Safety and Efficacy of Minimally Invasive Video-Assisted Ablation of Pilonidal Sinus: A Randomized Clinical Trial.

IMPORTANCE: Video-assisted ablation of pilonidal sinus (VAAPS) is a new minimally invasive treatment based on the complete removal of the sinus cavity with a minimal surgical wound. OBJECTIVE: To validate the safety and efficacy of VAAPS. DESIGN, SETTING, AND PARTICIPANTS: From January 1, 2012, through December 31, 2013, we enrolled 145 consecutive patients from an intention-to-treat population at a single academic center in Italy. The last date of follow-up for this analysis was December 31, 2014. Patients with chronic nonrecurrent pilonidal sinus were randomized to minimally invasive (76 patients) or conventional (69 patients) treatment of pilonidal sinus. INTERVENTIONS: VAAPS and Bascom cleft lift procedure. MAIN OUTCOMES AND MEASURES: The primary end point of the study was time off work. Secondary end points were the rates of operative success and perioperative complications (infection and recurrence), operative time, patient satisfaction, and intraoperative and postoperative pain ratings. RESULTS: Of the 145 patients, 60 (78.9%) were male and 16 (21.1%) were female in the minimally invasive treatment group, and 54 (78.3%) were male and 15 (21.7%) were female in the conventional treatment group. The mean (SD) age of the patients was 25.5 (5.9) years in the minimally invasive treatment group and 25.7 (5.3) in the conventional treatment group. In the minimally invasive treatment group, mean (SD) time off work was significantly less compared with the conventional treatment group (1.6 [1.7] vs 8.2 [3.9] days; P < .001). Mean (SD) operative time was significantly longer in the minimally invasive treatment group (42.9 [9.8] minutes) vs the conventional treatment group (26.5 [8.7] minutes), P < .001. Although the overall complication rate was similar in both groups, there were fewer infections (1 [1.3%] vs 5 [7.2%]; P = .10) recorded in the minimally invasive treatment group. Similarly, patients enrolled in the minimally invasive treatment group expressed significantly less pain and higher satisfaction. CONCLUSIONS AND RELEVANCE: In the new era of minimally invasive treatment surgery, pilonidal sinus could become a disease treated with an endoscopic approach. Although additional studies are needed to provide a definitive conclusion, our results encourage considering the adoption of this treatment as the most effective way to treat pilonidal sinus. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01963273.

Colorectal resection in deep pelvic endometriosis: Surgical technique and post-operative complications.

AIM: To investigate the impact of different surgical techniques on post-operative complications after colorectal resection for endometriosis. METHODS: A multicenter case-controlled study using the prospectively collected data of 90 women (22 with and 68 without post-operative complications) who underwent laparoscopic colorectal resection for endometriosis was designed to evaluate any risk factors of post-operative complications. The prospectively collected data included: gender, age, body mass index, American Society of Anesthesiologists risk class, endometriosis localization (from anal verge), operative time, conversion, intraoperative complications, and post-operative surgical complications such as anastomotic dehiscence, bleeding, infection, and bowel dysfunction. RESULTS: A similar number of complicated cases have been registered for the different surgical techniques evaluated (laparoscopy, single access, flexure mobilization, mesenteric artery ligation, and transvaginal specimen extraction). A multivariate regression analysis showed that, after adjusting for major clinical, demographic, and surgical characteristics, complicated cases were only associated with endometriosis localization from the anal verge (OR = 0.8, 95%CI: 0.74-0.98, P = 0.03). After analyzing the association of post-operative complications and each different surgical technique, we found that only bowel dysfunction after surgery was associated with mesenteric artery ligation (11 out of 44 dysfunctions in the mesenteric artery ligation group vs 2 out of 36 cases in the no mesenteric artery ligation group; P = 0.03). CONCLUSION: Although further randomized clinical trials are needed to give a definitive conclusion, laparoscopic colorectal resection for deep infiltrating endometriosis appears to be both feasible and safe. Surgical technique cannot be considered a risk factor of post-operative complications.

The potential role of endometrial nerve fibers in the pathogenesis of pain during endometrial biopsy at office hysteroscopy.

We aimed to evaluate whether nerve fibers are present in the endometrial layer of patients submitted to office hysteroscopy and their potential contribution to the pathogenesis of pain during that procedure. Through a prospective case-control study performed in tertiary centers for women's health, endometrium samples were collected during operative office hysteroscopy from 198 cycling women who previously underwent laparoscopy and/or magnetic resonance imaging investigation for infertility assessment. Samples were classified according to the degree of the pain patients experienced and scored from values ranging from 0 (absence of discomfort/pain) to 10 (intolerable pain) on a 10-cm visual analog scale (VAS). The presence of nerve fiber markers (S100, NSE, SP, VIP, NPY, NKA, NKB, NKR1, NKR2, and NKR3) in the endometrium was also evaluated by morphologic and immunohistochemical analyses. We found that S-100, NSE, NKR1, NK-A, NK-B, VIP, and NPY, were immunolocalized in samples of endometrium, in significantly (P < .01, for all) higher levels in samples collected from patients with VAS score > 5 (group A) than ≤ 5 (group B) and significantly (P < .0001 for all) positively correlated with VAS levels. A statistically significant (P = .018) higher prevalence of endometriosis and/or adenomyosis was depicted in patients of group A than group B. Data from the present study led us to conclude that nerve fibers are expressed at the level of the functional layer of the endometrium and may contribute to pain generation during office hysteroscopy, mainly in women affected by endometriosis and adenomyosis.

Varicocele repair in severe oligozoospermia: A case report of post-operative azoospermia.

Varicocele has been implicated as a cause in 35%-50% of patients with primary infertility and up to 81% of men with secondary infertility. Although a large number of reports have shown improvement in the semen parameters after correction of varicocele, other studies have suggested no benefit. We report the first case of azoospermia after surgery in a young infertile male patient with left-sided varicocele and severe oligozoospermia undergoing laparoscopic varicocelectomy. A pregnancy was only achieved with assisted reproductive technology because semen cryopreservation was performed before surgery. In the light of the above, the deterioration of sperm count after varicocele repair in patients with severe oligozoospermia could be due to irreversible impairment of spermatogenesis of such patients, together with the possible temporary damage of the surgical repair. This possible complication could therefore turn the severe oligozoospermia into an indication to perform cryopreservation before surgery, on both clinical and medico-legal grounds. Further research is needed before drawing definitive conclusions regarding the management of varicocele-related severe oligozoospermia.

The potential role of intragastric balloon in the treatment of obese-related infertility: personal experience.

The prevalence of people who are overweight or obese has increased dramatically in high-income countries over the past 20 years. There is a strong association between obesity and infertility, and weight loss can result in increased fecundity in obese women. The aim of this study is to demonstrate the potential role of intragastric balloon in the treatment of obese-related infertility. This is a retrospective study. A chart review of 27 obese women seen between September 2003 and July 2008 was performed. They all presented with the diagnosis of infertility and had undergone endoscopic intragastric balloon positioning. Among these women who tried unsuccessfully to become pregnant before weight loss, 15 became pregnant afterward. The pregnancies proceeded without complications and ended with live births. An improvement in the fertility status after weight loss has been described, although data on fertility after weight loss following bariatric surgery are still limited. The results obtained in our experience are not different from data reported in literature for bariatric surgery. Therefore, balloon treatment might be effective in young infertile obese women who wish to become pregnant.

Review of the safety, efficacy and patient acceptability of the combined dienogest/estradiol valerate contraceptive pill.

The aim of this review is to define the role of the combined dienogest (DNG)/estradiol valerate (E2V) contraceptive pill, in terms of biochemistry, metabolic and pharmacological effects and clinical application as well. E2V is the esterified form of 17ß-estradiol (E2), while dienogest is a fourth-generation progestin with a partial antiandrogenic effect. The cycle stability is achieved with 2 to 3 mg DNG, supporting contraceptive efficacy. In this new oral contraceptive, E2V is combined with DNG in a four-phasic dose regimen (the first two tablets contain 3 mg E2V; the next five tablets include 2 mg E2V + 2 mg DNG, followed by 17 tablets with 2 mg E2V + 3 mg DNG; followed by two tablets with 1 mg E2V only, and finally two placebo tablets). Duration and intensity of scheduled withdrawal bleeding are lower with this contraceptive pill, whereas the incidence and the intensity of intra-cyclic bleeding are similar to the other oral contraceptive. With this new pill the levels of high density lipoprotein increased, while the levels of prothrombin fragment 1 + 2 and D-dimer remained relatively unchanged; the levels of sex hormone binding globulin, cortisol binding globulin, thyroxine binding globulin increased. The most frequently reported adverse events are: breast pain, headache, acne, alopecia, migraine, increase of bodyweight. The satisfaction rate is about 79.4%.