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The Cochrane Database of Systematic... Aug 2023Currently, there are five major approaches to hysterectomy for benign gynaecological disease: abdominal hysterectomy (AH), vaginal hysterectomy (VH), laparoscopic... (Review)
Review
BACKGROUND
Currently, there are five major approaches to hysterectomy for benign gynaecological disease: abdominal hysterectomy (AH), vaginal hysterectomy (VH), laparoscopic hysterectomy (LH), robotic-assisted hysterectomy (RH) and vaginal natural orifice hysterectomy (V-NOTES). Within the LH category we further differentiate the laparoscopic-assisted vaginal hysterectomy (LAVH) from the total laparoscopic hysterectomy (TLH) and single-port laparoscopic hysterectomy (SP-LH).
OBJECTIVES
To assess the effectiveness and safety of different surgical approaches to hysterectomy for women with benign gynaecological conditions.
SEARCH METHODS
We searched the following databases (from their inception to December 2022): the Cochrane Gynaecology and Fertility Specialised Register of Controlled Trials, CENTRAL, MEDLINE, Embase, CINAHL and PsycINFO. We also searched the trial registries and relevant reference lists, and communicated with experts in the field for any additional trials.
SELECTION CRITERIA
We included randomised controlled trials (RCTs) in which clinical outcomes were compared between one surgical approach to hysterectomy and another.
DATA COLLECTION AND ANALYSIS
At least two review authors independently selected trials, assessed risk of bias and performed data extraction. Our primary outcomes were return to normal activities, satisfaction and quality of life, intraoperative visceral injury and major long-term complications (i.e. fistula, pelvic-abdominal pain, urinary dysfunction, bowel dysfunction, pelvic floor condition and sexual dysfunction).
MAIN RESULTS
We included 63 studies with 6811 women. The evidence for most comparisons was of low or moderate certainty. The main limitations were poor reporting and imprecision. Vaginal hysterectomy (VH) versus abdominal hysterectomy (AH) (12 RCTs, 1046 women) Return to normal activities was probably faster in the VH group (mean difference (MD) -10.91 days, 95% confidence interval (CI) -17.95 to -3.87; 4 RCTs, 274 women; I = 67%; moderate-certainty evidence). This suggests that if the return to normal activities after AH is assumed to be 42 days, then after VH it would be between 24 and 38 days. We are uncertain whether there is a difference between the groups for the other primary outcomes. Laparoscopic hysterectomy (LH) versus AH (28 RCTs, 3431 women) Return to normal activities may be sooner in the LH group (MD -13.01 days, 95% CI -16.47 to -9.56; 7 RCTs, 618 women; I = 68%, low-certainty evidence), but there may be more urinary tract injuries in the LH group (odds ratio (OR) 2.16, 95% CI 1.19 to 3.93; 18 RCTs, 2594 women; I = 0%; moderate-certainty evidence). This suggests that if the return to normal activities after abdominal hysterectomy is assumed to be 37 days, then after laparoscopic hysterectomy it would be between 22 and 25 days. It also suggests that if the rate of ureter injury during abdominal hysterectomy is assumed to be 0.2%, then during laparoscopic hysterectomy it would be between 0.2% and 2%. We are uncertain whether there is a difference between the groups for the other primary outcomes. LH versus VH (22 RCTs, 2135 women) We are uncertain whether there is a difference between the groups for any of our primary outcomes. Both short- and long-term complications were rare in both groups. Robotic-assisted hysterectomy (RH) versus LH (three RCTs, 296 women) None of the studies reported satisfaction rates or quality of life. We are uncertain whether there is a difference between the groups for our other primary outcomes. Single-port laparoscopic hysterectomy (SP-LH) versus LH (seven RCTs, 621 women) None of the studies reported satisfaction rates, quality of life or major long-term complications. We are uncertain whether there is a difference between the groups for rates of intraoperative visceral injury. Total laparoscopic hysterectomy (TLH) versus laparoscopic-assisted vaginal hysterectomy (LAVH) (three RCTs, 233 women) None of the studies reported satisfaction rates or quality of life. We are uncertain whether there is a difference between the groups for rates of intraoperative visceral injury or major long-term complications. Transvaginal natural orifice transluminal endoscopic surgery (V-NOTES) versus LH (two RCTs, 96 women) We are uncertain whether there is a difference between the groups for rates of bladder injury. Our other primary outcomes were not reported. Overall, adverse events were rare in the included studies.
AUTHORS' CONCLUSIONS
Among women undergoing hysterectomy for benign disease, VH appears to be superior to AH. When technically feasible, VH should be performed in preference to AH because it is associated with faster return to normal activities, fewer wound/abdominal wall infections and shorter hospital stay. Where VH is not possible, LH has advantages over AH including faster return to normal activities, shorter hospital stay, and decreased risk of wound/abdominal wall infection, febrile episodes or unspecified infection, and transfusion. These advantages must be balanced against the increased risk of ureteric injury and longer operative time. When compared to LH, VH was associated with no difference in time to return to normal activities but shorter operative time and shorter hospital stay. RH and V-NOTES require further evaluation since there is a lack of evidence of any patient benefit over conventional LH. Overall, the evidence in this review has to be interpreted with caution as adverse event rates were low, resulting in low power for these comparisons. The surgical approach to hysterectomy should be discussed with the patient and decided in the light of the relative benefits and hazards. Surgical expertise is difficult to quantify and poorly reported in the available studies and this may influence outcomes in ways that cannot be accounted for in this review. In conclusion, when VH is not feasible, LH has multiple advantages over AH, but at the cost of more ureteric injuries. Evidence is limited for RH and V-NOTES.
Topics: Female; Humans; Hysterectomy; Abdominal Injuries; Fever; Hospitals
PubMed: 37642285
DOI: 10.1002/14651858.CD003677.pub6 -
The Cochrane Database of Systematic... Jul 2023Apical vaginal prolapse is the descent of the uterus or vaginal vault (post-hysterectomy). Various surgical treatments are available, but there are no guidelines to... (Review)
Review
BACKGROUND
Apical vaginal prolapse is the descent of the uterus or vaginal vault (post-hysterectomy). Various surgical treatments are available, but there are no guidelines to recommend which is the best.
OBJECTIVES
To evaluate the safety and efficacy of any surgical intervention compared to another intervention for the management of apical vaginal prolapse.
SEARCH METHODS
We searched the Cochrane Incontinence Group's Specialised Register of controlled trials, which contains trials identified from the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, ClinicalTrials.gov, WHO ICTRP and handsearching of journals and conference proceedings and ClinicalTrials.gov (searched 14 March 2022).
SELECTION CRITERIA
We included randomised controlled trials (RCTs).
DATA COLLECTION AND ANALYSIS
We used Cochrane methods. Our primary outcomes were awareness of prolapse, repeat surgery and recurrent prolapse (any site).
MAIN RESULTS
We included 59 RCTs (6705 women) comparing surgical procedures for apical vaginal prolapse. Evidence certainty ranged from very low to moderate. Limitations included imprecision, poor methodology, and inconsistency. Vaginal procedures compared to sacral colpopexy for vault prolapse (seven RCTs, n=613; six months to f four-year review) Awareness of prolapse was more common after vaginal procedures (risk ratio (RR) 2.31, 95% confidence interval (CI) 1.27 to 4.21, 4 RCTs, n = 346, I = 0%, moderate-certainty evidence). If 8% of women are aware of prolapse after sacral colpopexy, 18% (10% to 32%) are likely to be aware after vaginal procedures. Surgery for recurrent prolapse was more common after vaginal procedures (RR 2.33, 95% CI 1.34 to 4.04; 6 RCTs, n = 497, I = 0%, moderate-certainty evidence). The confidence interval suggests that if 6% of women require repeat prolapse surgery after sacral colpopexy, 14% (8% to 25%) are likely to require it after vaginal procedures. Prolapse on examination is probably more common after vaginal procedures (RR 1.87, 95% CI 1.32 to 2.65; 5 RCTs, n = 422; I = 24%, moderate-certainty evidence). If 18% of women have recurrent prolapse after sacral colpopexy, between 23% and 47% are likely to do so after vaginal procedures. Other outcomes: Stress urinary incontinence (SUI) was more common after vaginal procedures (RR 1.86, 95% CI 1.17 to 2.94; 3 RCTs, n = 263; I = 0%, moderate-certainty evidence). The effect of vaginal procedures on dyspareunia was uncertain (RR 3.44, 95% CI 0.61 to 19.53; 3 RCTs, n = 106, I = 65%, low-certainty evidence). Vaginal hysterectomy compared to sacral hysteropexy/cervicopexy (six RCTS, 554 women, one to seven year review) Awareness of prolapse - There may be little or no difference between the groups for this outcome (RR 1.01 95% CI 0.10 to 9.98; 2 RCTs, n = 200, very low-certainty evidence). Surgery for recurrent prolapse - There may be little or no difference between the groups for this outcome (RR 0.85, 95% CI 0.47 to 1.54; 5 RCTs, n = 403; I = 9%, low-certainty evidence). Prolapse on examination- there was little or no difference between the groups for this outcome (RR 0.78, 95% CI 0.54 to 1.11; 2 RCTs n = 230; I = 9%, moderate-certainty evidence). Vaginal hysteropexy compared to sacral hysteropexy/cervicopexy (two RCTs, n = 388, 1-four-year review) Awareness of prolapse - No difference between the groups for this outcome (RR 0.55 95% CI 0.21 to 1.44; 1 RCT n = 257, low-certainty evidence). Surgery for recurrent prolapse - No difference between the groups for this outcome (RR 1.34, 95% CI 0.52 to 3.44; 2 RCTs, n = 345; I = 0%, moderate-certainty evidence). Prolapse on examination- There were little or no difference between the groups for this outcome (RR 0.99, 95% CI 0.83 to 1.19; 2 RCTs n =367; I =9%, moderate-certainty evidence). Vaginal hysterectomy compared to vaginal hysteropexy (four RCTs, n = 620, 6 months to five-year review) Awareness of prolapse - There may be little or no difference between the groups for this outcome (RR 1.0 95% CI 0.44 to 2.24; 2 RCTs, n = 365, I = 0% moderate-quality certainty evidence). Surgery for recurrent prolapse - There may be little or no difference between the groups for this outcome (RR 1.32, 95% CI 0.67 to 2.60; 3 RCTs, n = 443; I = 0%, moderate-certainty evidence). Prolapse on examination- There were little or no difference between the groups for this outcome (RR 1.44, 95% CI 0.79 to 2.61; 2 RCTs n =361; I =74%, low-certainty evidence). Other outcomes: Total vaginal length (TVL) was shorter after vaginal hysterectomy (mean difference (MD) 0.89cm 95% CI 0.49 to 1.28cm shorter; 3 RCTs, n=413, low-certainty evidence). There is probably little or no difference between the groups in terms of operating time, dyspareunia and stress urinary incontinence. Other analyses There were no differences identified for any of our primary review outcomes between different types of vaginal native tissue repair (4 RCTs), comparisons of graft materials for vaginal support (3 RCTs), pectopexy versus other apical suspensions (5 RCTs), continuous versus interrupted sutures at sacral colpopexy (2 RCTs), absorbable versus permanent sutures at apical suspensions (5 RCTs) or different routes of sacral colpopexy. Laparoscopic sacral colpopexy is associated with shorter admission time than open approach (3 RCTs) and quicker operating time than robotic approach (3 RCTs). Transvaginal mesh does not confer any advantage over native tissue repair, however is associated with a 17.5% rate of mesh exposure (7 RCTs).
AUTHORS' CONCLUSIONS
Sacral colpopexy is associated with lower risk of awareness of prolapse, recurrent prolapse on examination, repeat surgery for prolapse, and postoperative SUI than a variety of vaginal interventions. The limited evidence does not support the use of transvaginal mesh compared to native tissue repair for apical vaginal prolapse. There were no differences in primary outcomes for different routes of sacral colpopexy. However, the laparoscopic approach is associated with a shorter operating time than robotic approach, and shorter admission than open approach. There were no significant differences between vaginal hysteropexy and vaginal hysterectomy for uterine prolapse nor between vaginal hysteropexy and abdominal hysteropexy/cervicopexy. There were no differences detected between absorbable and non absorbable sutures however, the certainty of evidence for mesh exposure and dyspareunia was low.
Topics: Female; Humans; Dyspareunia; Suspensions; Urinary Incontinence, Stress; Uterine Prolapse
PubMed: 37493538
DOI: 10.1002/14651858.CD012376.pub2 -
Surgery Journal (New York, N.Y.) Dec 2021Recently, radical vaginal hysterectomy (RVH) has developed into laparoscopically assisted radical vaginal hysterectomy (LARVH), which is associated with the...
Recently, radical vaginal hysterectomy (RVH) has developed into laparoscopically assisted radical vaginal hysterectomy (LARVH), which is associated with the laparoscopical procedure, and it is applied as radical vaginal trachelectomy and semi-radical vaginal hysterectomy. LARVH is indicated for patients with stage IB1 and IIA1 cervical carcinoma, especially those with a tumor size of less than 2 cm, because the cardinal ligaments cannot be resected widely. Although RVH that is associated with laparoscopic pelvic lymphadenectomy is the most used surgical procedure, radical trachelectomy may be performed either abdominally or vaginally (laparoscopic or robotic). One report found that the pregnancy rate was higher in patients who underwent minimally invasive or radical vaginal trachelectomy than in those who underwent radical abdominal trachelectomy.
PubMed: 35111936
DOI: 10.1055/s-0041-1739120 -
JAMA Aug 2023Surgical repairs of apical/uterovaginal prolapse are commonly performed using native tissue pelvic ligaments as the point of attachment for the vaginal cuff after a... (Comparative Study)
Comparative Study Randomized Controlled Trial
IMPORTANCE
Surgical repairs of apical/uterovaginal prolapse are commonly performed using native tissue pelvic ligaments as the point of attachment for the vaginal cuff after a hysterectomy. Clinicians may recommend vaginal estrogen in an effort to reduce prolapse recurrence, but the effects of intravaginal estrogen on surgical prolapse management are uncertain.
OBJECTIVE
To compare the efficacy of perioperative vaginal estrogen vs placebo cream on prolapse recurrence following native tissue surgical prolapse repair.
DESIGN, SETTING, AND PARTICIPANTS
This randomized superiority clinical trial was conducted at 3 tertiary US clinical sites (Texas, Alabama, Rhode Island). Postmenopausal women (N = 206) with bothersome anterior and apical vaginal prolapse interested in surgical repair were enrolled in urogynecology clinics between December 2016 and February 2020.
INTERVENTIONS
The intervention was 1 g of conjugated estrogen cream (0.625 mg/g) or placebo, inserted vaginally nightly for 2 weeks and then twice weekly to complete at least 5 weeks of application preoperatively; this continued twice weekly for 12 months postoperatively. Participants underwent a vaginal hysterectomy (if uterus present) and standardized apical fixation (either uterosacral or sacrospinous ligament fixation).
MAIN OUTCOMES AND MEASURES
The primary outcome was time to failure of prolapse repair by 12 months after surgery defined by at least 1 of the following 3 outcomes: anatomical/objective prolapse of the anterior or posterior walls beyond the hymen or the apex descending more than one-third of the vaginal length, subjective vaginal bulge symptoms, or repeated prolapse treatment. Secondary outcomes included measures of urinary and sexual function, symptoms and signs of urogenital atrophy, and adverse events.
RESULTS
Of 206 postmenopausal women, 199 were randomized and 186 underwent surgery. The mean (SD) age of participants was 65 (6.7) years. The primary outcome was not significantly different for women receiving vaginal estrogen vs placebo through 12 months: 12-month failure incidence of 19% (n = 20) for vaginal estrogen vs 9% (n = 10) for placebo (adjusted hazard ratio, 1.97 [95% CI, 0.92-4.22]), with the anatomic recurrence component being most common, rather than vaginal bulge symptoms or prolapse repeated treatment. Masked surgeon assessment of vaginal tissue quality and estrogenization was significantly better in the vaginal estrogen group at the time of the operation. In the subset of participants with at least moderately bothersome vaginal atrophy symptoms at baseline (n = 109), the vaginal atrophy score for most bothersome symptom was significantly better at 12 months with vaginal estrogen.
CONCLUSIONS AND RELEVANCE
Adjunctive perioperative vaginal estrogen application did not improve surgical success rates after native tissue transvaginal prolapse repair.
TRIAL REGISTRATION
ClinicalTrials.gov Identifier: NCT02431897.
Topics: Aged; Female; Humans; Middle Aged; Administration, Intravaginal; Estrogens, Conjugated (USP); Gynecologic Surgical Procedures; Hysterectomy; Hysterectomy, Vaginal; Pelvic Organ Prolapse; Secondary Prevention; Treatment Outcome; Uterine Prolapse; Vagina; Vaginal Creams, Foams, and Jellies
PubMed: 37581673
DOI: 10.1001/jama.2023.12317 -
BMJ (Clinical Research Ed.) Sep 2019To evaluate the effectiveness and success of uterus preserving sacrospinous hysteropexy as an alternative to vaginal hysterectomy with uterosacral ligament suspension in... (Comparative Study)
Comparative Study Observational Study Randomized Controlled Trial
Sacrospinous hysteropexy versus vaginal hysterectomy with uterosacral ligament suspension in women with uterine prolapse stage 2 or higher: observational follow-up of a multicentre randomised trial.
OBJECTIVE
To evaluate the effectiveness and success of uterus preserving sacrospinous hysteropexy as an alternative to vaginal hysterectomy with uterosacral ligament suspension in the surgical treatment of uterine prolapse five years after surgery.
DESIGN
Observational follow-up of SAVE U (sacrospinous fixation versus vaginal hysterectomy in treatment of uterine prolapse ≥2) randomised controlled trial.
SETTING
Four non-university teaching hospitals, the Netherlands.
PARTICIPANTS
204 of 208 healthy women in the initial trial (2009-12) with uterine prolapse stage 2 or higher requiring surgery and no history of pelvic floor surgery who had been randomised to sacrospinous hysteropexy or vaginal hysterectomy with uterosacral ligament suspension. The women were followed annually for five years after surgery. This extended trial reports the results at five years.
MAIN OUTCOME MEASURES
Prespecified primary outcome evaluated at five year follow-up was recurrent prolapse of the uterus or vaginal vault (apical compartment) stage 2 or higher evaluated by pelvic organ prolapse quantification system in combination with bothersome bulge symptoms or repeat surgery for recurrent apical prolapse. Secondary outcomes were overall anatomical failure (recurrent prolapse stage 2 or higher in apical, anterior, or posterior compartment), composite outcome of success (defined as no prolapse beyond the hymen, no bothersome bulge symptoms, and no repeat surgery or pessary use for recurrent prolapse), functional outcome, quality of life, repeat surgery, and sexual functioning.
RESULTS
At five years, surgical failure of the apical compartment with bothersome bulge symptoms or repeat surgery occurred in one woman (1%) after sacrospinous hysteropexy compared with eight women (7.8%) after vaginal hysterectomy with uterosacral ligament suspension (difference-6.7%, 95% confidence interval -12.8% to-0.7%). A statistically significant difference was found in composite outcome of success between sacrospinous hysteropexy and vaginal hysterectomy (89/102 (87%) 77/102 (76%). The other secondary outcomes did not differ. Time-to-event analysis at five years showed no differences between the interventions.
CONCLUSIONS
At five year follow-up significantly less anatomical recurrences of the apical compartment with bothersome bulge symptoms or repeat surgery were found after sacrospinous hysteropexy compared with vaginal hysterectomy with uterosacral ligament suspension. After hysteropexy a higher proportion of women had a composite outcome of success. Time-to-event analysis showed no differences in outcomes between the procedures.
TRIAL REGISTRATION
trialregister.nl NTR1866.
Topics: Adult; Aged; Aged, 80 and over; Female; Follow-Up Studies; Humans; Hysterectomy, Vaginal; Ligaments; Middle Aged; Netherlands; Quality of Life; Recurrence; Reoperation; Severity of Illness Index; Suture Techniques; Treatment Outcome; Uterine Prolapse
PubMed: 31506252
DOI: 10.1136/bmj.l5149 -
Current Opinion in Obstetrics &... Dec 2021Pelvic organ prolapse surgery is performed via native tissue or graft augmented repair. Graft augmentation with synthetic mesh was introduced to improve long-term... (Review)
Review
PURPOSE OF REVIEW
Pelvic organ prolapse surgery is performed via native tissue or graft augmented repair. Graft augmentation with synthetic mesh was introduced to improve long-term surgical outcomes compared with vaginal native tissue repairs. Vaginal hysteropexy has recently become increasingly popular due to patient preference and an improved morbidity profile over hysterectomy, while maintaining comparable efficacy. As long-term outcomes remain unanswered, mesh augmentation to vaginal hysteropexy has sought to improve efficacy while minimizing complications.
RECENT FINDINGS
Recent studies have demonstrated superiority of vaginal mesh hysteropexy to vaginal hysterectomy with native tissue vault suspension. Short-term follow-up of vaginal mesh hysteropexy has also demonstrated lower blood loss and operative time with improved vaginal length compared with hysterectomy. Mesh exposure rates across studies were low and comparable to those of abdominally placed prolapse mesh.
SUMMARY
Vaginal mesh hysteropexy is a comparably well tolerated and effective surgical treatment option for women with uterovaginal prolapse. Although vaginal mesh kits are not commercially available, this procedure may be a viable treatment option in select patients.
Topics: Female; Gynecologic Surgical Procedures; Humans; Hysterectomy, Vaginal; Pelvic Organ Prolapse; Surgical Mesh; Treatment Outcome; Uterine Prolapse; Vagina
PubMed: 34747883
DOI: 10.1097/GCO.0000000000000748 -
International Urogynecology Journal Apr 2023Vaginal packing is often used after vaginal hysterectomy to reduce the risk of haemorrhagic and infectious complications, but the procedure may impair spontaneous... (Review)
Review
INTRODUCTION AND HYPOTHESIS
Vaginal packing is often used after vaginal hysterectomy to reduce the risk of haemorrhagic and infectious complications, but the procedure may impair spontaneous bladder emptying and necessitate permanent bladder catheterization, which itself increases the risk of urinary infection, patient bother, delayed discharge, and increased costs. This systematic review was aimed at assessing the complications and outcomes associated with vaginal packing after vaginal hysterectomy.
METHODS
We conducted a systematic review following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) Statement, using the Population, Interventions, Comparators, Outcomes, and Study design (PICOS) framework to define eligibility. Following data synthesis and subgroup analyses, we assessed the certainty of evidence according to GRADE guidance and formulated a clinical recommendation.
RESULTS
The review included four clinical trials (involving 337 participants). These provided no clear evidence that vaginal packing led to clinically meaningful reductions in adverse effects, such as vaginal bleeding, hematoma formation, or postoperative vaginal cuff infection. Overall, the intervention produced no clear benefit regarding the predefined outcomes.
CONCLUSIONS
Routine vaginal packing after vaginal hysterectomy had no clear benefit on outcomes. We therefore advise against this procedure.
Topics: Female; Humans; Hysterectomy, Vaginal; Postoperative Complications; Uterine Hemorrhage; Hematoma; Research Design; Hysterectomy
PubMed: 36018354
DOI: 10.1007/s00192-022-05331-1