Gynaecologic surgery from uncertainty to science: evolution of randomized control trials. The psychosocial outcomes of total and subtotal hysterectomy: A randomized controlled trial. Effects of a nursing intervention on quality of life outcomes in post-surgical women with gynecological cancers. The AESOP robot system in laparoscopic surgery: increased risk or advantage for surgeon and patient? The effects of psychological preparation on pain and recovery after minor gynaecological surgery: a preliminary report. Prophylactic oophorectomy at elective hysterectomy. Effects on psychological well-being at 1-year follow-up and its correlations to sexuality. Clinical follow-up after bilateral risk reducing ('prophylactic') mastectomy: mental health and body image outcomes. Laparoscopic compared with robotic sacrocolpopexy for vaginal prolapse: a randomized controlled trial. The effect of a clinical nurse specialist in gynaecological oncology on quality of life and sexuality.
It is now accepted that both medical and surgical practice should be based on reliable and sound clinical evidence. However, randomized control trials comparing surgical interventions have been associated with many problems. The aim of this review is to assess if there has been progress made in establishing the evidence base for surgical interventions in gynaecology.
                Relevant reviews were identified from Cochrane Database of Systematic Reviews (Issue , 2006) and data from individual randomized control trials extracted. Chi-squared test was used to compare quality pre- and post-Consolidated Standards of Reporting Trials (CONSORT) statement. Meta-regression analyses were performed to test the hypothesis that effect size decreased over time. Further multiple linear regression analyses were used to test the hypothesis that precision increased over time and finally a logistic regression model was used to estimate whether treatment effects differed between trials with and without allocation concealment.
                Twenty-three relevant reviews were identified, including 94 trials. The proportion of studies reporting allocation concealment significantly increased after the introduction of the CONSORT statement (P = 0.002). There was a trend towards improvement in precision over time. Similarly, there was a reduction in size of treatment effect over time (log of the ratio of odds ratios per year 0.96; 95% confidence interval 0.93-0.99, P = 0.04).
                Gynaecologic surgical practice appears to be benefiting from improvement in its research base in a subject where practitioners do not participate readily in randomized evaluation. Current controversies involve the adverse effects of hysterectomy on women's psychosocial functioning and whether subtotal as opposed to total hysterectomy mitigates these effects.
                To investigate the psychosocial effects of hysterectomy by examining sexual, pain, and psychological outcomes of total vs. subtotal hysterectomy in a randomized controlled trial.
                Patients suffering from benign gynecological conditions were randomly assigned to one of two groups: (i) total hysterectomy, that is, laparoscopic assisted vaginal hysterectomy (TOT, N = 32); or (ii) subtotal hysterectomy, that is, supracervical laparoscopic hysterectomy (SUB, N = 31). Both groups were premenopausal and underwent hysterectomy without concurrent oophorectomy. Two premenopausal control groups: (i) minor gynecological surgery (SURG-CON, N = 30); and (ii) healthy nonsurgical controls (NORM-CON, N = 40), were also tested. All surgical groups were assessed 2-3 weeks before surgery and then 6-7 months afterward; the nonsurgical control group was assessed at the time of recruitment and 6-7 months later.
                Assessments included semistructured interviews, standardized questionnaires, and standardized gynecological examinations.
                For the TOT group, sexual drive, arousal, and sexual behavior significantly improved postoperatively. For the SUB group, sexual behavior and overall sexual functioning significantly improved. For both TOT and SUB groups, unprovoked pain in the abdomen and pain in the abdomen during gynecological examinations was significantly reduced. For both TOT and SUB groups, overall psychological functioning did not significantly change postoperatively. Although between 3% and 16% of women undergoing hysterectomy reported adverse changes in psychosocial well-being after surgery, similar percentages of women in the control groups reported such effects.
                Hysterectomy resulted in a consistent reduction in abdominal pain, some improvement in sexual functioning, but no change in overall psychological functioning. There was no evidence supporting the idea that subtotal hysterectomy produced more favorable psychosocial outcomes than total hysterectomy nor was there any evidence that either type of hysterectomy resulted in adverse effects. Women with gynecological cancers have reported poor health-related quality of life (QOL), with complex physical and psychological needs post-surgery and during chemotherapy treatment. There are no studies reporting interventions addressing these needs post-hospital discharge in this population.
                Patients were randomized into two groups. The intervention group received 6 months of specialized care by an Advanced Practice Nurse (APN); in addition, women with high distress were evaluated and monitored by a psychiatric consultation-liaison nurse (PCLN). The attention control group was assisted with symptom management by a research assistant. The effects of the 6-month intervention were evaluated using self-report questionnaires at baseline (24-48 h after surgery), 1, 3, and 6 months post- surgery. QOL assessments included the Center for Epidemiological Studies-Depression Scale , the ambiguity subscale of the Mishel Uncertainty in Illness Scale , the Symptom Distress Scale, and the Short-Form Health Survey (SF-12). The sample for the longitudinal analysis included 123 who completed QOL outcome measures across three occasions post-surgery.
                The APN intervention resulted in significantly less uncertainty than the attention control intervention 6 months after surgery. When the sub-group who received the APN plus PCLN intervention was compared with the total attention control group, the sub-group had significantly less uncertainty, less symptom distress, and better SF-12 mental and physical QOL over time.
                Nurse tailored interventions that target both physical and psychological aspects of QOL in women recovering from cancer surgery and undergoing chemotherapy produce stronger outcomes than interventions that target solely one QOL aspect.
                (c) 2008 John Wiley & Sons, Ltd. The aim of this study was to examine the advantages and risks of the Automated Endoscopic System for Optical Positioning (AESOP) 3000 robot system during uncomplicated laparoscopic cholecystectomies or laparoscopic hernioplasty.
                In a randomized study, we examined two groups of 120 patients each with the diagnosis cholecystolithiasis respectively the unilateral inguinal hernia. We worked with the AESOP 3000, a robotic arm system that is voice-controlled by the surgeon. The subjective and objective comfort of the surgeon as well as the course and length of the operation were measured.
                The robot-assisted operations required significantly longer preparation and operation times. With regard to the necessary commands and manual camera corrections, the assistant group was favored. The same was true for the subjective evaluation of the surgical course by the surgeon.
                Our study showed that the use of AESOP during laparoscopic cholecystectomy and hernioplasty is possible in 94% of all cases. The surgeon must accept a definite loss of comfort as well as a certain loss of time against the advantage of saving on personnel. Investigated the effects of psychologically preparing patients for minor gynaecological surgery. A total of 59 women who were undergoing elective laparoscopy were assigned randomly to three experimental conditions: Preparation, in which an informative preoperative interview was conducted; placebo, in which a reassuring preoperative interview was held; and control, in which no contact was made prior to surgery. The women were assessed postoperatively in terms of pain, anxiety and attitudes and required to complete a follow-up questionnaire that followed a 3-week interval, which assessed subjective report of recovery rate. The results showed similar levels of pain report for all groups, although significantly fewer prepared patients requested postoperative analgesia. No differences in pain reports emerged at follow-up, although there was a tread for prepared patients to report a more rapid return to full health. The results are considered in the context of explanatory models that have been proposed to account for the effects of psychological preparation. In a prospective study, the 1-year psychological well-being outcome after oophorectomy-hysterectomy, compared to hysterectomy-only and the correlations between the changes in psychological well-being and the changes in sexuality were evaluated.
                Perimenopausal sexually active women (n=362), scheduled for hysterectomy on benign indication, were recruited. Three hundred and twenty-three women (89%) completed the 1-year follow-up; 217 women spared their ovaries and 106 underwent concomitant oophorectomy.
                Psychological well-being was studied by the psychological general well-being index (PGWB) and sexuality by the McCoy's sex questionnaire. The prevalence of climacteric symptoms was reported by the modified Kupperman's index. Hormone-replacement therapy was recorded. Postoperative, all oophorectomized and the hysterectomy-only women with climacteric symptoms were recommended estrogen-replacement therapy.
                The two groups did not differ in PGWB, neither before surgery nor at 1-year follow-up. Postoperative, both groups showed increased well-being regarding depressed mood, general health and total score. Besides, the hysterectomy-only group had increased vitality and the hysterectomy-oophorectomy group showed increased positive well-being and decreased anxiety. Most of the sexual parameters showed positive correlation to the PGWB parameters. The correlations were strong regarding parameters of overall sexual satisfaction, weak, regarding sexual motivation and relationship to partner, while absent regarding coital frequency.
                Concomitant prophylactic oophorectomy, at elective hysterectomy, does not negatively affect psychological well-being in adequately estrogenized perimenopausal women. Indeed, both hysterectomy-only and hysterectomy-oophorectomy have a positive effect on psychological well-being. Most aspects of sexuality are correlated to aspects of psychological well-being. In Manchester, approximately 120 women at > or = 1:4 lifetime risk of breast cancer have considered preventative surgery since 1992. Women treated within the Manchester protocol receive two genetic counselling sessions, a psychological assessment and a surgical consultation pre-operatively and annual follow-up post-operatively. The vast majority of women have breast reconstruction.
                Since 1996, mental health and body image have been assessed in women attending annual follow-up using self-report questionnaires: the 28-item General Health Questionnaire (GHQ) and 10-item Body Image Scale (BIS). Women with high scores are assessed by clinical interview together with a proportion who have no significant problems.
                Between 1995 and 1999, 76 women completed surgery. Ten were awaiting post-operative review and 60 (91%) attended for follow-up of whom 45 (75%) were interviewed. Questionnaire data were available for 52 (79%) women, mean age 40.8 years (range 27-58). Six women were gene mutation carriers and of these three had had breast cancer. One additional patient was affected but had not been genetically tested. Eight (17%) of 47 women with assessments in the first post-operative year scored in the 'caseness' range on the GHQ: the mean GHQ score was 3.8 (S.D. 6.7), range 0-25. Results were comparable with those for women attending the Family History Clinic for risk assessment. The mean score on the BIS was 5.1 (S.D. 5.5), range 0-25, comparable with scores for women undergoing conservative surgery for breast cancer. Twenty-one percent of women reported no negative change in body image following surgery (i.e. zero questionnaire summary scores) and the majority of changes reported were of minor degree (item scores 0 or 1). The most frequently reported changes were in sexual attractiveness (55%), feeling less physically attractive (53%) and self-consciousness about appearance (53%): a third of women felt less feminine to a minimal degree. These results appeared stable over time. A minority of women had more serious psychological or body image concerns, usually in relation to surgical complications: they received further psychiatric intervention.
                For the majority of women there is no evidence of significant mental health or body image problems in the first 3 years following Bilateral Prophylactic Mastectomy (BPM), but women who have complications warrant additional psychological help. Careful pre-operative preparation and long-term monitoring are advocated in this new field of cancer prevention. To compare conventional laparoscopic and robotic-assisted laparoscopic sacrocolpopexy for vaginal apex prolapse.
                This single-center, blinded randomized trial included participants with stage 2-4 posthysterectomy vaginal prolapse. Participants were randomized to laparoscopic or robotic sacrocolpopexy. The primary outcome was total operative time from incision to closure. Secondary outcomes were postoperative pain, functional activity, bowel and bladder symptoms, quality of life, anatomic vaginal support, and cost from a health care system perspective.
                A total of 78 patients enrolled and were randomized (laparoscopic n=38; robotic n=40). Total operative time was significantly longer in the robotic group compared with the laparoscopic group (+67-minute difference; 95% confidence interval [CI] 43-89; P<.001). Anesthesia time, total time in the operating room, total sacrocolpopexy time, and total suturing time were all significantly longer in the robotic group. Participants in the robotic group also had significantly higher pain at rest and with activity during weeks 3 through 5 after surgery and required longer use of nonsteroidal anti-inflammatory drugs (median, 20 compared with 11 days, P<.005). The robotic group incurred greater cost than the laparoscopic group (mean difference +$1,936; 95% CI $417-$3,454; P=.008). Both groups demonstrated significant improvement in vaginal support and functional outcomes 1 year after surgery with no differences between groups.
                Robotic-assisted sacrocolpopexy results in longer operating time and increased pain and cost compared with the conventional laparoscopic approach. Gynaecological malignancy has an immense impact on the well-being of women. For many women, however, treatment such as surgery is curative and healthcare intervention focuses on the physiological status of the women. The psychological, social and sexual consequences of the malignancy and its treatment have received little attention in research or in practice. The present study used a mixed quantitative and qualitative design to analyse a specialist nurse intervention (including psychosexual intervention), and to explain the impact of the illness on women's lives. The qualitative arm of the study collected interview data from 20 women and six partners. The randomized controlled trial sample consisted of 36 women, with data collected using a quality of life measure (the EORTC QLQ-C30) and the Lasry Sexual Functioning scale. This paper focuses on the randomized controlled trial data, which identified that sexual functioning and quality of life were improved in the active group who received specialist psychosexual counselling. However, the validity of the sexual functioning scale is challenged by the qualitative results of the study, which emphasize the social meaning of sexuality.
Currently, the limited evidence showed that robotic surgery did not benefit women with benign gynaecological disease in effectiveness or in safety. Further well-designed RCTs with complete reported data are required to confirm or refute this conclusion.