Dataset Information

Immediate versus delayed removal of urinary catheter after laparoscopic hysterectomy: a randomised controlled trial.

ABSTRACT: OBJECTIVE:To evaluate if immediate catheter removal (ICR) after laparoscopic hysterectomy is associated with similar retention outcomes compared with delayed removal (DCR). STUDY DESIGN:Non-inferiority randomised controlled trial. POPULATION:Women undergoing laparoscopic hysterectomy in six hospitals in the Netherlands. METHODS:Women were randomised to ICR or DCR (between 18 and 24 hours after surgery). PRIMARY OUTCOME:The inability to void within 6 hours after catheter removal. RESULTS:One hundred and fifty-five women were randomised to ICR (n = 74) and DCR (n = 81). The intention-to-treat and per-protocol analysis could not demonstrate the non-inferiority of ICR: ten women with ICR could not urinate spontaneously within 6 hours compared with none in the delayed group (risk difference 13.5%, 5.6-24.8, P = 0.88). However, seven of these women could void spontaneously within 9 hours without additional intervention. Regarding the secondary outcomes, eight women from the delayed group requested earlier catheter removal because of complaints (9.9%). Three women with ICR (4.1%) had a urinary tract infection postoperatively versus eight with DCR (9.9%, risk difference -5.8%, -15.1 to 3.5, P = 0.215). Women with ICR mobilised significantly earlier (5.7 hours, 0.8-23.3 versus 21.0 hours, 1.4-29.9; P ? 0.001). CONCLUSION:The non-inferiority of ICR could not be demonstrated in terms of urinary retention 6 hours after procedure. However, 70% of the women with voiding difficulties could void spontaneously within 9 hours after laparoscopic hysterectomy. It is therefore questionable if all observed urinary retention cases were clinically relevant. As a result, the clinical advantages of ICR may still outweigh the risk of bladder retention and it should therefore be considered after uncomplicated laparoscopic hysterectomy. TWEETABLE ABSTRACT:The advantages of immediate catheter removal after laparoscopic hysterectomy seem to outweigh the risk of bladder retention.

SUBMITTER: Sandberg EM

PROVIDER: S-EPMC6593458 | biostudies-literature | 2019 May

REPOSITORIES: biostudies-literature

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Immediate versus delayed removal of urinary catheter after laparoscopic hysterectomy: a randomised controlled trial.

Sandberg E M EM Twijnstra Arh A van Meir C A CA Kok H S HS van Geloven N N Gludovacz K K Kolkman W W Nagel Htc H Haans Lcf L Kapiteijn K K Jansen F W FW

BJOG : an international journal of obstetrics and gynaecology 20190301 6

<h4>Objective</h4>To evaluate if immediate catheter removal (ICR) after laparoscopic hysterectomy is associated with similar retention outcomes compared with delayed removal (DCR).<h4>Study design</h4>Non-inferiority randomised controlled trial.<h4>Population</h4>Women undergoing laparoscopic hysterectomy in six hospitals in the Netherlands.<h4>Methods</h4>Women were randomised to ICR or DCR (between 18 and 24 hours after surgery).<h4>Primary outcome</h4>The inability to void within 6 hours afte ...[more]

PMID: 30548529

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Project description:BackgroundEnhanced Recovery After Surgery (ERAS) represents the standard of care in colorectal surgery. Among ERAS items, early removal of urinary catheter (UC) is considered a key issue, though adherence to this specific item still varies among centers. UC placement allows for monitoring of post-operative urinary output but relates to an increased risk of urinary tract infection (UTI), reduced mobility, and patient's discomfort. Several studies investigated the role of early UC removal specifically looking at the rate of acute urinary retention (AUR) but most of them were retrospective, single-center, underpowered, cohort studies. The main purpose of this study is to compare the rate of AUR after immediate (at the end of the surgery) versus early (within 24 h from the completion of surgery) removal of UC in patients undergoing minimally invasive colonic resection (MICR). The secondary outcomes focus on goals that could be positively impacted by the immediate removal of the UC at the end of the surgery. In particular, the rate of UTIs, perception of pain, time-to-return of bowel and physical functions, postoperative complications, and length of hospital stay will be measured.MethodsThis is a prospective, randomized, controlled, two-arm, multi-center, study comparing the rate of AUR after immediate versus early removal of UC in patients undergoing MICR. The investigators hypothesize that immediate UC removal is non-inferior to 24-h UC removal in terms of AUR rate. Randomization is at the patient level and participants are randomized 1:1 to remove their UC either immediately or within 24 h from the completion of surgery. Those eligible for inclusion were patients undergoing any MICR with an anastomosis above the peritoneal reflection. Those patients who need to continue urinary output monitoring after the surgery will be excluded. The number of patients calculated to be enrolled in each group is 108 based on an expected AUR rate of 3% for the 24-h UC removal group and considering acceptable an AUR of 9% for the immediate UC removal group.DiscussionThe demonstration of a non-inferiority of immediate versus 24-h removal of UC would call into question the usefulness of urinary drainage in the setting of MICR.Trial registrationClinicalTrials.gov NCT05249192. Prospectively registered on February 21, 2022.

Project description:BackgroundHeavy menstrual bleeding affects 25% of women in the UK, many of whom require surgery to treat it. Hysterectomy is effective but has more complications than endometrial ablation, which is less invasive but ultimately leads to hysterectomy in 20% of women. We compared laparoscopic supracervical hysterectomy with endometrial ablation in women seeking surgical treatment for heavy menstrual bleeding.MethodsIn this parallel-group, multicentre, open-label, randomised controlled trial in 31 hospitals in the UK, women younger than 50 years who were referred to a gynaecologist for surgical treatment of heavy menstrual bleeding and who were eligible for endometrial ablation were randomly allocated (1:1) to either laparoscopic supracervical hysterectomy or second generation endometrial ablation. Women were randomly assigned by either an interactive voice response telephone system or an internet-based application with a minimisation algorithm based on centre and age group (<40 years vs ≥40 years). Laparoscopic supracervical hysterectomy involves laparoscopic (keyhole) surgery to remove the upper part of the uterus (the body) containing the endometrium. Endometrial ablation aims to treat heavy menstrual bleeding by destroying the endometrium, which is responsible for heavy periods. The co-primary clinical outcomes were patient satisfaction and condition-specific quality of life, measured with the menorrhagia multi-attribute quality of life scale (MMAS), assessed at 15 months after randomisation. Our analysis was based on the intention-to-treat principle. The trial was registered with the ISRCTN registry, number ISRCTN49013893.FindingsBetween May 21, 2014, and March 28, 2017, we enrolled and randomly assigned 660 women (330 in each group). 616 (93%) of 660 women were operated on within the study period, 588 (95%) of whom received the allocated procedure and 28 (5%) of whom had an alternative surgery. At 15 months after randomisation, more women allocated to laparoscopic supracervical hysterectomy were satisfied with their operation compared with those in the endometrial ablation group (270 [97%] of 278 women vs 244 [87%] of 280 women; adjusted percentage difference 9·8, 95% CI 5·1-14·5; adjusted odds ratio [OR] 2·53, 95% CI 1·83-3·48; p<0·0001). Women randomly assigned to laparoscopic supracervical hysterectomy were also more likely to have the best possible MMAS score of 100 than women assigned to endometrial ablation (180 [69%] of 262 women vs 146 [54%] of 268 women; adjusted percentage difference 13·3, 95% CI 3·8-22·8; adjusted OR 1·87, 95% CI 1·31-2·67; p=0·00058). 14 (5%) of 309 women in the laparoscopic supracervical hysterectomy group and 11 (4%) of 307 women in the endometrial ablation group had at least one serious adverse event (adjusted OR 1·30, 95% CI 0·56-3·02; p=0·54).InterpretationLaparoscopic supracervical hysterectomy is superior to endometrial ablation in terms of clinical effectiveness and has a similar proportion of complications, but takes longer to perform and is associated with a longer recovery.FundingUK National Institute for Health Research Health Technology Assessment Programme.

Project description:BackgroundHeavy menstrual bleeding (HMB) is a common problem affecting approximately 1.5 million women in England and Wales with a major impact on their physical, emotional, social and material quality of life. It is the fourth most common reason why women attend gynaecology outpatient clinics and accounts for one-fifth of all gynaecology outpatient referrals. Initial treatment in primary care is medical - either by means of oral or injected medication or the levonorgestrel-intrauterine system (Mirena®). If medical treatment fails then surgical treatment can be offered, either endometrial ablation (EA), which destroys the lining of the cavity of the uterus (endometrium), or hysterectomy, i.e. surgical removal of the uterus. While effective, conventional hysterectomy is invasive and carries a risk of complications due to injury to other pelvic structures. The procedure can be simplified and complications minimised by undertaking a 'supracervical' hysterectomy where the cervix is left in situ and only the body of the uterus removed. Recent advances in endoscopic technologies have facilitated increased use of laparoscopic supracervical hysterectomy (LASH) which can be performed as a day-case procedure and is relatively easy for the surgeon to learn. HEALTH (Hysterectomy or Endometrial AbLation Trial for Heavy menstrual bleeding) aims to address the question 'Is LASH superior to second generation EA for the treatment of HMB in terms of clinical and cost effectiveness?'Methods/designWomen aged?<?50 years, with HMB, in whom medical treatment has failed and who are eligible for EA will be considered for trial entry. We aim to recruit women from approximately 30 active secondary care centres in the UK NHS who carry out both surgical procedures. All women who consent will complete a diary of pain symptoms from day 1 to day 14 after surgery, postal questionnaires at six weeks and six months after surgery and 15 months post randomisation. Healthcare utilisation questions will also be completed at the six-week, six-month and 15-month time-points.DiscussionMeasuring the comparative effectiveness of LASH vs EA will provide the robust evidence required to determine whether the new technique should be adopted widely in the NHS.Trial registrationInternational Standard Randomised Controlled Trials, ISRCTN49013893 . Registered on 28 January 2014.

Project description:OBJECTIVE:To compare the effects of laparoscopic hysterectomy and abdominal hysterectomy in the abdominal trial, and laparoscopic hysterectomy and vaginal hysterectomy in the vaginal trial. DESIGN:Two parallel, multicentre, randomised trials. SETTING:28 UK centres and two South African centres. PARTICIPANTS:1380 women were recruited; 1346 had surgery; 937 were followed up at one year. Primary outcome Rate of major complications. RESULTS:In the abdominal trial laparoscopic hysterectomy was associated with a higher rate of major complications than abdominal hysterectomy (11.1% v 6.2%, P = 0.02; difference 4.9%, 95% confidence interval 0.9% to 9.1%) and the number needed to treat to harm was 20. Laparoscopic hysterectomy also took longer to perform (84 minutes v 50 minutes) but was less painful (visual analogue scale 3.51 v 3.88, P = 0.01) and resulted in a shorter stay in hospital after the operation (3 days v 4 days). Six weeks after the operation, laparoscopic hysterectomy was associated with less pain and better quality of life than abdominal hysterectomy (SF-12, body image scale, and sexual activity questionnaires). In the vaginal trial we found no evidence of a difference in major complication rates between laparoscopic hysterectomy and vaginal hysterectomy (9.8% v 9.5%, P = 0.92; difference 0.3%, -5.2% to 5.8%), and the number needed to treat to harm was 333. We found no evidence of other differences between laparoscopic hysterectomy and vaginal hysterectomy except that laparoscopic hysterectomy took longer to perform (72 minutes v 39 minutes) and was associated with a higher rate of detecting unexpected pathology (16.4% v 4.8%, P = < 0.01). However, this trial was underpowered. CONCLUSIONS:Laparoscopic hysterectomy was associated with a significantly higher rate of major complications than abdominal hysterectomy. It also took longer to perform but was associated with less pain, quicker recovery, and better short term quality of life. The trial comparing vaginal hysterectomy with laparoscopic hysterectomy was underpowered and is inconclusive on the rate of major complications; however, vaginal hysterectomy took less time.

Project description:Non-randomised studies have suggested that the postoperative complications of (Campos LS, Limberger LF, Stein AT, Kalil AN) laparoscopic radical hysterectomy are similar to those in abdominal radical hysterectomy. However, no study evaluating postoperative pain comparing both techniques has been published thus far. Our objective was to compare pain intensity and other perioperative outcomes between laparoscopic radical hysterectomy (LRH) and abdominal radical hysterectomy (ARH) in early cervical cancer.This single centre, randomised, controlled trial enrolled 30 cervical cancer patients who were clinically staged IA2 with lymph vascular invasion and IB according to the FIGO (International Federation of Gynaecology and Obstetrics) classification, and underwent LRH or ARH between late 1999 and early 2004. Postoperative pain, as measured by a 10-point numerical rate scale, was considered the primary endpoint. Postoperative pain was assessed every six hours during a patient's usual postoperative care. Perioperative outcomes were also registered. Both surgical techniques were executed by the same surgical team. Secondary outcomes included intraoperative and other postoperative surgicopathological factors and 5-year survival rates.IA2 patients with lymphatic vascular space invasion and IB cervical cancer patients were randomised to either the LRH group (16 patients) or the ARH group (14 patients). Four patients (25%) in the LRH group and 5 patients (36%) in the ARH group presented with transoperative or serious postoperative complications. All of the transoperative complications occurred in the LRH group. The relative risk of presenting with complications was 0.70; CI 95% (0.23-2.11); P?=?0.694. LRH group mean pain score was significantly lower than ARH after 36 h of observation (P?=?0.044; mean difference score: 1.42; 95% CI: 0.04-2.80). The survival results will be published elsewhere.LRH provided lower pain scores after 36 h of observation in this series. The perioperative and serious postoperative complications ratios were comparable between the groups.NCT01258413.

Dataset Information

Immediate versus delayed removal of urinary catheter after laparoscopic hysterectomy: a randomised controlled trial.

Publications

Immediate versus delayed removal of urinary catheter after laparoscopic hysterectomy: a randomised controlled trial.

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