A cohort of female patients with OGIB who underwent CE after bidirectional endoscopy at Centro Hospital Vila Nova de Gaia from May 2011 to December 2016 was evaluated. Patients were followed-up until April 2018. Patients were then divided into 2 groups according to age, considering fertile age as ≤ 55 years and postmenopausal age as > 55 years.

Patient clinical information was retrospectively collected from electronic medical records, and included demographic characteristics (gender, age); comorbidities (cardiovascular, renal, hepatic disease); medical therapy [anticoagulants, antiplatelet and nonsteroidal anti-inflammatory drugs (NSAIDs)]; hemoglobin (Hg) at admission and number of units of packed red blood cells (RBC) transfused prior to CE.

Written informed consent was obtained from all patients. In this study the Mirocam^® Video Capsule system was used and the examinations were carried out according to our unit protocol. Patients underwent a clear liquid diet the day before and a fasting period of 12 h before the exam. Oral iron supplements were suspended at least 8 d before the procedure.

After CE ingestion, patients were evaluated 1-2 h after, through realtime visualization and a prokinetic agent was administered if the CE was retained in the stomach. Oral light diet was initiated 4 h after CE ingestion. The recorder was removed 12 h after CE ingestion. Earlier removal of the recorder demanded realtime visualization, confirming a colonic location of CE.

CE cleansing was evaluated according to the qualitative scale developed by Brotz et al[16], and appropriate cleansing was assumed when graduated as excellent, good or fair.

CE findings were classified as positive and negative findings. Positive findings included bleeding without visible lesions, angiodysplasia, varices, hemangioma, ulcer, erosion, eroded polyps, diverticulum with bleeding stigmata or small-bowel tumor.

The DY was defined as the proportion of CE with positive findings compared to the total number of female patients included in the study. The TY was defined as the proportion of patients performing endoscopic treatment compared to the total number of female patients included in the study. Rebleeding, time to rebleed, hospitalization and mortality were also evaluated. Rebleeding episodes were defined as evidence of melena or hematochezia, a drop in Hg ≥ 2 g/dL from baseline, and/or the need for transfusion[17-19].

Data were analyzed using SPSS version 23.0. Descriptive statistics were used to describe the patient’s demographic features, clinical characteristics and type of endoscopic findings. Categorical variables were presented as percentages and numeric variables as means. Results are expressed as percentages or mean ± SD for continuous variables.

The χ² test was used to compare non-continuous variables. The t-test was used to compare continuous variables. The Kaplan-Meier test was used to calculate the time to rebleed. The Log-Rank test was used to compare the time to rebleed between groups. A P < 0.05 was considered to be statistically significant.

In our study, 183 female patients underwent CE for OGIB, of whom 30.6% were PMW (n = 56) and 69.4% were MW (n = 127). Patient characteristics are shown in Table 1. The mean age was 64.3 years (SD 15.8). Most patients were referred for occult OGIB (82.5%, n = 151), while 17.5% (n = 32) had overt OGIB. Iron deficiency anemia (IDA) was the most common indication (81.4%, n = 149) followed by melena (9.8%, n = 18), hematochezia (7.7%, n = 14) and positive fecal occult blood test (1.1%, n = 2). Mean Hg value before CE was 9.7 g/dL (SD 2.0). OGIB needing transfusional support was identified in 34.4% (n = 63). Indication for CE, mean Hg value and need of transfusional support are shown in Table 2.

Concerning comorbidities, 25.7% had heart failure (n = 47), 18% had atrial fibrillation (n = 33), 13.1% had chronic kidney disease (n = 24) and 3.8% had liver disease (n = 7). Drugs increasing bleeding risk were also evaluated: 19.1% took vitamin K antagonists or direct oral anticoagulants, 31.2% were medicated with aspirin or thienopyridines and 33.3% took NSAIDs.

CE findings are presented in Table 3. Small bowel cleansing was considered appropriate in 77.6% (n = 142) CE studies. Most patients had positive findings (66.7%, n = 122). Angiodysplasias were the most frequent finding (37.7%, n = 69) followed by ulcers/erosions (9.8%, n = 18) (Figure 1) and mass lesions (8.7%), namely tumors 7.1% [gastrointestinal stromal tumor (GIST) and subepitelial lesions] and polyps 1.6%. Blood in the GI tract was observed in 12.6% CE (n = 23), of which in 60.9% no lesions were identified. Angiodysplasias were classified according to the Saurin et al[7] classification system as P1 (66.7%, n = 46) and P2 (33.3%, n = 23). Considering the timing of CE most patients were studied > 14 d (88.0%, n = 161) while a minority underwent CE within the first 14 d (48 h-14 d in 8.2%, n = 15 and < 48 h in 3.8%, n = 7).

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Figure 1 Capsule endoscopy of menopausal women with milimetric erosions in the jejunum.

The outcomes of CE are shown in Table 4. The DY was 53.6% (n = 98), TY 12.6% (n = 23). The rebleeding rate was 16.4%, at 1 year, 25.8%, at 3 years and 27.2% at 5 years (Figure 2). The hospitalization rate was 7.1% (n = 13) and the global mortality 1.0% (n = 2) (Table 4).

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Figure 2 Kaplan-Meier curves according to the time to rebleed.

The mean age of MW was 73.4 ± 7.9 years and for PMW 43.7 ± 8.0 years. Post-menopausal age was associated with significantly higher comorbidities, namely heart failure (P < 0.001), chronic kidney disease (P < 0.001) and atrial fibrillation (P = 0.001). In this group use of anticoagulants, anti-aggregants and NSAIDs was significantly higher (P < 0.001). Mean Hg level at CE study was lower in MW (9.3 ± 2.1 g/dL) compared to PMW (10.4 ± 1.7 g/dL). The need of blood transfusion before CE was significantly higher in MW (44.1% vs 12.5%) (P < 0.001). IDA was the most common indication in both groups (MW 78.0%; PMW 89.3%).

MW had more frequently positive findings in CE study (71.1% vs 55.4%) (P = 0.031). Angiodysplasias were the most frequent finding in both groups, diagnosed in 44.9% of MW (n = 57) and in 21.4% of PMW (n = 12) (P = 0.003). MW had more frequently lesions with a high bleeding potential, classified as P2 lesions (38.6% vs 8.3%) (P = 0.043). Blood in the GI tract was identified more frequently in MW (15.7%, n = 20) than PMW (5.4%, n = 3) (P = 0.051). Cleansing adequacy was not significantly different between groups (P = 0.83). Timing to CE was not significantly different between groups (P = 0.31). However in MW timing of CE was associated with higher DY (P = 0.002) and TY (0.024). In PMW there timing to CE was not associated with higher DY (P = 0.23) nor TY (P = 0.96).

DY was higher in MW (63.8%, n = 81) than PMW (30.4%, n = 17), and post-menopausal status was significantly associated with higher DY (P < 0.001). TY was significantly higher in MW (17.3%, n = 22) compared to PMW (1.8%, n = 1) (P = 0.003).

The rebleeding rate was significantly higher in MW (P = 0,031). Considering a follow-up period of 1, 3 and 5 years, MW had a significantly higher rebleeding rate (MW 22.0%; 32.3%; 34.2% vs PMW 3.6%; 10.2%; 10.2%) (P = 0.001) (Table 4 and Figure 3).

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Figure 3 Kaplan-Meier curves according to the time to rebleed between premenopausal and menopausal women.

In the MW group hospitalization due to OGIB was higher (MW-9.4%, PMW-1.8%). Mortality due to OGIB in MW was 1.6%, and there was no death in PMW. There was no significant differences between groups concerning hospitalization (P = 0.063) and mortality (P = 0.345).

Findings of capsule endoscopy (CE) for obscure gastrointestinal bleeding (OGIB) investigation performed in females may vary substantially according to menopause status. In this paper we estimated and compared diagnostic yield (DY) of CE as well as its therapeutic yield (TY) and clinical outcomes in premenopausal women (PMW) and menopausal women (MW).

Negative CE may lead to increased health costs and delayed diagnosis when performed in patients who were not fully investigated, as OGIB is an exclusion diagnosis.

To compare the DY of CE for OGIB study and correlated this outcome with menopause presence.

The DY, TY, rebleeding rate, hospitalization and mortality were calculated and compared according to menopausal status.

Postmenopausal age was associated with higher DY, need for endoscopic treatment, rebleeding, and hospitalization.

PMW with suspected OGIB is less likely to have significant findings in CE. This suggests that fertile age women should be carefully studied, preferably by a multidisciplinary approach, before CE.

Our study has a retrospective design with a small number of patients, so a prospective comparative assessment of CE findings between PMW and MW with a larger population is warranted. In addition routine evaluation by a Gynecologist may reduce the negative CE burden.