INTRODUCTION AND HYPOTHESIS: The objective of this study was to evaluate the effect of vaginal packing following pelvic floor surgery with regard to post-operative pain, bleeding and infection. This was a double-blind randomised study of women undergoing vaginal hysterectomy and/or pelvic floor repair at a tertiary urogynaecology unit. METHODS: The primary outcome of day 1 post-operative pain was assessed using the short-form McGill Pain score. Secondary outcomes were haematological and infective morbidity, evaluated using changes in full blood count, and cultures of midstream urine and high vaginal swabs. A transvaginal ultrasound scan to exclude pelvic haematoma was performed at 6 weeks in all women who underwent vaginal hysterectomy with or without a pelvic floor repair. RESULTS: In total, 190 women were recruited: mean age 58.3 years (27-91 years), mean body mass index 27.4 kg/m(2) and median parity 3. Women were randomised into the 'pack' (n = 86) and 'no pack' (n = 87) arms with no demographic differences between the groups. No statistically significant differences in the post-operative pain scores or secondary outcome measures were demonstrated. Incidence of haematoma formation (14.8 % no pack, 7.3 % pack, p = 0.204) was not statistically significant. There were three clinically significant complications in the no pack group and none in the pack group. CONCLUSIONS: This is the first study to examine pain in association with post-operative vaginal packing. There is no evidence to suggest that packing increases pain scores or post-operative morbidity. A trend towards increased haematoma and significant complications was seen in the no pack group. As vaginal packing does no harm and may be of some benefit it may be argued that packing should be recommended as routine clinical practice.
RCT Entities:
INTRODUCTION AND HYPOTHESIS: The objective of this study was to evaluate the effect of vaginal packing following pelvic floor surgery with regard to post-operative pain, bleeding and infection. This was a double-blind randomised study of women undergoing vaginal hysterectomy and/or pelvic floor repair at a tertiary urogynaecology unit. METHODS: The primary outcome of day 1 post-operative pain was assessed using the short-form McGill Pain score. Secondary outcomes were haematological and infective morbidity, evaluated using changes in full blood count, and cultures of midstream urine and high vaginal swabs. A transvaginal ultrasound scan to exclude pelvic haematoma was performed at 6 weeks in all women who underwent vaginal hysterectomy with or without a pelvic floor repair. RESULTS: In total, 190 women were recruited: mean age 58.3 years (27-91 years), mean body mass index 27.4 kg/m(2) and median parity 3. Women were randomised into the 'pack' (n = 86) and 'no pack' (n = 87) arms with no demographic differences between the groups. No statistically significant differences in the post-operative pain scores or secondary outcome measures were demonstrated. Incidence of haematoma formation (14.8 % no pack, 7.3 % pack, p = 0.204) was not statistically significant. There were three clinically significant complications in the no pack group and none in the pack group. CONCLUSIONS: This is the first study to examine pain in association with post-operative vaginal packing. There is no evidence to suggest that packing increases pain scores or post-operative morbidity. A trend towards increased haematoma and significant complications was seen in the no pack group. As vaginal packing does no harm and may be of some benefit it may be argued that packing should be recommended as routine clinical practice.
Authors: Constantin M Durnea; Vasilios Pergialiotis; James M N Duffy; Lina Bergstrom; Abdullatif Elfituri; Stergios K Doumouchtsis Journal: Int Urogynecol J Date: 2018-10-22 Impact factor: 2.894