16 months. During the follow-up time, there were no recurrence. Conclusions: The‘8’suture suspension LRH is a feasible and safe surgical procedure for early stage cervical cancer, with acceptable surgical and oncological outcomes in the hands of well-trained and experienced laparoscopic surgeons.[Table: see text]

Application of Novel Tumor-free Techniques in Laparoscopic Radical Hysterectomy for Early Cervical Cancer.

Objective: Minimally invasive radical hysterectomy has been historically considered oncologically equivalent to open radical hysterectomy for patients with early cervical cancer. However, it was recently reported to be significantly inferior in long-term outcomes of the minimally invasive approach to open approach. The underlying causes of this finding arouse great concern and remain controversial. Here we would like to share some initial experience of tumor-free techniques in laparoscopic procedures for early cervical cancer, including uterine manipulator-free manipulation and enclosed colpotomy. Methods: Between December 2019 and May 2020, we performed manipulator-free laparoscopic radical hysterectomy in 26 cases with early cervical cancer. The modified tumor-free techniques, including uterine manipulator-free manipulation and enclosed colpotomy, was described in detail with illustrations.Results: The procedures went well in all patients. In our initial experience, these modifications do not increase the difficulty of surgical techniques, and can be well performed by the experienced surgeons.Conclusions: These techniques are safe and feasible, and the effects on oncological outcomes deserve follow-up and further clinical studies.