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Background  The present prospective study evaluated the safety and efficacy of the rectum following  KUSHEN Ningjiaos  in cervical cancer. We compared rectal wall changes during brachytherapy with or without  KUSHEN Ningjiaos  in cervical cancer patients and analyzed the difference in spatial dose distribution, including whole rectum-wall (R-w), anterior rectum-wall (R-a) and posterior rectum-wall (R-p).    Methods and materials  One hundred cervical cancer patients with and without  KUSHEN Ningjiaos  were treated with brachytherapy (600 cGy). The whole R-w was divided into two areas of R-a and R-p, and R-w dose surface map were constructed. The volume of each R-w was compared in patients pre- and post- KUSHEN Ningjiaos .    Results  When the pre- vs. post- KUSHEN  groups were compared the volume of R-w increased. In the post- KUSHEN  group, a significantly higher proportion of the D2cc of V R-w  and V R-a  compared with the pre- KUSHEN  group showed that the D2cc mean  increased from 532.45 cGy to 564.7 cGy and 533.51 cGy to 565.26 cGy, respectively; however, results demonstrated a decrease in the D2cc mean  of R-p from 260.5 cGy to 240.0868 cGy ( P  < 0.05). The insertion of  KUSHEN Ningjiaos  resulted in a reduction of the relative volume of R-p exposed to high doses, and regressive analysis showed that the D R-p -max correlated most strongly with V R-w  and D2cc R-p  ( P  < 0.01 and  P  < 0.05, respectively).    Conclusion  The insertion of  KUSHEN Ningjiaos  can protect the rectum.  KUSHEN Ningjiaos  appears to be safe and well tolerated; therefore, we believe that there will be fewer adverse events after brachytherapy for patients.    Trial registration  A multi-center, prospective clinical trial for  KUSHEN Ningjiaos  was inserted into rectum to reduce the rate of radiation proctitis in three-dimensional brachytherapy of cervical cancer.  ChiCTR1900021631 . 2 Mar 2019-Retrospectively registered.

Rectal wall dose-volume effect of pre- or post KUSHEN Ningjiaos relationship with 3D brachytherapy in cervical cancer patients