Vaginal Packing After Pelvic Floor Reconstructive Surgery: Does the Soaking Agent Used for Packing (Bupivacaine, Estrogen or Saline) Impact Post-operative Pain Scores?"

STUDY OBJECTIVE: Vaginal packing is traditionally placed after pelvic floor reconstructive surgery (PFRS) to prevent hematoma formation. We seek to determine if there is a difference in post-operative pain scores after PFRS if vaginal packing is soaked with estrogen cream, bupivacaine, or saline. The primary outcome was pain as measured by a visual analog scale (VAS) at 2 hours, 6 hours, and 1 day post-operatively. Secondary outcomes include change in hemoglobin, urinary retention and length of stay (LOS) in hospital. DESIGN: Prospective cohort study SETTING: Tertiary care academic teaching hospital. All PFRS performed by fellowship-trained urogynecologists. PARTICIPANTS: Consenting patients undergoing PFRS. INTERVENTIONS: At the completion of surgery, gauze packing soaked with either estrogen cream 0.25% bupivacaine with 1% epinephrine, or normal saline was placed inside the vagina and removed on post-operative day 1. RESULTS: We included 210 patients (74 estrogen, 66 bupivacaine, 70 saline). There was no significant difference in mean post-operative pain scores between the groups (estrogen, bupivacaine, saline-soaked vaginal packs respectively) at 2 hours (2.66±2.25, 2.30±2.17, 2.24±2.07; p=.4656), 6 hours (2.99±2.38, 2.52±2.30, 2.36±2.01; p=.2181) or on post operative day 1 (1.89±2.01 vs. 2.08±2.15 vs. 2.44±2.19; p=.2832) as measured by VAS scores (0-10). There was no difference in the secondary outcomes of change in pre-/post-operative hemoglobin (21.8±10.73g/L, 20.09±11.55g/L, 21.7±9.62g/L, p=.68), urinary retention (37%, 45% and 48%, p=.45), LOS (1.05±0.46 days, 1.02±0.12, 1.03±0.24, p=.97) or in-hospital opioid usage during admission (represented in morphine milligram equivalents (median (IQR1, IQR3), Kruskal-Wallis test): 11.25mg (0,33), 7.5mg (0, 22.5) and 15mg (0, 33.88) p =0.41. CONCLUSION: There was no difference found between soaking vaginal packing with estrogen cream, bupivacaine, or saline after PFRS with respect to post-operative pain scores, LOS, in-hospital opioid usage, or urinary retention. Saline-soaked packing is an equivalent alternative to estrogen or bupivacaine vaginal packing. CLINICAL TRIAL REGISTRATION: NCT03266926. Registered February 1, 2017. https://clinicaltrials.gov/study/NCT03266926.

Early Removal of Indwelling Catheter and Vaginal Pack After Vaginal Prolapse Surgery: A Retrospective Cohort Study.

INTRODUCTION AND HYPOTHESIS: After vaginal pelvic organ prolapse (POP) surgery a vaginal pack and indwelling bladder catheter are inserted to reduce blood loss and bladder overdistension. The ideal timing of removal remains unclear. In this study we compared removal of vaginal pack and indwelling catheter 3 h post-surgery with removal the next day. METHODS: This retrospective cohort study performed in the Netherlands included patients undergoing POP surgery between 1 January 2019 and 31 December 2020. Patients in whom the vaginal pack and catheter were removed the day after surgery (group A) were compared with patients in which the vaginal pack and catheter were removed 3 h post-surgery (group B). Both groups were compared regarding urinary retention and the need for re-intervention owing to active blood loss within 6 weeks postoperatively. RESULTS: Baseline characteristics, such as age, type of operation and type of anaesthesia in group A (n = 280) and group B (n = 207) were comparable. No significant differences were found regarding complications such as urinary retention (17.2 versus 23.2%; p = 0.255). The rates of re-intervention because of active blood loss and occurrence of infection were also comparable. CONCLUSIONS: Removal of the indwelling catheter and vaginal pack 3 h after vaginal POP surgery does not lead to more postoperative complications than removal the 1st day after surgery. Therefore, early removal is a feasible and safe alternative to the standard timing of removal the morning after surgery of women undergoing POP surgery. In the future this could help with introducing same-day discharge.

A randomized trial evaluating a novel hydrogel packing system compared to standard packing during image-guided high-dose rate brachytherapy boost for cervical cancer.

INTRODUCTION: The purpose of this prospective randomized trial was to compare the use of a novel vaginal hydrogel packing system (BrachyGel) to standard vaginal packing (VP) during high dose rate (HDR) brachytherapy (BT) for locally advanced cervical cancer (LACC). METHODS: This cross-over study included LACC patients receiving HDR BT boost (intracavitary +/- interstitial). All patients received alternating gauze or BrachyGel VP on Arms A and B. Patients, physicians, and physicists evaluated BT characteristics via a 4-point Likert scale. Adverse events (AEs) were prospectively collected and scored per CTCAE. RESULTS: The 20 patients enrolled. The mean bladder D2cc difference between gauze and BrachyGel in Arm A was 0.117 Gray (Gy) and in Arm B 0.013 Gy. The mean difference in rectum D2cc in Arm A and Arm B was -0.189 Gy and -0.191 Gy, respectively. The mean dose to 90% of the high-risk clinical target volume (HR-CTV) for gauze compared to BrachyGel was -0.032 Gy (95% CI: 0.472, 0.409). Patient-reported discomfort was similar with BrachyGel and gauze ("mild/moderate" 70.0% vs 74.0%, respectively). The clarity of VP was similar between BrachyGel and gauze (86.8% vs 89.7%, respectively). The completeness of VP was more frequently "excellent/good" with BrachyGel (79.0%) compared to gauze (56.4%). The ease of packing was more frequently "extremely easy" with BrachyGel (21.2% vs 0%). No serious AEs were reported. CONCLUSION: This randomized trial found no clinically significant difference in OAR or HR-CTV dosimetry between BrachyGel and standard VP. BrachyGel performed well compared to gauze for the patient and physician use experience.

Importance of vaginal packing after laparoscopic sacrocolpopexy - retrospective study.

OBJECTIVE: To compare the subjective and objective results of laparoscopic sacrocolpopexy (LSC) with and without the introduction of a vaginal packing one year after surgery. Methodology: This is a retrospective cohort study of 125 women after laparoscopic sacrocolpopexy operated on in 2013-2016 with complete annual follow-up. Patients with a total hysterectomy were excluded from the study. Basic patient characteristics, preoperative POP-Q and surgery data were collected. The subjective outcome of the surgery was assessed using the PGI-I (patient global impression of improvement). The anatomic outcome of the surgery was evaluated using the composite definition of surgical failure based on POP-Q (Ba ≥ -1, C ≥ -3, Bp ≥ -1). Patients were divided into two groups according to whether or not they had vaginal packing after surgery. Statistical analysis was performed using c2, Wilcoxon and Fischer test according to the distribution of normality. Results: A total of 125 women were enrolled in the study; 48 (38.4%) after LSC, 58 (46.4%) with concomitant supracervical hysterectomy and 19 (15.2%) after sacrohysterocolpopexy. Vaginal packing was introduced for 24-48 hours after surgery in 86 (68.8%) women. The groups did not differ in age, body mass index, smoking or preoperative pelvic organ prolapse quantification system. We did not observe statistically significant differences in PGI-I first year after surgery. The difference in anatomic surgical failure did not reach statistical significance, although more failures were observed in the group without packing (12.8 vs. 3.5%; P = 0.09). The mean C-point value one year after surgery was lower in the non-tamponade group (-7 vs. -7.5; P < 0.009). No mesh extrusion or serious complications were recorded in the monitored group. Conclusion: Vaginal packing after LSC probably does not affect patient satisfaction after surgery, however, it may be associated with better anatomical outcome one year after the surgery. The results of the study must be confirmed by a more detailed prospective evaluation.

Vaginal packing after vaginal hysterectomy: systematic review and recommendations.

INTRODUCTION AND HYPOTHESIS: Vaginal packing is often used after vaginal hysterectomy to reduce the risk of haemorrhagic and infectious complications, but the procedure may impair spontaneous bladder emptying and necessitate permanent bladder catheterization, which itself increases the risk of urinary infection, patient bother, delayed discharge, and increased costs. This systematic review was aimed at assessing the complications and outcomes associated with vaginal packing after vaginal hysterectomy. METHODS: We conducted a systematic review following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) Statement, using the Population, Interventions, Comparators, Outcomes, and Study design (PICOS) framework to define eligibility. Following data synthesis and subgroup analyses, we assessed the certainty of evidence according to GRADE guidance and formulated a clinical recommendation. RESULTS: The review included four clinical trials (involving 337 participants). These provided no clear evidence that vaginal packing led to clinically meaningful reductions in adverse effects, such as vaginal bleeding, hematoma formation, or postoperative vaginal cuff infection. Overall, the intervention produced no clear benefit regarding the predefined outcomes. CONCLUSIONS: Routine vaginal packing after vaginal hysterectomy had no clear benefit on outcomes. We therefore advise against this procedure.

Comparison of vaginal gauze packing technique with or without balloon in high-dose-rate brachytherapy of uterine cervical cancer: A crossover randomized controlled trial.

Purpose: To compare the rectal and bladder doses using two different vaginal packing techniques among uterine cervical cancer patients receiving high-dose-rate (HDR) intracavitary brachytherapy (ICBT). Material and methods: Forty-five patients with cervical cancer were randomized to receive two sessions of ICBT using tandem and ring applicator (Varian©), following completion of pelvic external beam radiotherapy treatment. The procedure was performed with vaginal balloon plus gauze packing or vaginal gauze packing alone, each of which was used in one of two sessions. Sequence of the type of vaginal packing was chosen with computer-generated block randomization. A HDR dose of 8.5 Gy was prescribed to point A in all patients. Volumetric dose parameters, such as D0.1cc, D0.5cc, D1cc, and D2cc of the rectum and bladder were compared between the two techniques of vaginal packing. Results: The mean age of patients was 51 years. Majority (88%) of patients had locally advanced stages of cancer at baseline (stage IIB or more). Rectal doses were significantly less in combined packing technique (D0.1cc: 7.52 Gy vs. 9.02 Gy, p = 0.01; D0.5cc: 6.46 Gy vs. 7.42 Gy, p < 0.01; D1cc: 5.91 Gy vs. 6.7 Gy, p < 0.01; D2cc: 5.29 Gy vs. 5.97 Gy, p < 0.01). Bladder doses were higher in the combined packing technique (D0.1cc: 11.20 Gy vs. 10.76 Gy, p = 0.18; D0.5cc: 9.64 Gy vs. 9.32 Gy, p = 0.56; D1cc: 8.64 Gy vs. 8.36 Gy, p = 0.55; D2cc: 7.56 vs. 7.33 Gy, p = 0.55). Conclusions: Combined vaginal packing resulted in statistically significant reduction in rectal radiation dose compared with standard vaginal gauze packing in high-dose-rate brachytherapy of cervix cancer using tandem and ring applicators.

Development and preclinical testing of a novel biodegradable hydrogel vaginal packing technology for gynecologic high-dose-rate brachytherapy.

PURPOSE: We evaluated the performance of a novel hydrogel-based strategy developed for clinical use as vaginal packing using phantoms and cadavers, and to compare the hydrogel to gauze and balloon packing. MATERIAL AND METHODS: The biocompatible hydrogel is based on a thiol-Michael addition reaction, with delivery of reagents into the vaginal cavity using a custom-made system. Soft-cured cadavers were used for soft tissue-like mechanical properties. Two cadavers with intact uteri had magnetic resonance imaging (MRI) compatible with tandem and ovoids. For one cadaver, the temperature of the vaginal canal was measured before hydrogel application, during polymerization, and after hydrogel removal. The hydrogel packing and applicator was kept in a second cadaver, which was imaged using computed tomography (CT) and MRI. The hydrogel packing and imaging was repeated for an open multichannel MRI compatible, titanium-based vaginal cylinder placed in a post-hysterectomy cadaver. RESULTS: The gel reaction occurred within 90 seconds, indicating polymerization at clinical quantities with a 5°C increase in vaginal temperature. CT and MRI imaging identified the hydrogel readily and showed a conformance to anatomy with few air pockets. The entire hydrogel packing was readily retrieved upon completion of imaging. CONCLUSIONS: The novel strategy for polyethylene glycol (PEG)-based hydrogel intra-vaginal packing was able to rapidly polymerize in human cadavers with minimal heat production. Delivery was efficient and able to fill the contours of the vaginal cavity and displace tissue away from the applicator axis. The hydrogel has favorable imaging characteristics on CT and MRI, and shows a potential for clinical use, warranting additional studies for the use in humans.

The use of QuikClot combat gauze in cervical and vaginal hemorrhage.

QuikClot combat gauze is a synthetic hemostatic dressing used for hemorrhage control. There is a paucity of data describing the clinical use and hemostatic results of combat gauze in the obstetric and gynecologic setting. This case series demonstrates the use of combat gauze as an effective hemostatic agent when used as vaginal packing in cervical and vaginal hemorrhage. Hemostasis was achieved rapidly in all cases and further interventions were avoided. The combat gauze remained in place for a mean time of 15 h with no adverse side effects observed. The use of combat gauze as vaginal packing may provide an alternative option in the treatment of cervical and vaginal hemorrhage when other traditional conservative and surgical interventions fail or are unavailable.

Rectal and bladder dose reduction with the addition of intravaginal balloons to vaginal packing in intracavitary brachytherapy for cervical cancer.

PURPOSE: The use of intravaginal Foley balloons in addition to conventional packing during high-dose-rate (HDR) tandem and ovoids intracavitary brachytherapy (ICBT) is a means to improve displacement of organs at risk, thus reducing dose-dependent complications. The goal of this project was to determine the reduction in dose achieved to the bladder and rectum with intravaginal Foley balloons with CT-based planning and to share our packing technique. METHODS AND MATERIALS: One hundred and six HDR-ICBT procedures performed for 38 patients were analyzed for this report. An uninflated Foley balloon was inserted into the vagina above and below the tandem flange separately and secured in place with vaginal packing. CT images were then obtained with both inflated and deflated Foley balloons. Plan optimization occurred and dose volume histogram data were generated for the bladder and rectum. Maximum dose to 0.1, 1.0, and 2.0 cm(3) volumes for the rectum and bladder were analyzed and compared between inflated and deflated balloons using parametric statistical analysis. RESULTS: Inflation of intravaginal balloons allowed significant reduction of dose to the bladder and rectum. Amount of reduction was dependent on the anatomy of the patient and the placement of the balloons. Displacement of the organs at risk by the balloons allowed an average of 7.2% reduction in dose to the bladder (D0.1 cm(3)) and 9.3% to the rectum (D0.1 cm(3)) with a maximum reduction of 41% and 43%, respectively. CONCLUSIONS: For patients undergoing HDR-ICBT, a significant dose reduction to the bladder and rectum could be achieved with further displacement of these structures using intravaginal Foley balloons in addition to conventional vaginal packing.

Oestrogen-soaked vaginal packing for decubitus ulcer in advanced pelvic organ prolapse: a case series.

INTRODUCTION: Cervicovaginal decubitus ulceration is a well-known complication of advanced pelvic organ prolapse (POP). There is no consensus for its management. This case series describes the outcome of using repeated vaginal packs soaked with oestrogen cream to reduce POP and promote decubitus ulcer healing. We aimed to investigate the speed of ulcer healing and endometrial safety with this regimen. METHODS: This was a retrospective study of patients with stage 3 or 4 POP and intact uterus with decubitus ulcer who were planned for surgery that included hysterectomy after ulcer healing. Vaginal packs are replaced at least biweekly-or more frequently if extruded-until ulcer resolution. RESULTS: Thirteen patients were studied. Mean age was 69 ± 6 years and mean duration of menopause was 19 ± 6 years. Nine patients had a single ulcer and four had multiple ulcers. Mean ulcer diameter was 2.8 ± 1.5 cm and mean duration for ulcer healing was 26 ± 14 days. Hysterectomy and pelvic floor reconstruction was performed a median of 5 (range 0-153) days after ulcer healing was first noted. Histopathological examination of the endometrium following hysterectomy showed three specimens with endocervical hyperplasia; one had concurrent proliferative endometrium, two had simple endometrial hyperplasia and another two had proliferative endometrium. CONCLUSION: Oestrogen-soaked vaginal packing is a viable option for managing a decubitus ulcer in advanced POP. We document a measurable impact on the endometrium with this short-term preoperative regimen. Further research is needed to evaluate its efficacy in promoting ulcer healing and endometrial safety.

Optimizing packing contrast for MRI-based intracavitary brachytherapy planning for cervical cancer.

PURPOSE: We prospectively tested five variations in vaginal gauze packing in an effort to improve contrast between the packing, cervix, and applicator for MRI-based intracavitary brachytherapy planning. METHODS AND MATERIALS: Five patients enrolled on a prospective study from May 2013 to October 2013 received MRI-based intracavitary brachytherapy for cervical cancer with variations of impregnated gauze packing. Substances tested included antibiotic cream alone, antibiotic cream mixed with ultrasound gel, conjugated estrogens cream mixed with ultrasound gel, ultrasound gel alone, and gadolinium. Images from the T2-weighted pelvic MRI were used to obtain signal intensity measurements at points within the packing, cervix, and applicator. Signal intensity values were normalized using the signal-to-noise ratio and compared using an unpaired t-test. RESULTS: Ultrasound gel-impregnated gauze allowed for the greatest contrast between the packing and the cervix with a difference in mean normalized signal intensity of 38.2 (p < 0.01). Conjugated estrogens cream mixed with ultrasound gel and gadolinium also provided contrast when compared with cervix, with differences in mean normalized signal intensity of 25.3 and -16.2, respectively (p < 0.01 for both). For all variations but gadolinium, the normalized mean signal intensity of the packing was found to be significantly different from the applicator, with the ultrasound gel again demonstrating the greatest contrast with a difference of 42.5 (p < 0.01). CONCLUSIONS: Gauze impregnated with ultrasound gel, conjugated estrogens cream mixed with ultrasound gel, and gadolinium allowed for a significant difference in MRI signal intensity between the packing and the cervix. With respect to both the cervix and the applicator, ultrasoundgel-impregnated gauze provided the best contrast overall.

Uterine packing with chitosan-covered gauze for control of postpartum hemorrhage.

OBJECTIVE: To describe the use of gauze covered with chitosan, a potent hemostatic agent derived from chitin, in the treatment of postpartum hemorrhage (PPH). STUDY DESIGN: Patients suffering from postpartum hemorrhage were treated by uterine packing with chitosan-covered gauze, either through the hysterotomy in case of cesarean delivery or transvaginally, for up to 24 hours. RESULTS: Chitosan-covered gauze was used in 19 cases of postpartum hemorrhage due to uterine atony, placenta accreta/increta, or anticoagulation, including 5 severe cases where a hysterectomy seemed inevitable otherwise. In all but one case, the bleeding stopped and further interventions were avoided. Over comparable periods of time (18 months) and births (3822 vs 4077) before and after the introduction of the chitosan gauze in our clinic, the rate of peripartum hysterectomies was reduced by 75% (8 vs 2; odds ratio, 4.27; P = .044). CONCLUSION: Chitosan-covered gauze is a viable option in the treatment of (severe) postpartum hemorrhage. It is easy to use and requires no special training. It can be used after both vaginal and cesarean deliveries, and there are no adverse side effects. Furthermore, it is very inexpensive compared with other treatment options, making it suitable for use also in low resource-countries, where the death toll due to postpartum hemorrhage is especially high.