Results of a Novel Device Designed to Reduce the Occurrence of Hemorrhoids
Based upon a review of the literature and consultation with practitioners, our power analysis reflected an anticipated incidence of delivery-induced hemorrhoids of 30% for untreated control patients. The study’s primary objective was to evaluate the safety and efficacy of the Hem-Avert device in reducing the occurrence and/or severity of hemorrhoids and/or TEH. For patients hemorrhoid-free at time of admission, success was defined as the absence of hemorrhoids and/or TEH after normal vaginal delivery. For patients with low-grade hemorrhoids at admission, success was defined as preventing hemorrhoid progression.
Methods and Materials
This prospective study was conducted in a randomized manner with 176 patients divided into two groups. Investigational patients received the Hem-Avert device during vaginal delivery. Control patients underwent the normal birthing process without the study device. Both groups met the same inclusion/exclusion and continuation criteria.
The study involved four obstetrics and gynecology (OBGYN) physician clinics (Women’s Care Center, Memphis, TN; Southaven OBGYN, Southaven, MS; Just for Women, Memphis, TN; and Premier Women’s Care, Covington, TN), and three delivery sites (Baptist Memorial Hospital for Women, Memphis, TN; Baptist Memorial Hospital-DeSoto, Southaven, MS; and Baptist Memorial Hospital-Tipton, Covington, TN). The study population consisted of women between the ages of 18 and 40, all scheduled for vaginal deliveries. Prenatal examinations indicated all participants anticipated single-birth deliveries.
At the time of the prenatal screenings, none of the prospective patients subsequently enrolled in the study demonstrated signs of hemorrhoids, lacerations, or anal fissures. Patients were automatically excluded if they had a previous rectal surgery, or if a rectal tag was present at the time of the initial physical examination. Presence of a rectal tag suggests previous hemorrhoids that have been reabsorbed.
Subjects were enrolled on a 1:1 (investigational:control) treatment randomization scheme. Eighty-seven subjects were enrolled in the investigational group and 89 subjects were enrolled in the control group. Informed consents were obtained from all study patients.
Upon admission for delivery, a physical examination was performed to document the presence of hemorrhoids, lacerations, and/or anal fissures at the initial stages of cervical dilation. Patients admitted already fully dilated or evidencing crowning were excluded from the study. Investigators measured the perineum to determine if the area was sufficient to properly seat the device. Patients with a perineum length <2 cm were excluded from the study. Physical variables were not significantly different for either group of patients who were hemorrhoid-free at admission as shown in Table 1.
Investigational patients had the Hem-Avert device attached when cervical dilation reached 8–10 cm. Application of the device was performed using two hook-and-loop fastener adhesive strips attached to the patient’s buttocks and outer thighs. Natural tension created by the straps provided constant pressure to the perianal region and kept the device firmly in place. The device remained attached until the end of the second stage of labor (see Figure 1).
US OBSTETRICS & GYNECOLOGY
Table 1: Comparison of Patient and Delivery Characteristics
Characteristic Compared Total patients
Mean age (years)
Mean patient weight (lbs) Previous pregnancies Mean infant weight (lbs) Minimum–maximum
Table 2: Study Results Summary
Efficacy subjects
Treatment success for subjects with low-grade hemorrhoids at admission Success Failure Total
Treatment success for subjects with no hemorrhoids at admission Success Failure Total
Hem-Avert Group 34
25.3 186.4
25 (73.5 %) 7.0
5.0–9.3
Control Group 52
23.6 188
32 (61.5 %) 7.1
4.1–8.9
Hem-Avert 40
6 (100 %) 0 6
34 (100 %) 0
34 Figure 1: Placement of Hem-Avert Device
Control 58
4 (66.7 %) 2 (33.3 %) 6
39 (75 %) 13 (25 %) 52
p-value
0.0003
0.0012
Hem-Avert placement prior to delivery Results
Investigators screened 202 subjects for the study between July 31, 2007 and May 26, 2009, with 176 patients meeting the enrollment criteria. Seventy-eight of the 176 randomized subjects were excluded due to protocol restrictions (e.g., perineum <2 cm; baby crowning at admission; delivered at non-investigational facility; converted to Cesarean section; episiotomy required). Biostatistical analysis included Fisher’s exact test for categorical variables, Pocock alpha for determining p-values, and the rank-sum test for numeric measures. Ninety-eight patients were evaluated for the final analysis reported in Table 2.
Device efficacy was determined through a subject postpartum physical evaluation on the day of discharge. Investigators recorded whether hemorrhoids and/or TEH were observed. If either were present, the investigator graded the severity of the condition observed in each group using a five-point scale developed by the investigator. This scale measured the percentage of anal coverage involvement and was implemented at admission and at 24 hours postpartum.
39
Infant delivered with Hem-Avert in place
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