Applicazione di tachosil ® dopo miomectomia laparoscopica: Studio prospettico randomizzato

Translated title of the contribution: Tachosil ® application after laparoscopic myomectomy: A prospective randomized trial

U. Leone Roberti Maggiore, F. Alessandri, S. Ferrero

Research output: Contribution to journalArticle

Abstract

Introduction. The aim of this prospective randomized trial is to evaluate if a haemostatic device (Tachosil ®) improves haemostasis in patients undergoing laparoscopic myomectomy. Materials and methods. This study included patients of reproductive age who underwent laparoscopic myomectomy because of intramural uterine myomas. Exclusion criteria for the study were: presence of more than three intramural uterine myomas; presence of subserosal or submucosal uterine myomas (alone or associated with intramural myomas); main myoma diameter larger than 10 cm; use of hormonal therapies within 6 months before surgery; previous uterine surgery; coexistence of other diseases which required additional surgical procedures (such as hydrosalpinx, endometriosis). Patients were randomized 1:1 in two groups. In one group, Tachosil ® was used to obtain haemostasis in the site of the suture of uterine defect (group A); in the other group, no haemostatic device was used to obtain haemostasis (group B). The number, location and size of myomas were evaluated before surgery. Each patient was requested to use contraception in the first six months after surgery; subsequently, the patients could try to conceive. The follow-up included vaginal examination and gynaecologic ultrasounds; it was performed at 1-month, 3-month and one year from surgery. Continuous variables were analyzed by using the student t test or Mann-Whitney test. Categorical variables were compared using the chi-square test or Fisher exact test. Results. Ninety-one women were invited to participate in the study, 75 (82.4%) accepted to participate. Five patients were excluded from the study during surgery before randomization because they needed additional surgical procedures other than the myomectomy. Therefore, 70 patients were randomized in the two groups. After randomization, the two study groups had similar distribution of demographic and clinical characteristics. All surgical procedures were performed laparoscopically and no conversionto laparotomy was needed. There was no major operative complication, such as bowel, bladder or ureteral injuries. Operative time (p = 0.870) and hospitalization (p = 0.306) were similar in the two study groups. The median number of TachosilR applied in patients included in group Awas 1 (range, 1-3); the mean time (± SD) required for Tachosil ® application was 7.1 ± 3.4 minutes. Blood loss in group Awas significantly lower than in group B (p=0.005); no blood transfusion was needed in both groups of patients. The fluid collected in the drainage was significantly lower in group A than in group B (p <0.001). Fifteen patients in group A e 13 in group B tried to conceive after 6 months from surgery. Eight patients in group A (53.3%) and 3 in group B (23.1%) conceived (p = 0.212). Discussion. This prospective study demonstrates that TachosilR application during laparoscopic myomectomy is easy and the device is effective in reducing intraoperative and postoperative blood loss. Further studies should evaluate if this haemostatic device could help in preserving fertility in patients who undergo laparoscopic myomectomy.

Original languageItalian
Pages (from-to)147-154
Number of pages8
JournalItalian Journal of Gynaecology and Obstetrics
Volume23
Issue number4
Publication statusPublished - Oct 2011

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Uterine Myomectomy
Myoma
Hemostatics
Hemostasis
Equipment and Supplies
Random Allocation
TachoSil
Hospital Distribution Systems
Postoperative Hemorrhage
Gynecological Examination

ASJC Scopus subject areas

  • Obstetrics and Gynaecology

Cite this

Applicazione di tachosil ® dopo miomectomia laparoscopica : Studio prospettico randomizzato. / Leone Roberti Maggiore, U.; Alessandri, F.; Ferrero, S.

In: Italian Journal of Gynaecology and Obstetrics, Vol. 23, No. 4, 10.2011, p. 147-154.

Research output: Contribution to journalArticle

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abstract = "Introduction. The aim of this prospective randomized trial is to evaluate if a haemostatic device (Tachosil {\circledR}) improves haemostasis in patients undergoing laparoscopic myomectomy. Materials and methods. This study included patients of reproductive age who underwent laparoscopic myomectomy because of intramural uterine myomas. Exclusion criteria for the study were: presence of more than three intramural uterine myomas; presence of subserosal or submucosal uterine myomas (alone or associated with intramural myomas); main myoma diameter larger than 10 cm; use of hormonal therapies within 6 months before surgery; previous uterine surgery; coexistence of other diseases which required additional surgical procedures (such as hydrosalpinx, endometriosis). Patients were randomized 1:1 in two groups. In one group, Tachosil {\circledR} was used to obtain haemostasis in the site of the suture of uterine defect (group A); in the other group, no haemostatic device was used to obtain haemostasis (group B). The number, location and size of myomas were evaluated before surgery. Each patient was requested to use contraception in the first six months after surgery; subsequently, the patients could try to conceive. The follow-up included vaginal examination and gynaecologic ultrasounds; it was performed at 1-month, 3-month and one year from surgery. Continuous variables were analyzed by using the student t test or Mann-Whitney test. Categorical variables were compared using the chi-square test or Fisher exact test. Results. Ninety-one women were invited to participate in the study, 75 (82.4{\%}) accepted to participate. Five patients were excluded from the study during surgery before randomization because they needed additional surgical procedures other than the myomectomy. Therefore, 70 patients were randomized in the two groups. After randomization, the two study groups had similar distribution of demographic and clinical characteristics. All surgical procedures were performed laparoscopically and no conversionto laparotomy was needed. There was no major operative complication, such as bowel, bladder or ureteral injuries. Operative time (p = 0.870) and hospitalization (p = 0.306) were similar in the two study groups. The median number of TachosilR applied in patients included in group Awas 1 (range, 1-3); the mean time (± SD) required for Tachosil {\circledR} application was 7.1 ± 3.4 minutes. Blood loss in group Awas significantly lower than in group B (p=0.005); no blood transfusion was needed in both groups of patients. The fluid collected in the drainage was significantly lower in group A than in group B (p <0.001). Fifteen patients in group A e 13 in group B tried to conceive after 6 months from surgery. Eight patients in group A (53.3{\%}) and 3 in group B (23.1{\%}) conceived (p = 0.212). Discussion. This prospective study demonstrates that TachosilR application during laparoscopic myomectomy is easy and the device is effective in reducing intraoperative and postoperative blood loss. Further studies should evaluate if this haemostatic device could help in preserving fertility in patients who undergo laparoscopic myomectomy.",
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N2 - Introduction. The aim of this prospective randomized trial is to evaluate if a haemostatic device (Tachosil ®) improves haemostasis in patients undergoing laparoscopic myomectomy. Materials and methods. This study included patients of reproductive age who underwent laparoscopic myomectomy because of intramural uterine myomas. Exclusion criteria for the study were: presence of more than three intramural uterine myomas; presence of subserosal or submucosal uterine myomas (alone or associated with intramural myomas); main myoma diameter larger than 10 cm; use of hormonal therapies within 6 months before surgery; previous uterine surgery; coexistence of other diseases which required additional surgical procedures (such as hydrosalpinx, endometriosis). Patients were randomized 1:1 in two groups. In one group, Tachosil ® was used to obtain haemostasis in the site of the suture of uterine defect (group A); in the other group, no haemostatic device was used to obtain haemostasis (group B). The number, location and size of myomas were evaluated before surgery. Each patient was requested to use contraception in the first six months after surgery; subsequently, the patients could try to conceive. The follow-up included vaginal examination and gynaecologic ultrasounds; it was performed at 1-month, 3-month and one year from surgery. Continuous variables were analyzed by using the student t test or Mann-Whitney test. Categorical variables were compared using the chi-square test or Fisher exact test. Results. Ninety-one women were invited to participate in the study, 75 (82.4%) accepted to participate. Five patients were excluded from the study during surgery before randomization because they needed additional surgical procedures other than the myomectomy. Therefore, 70 patients were randomized in the two groups. After randomization, the two study groups had similar distribution of demographic and clinical characteristics. All surgical procedures were performed laparoscopically and no conversionto laparotomy was needed. There was no major operative complication, such as bowel, bladder or ureteral injuries. Operative time (p = 0.870) and hospitalization (p = 0.306) were similar in the two study groups. The median number of TachosilR applied in patients included in group Awas 1 (range, 1-3); the mean time (± SD) required for Tachosil ® application was 7.1 ± 3.4 minutes. Blood loss in group Awas significantly lower than in group B (p=0.005); no blood transfusion was needed in both groups of patients. The fluid collected in the drainage was significantly lower in group A than in group B (p <0.001). Fifteen patients in group A e 13 in group B tried to conceive after 6 months from surgery. Eight patients in group A (53.3%) and 3 in group B (23.1%) conceived (p = 0.212). Discussion. This prospective study demonstrates that TachosilR application during laparoscopic myomectomy is easy and the device is effective in reducing intraoperative and postoperative blood loss. Further studies should evaluate if this haemostatic device could help in preserving fertility in patients who undergo laparoscopic myomectomy.

AB - Introduction. The aim of this prospective randomized trial is to evaluate if a haemostatic device (Tachosil ®) improves haemostasis in patients undergoing laparoscopic myomectomy. Materials and methods. This study included patients of reproductive age who underwent laparoscopic myomectomy because of intramural uterine myomas. Exclusion criteria for the study were: presence of more than three intramural uterine myomas; presence of subserosal or submucosal uterine myomas (alone or associated with intramural myomas); main myoma diameter larger than 10 cm; use of hormonal therapies within 6 months before surgery; previous uterine surgery; coexistence of other diseases which required additional surgical procedures (such as hydrosalpinx, endometriosis). Patients were randomized 1:1 in two groups. In one group, Tachosil ® was used to obtain haemostasis in the site of the suture of uterine defect (group A); in the other group, no haemostatic device was used to obtain haemostasis (group B). The number, location and size of myomas were evaluated before surgery. Each patient was requested to use contraception in the first six months after surgery; subsequently, the patients could try to conceive. The follow-up included vaginal examination and gynaecologic ultrasounds; it was performed at 1-month, 3-month and one year from surgery. Continuous variables were analyzed by using the student t test or Mann-Whitney test. Categorical variables were compared using the chi-square test or Fisher exact test. Results. Ninety-one women were invited to participate in the study, 75 (82.4%) accepted to participate. Five patients were excluded from the study during surgery before randomization because they needed additional surgical procedures other than the myomectomy. Therefore, 70 patients were randomized in the two groups. After randomization, the two study groups had similar distribution of demographic and clinical characteristics. All surgical procedures were performed laparoscopically and no conversionto laparotomy was needed. There was no major operative complication, such as bowel, bladder or ureteral injuries. Operative time (p = 0.870) and hospitalization (p = 0.306) were similar in the two study groups. The median number of TachosilR applied in patients included in group Awas 1 (range, 1-3); the mean time (± SD) required for Tachosil ® application was 7.1 ± 3.4 minutes. Blood loss in group Awas significantly lower than in group B (p=0.005); no blood transfusion was needed in both groups of patients. The fluid collected in the drainage was significantly lower in group A than in group B (p <0.001). Fifteen patients in group A e 13 in group B tried to conceive after 6 months from surgery. Eight patients in group A (53.3%) and 3 in group B (23.1%) conceived (p = 0.212). Discussion. This prospective study demonstrates that TachosilR application during laparoscopic myomectomy is easy and the device is effective in reducing intraoperative and postoperative blood loss. Further studies should evaluate if this haemostatic device could help in preserving fertility in patients who undergo laparoscopic myomectomy.

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