Israel Medical Association Journal

Background: The current approach to performing sacral neuromodulation consists of a two-stage procedure, the first of which includes insertion of the sacral electrode under fluoroscopic visualization of the S3 foramen. Alternatively, in certain situations computed tomography (CT)-guided insertion can be used.

Objectives: To evaluate the use of CT in cases of reinsertion of the electrode due to infection, dislocation, or rupture.

Methods: Medical records of patients who underwent neuromodulation device reinsertion between 2005 and 2016 for fecal incontinence were reviewed. Study outcomes included procedure course, successful placement, and long-term treatment success.

Results: During the study period, we inserted a neuromodulation device in 67 patients. A CT-guided insertion of a sacral electrode was performed in 10 patients. In nine patients, the insertion and the final location of the electrode were successful. In one patient, the electrode migrated upward due to a malformation of the S3 foramen on both sides and had to be placed in S4. In a mean follow-up of 68.4 ± 30.0 months following the re-insertion, there was a significant reduction in the number of incontinence episodes per day (P < 0.001) and the number of pads used per day (P = 0.002).

Conclusions: CT-guided insertion of a sacral electrode is a safe and promising option, especially in recurrent and or selected cases

Background: There is a lack of real-life clinical data for biosimilar etanercept, an anti-TNF blocking fusion protein. We describe the comparable efficacy and safety of originator and biosimilar etanercept in rheumatoid arthritis (RA) patients in a real-life clinical setting. Our data confirm that a biosimilar etanercept can be safely used as first-line treatment as well as in patients switched from a previous originator compound.

Objectives: To compare the efficacy and safety of originator and biosimilar etanercept in a cohort of RA patients attending two Italian hospitals.

Methods: The study involved 81 consecutive adult RA patients treated for at least 6 months with originator or biosimilar etanercept and considered their clinical and laboratory data, concomitant medications, and adverse events at baseline, and after 3 and 6 months of treatment.

Results: Group 1 included 51 patients taking originator etanercept; group 2 included 30 taking biosimilar etanercept, including 19 who had been switched from the reference product. Despite a significant baseline difference in clinical disease activity, one-way analysis of variance showed that the two groups were clinically comparable after 6 months of treatment, and the same was true when only those receiving etanercept as first-line biological treatment were considered. Nine patients discontinued the treatment due to inefficacy or adverse events, which were never serious and were only reported in group 1.

Conclusions: The efficacy and safety profiles of originator and biosimilar etanercept are comparable in RA patients in a real-life clinical setting. Further studies are needed to confirm these preliminary findings

Background: Chronic lung diseases, especially emphysema and pulmonary fibrosis, are the third leading cause of mortality worldwide. Their treatment includes symptom alleviation, slowing of the disease progression, and ultimately organ transplant. Regenerative medicine represents an attractive alternative.

Objectives: To develop a dual approach to lung therapy by engineering a platform dedicated to both remodeling pulmonary architecture (bronchoscopic lung volume reduction) and regeneration of lost respiratory tissue (scaffold).

Methods: The authors developed a hydrogel scaffold based on the natural polymers gelatin and alginate. The unique physical properties allow its injection through long catheters that pass through the working channel of a bronchoscope. The scaffold might reach the diseased area; thus, serving a dual purpose: remodeling the lung architecture as a lung volume reduction material and developing a platform for tissue regeneration to allow for cell or organoid implant.

Results: The authors’ novel hydrogel scaffold can be injected through long catheters, exhibiting the physical and mechanical properties necessary for the dual treatment objectives. Its biocompatibility was analyzed on human fibroblasts and mouse mesenchymal cells. Cells injected with the scaffold through long narrow catheters exhibited at least 70% viability up to 7 days.

Conclusions: The catheter-injectable gelatin-alginate hydrogel represents a new concept, which combines tissue engineering with minimal invasive procedure. It is an inexpensive and convenient to use alternative to other types of suggested scaffolds for lung tissue engineering. This novel concept may be used for additional clinical applications in regenerative medicine.

Background: Isolated fallopian tube torsion (IFTT) is a rare gynecological entity and its diagnosis is challenging.

Objectives: To compare clinical characteristics, sonographic findings, surgical management, and outcomes of women with surgically verified IFTT compared to those diagnosed with adnexal torsion.

Methods: A retrospective case-control study in a university hospital was conducted. Thirty-four women with surgically verified IFTT between March 1991 and June 2017 were compared to 333 women diagnosed with adnexal torsion within the same time period.

Results: Both groups presented primarily with abdominal pain, which lasted longer prior to admission among the IFTT group (46.8 ± 39.0 vs. 30.0 ± 39.4 hours, P < 0.001). Higher rates of abdominal tenderness with or without peritoneal signs were found in the adnexal torsion group (90.3% vs. 70.6%, P < 0.001). Sonographic findings were similar; however, an increased rate of hydrosalpinx was found among the IFTT group (5.9% vs. 0.0%, P = 0.008). Suspected adnexal torsion was the main surgical indication in only 61.8% of IFTT cases compared with 79.0% in the adnexal torsion group (P = 0.02). Salpingectomy with or without cystectomy was more commonly performed in the IFTT group (35.3% vs. 1.5%, P < 0.001). The leading pathological findings among the IFTT group were hydrosalpinx and paraovarian cysts.

Conclusions: The clinical signs and symptoms of IFTT and adnexal torsion are similar. Although sonographic imaging demonstrating a paraovarian cyst or hydrosalpinx may be helpful in diagnosing IFTT, it is rarely done preoperatively.

Background: Hysterectomy is common in the management of symptomatic uterine prolapse. Vaginal wall repair is often necessary, for which vaginal mesh remains a popular option.

Objectives: To evaluate the risk of mesh erosion following mesh-augmented vaginal prolapse repair, with or without concomitant vaginal hysterectomy.

Methods: This retrospective cohort comprised 70 women who underwent vaginal mesh-augmented pelvic organ prolapse repair from 2007 to 2010. Of the participants, 36 (51.4%) had a vaginal hysterectomy concomitant to the anterior and/or posterior vaginal mesh repair (hysterectomy group) and 34 (48.6%) underwent mesh repair without vaginal hysterectomy (no hysterectomy group).

Results: There were no inter-group differences in age, parity, menopausal state, hormonal use, or presenting symptoms. Previous prolapse repair surgery was much more common in the no hysterectomy group (29.4% vs. 5.5%, P = 0.01). Eleven patients (32.3%) in the no hysterectomy group had previously undergone hysterectomy. Anterior mesh repair was performed in 77.7% and 67.6% of hysterectomy and no hysterectomy patients, respectively. Posterior mesh repair was performed in 27.7% and 44.1%, respectively. One patient in the hysterectomy group underwent immediate removal of mesh due to infection. Surgically treated mesh erosion (limited local excision) occurred in three patients (8.3%) in the hysterectomy group (3, 16, and 18 months following surgery) and in two patients (5.8%) in the no hysterectomy group at 6 months following surgery (P = 0.67).

Conclusions: Vaginal mesh-augmentation concomitant with vaginal hysterectomy for pelvic organ prolapse repair does not carry an increased risk of erosion.

Background: When a woman with an endometrioma presents with acute abdominal pain, it is unclear whether ovarian torsion should be suspected.

Objectives: To compare patient characteristics, imaging results, and surgical management of endometriomas in elective versus emergent surgeries.

Methods: This retrospective cohort study included women treated at our institution during the period 1990–2015 who presented with histologically verified endometrioma and who underwent either planned surgery or emergent surgery due to suspected adnexal torsion.

Results: Of 225 surgeries performed, 174 were elective and 51 emergent. Patients in the emergent group were significantly younger (33.9 ± 11.1 vs. 39.01 ± 10.9 years, P = 0.004). Abdominal pain was the main complaint of all the emergent surgery patients and the leading complaint in 21% of the elective surgery patients (P < 0.001), with right-sided predominance in both groups. Sonographic parameters were similar in both groups. Bilateral ovarian cysts were noted in 11.7% and 11.0% of emergent and elective patients, respectively (P = 0.87). Laboratory evaluation was notable for a higher white blood cell count and CA125 levels among emergent patients. All patients in the emergent group and 93% of patients in the elective group were managed laparoscopically. No cases of torsion were noted. The rate of intra-pelvic adhesions was similar in both groups (56.8% vs. 66.6%, P = 0.19).

Conclusions: Endometrioma may present with acute abdominal pain. However, adnexal torsion in these patients is rare. These cases can be managed using a minimally invasive approach, assuming an optimal surgical setting.

Background: Different clinical and sonographic parameters have been suggested to identify patients with retained products of conception. In suspected cases, the main treatment is hysteroscopic removal.

Objectives: To compare clinical, sonographic, and intraoperative findings in cases of hysteroscopy for retained products of conception, according to histology.

Methods: The results of operative hysteroscopies that were conducted between 2011 and 2016 for suspected retained products of conception were evaluated. Material was obtained and evaluated histologically. The positive histology group (n=178) included cases with confirmed trophoblastic material. The negative histology group (n=26) included cases with non-trophoblastic material.

Results: Patient demographics were similar in the groups, and both underwent operative hysteroscopy an average of 7 to 8 weeks after delivery/abortion. A history of vaginal delivery was more common among the positive histology group. The main presenting symptom in all study patients was vaginal bleeding, and the majority of cases were diagnosed at their routine postpartum/abortion follow-up visit. Sonographic parameters were similar in the groups. Intraoperatively, the performing surgeon was significantly more likely to identify true trophoblastic tissue as such than to correctly identify non-trophoblastic tissue (P < 0.001).

Conclusions: Suspected retained trophoblastic material cannot be accurately differentiated from non-trophoblastic material according to clinical, sonographic, and intraprocedural criteria. Thus, hysteroscopy seems warranted in suspected cases.

Background: Several studies have addressed the issue of undetected uterine pathology in women undergoing hysterectomy for pelvic organ prolapse (POP). However, these studies differ largely with respect to the incidence of malignancy found, study population, and preoperative evaluation.

Objectives: To assess the risk of unexpected pre-malignant and malignant uterine pathological findings after vaginal hysterectomy for POP repair, in a single medical center in Israel.

Methods: A retrospective study was performed of all patients who underwent vaginal hysterectomy due to symptomatic POP between January 1990 and April 2015 in a single tertiary medical center. Selected clinical and pathological data were retrieved from the computerized medical records. All specimens were routinely sent for histopathological assessment. All women were managed according to a uniform protocol that required the presence of a preoperative normal Pap smear, and included preoperative transvaginal sonography and endometrial biopsy when indicated. Patients in whom premalignant or malignant lesions were found preoperatively were not included in the study.

Results: The study comprised 667 patients. The overall rate of malignant or significant premalignant pathologies (6 cases) was 0.89%, including one (0.14%) case of endometrial carcinoma. All premalignant and malignant pathologies were found only in post-menopausal patients. The rate of significant endometrial pathological lesions found in asymptomatic post-menopausal women was only 0.35%.

Conclusions: The rate of preoperatively undetected abnormal histopathological findings in patients who undergo vaginal hysterectomy due to POP is very low, and therefore more extensive preoperative evaluation is not warranted in them.

Abstract                          

Background: A new device, the CCS-30 Contour Transtar, was recently launched for the treatment of obstructed defecation syndrome (ODS).

Objectives: To evaluate the efficacy of the Contour Transtar in resection of true rectal prolapse in relation to age and concomitant urogynecologic procedures.

Methods: During a 50 (median) month period 15 women with rectal prolapse of ≥ 5 cm and complaints of obstructed defecation underwent perineal resection of rectal prolapse with the Contour Transtar.

Results: In 3 of the 15 patients (20%) rectal prolapse recurred. Amelioration of ODS symptoms and improved continence were noted in 82% and 75%, respectively, following surgery.

Conclusions: The Contour Transtar procedure for full-thickness rectal prolapse is a safe and promising procedure and is likely suitable for elderly poor risk patients.