Hydraulic dilatation: a novel approach to cervical dilatation
ESC Congress Library. Zivanovic A. 05/06/16; 126833; A-006
Prof. Dr. Aleksandar Zivanovic
Prof. Dr. Aleksandar Zivanovic
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Abstract
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Hydraulic dilatation: a novel approach to cervical dilatation

Objective: A prerequisite for any intervention in the uterine cavity is the dilation of the cervical canal. It is most commonly used procedure in gynecology practice, and basically, always represents an act of violence. Cervical dilation is used before both diagnostic and therapeutical interventions, most frequently it is used before curettage, for the termination of unwanted pregnancy. No matter the reason that is applied for, the cervical dilation is a risky intervention, painful for the patient and stressful for the physician. In the aim to reduce the risk and to make the procedure of cervical dilatation less risky and painful, we created a continuous controllable balloon dilator (CBBD)1.
Design and methods: In the aim to prove the advantage of the CCBD over the current methods of mechanical cervical dilatation, a multicenter clinical study was conducted at the Clinical Center Kragujevac, Serbia and Clinical Center Podgorica, Montenegro2. The study included 120 pregnant women randomly assigned to one of the following three groups: Control group consisted of 40 pregnant women who did not undergo a dilatation procedure; Group I (40 pregnant women), who undergone cervical dilatation using Hegar's dilators (HeD) and Group II (40 pregnant women), who undergone hydraulic dilatation. A tissue material of the cervix, for the histological evaluation, was obtained after every dilatation.
Results: The CCBD dilations were successful and had no complications in all 40 patients of Group II. The cervical tissue was markedly less damaged after CCBD dilation compared with HeD dilation (epithelium damage: 95% (HeD) vs. 45% (CCBD), P <0.001; basal membrane damage: 82.5% (HeD) vs. 27.5% (CCBD), P <0.001; stromal damage: 62.5% (HeD) vs. 37.5% (CCBD), P <0.01). Intracervical hemorrhage was observed in 90% of the patients after HeD dilation versus in 32.5% of the patients after CCBD dilation.
Conclusion: CCBD dilation is a new, original, non-invasive, fully controllable and safe technique for cervical dilation, with clear advantage over the current methods of mechanical dilatation. The future studies about CCBD are necessary to further prove its effectiveness and to determine biomechanical aspects of mechanical cervical dilatation.3


References:
1. Arsenijevic, Slobodan, et al. 'Continuous controllable balloon dilation: a novel approach for cervix dilation.' Trials 13.1 (2012): 1-7.
2. http://www.isrctn.com/ISRCTN54007498
3. Arsenijevic, Petar, et al. 'Analysis of cervical resistance during continuous controllable balloon dilatation: controlled clinical and experimental study.' Trials 16.1 (2015): 1-8.

Hydraulic dilatation: a novel approach to cervical dilatation

Objective: A prerequisite for any intervention in the uterine cavity is the dilation of the cervical canal. It is most commonly used procedure in gynecology practice, and basically, always represents an act of violence. Cervical dilation is used before both diagnostic and therapeutical interventions, most frequently it is used before curettage, for the termination of unwanted pregnancy. No matter the reason that is applied for, the cervical dilation is a risky intervention, painful for the patient and stressful for the physician. In the aim to reduce the risk and to make the procedure of cervical dilatation less risky and painful, we created a continuous controllable balloon dilator (CBBD)1.
Design and methods: In the aim to prove the advantage of the CCBD over the current methods of mechanical cervical dilatation, a multicenter clinical study was conducted at the Clinical Center Kragujevac, Serbia and Clinical Center Podgorica, Montenegro2. The study included 120 pregnant women randomly assigned to one of the following three groups: Control group consisted of 40 pregnant women who did not undergo a dilatation procedure; Group I (40 pregnant women), who undergone cervical dilatation using Hegar's dilators (HeD) and Group II (40 pregnant women), who undergone hydraulic dilatation. A tissue material of the cervix, for the histological evaluation, was obtained after every dilatation.
Results: The CCBD dilations were successful and had no complications in all 40 patients of Group II. The cervical tissue was markedly less damaged after CCBD dilation compared with HeD dilation (epithelium damage: 95% (HeD) vs. 45% (CCBD), P <0.001; basal membrane damage: 82.5% (HeD) vs. 27.5% (CCBD), P <0.001; stromal damage: 62.5% (HeD) vs. 37.5% (CCBD), P <0.01). Intracervical hemorrhage was observed in 90% of the patients after HeD dilation versus in 32.5% of the patients after CCBD dilation.
Conclusion: CCBD dilation is a new, original, non-invasive, fully controllable and safe technique for cervical dilation, with clear advantage over the current methods of mechanical dilatation. The future studies about CCBD are necessary to further prove its effectiveness and to determine biomechanical aspects of mechanical cervical dilatation.3


References:
1. Arsenijevic, Slobodan, et al. 'Continuous controllable balloon dilation: a novel approach for cervix dilation.' Trials 13.1 (2012): 1-7.
2. http://www.isrctn.com/ISRCTN54007498
3. Arsenijevic, Petar, et al. 'Analysis of cervical resistance during continuous controllable balloon dilatation: controlled clinical and experimental study.' Trials 16.1 (2015): 1-8.

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