PURPOSE The Groningen International Study on Sentinel nodes in Vulvar cancer (GROINSS-V)-II investigated whether inguinofemoral radiotherapy is a safe alternative to inguinofemoral lymphadenectomy (IFL) in vulvar cancer patients with a metastatic sentinel node (SN). METHODS GROINSS-V-II was a prospective multicenter phase-II single-arm treatment trial, including patients with early-stage vulvar cancer (diameter < 4 cm) without signs of lymph node involvement at imaging, who had primary surgical treatment (local excision with SN biopsy). Where the SN was involved (metastasis of any size), inguinofemoral radiotherapy was given (50 Gy). The primary end point was isolated groin recurrence rate at 24 months. Stopping rules were defined for the occurrence of groin recurrences. RESULTS From December 2005 until October 2016, 1,535 eligible patients were registered. The SN showed metastasis in 322 (21.0%) patients. In June 2010, with 91 SN-positive patients included, the stopping rule was activated because the isolated groin recurrence rate in this group went above our predefined threshold. Among 10 patients with an isolated groin recurrence, nine had SN metastases > 2 mm and/or extracapsular spread. The protocol was amended so that those with SN macrometastases (> 2 mm) underwent standard of care (IFL), whereas patients with SN micrometastases (≤ 2 mm) continued to receive inguinofemoral radiotherapy. Among 160 patients with SN micrometastases, 126 received inguinofemoral radiotherapy, with an ipsilateral isolated groin recurrence rate at 2 years of 1.6%. Among 162 patients with SN macrometastases, the isolated groin recurrence rate at 2 years was 22% in those who underwent radiotherapy, and 6.9% in those who underwent IFL ( P = .011). Treatment-related morbidity after radiotherapy was less frequent compared with IFL. CONCLUSION Inguinofemoral radiotherapy is a safe alternative for IFL in patients with SN micrometastases, with minimal morbidity. For patients with SN macrometastasis, radiotherapy with a total dose of 50 Gy resulted in more isolated groin recurrences compared with IFL.

Objective To determine whether the day-by-day postoperative recovery differs between women undergoing subtotal and total abdominal hysterectomy, and to analyse factors associated with postoperative recovery and sick leave.Design A prospective, open, randomised multicentre trial.Setting Seven hospitals and one private clinic in the south-east of Sweden.Population Two-hundred women scheduled for hysterectomy for benign conditions were enrolled in the study, and 178 women completed the study. Ninety-four women were randomised to subtotal abdominal hysterectomy; 84 women were randomised to total abdominal hysterectomy.Methods The day-by-day recovery of general wellbeing was measured on a visual analogue scale in a diary 7 days preoperatively and 35 days postoperatively. Psychometric measurements included depression, anxiety and general psychological wellbeing.Main outcome measures Effects of operating method and preoperative wellbeing on the day-by-day recovery and duration of sick leave.Results No significant difference was found in the day-by-day recovery between operating methods. The day-by-day recovery of general wellbeing and duration of sick leave was strongly associated with the occurrence of minor complications, but not with major complications. The level of psychological wellbeing preoperatively was strongly associated with the day-by-day recovery of general wellbeing and duration of sick leave.Conclusions Day-by-day recovery of general wellbeing is no faster in subtotal versus total abdominal hysterectomy. Independent of operation method there is an interaction between preoperative psychological wellbeing, postoperative recovery of general wellbeing and the duration of sick leave. Postoperative complications and preoperative psychological wellbeing are strong determinants for the duration of sick leave. There is a need for intervention studies with a focus on complications and preoperative wellbeing.Keywords Hysterectomy, randomised study, recovery, subtotal.Please cite this paper as: Persson P, Brynhildsen J, Kjølhede P on behalf of the Hysterectomy Multicentre Study Group in South-East Sweden. Short-term recovery after subtotal and total abdominal hysterectomy-a randomised clinical trial. BJOG 2010;117:469-478.

Objective To analyse the development of pelvic organ prolapse (POP) after subtotal (SH) and total hysterectomy (TH) in the long-term, and to assess patient-reported symptoms regarding pelvic floor dysfunction (PFD).Design Long-term follow-up study of a randomised controlled multicentre study.Setting Seven hospitals and one private clinic in the south-east of Sweden.Population Of the 184 women who were eligible from the original trial, 151 (82%) responded to a postal questionnaire and 128 (70%) were clinically examined.Methods Postal questionnaire using the short-form version of the Pelvic Floor Distress Inventory (PFDI-20) and clinical examination using the POP-Q system. Multivariate analyses were used.Main outcome measures POP-Q measurements and symptoms of PFD.Results Follow-up time was a median of 11.3 years. Less than 3% had stage-3 prolapse. No significant difference was found in the presence of stage-2 or higher stage prolapse between the two hysterectomy groups (39% in SH versus 37% in TH; OR 1.28, 95% CI 0.59-2.80). Nor was there any significant difference in the quality-of-life measurement between the SH and TH groups [summary score PFDI-20: median 93 (range 60-201) versus 87 (range 60-186); Fisher's protected least significant difference post hoc test, P = 0.78 ). None of the symptoms of PFD revealed statistically significant differences between the hysterectomy groups.Conclusions This long-term follow-up study of PFD showed basically no significant differences in subjective or objective measurements of POP, or in specific pelvic floor quality-of-life aspects after SH and TH. However, because of the low statistical power the results are inconclusive. Larger trials, and probably also a longer follow-up period, are necessary.Keywords Hysterectomy, long-term follow-up, pelvic organ prolapse, pelvic organ prolapse-quantification, randomised trial.Please cite this paper as: Persson P, Brynhildsen J, Kjølhede P. Pelvic organ prolapse after subtotal and total hysterectomy: a long-term follow-up of an open randomised controlled multicentre study BJOG 2013;120:1556-1565

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Objective To compare subtotal abdominal hysterectomy (SH) and total abdominal hysterectomy (TH) regarding influence on postoperative psychological wellbeing and surgical outcome measurements.Design A prospective, open, randomised multicentre trial.Setting Seven hospitals and one private clinic in the south-east of Sweden.Population Two-hundred women scheduled for abdominal hysterectomy for benign conditions were enrolled in the study; 179 women completed the study (94 SH and 85 TH).Methods Four different psychometric tests were used to measure general wellbeing, depression and anxiety preoperatively, and at 6 and 12 months postoperatively. Statistical analysis of variance and covariance were used.Main outcome measures Effects of operating method on psychological wellbeing postoperatively. Analysis of demographic, clinical and surgical data, including peri-and postoperative complications and complaints at follow up.Results No significant differences were observed between the two groups in any of the psychometric tests. Both surgical methods were associated with a significantly higher degree of psychological wellbeing at 6 and 12 months postoperatively, compared with preoperatively. No significant differences were found in the clinical measures including complications. A substantial number of women experienced persistent cyclic vaginal bleedings after SH. Neither minor or major postoperative complications, nor serum concentration of sex hormones, were associated with general psychological wellbeing 12 months after the operation.Conclusions General psychological wellbeing is equally improved after both SH and TH within 12 months of the operation, and does not seem to be associated with the occurrence of peroperative complications or serum concentration of sex hormones.Keywords Hysterectomy, psychological wellbeing, randomised study, subtotal.Please cite this paper as: Persson P, Brynhildsen J, Kjølhede P on behalf of the Hysterectomy Multicentre Study Group in South-East Sweden. A 1-year follow up of psychological wellbeing after subtotal and total hysterectomy-a randomised study. BJOG 2010;117:479-487.