The effect of a uterine manipulator on the recurrence and mortality of endometrial cancer: a multi-centric study by the Italian Society of Gynecological Endoscopy
Although widely adopted, the use of a uterine manipulator during laparoscopic treatment of endometrial cancer represents a debated issue, and some authors hypothesize that it potentially may cause an increased risk of relapse, particularly at specific sites. Our aim was to evaluate the risk and site...
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Published in | American journal of obstetrics and gynecology Vol. 216; no. 6; pp. 592.e1 - 592.e11 |
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Main Authors | , , , , , , , , , , , , , , , , , , , |
Format | Journal Article |
Language | English |
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United States
Elsevier Inc
01.06.2017
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Subjects | |
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Abstract | Although widely adopted, the use of a uterine manipulator during laparoscopic treatment of endometrial cancer represents a debated issue, and some authors hypothesize that it potentially may cause an increased risk of relapse, particularly at specific sites.
Our aim was to evaluate the risk and site of disease recurrence, overall survival, and disease-specific survival in women who had laparoscopic surgery with and without the use of a uterine manipulator.
Data were reviewed from consecutive patients who had laparoscopic surgery for endometrial cancer staging in 7 Italian centers. Subjects were stratified according to whether a uterine manipulator was used during surgery; if so, the type of manipulator was identified. Multivariable analysis to correct for possible confounders and propensity score that matched the minimize selection bias were utilized. The primary outcome was the risk of disease recurrence. Secondary outcomes were disease-specific and overall survival and the site of recurrence, according to the use or no use of the uterine manipulator and to the different types of manipulators used.
We included 951 patients: 579 patients in the manipulator group and 372 patients in the no manipulator group. After a median follow-up period of 46 months (range,12–163 months), the rate of recurrence was 13.5% and 11.6% in the manipulator and no manipulator groups, respectively (P=.37). Positive lymph nodes and myometrial invasion of >50% were associated independently with the risk of recurrence after adjustment for possible confounders. The use of a uterine manipulator did not affect the risk of recurrence, both at univariate (odds ratio, 1.18; 95% confidence interval, 0.80–1.77) and multivariable analysis (odds ratio, 1.00; 95% confidence interval, 0.60–1.70). Disease-free, disease-specific, and overall survivals were similar between groups. Propensity-matched analysis confirmed these findings. The site of recurrence was comparable between groups. In addition, the type of uterine manipulator and the presence or not of a balloon at the tip of the device were not associated significantly with the risk of recurrence.
The use of a uterine manipulator during laparoscopic surgery does not affect the risk of recurrence and has no impact on disease-specific or overall survival and on the site of recurrence in women affected by endometrial cancer. |
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AbstractList | Although widely adopted, the use of a uterine manipulator during laparoscopic treatment of endometrial cancer represents a debated issue, and some authors hypothesize that it potentially may cause an increased risk of relapse, particularly at specific sites.
Our aim was to evaluate the risk and site of disease recurrence, overall survival, and disease-specific survival in women who had laparoscopic surgery with and without the use of a uterine manipulator.
Data were reviewed from consecutive patients who had laparoscopic surgery for endometrial cancer staging in 7 Italian centers. Subjects were stratified according to whether a uterine manipulator was used during surgery; if so, the type of manipulator was identified. Multivariable analysis to correct for possible confounders and propensity score that matched the minimize selection bias were utilized. The primary outcome was the risk of disease recurrence. Secondary outcomes were disease-specific and overall survival and the site of recurrence, according to the use or no use of the uterine manipulator and to the different types of manipulators used.
We included 951 patients: 579 patients in the manipulator group and 372 patients in the no manipulator group. After a median follow-up period of 46 months (range,12–163 months), the rate of recurrence was 13.5% and 11.6% in the manipulator and no manipulator groups, respectively (P=.37). Positive lymph nodes and myometrial invasion of >50% were associated independently with the risk of recurrence after adjustment for possible confounders. The use of a uterine manipulator did not affect the risk of recurrence, both at univariate (odds ratio, 1.18; 95% confidence interval, 0.80–1.77) and multivariable analysis (odds ratio, 1.00; 95% confidence interval, 0.60–1.70). Disease-free, disease-specific, and overall survivals were similar between groups. Propensity-matched analysis confirmed these findings. The site of recurrence was comparable between groups. In addition, the type of uterine manipulator and the presence or not of a balloon at the tip of the device were not associated significantly with the risk of recurrence.
The use of a uterine manipulator during laparoscopic surgery does not affect the risk of recurrence and has no impact on disease-specific or overall survival and on the site of recurrence in women affected by endometrial cancer. Background Although widely adopted, the use of a uterine manipulator during laparoscopic treatment of endometrial cancer represents a debated issue, and some authors hypothesize that it potentially may cause an increased risk of relapse, particularly at specific sites. Objective Our aim was to evaluate the risk and site of disease recurrence, overall survival, and disease-specific survival in women who had laparoscopic surgery with and without the use of a uterine manipulator. Study Design Data were reviewed from consecutive patients who had laparoscopic surgery for endometrial cancer staging in 7 Italian centers. Subjects were stratified according to whether a uterine manipulator was used during surgery; if so, the type of manipulator was identified. Multivariable analysis to correct for possible confounders and propensity score that matched the minimize selection bias were utilized. The primary outcome was the risk of disease recurrence. Secondary outcomes were disease-specific and overall survival and the site of recurrence, according to the use or no use of the uterine manipulator and to the different types of manipulators used. Results We included 951 patients: 579 patients in the manipulator group and 372 patients in the no manipulator group. After a median follow-up period of 46 months (range,12–163 months), the rate of recurrence was 13.5% and 11.6% in the manipulator and no manipulator groups, respectively ( P =.37). Positive lymph nodes and myometrial invasion of >50% were associated independently with the risk of recurrence after adjustment for possible confounders. The use of a uterine manipulator did not affect the risk of recurrence, both at univariate (odds ratio, 1.18; 95% confidence interval, 0.80–1.77) and multivariable analysis (odds ratio, 1.00; 95% confidence interval, 0.60–1.70). Disease-free, disease-specific, and overall survivals were similar between groups. Propensity-matched analysis confirmed these findings. The site of recurrence was comparable between groups. In addition, the type of uterine manipulator and the presence or not of a balloon at the tip of the device were not associated significantly with the risk of recurrence. Conclusion The use of a uterine manipulator during laparoscopic surgery does not affect the risk of recurrence and has no impact on disease-specific or overall survival and on the site of recurrence in women affected by endometrial cancer. Although widely adopted, the use of a uterine manipulator during laparoscopic treatment of endometrial cancer represents a debated issue, and some authors hypothesize that it potentially may cause an increased risk of relapse, particularly at specific sites.BACKGROUNDAlthough widely adopted, the use of a uterine manipulator during laparoscopic treatment of endometrial cancer represents a debated issue, and some authors hypothesize that it potentially may cause an increased risk of relapse, particularly at specific sites.Our aim was to evaluate the risk and site of disease recurrence, overall survival, and disease-specific survival in women who had laparoscopic surgery with and without the use of a uterine manipulator.OBJECTIVEOur aim was to evaluate the risk and site of disease recurrence, overall survival, and disease-specific survival in women who had laparoscopic surgery with and without the use of a uterine manipulator.Data were reviewed from consecutive patients who had laparoscopic surgery for endometrial cancer staging in 7 Italian centers. Subjects were stratified according to whether a uterine manipulator was used during surgery; if so, the type of manipulator was identified. Multivariable analysis to correct for possible confounders and propensity score that matched the minimize selection bias were utilized. The primary outcome was the risk of disease recurrence. Secondary outcomes were disease-specific and overall survival and the site of recurrence, according to the use or no use of the uterine manipulator and to the different types of manipulators used.STUDY DESIGNData were reviewed from consecutive patients who had laparoscopic surgery for endometrial cancer staging in 7 Italian centers. Subjects were stratified according to whether a uterine manipulator was used during surgery; if so, the type of manipulator was identified. Multivariable analysis to correct for possible confounders and propensity score that matched the minimize selection bias were utilized. The primary outcome was the risk of disease recurrence. Secondary outcomes were disease-specific and overall survival and the site of recurrence, according to the use or no use of the uterine manipulator and to the different types of manipulators used.We included 951 patients: 579 patients in the manipulator group and 372 patients in the no manipulator group. After a median follow-up period of 46 months (range,12-163 months), the rate of recurrence was 13.5% and 11.6% in the manipulator and no manipulator groups, respectively (P=.37). Positive lymph nodes and myometrial invasion of >50% were associated independently with the risk of recurrence after adjustment for possible confounders. The use of a uterine manipulator did not affect the risk of recurrence, both at univariate (odds ratio, 1.18; 95% confidence interval, 0.80-1.77) and multivariable analysis (odds ratio, 1.00; 95% confidence interval, 0.60-1.70). Disease-free, disease-specific, and overall survivals were similar between groups. Propensity-matched analysis confirmed these findings. The site of recurrence was comparable between groups. In addition, the type of uterine manipulator and the presence or not of a balloon at the tip of the device were not associated significantly with the risk of recurrence.RESULTSWe included 951 patients: 579 patients in the manipulator group and 372 patients in the no manipulator group. After a median follow-up period of 46 months (range,12-163 months), the rate of recurrence was 13.5% and 11.6% in the manipulator and no manipulator groups, respectively (P=.37). Positive lymph nodes and myometrial invasion of >50% were associated independently with the risk of recurrence after adjustment for possible confounders. The use of a uterine manipulator did not affect the risk of recurrence, both at univariate (odds ratio, 1.18; 95% confidence interval, 0.80-1.77) and multivariable analysis (odds ratio, 1.00; 95% confidence interval, 0.60-1.70). Disease-free, disease-specific, and overall survivals were similar between groups. Propensity-matched analysis confirmed these findings. The site of recurrence was comparable between groups. In addition, the type of uterine manipulator and the presence or not of a balloon at the tip of the device were not associated significantly with the risk of recurrence.The use of a uterine manipulator during laparoscopic surgery does not affect the risk of recurrence and has no impact on disease-specific or overall survival and on the site of recurrence in women affected by endometrial cancer.CONCLUSIONThe use of a uterine manipulator during laparoscopic surgery does not affect the risk of recurrence and has no impact on disease-specific or overall survival and on the site of recurrence in women affected by endometrial cancer. |
Author | Scambia, Giovanni Uccella, Stefano Shakir, Fevzi Corrado, Giacomo Berretta, Roberto Vizza, Enrico Palomba, Stefano Roviglione, Giovanni Ferrero, Annamaria Cicinelli, Ettore Volpi, Eugenio Bonzini, Matteo Seracchioli, Renato Casarella, Lucia Ceccaroni, Marcello Malzoni, Mario Fanfani, Francesco Ghezzi, Fabio Aletti, Giovanni Tinelli, Raffaele |
Author_xml | – sequence: 1 givenname: Stefano orcidid: 0000-0002-4456-0822 surname: Uccella fullname: Uccella, Stefano email: stefucc@libero.it organization: Department of Obstetrics and Gynecology, University of Insubria, Del Ponte Hospital, Varese, Italy – sequence: 2 givenname: Matteo surname: Bonzini fullname: Bonzini, Matteo organization: Department of Clinical Sciences and Community Health, University of Milan, Milan, Italy – sequence: 3 givenname: Mario surname: Malzoni fullname: Malzoni, Mario organization: Endoscopica Malzoni-Center for Advanced Endoscopic Gynecological Surgery, Avellino, Italy – sequence: 4 givenname: Francesco surname: Fanfani fullname: Fanfani, Francesco organization: Gynecologic Oncology Unit, Catholic University of the Sacred Heart, Rome, Italy – sequence: 5 givenname: Stefano surname: Palomba fullname: Palomba, Stefano organization: Unit of Obstetrics and Gynecology, IRCCS – ASMN of Reggio Emilia, Italy – sequence: 6 givenname: Giovanni surname: Aletti fullname: Aletti, Giovanni organization: Division of Gynecologic Oncology, European Institute of Oncology, Milan, Italy – sequence: 7 givenname: Giacomo surname: Corrado fullname: Corrado, Giacomo organization: Department of Oncological Surgery, Gynecologic Oncologic Unit, “Regina Elena” National Cancer Institute, Rome, Italy – sequence: 8 givenname: Marcello surname: Ceccaroni fullname: Ceccaroni, Marcello organization: Department of Obstetrics and Gynecology, Gynecologic Oncology and Minimally-Invasive Pelvic Surgery, International School of Surgical Anatomy, Sacred Heart Hospital, Negrar, Verona, Italy – sequence: 9 givenname: Renato surname: Seracchioli fullname: Seracchioli, Renato organization: Minimally-Invasive Gynecological Surgery Unit, Sant’Orsola-Malpighi Hospital, Bologna, Italy – sequence: 10 givenname: Fevzi surname: Shakir fullname: Shakir, Fevzi organization: Department of Obstetrics and Gynecology, Royal Free Hospital, London, UK – sequence: 11 givenname: Annamaria surname: Ferrero fullname: Ferrero, Annamaria organization: Department of Gynecology and Obstetrics, University of Torino, Mauriziano Hospital, Torino, Italy – sequence: 12 givenname: Roberto surname: Berretta fullname: Berretta, Roberto organization: Department of Gynecology and Obstetrics, University of Parma, Parma, Italy – sequence: 13 givenname: Raffaele surname: Tinelli fullname: Tinelli, Raffaele organization: II Department of Obstetrics and Gynecology, Medical School, University “Aldo Moro”, Bari, Italy – sequence: 14 givenname: Enrico surname: Vizza fullname: Vizza, Enrico organization: Department of Oncological Surgery, Gynecologic Oncologic Unit, “Regina Elena” National Cancer Institute, Rome, Italy – sequence: 15 givenname: Giovanni surname: Roviglione fullname: Roviglione, Giovanni organization: Department of Obstetrics and Gynecology, Gynecologic Oncology and Minimally-Invasive Pelvic Surgery, International School of Surgical Anatomy, Sacred Heart Hospital, Negrar, Verona, Italy – sequence: 16 givenname: Lucia surname: Casarella fullname: Casarella, Lucia organization: Endoscopica Malzoni-Center for Advanced Endoscopic Gynecological Surgery, Avellino, Italy – sequence: 17 givenname: Eugenio surname: Volpi fullname: Volpi, Eugenio organization: Department of Gynecology and Obstetrics, University of Torino, Mauriziano Hospital, Torino, Italy – sequence: 18 givenname: Ettore surname: Cicinelli fullname: Cicinelli, Ettore organization: II Department of Obstetrics and Gynecology, Medical School, University “Aldo Moro”, Bari, Italy – sequence: 19 givenname: Giovanni surname: Scambia fullname: Scambia, Giovanni organization: Gynecologic Oncology Unit, Catholic University of the Sacred Heart, Rome, Italy – sequence: 20 givenname: Fabio surname: Ghezzi fullname: Ghezzi, Fabio organization: Department of Obstetrics and Gynecology, University of Insubria, Del Ponte Hospital, Varese, Italy |
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Keywords | laparoscopy recurrence endometrial cancer uterine manipulator oncological safety prognosis |
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SubjectTerms | Aged endometrial cancer Endometrial Neoplasms - mortality Endometrial Neoplasms - pathology Female Gynecologic Surgical Procedures - instrumentation Gynecologic Surgical Procedures - methods Humans Italy laparoscopy Laparoscopy - instrumentation Lymphatic Metastasis Middle Aged Myometrium - pathology Neoplasm Invasiveness - pathology Neoplasm Recurrence, Local - epidemiology Neoplasm Recurrence, Local - mortality Neoplasm Recurrence, Local - surgery Neoplasm Staging Obstetrics and Gynecology oncological safety prognosis recurrence Risk Factors Societies, Medical Survival Rate uterine manipulator |
Title | The effect of a uterine manipulator on the recurrence and mortality of endometrial cancer: a multi-centric study by the Italian Society of Gynecological Endoscopy |
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