Daniel Altman

Anterior colporrhaphy versus transvaginal mesh for pelvic-organ prolapse

BACKGROUND The use of standardized mesh kits for repair of pelvic-organ prolapse has spread rapidly in recent years, but it is unclear whether this approach results in better outcomes than traditional colporrhaphy. METHODS In this multicenter, parallel-group, randomized, controlled trial, we compared the use of a trocar-guided, transvaginal polypropylene-mesh repair kit with traditional colporrhaphy in women with prolapse of the anterior vaginal wall (cystocele). The primary outcome was a composite of the objective anatomical designation of stage 0 (no prolapse) or 1 (position of the anterior vaginal wall more than 1 cm above the hymen), according to the Pelvic Organ Prolapse Quantification system, and the subjective absence of symptoms of vaginal bulging 12 months after the surgery. RESULTS Of 389 women who were randomly assigned to a study treatment, 200 underwent prolapse repair with the transvaginal mesh kit and 189 underwent traditional colporrhaphy. At 1 year, the primary outcome was significantly more common in the women treated with transvaginal mesh repair (60.8%) than in those who underwent colporrhaphy (34.5%) (absolute difference, 26.3 percentage points; 95% confidence interval, 15.6 to 37.0). The surgery lasted longer and the rates of intraoperative hemorrhage were higher in the mesh-repair group than in the colporrhaphy group (P<0.001 for both comparisons). Rates of bladder perforation were 3.5% in the mesh-repair group and 0.5% in the colporrhaphy group (P=0.07), and the respective rates of new stress urinary incontinence after surgery were 12.3% and 6.3% (P=0.05). Surgical reintervention to correct mesh exposure during follow-up occurred in 3.2% of 186 patients in the mesh-repair group. CONCLUSIONS As compared with anterior colporrhaphy, use of a standardized, trocar-guided mesh kit for cystocele repair resulted in higher short-term rates of successful treatment but also in higher rates of surgical complications and postoperative adverse events. (Funded by the Karolinska Institutet and Ethicon; ClinicalTrials.gov number, NCT00566917.).

Late adverse effects of short-course preoperative radiotherapy in rectal cancer.

Preoperative radiotherapy improves local control and survival in rectal cancer, but there are few reports on long‐term morbidity. The aims of this study were to compare long‐term morbidity and quality of life in patients undergoing rectal cancer surgery with or without preoperative radiotherapy.

Hysterectomy and risk of stress-urinary-incontinence surgery: nationwide cohort study

BACKGROUND Hysterectomy for benign indications has been associated with an increased risk for lower-urinary-tract sequela, but results have been inconclusive. We aimed to establish the risk for stress-urinary-incontinence surgery after hysterectomy for benign indications. METHODS We did a nationwide, population-based, cohort study from 1973 to 2003 in Sweden. We identified our population from the Swedish Inpatient Registry. We selected 165 260 women who had undergone hysterectomy (exposed cohort) and a control group of 479 506 individuals who had not had this procedure (unexposed cohort), matched by year of birth and county of residence. In both cohorts, occurrence of stress-urinary-incontinence surgery was established from the Swedish Inpatient Registry. Hazard ratios with 95% CIs were calculated by Coxs proportional-hazards regression. FINDINGS During the 30-year observational period, the rate of stress-urinary-incontinence surgery per 100,000 person-years was 179 (95% CI 173-186) in the exposed cohort versus 76 (73-79) in the unexposed cohort. Correspondingly, individuals in the exposed cohort were at increased risk for stress-urinary-incontinence surgery compared with those in the unexposed cohort (hazard ratio 2.4; 95% CI 2.3-2.5), irrespective of surgical technique. Risk for stress-urinary-incontinence surgery varied slightly with time of follow-up: the highest overall risk was recorded within 5 years of surgery (2.7; 2.5-2.9) and the lowest risk was seen after an observation period of 10 years or more (2.1, 1.9-2.2). INTERPRETATION Hysterectomy for benign indications, irrespective of surgical technique, increases the risk for subsequent stress-urinary-incontinence surgery. Women should be counselled on associated risks related to hysterectomy, and other treatment options should be considered before surgery.

Anal incontinence after vaginal delivery: a five-year prospective cohort study.

OBJECTIVE: The long-term prevalence of anal incontinence after vaginal delivery is unknown. The aim of the present study was to evaluate the prevalence of anal incontinence in primiparous women 5 years after their first delivery and to evaluate the influence of subsequent childbirth. METHODS: A total of 349 nulliparous women were prospectively followed up with questionnaires before pregnancy, at 5 and 9 months, and 5 years after delivery. A total of 242 women completed all questionnaires. Women with sphincter tear at their first delivery were compared with women without such injury. Risk factors for development of anal incontinence were also analyzed. RESULTS: Anal incontinence increased significantly during the study period. Among women with sphincter tears, 44% reported anal incontinence at 9 months and 53% at 5 years (P = .002). Twenty-five percent of women without a sphincter tear reported anal incontinence at 9 months and 32% had symptoms at 5 years (P < .001). Risk factors for anal incontinence at 5 years were age (odds ratio [OR] 1.1; 95% confidence interval [CI] 1.0–1.2), sphincter tear (OR 2.3; 95% CI 1.1–5.0), and subsequent childbirth (OR 2.4; 95% CI 1.1–5.6). As a predictor of anal incontinence at 5 years after the first delivery, anal incontinence at both 5 months (OR 3.8; 95% CI 2.0–7.3) and 9 months (OR 4.3; 95% CI 2.2–8.2) was identified. Among women with symptoms, the majority had infrequent incontinence to flatus, whereas fecal incontinence was rare. CONCLUSION: Anal incontinence among primiparous women increases over time and is affected by further childbirth. Anal incontinence at 9 months postpartum is an important predictor of persisting symptoms.

Ovarian Cancer Risk After Salpingectomy: A Nationwide Population-Based Study

BACKGROUND Recent genetic and morphologic studies have challenged the traditional view on the pathogenesis of ovarian cancer; suggesting that ovarian cancer predominantly arises within the fallopian tubes or the uterus. We hypothesize that surgical removal of the fallopian tubes is associated with a reduced risk for ovarian cancer. METHODS In this population-based cohort study, we used data on women with previous surgery on benign indication (sterilization, salpingectomy, hysterectomy, and bilateral salpingo-oophorectomy [BSO], hysterectomy; n = 251465) compared with the unexposed population (n = 5449119) between 1973 and 2009 and analyzed with Cox regression models. The effects of one- and two-sided salpingectomy were considered in a subanalysis. All statistical tests were two-sided. RESULTS There was a statistically significantly lower risk for ovarian cancer among women with previous salpingectomy (HR = 0.65, 95% CI = 0.52 to 0.81) when compared with the unexposed population. In addition, statistically significant risk reductions were observed among women with previous hysterectomy (HR = 0.79, 95% CI = 0.70 to 0.88), sterilization (HR = 0.72, 95% CI = 0.64 to 0.81), and hysterectomy with BSO (HR = 0.06, 95% CI = 0.03 to 0.12). Bilateral salpingectomy was associated with a 50% decrease in risk of ovarian cancer compared with the unilateral procedure (HR = 0.35, 95% CI = 0.17 to 0.73, and 0.71, 95% CI = 0.56 to 0.91, respectively). CONCLUSION Salpingectomy on benign indication is associated with reduced risk of ovarian cancer. These data support the hypothesis that a substantial fraction of ovarian cancer arises in the fallopian tube. Our results suggest that removal of the fallopian tubes by itself, or concomitantly with other benign surgery, is an effective measure to reduce ovarian cancer risk in the general population.

Conservative treatment of acute colonic diverticulitis: Are antibiotics always mandatory?

Objective. Most patients admitted for acute colonic diverticulitis (AD) are managed conservatively and receive antibiotics, although it is uncertain whether all patients with AD benefit from this treatment. The aim of this study was to evaluate the influence of antibiotic treatment on outcome in the conservative management of patients with mild AD. Material and methods. A retrospective audit of 311 patients (64% F, mean age 60 years) hospitalized for AD was carried out. All patients were initially treated conservatively with observation and restriction of oral intake. Patients receiving antibiotics (n=118) were compared with patients treated with observation and restriction of oral intake only (n=193). Mean follow-up time (FU) was 30 months. Results. Inflammation in patients treated with antibiotics was more pronounced (laboratory parameters (C-reactive protein, white blood cell count) were higher (p<0.01), fever was more common (p<0.01) and CT grading of inflammation was classified as severe in a higher proportion (p<0.01)) compared with patients treated without antibiotics. When initially treated with antibiotics, 3 patients (3%) failed to respond to treatment and had to undergo surgery. There were 7 (4%) failures in patients initially treated without antibiotics, and antibiotics were then added. During FU, 29% of patients treated with antibiotics had further events (recurrent AD and/or subsequent surgery) compared with 28% (NS) among those treated without antibiotics. In a multivariate analysis, the risk of a further event was not influenced by antibiotic treatment (OR 1.03, CI 95% 0.61–1.74). Conclusions. Our results indicate that antibiotics are not mandatory in mild AD. Treatment without antibiotics appears to be safe and seems not to change the rate of further events. These results warrant further randomized prospective studies.

Perioperative morbidity using transvaginal mesh in pelvic organ prolapse repair

OBJECTIVE: To describe the perioperative morbidity associated with transvaginal mesh repair of pelvic organ prolapse. METHODS: During a 6-month time period, 25 centers registered all surgical procedures using a commercially available mesh. The frequency and type of perioperative complications, during surgery and the associated hospital stay, were documented using a standardized protocol. RESULTS: During the inclusion period, 248 women underwent transvaginal mesh surgery: anterior repair in 106 patients (43%), posterior repair in 71 (29%), combined anterior and posterior repair in 20 (8%), and total repair in 51 (21%). Mean age was 67.8 years (±10.3 standard deviation) and median parity was 2 (range 0–6). Surgery for prolapse recurrence was performed in 56% of the patients (n=140), and 91% (n=225) had undergone at least one previous pelvic floor surgical procedure. Serious complications occurred in 4.4% of patients (n=11) and were dominated by visceral injury (10 of 11 cases). One case of bleeding in excess of 1,000 mL occurred. Minor complications occurred in 14.5% of patients (n=36), and the majority were urinary tract infections, urinary retention, and postoperative fever. A multivariable risk analysis showed that concurrent pelvic floor surgery was associated with an increased risk for minor complications, odds ratio 2.8 (95% confidence interval 1.1–6.9). There were no other predictors of outcomes when assessing the association with age, parity, weight, previous pelvic floor surgery, previous hysterectomy, or concurrent hysterectomy. CONCLUSION: Perioperative serious complications are uncommon after transvaginal mesh procedures although particular care should be taken to detect visceral injury at the time of surgery. LEVEL OF EVIDENCE: III

A three-year prospective assessment of rectocele repair using porcine xenograft.

OBJECTIVE: To prospectively evaluate clinical outcome of rectocele repair using xenograft 3 years after surgery. METHODS: Twenty-three patients who completed evaluation preoperatively and 1 year after surgery were assessed at a 3-year follow-up. Clinical examination was performed preoperatively, and at the 1- and 3-year follow-ups, with the pelvic organ prolapse quantification system. Symptom assessment was performed with a validated bowel function questionnaire including questions on sexual function. RESULTS: There were no graft-related complications during the 3 years following surgery. Preoperatively, all patients had stage II prolapse of the posterior vaginal wall and a rectocele verified at defecography. At the 1-year follow-up, 11 of 29 patients (38%) had rectocele of stage II or more, and 4 patients were reoperated. At 3-year follow-up 7 of 23 patients (30%) had rectocele of stage II or more. When including the 4 early anatomical recurrences, a total of 11 of 27 patients (41%) had rectocele of stage II or more at 3-year follow-up. Preoperatively, all patients reported varying degrees of rectal emptying difficulties and symptoms of bowel dysfunction. There was a significant decrease in rectal emptying difficulties (P < .01), sense of incomplete evacuation (P < .01), need for manually assisted defecation (P < .05), and symptoms of pelvic heaviness (P < .001) at the 3-year follow-up compared with preoperatively. Cure of rectal emptying difficulties was reported by fewer than 50% of patients. There were no significant changes in anal incontinence scores or symptoms of sexual dysfunction at the 3-year follow-up compared with preoperatively. CONCLUSION: Rectocele repair using porcine dermal graft was associated with an unsatisfactory anatomical cure rate and persistent bowel-emptying difficulties in the majority of patients 3 years postoperatively. LEVEL OF EVIDENCE: II-3

Trocar-guided transvaginal mesh repair of pelvic organ prolapse.

OBJECTIVE: To prospectively assess clinical outcomes after pelvic organ prolapse repair with a standardized trocar-guided surgical device using polypropylene mesh. METHODS: This was a prospective multicenter cohort study performed throughout 26 clinics. Evaluation at baseline, 2 months, and 1 year after surgery included prolapse grading using the pelvic organ prolapse quantification system (POP-Q) and symptom assessment using the Incontinence Impact Questionnaire (IIQ-7) and Urogenital Distress Inventory (UDI-6). For the purpose of this study, postoperative POP-Q stage 0–I was considered anatomic cure. RESULTS: Two-hundred sixty-one patients were included in the study; 232 (89%) attended the 1-year follow-up. Mean±standard deviation age at surgery was 66.3±9.4 years. Anatomic cure 1 year after surgery was observed in 96 of 121 women (79%) after anterior repair with mesh (P<.001), and 56 of 68 (82%) after posterior repair with mesh (P<.001). For combined anterior and posterior mesh repair, cure was 51 of 63 (81%) and 54 of 63 (86%) for the anterior and posterior compartment, respectively (P<.001 for both). Bladder and rectal perforations occurred in 9 of 252 patients (3.4%). Vaginal erosions, the majority mild to moderate, occurred in 26 of 232 cases (11%). Surgical intervention due to mesh exposure occurred in seven cases (2.8%). There were significant quality-of-life improvements in all domains of the IIQ-7. Despite significant improvements in UDI-6 scores, symptoms specific for stress urinary incontinence were not ameliorated. CONCLUSION: Trocar-guided transvaginal mesh surgery for pelvic organ prolapse is associated with satisfactory objective and subjective outcomes 1 year after surgery. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00402844 LEVEL OF EVIDENCE: II

Risks of stress urinary incontinence and pelvic organ prolapse surgery in relation to mode of childbirth

OBJECTIVE To estimate the risk for stress urinary incontinence and pelvic organ prolapse surgery related to vaginal birth or cesarean delivery. STUDY DESIGN A cohort study of all women having their first and all subsequent deliveries by cesarean (n = 33,167), and an age-matched sample of women only having vaginal deliveries (n = 63,229) between 1973 and 1983. Hazard ratios were calculated using Cox regression models with 95% confidence intervals. RESULTS Women only having vaginal deliveries had increased overall risks of incontinence (hazard ratio, 2.9; 95% confidence interval, 2.4-3.6) and prolapse surgery (hazard ratio, 9.2; 95% confidence interval, 7.0-12.1) compared with women only having cesarean deliveries. CONCLUSION Having only vaginal childbirths was associated with a significantly increased risk of stress urinary incontinence and pelvic organ prolapse surgery later in life compared with only having cesarean deliveries.