Evidence Profile for Oophorectomy Versus No Oophorectomy ...€¦ · Length of Stay 1 100 1C(0)...

Jeppson PC, Balgobin S, Rahn DD, Matteson KA, Dieter AA, Ellington DR, et al. Comparison of vaginal hysterectomy techniques and interventions for benign indications: a systematic review. Obstet Gynecol 2017; 129. The authors provided this information as a supplement to their article. ©2017 American College of Obstetricians and Gynecologists. Page 1 of 30

Appendix 1. Evidence Profile for Oophorectomy Versus No Oophorectomy Outcome No.

Studies Total N Methodological

Quality Consistenc

y

Directnes

s

Other Considerations

Summary of Findings

Evidence Quality

Effect Outcome Importance

Bleeding 3 1216 3C 0 0 0 Low No difference

Moderate

Estimated Blood Loss

2 866 2C (0) 0 0 0 Low No differenc

e

Moderate

Transfusion (entrap or

postop)

3 1216 3C (-1) -1 0 0 Low No differenc

e

Moderate

Complications 3 1216 4 C 0 0 -1 Low No differenc

e

Moderate

Operative Time 3 1216 3C -1 0 0 Low Uncertain Moderate

Length of Stay 2 866 2C 0 0 -1 Low No differenc

e

Moderate

Total 3 1216

Balance of benefits and harms: Comparing oophorectomy to no oophorectomy in a population of Quality of overall evidence: Low


women undergoing vaginal hysterectomy, there are no net harms related to performing an oophorectomy in terms of bleeding complications, overall complications, or length of stay (low quality evidence). Oophorectomy at the time of VH is likely associated with a slightly higher length of surgery (low).


Appendix 2. Evidence Profile for Enhanced Recovery Pathway Outcome No.


Quality Consistenc

y

Directnes

s


Summary of Findings

Evidence Quality


Vaginal Packing

1 100 1C(0) Unknown

0 0 Low favors enhance

d recovery

Low

Hospital readmission

1 100 1C(0) Unknown

0 0 Low No differenc

e

High


1 100 1C(-1) Unknown


e

Moderate

Operative time 1 100 1C(0) Unknown


e

High

Catheter 1 100 1C(0) Unknown


d recovery

High


Length of Stay 1 100 1C(0) Unknown


d recovery

High

Pain 1 100 1C(0) Unknown


e

High

Total

Balance of benefits and harms: comparing an enhanced recovery pathway to routine care in a population of women undergoing vaginal hysterectomy, there are net benefits to standardized enhanced recovery protocols for decreased use of vaginal packing and shorter duration of vaginal packing if it is used, as well as shorter indwelling catheter use and overall time to discharge from the hospital (low quality evidence).

Quality of overall evidence: Low


Appendix 3. Evidence Profile for Accustimulation Outcome No.


Quality Consistenc

y

Directnes

s


Summary of Findings

Evidence Quality


Nausea and Vomiting

1 200 1A(0) Unknown

0 -1 Moderate favors accustimulatoin

High

Total 1 200 Balance of benefits and harms: comparing Accustimulation to routine care in a population of women undergoing vaginal hysterectomy, there are net benefits to accustimulation with regard to decreased nausea and vomiting(moderate quality evidence).

Quality of overall evidence: Moderate


Appendix 4. Evidence Profile for Bladder Management Outcome No.


Quality Consistenc

y

Directnes

s


Summary of Findings

Evidence Quality


Urinary Tract Infection

2 179 1B (0), 1C (0) -1 0 -1 Low No differenc

e

Moderate

Re-catheterization 2 179 1B (0), 1C (0) 0 0 0 Low No differenc

e

Moderate

Febrile Morbidity 1 99 1B (0) NA 0 -1 Insufficient Favors No

Catheter

Moderate

Mean Duration of Catheter

1 80 1C (0) NA 0 -1 Insufficient Favors Early

Removal

Moderate

Mean Hospital Stay 1 80 1C (0) NA 0 -1 Insufficient Favors Early

Removal

Moderate

Total 2 179

Balance of benefits and harms: comparing populations of women undergoing routine catheter use to no catheter use or shortened catheter use in a population of women undergoing vaginal hysterectomy, there are decreased risks of urinary tract infections, febrile morbidity, and length of hospital stay with shorter catheter use with an increased risk of needing to replace a catheter (low quality of evidence)



Appendix 5. Evidence Profile for Closing Peritoneum Outcome No.


Quality Consistenc

y

Directnes

s


Summary of Findings

Evidence Quality


Operative time 1 50 1B(0) NA 0 -1 Low No differenc

e

Moderate

Transfusion 3 154 2B(0) 0 0 0 Moderate No differenc

e

High

Fever/febrile morbidity

2 103 2B (0) 0 0 0 Moderate No differenc

e

High


1 53 1B(0) NA 0 -1 Low No differenc

e

High

Hematoma 3 207 2B(0), 1B (-2) 0 0 0 Moderate No differenc

e

Moderate

Cuff infection 2 154 2B(-2) 0 0 0 Low No differenc

e

High


Granulation tissue

2 103 2B(-2) 0 0 0 Moderate No differenc

e

Low

Fallopian tube prolapse

3 207 1B(-1), 2B (-2) -1 0 0 Moderate No differenc

e

Moderate

Length of stay (hospitalization)


e

Moderate


1 53 1B(-1) NA 0 -1 Low No differenc

e

Moderate

Total 3 207

Balance of benefits and harms: comparing peritoneal closure to non-closure at the time of vaginal colpotomy closure (cuff closure) in a population of women undergoing vaginal hysterectomy, there are no net benefits to closing the peritoneum with regard to operative time, fevers, infections, bleeding, fallopian tube prolapse or hospital stay (low quality evidence).



Appendix 6. Evidence Profile for Horizontal Versus Vertical Cuff Closure Outcome No.


Quality Consistenc

y

Directnes

s


Summary of Findings

Evidence Quality


TVL 3 202 2A(0), 1B(0) -1 0 0 Moderate favors vertical

Moderate

OR time 1 52 1A (0) NA 0 -1 Moderate No Differenc

e

Moderate

Transfusion 1 52 1A (0) NA 0 -1 Moderate No Differenc

e

Moderate

Hematoma/Cuff abscess/Cuff infection

1 107 1B (-2) NA 0 -1 insufficient No Differenc

e

Moderate

Total 3 202

Balance of benefits and harms: comparing vertical cuff closure to horizontal cuff closure in a population of women undergoing vaginal hysterectomy for benign indications, there are net benefits to vertical cuff closure for increased total vaginal length at 6 weeks (moderate quality evidence), with no differences seen between groups for operative time or complications (moderate quality evidence).



Appendix 7. Evidence Profile for Preoperative GNRH Agonist Versus No GNRH Agonist in Patients With 14-18 Week–Sized Fibroid Uteri

Outcome No. Studies

Total N Methodological Quality

Consistenc

y

Directnes

s


Summary of Findings

Evidence Quality


Hysterectomy Route/Uterine Size

Proportion of hysts completed vaginally

1 50 1B(-1) NA 0 -1 Low Favors GnRH agonist

High

Decrease preoperative uterine size (gestational week)

1 50 1B(-2) NA 0 -1 Low Favor GnRH agonist

Moderate

Decrease preoperative uterine volume (ultrasound)


e

Moderate


Uterine weight in operating room


e

Moderate

Uterine volume in operating room


e

Moderate

Bleeding-Related Outcomes

Intra/Postop transfusion


e

High

Hemoglobin pre-treatment and at 24h postop (g/dL)


e

Moderate

Hct pre-treatment and at 24h postop (%)


e

Moderate

Operative blood loss (mL)


Moderate


Operative time 1 50 1B(-1) NA 0 -1 Low No differenc

e

Moderate

Length of Stay/Convalescence

Postop hospital days


Moderate

Convalescence days


High

Total 1 50 Balance of benefits and harms: In a population of women with symptomatic 14-18wk sized fibroid uteri planning hysterectomy, comparing 8 weeks of preoperative GNRH agonist to no GNRH agonist, a greater proportion of those receiving GNRH agonists had their hysterectomies completed vaginally (low quality evidence), which was associated with less operative blood loss (low quality), fewer hospital days (low quality), and fewer convalescence days (low quality). There were no differences in final uterine weight or volume, transfusion rates, or postoperative Hgb/Hct levels (low quality). Data are lacking on risks and costs associated with 8weeks of GnRH agonist.



Appendix 8. Evidence Profile for TVH With Morcellation Versus No Morcellation Outcome No.


Quality Consistenc

y

Directnes

s


Summary of Findings

Evidence Quality



Need for post-operative transfusion

3 2432 1B(0), 1C(-1), 1C(0)

0 0 -1 Low No differenc

e

High

Postoperative vaginal bleeding and retroperitoneal hematoma

1 1365 1C(-1) NA 0 -2 Low No differenc

e

Moderate

Change in hematocrit


e

Moderate

Reoperation for bleeding


e

Moderate


Intraop/Postoperative Complications

Intraoperative laparotomy


e

Moderate

Bladder injury 2 1067 1B(0), 1C(0) 0 0 0 Moderate No differenc

e

Moderate

Ureteral obstruction


e

Moderate

Febrile morbidity 2 1067 1B(0), 1C(0) 0 0 0 Moderate No differenc

e

Moderate

Cystitis 1 1365 1C(-1) NA 0 -2 Low Favors morcellati

on

Moderate

Postoperative urinary retention

1 1365 1C(0) NA 0 -1 Low Favors morcellati

on

Moderate


Operative Time 2 1067 1B(0), 1C(0) -1 0 0 Low Favors no

morcellation

Moderate

Length of Stay 3 2432 1B(0), 2C(0) 0 0 0 Low No differenc

e

Moderate

Total 3 2432

Balance of benefits and harms: In a population of women undergoing vaginal hysterectomy with or without morcellation, there are no substantial harms associated with morcellation: operative time is increased with morcellation (low quality of evidence), but no differences are seen in postoperative transfusion rates or other bleeding-related outcomes (low quality), conversion to laparotomy (low quality), bladder injury (moderate quality), and postoperative febrile morbidity (moderate quality) or cystitis (very low quality). Length of hospital stay is not different with or without morcellation at time of vaginal hysterectomy (low quality).



Appendix 9. Evidence Profile for Vaginal Antisepsis (Cleaning Prior to Surgery) Outcome No.


Quality Consistenc

y

Directnes

s


Summary of Findings

Evidence Quality


Contamination 1 50 1A(0) Unknown

0 -1 High 30 min data

favors Chlorahe

xidine

High

Infections 2 83 1A(-2) 1C(-2) Consistent

-1 -1 Low No Differenc

e

High

Surgical Time 2 83 1A(0) 1C(0) Consistent

0 0 High No Differenc

e

Moderate

Total 2 83

Balance of benefits and harms: comparing 4% chlorhexidine gluconate to 10% povidone, chorahexidine decreases the number of bacteria present 30 min after the start of surgery with no difference over time (high quality). There is no difference in post-operative vaginal infection rates between patients that have preoperative vaginal cleaning with chlorhexidine, povidone, or saline however the results of povidone versus saline should be interpreted with caution as all patients in that study received 24 hours of post-operative prophylactic antibiotics (low quality). Preoperative vaginal cleaning does not impact overall surgical time for vaginal hysterectomy (high quality evidence) or Estimated Blood Loss (low quality evidence).



Appendix 10. Evidence Profile for Cervical injection of Vasopressin Outcome No.


Quality Consistenc

y

Directnes

s


Summary of Findings

Evidence Quality


Infection/Cuff cellulitis

3 245 2A(-1), 1C (-2) 0 0 -1 Moderate No differenc

e

High

EBL 5 345 2A(-1), 2B(-1), 1C(-1)

0 0 0 Moderate Favors Vasopres

sin

Moderate

Change in Hemoglobin and Hematocrit

3 245 2A(0), 1C(-1) -1 0 0 Moderate Favors Vasopres

sin

High

Length of Stay 2 129 1A(0), 1B(0) 0 0 0 High No differenc

e

Moderate

Surgical Time 3 158 1A(0), 2B(0) -1 0 0 Low No differenc

e

Moderate


Narcotic Use 1 58 1A(0) Unknown

-1 0 Low Favors Control

Moderate

Change in blood pressure after injection

3 245 2A(0), 1C(-1) -1 0 0 Low Variable Moderate

Total 5 345

Balance of benefits and harms: comparing intracervical injections of vasopressin to no injection or normal saline injection at the start of the surgery in a population of women undergoing vaginal hysterectomy, there are reductions in blood loss with vasopressin. There is some evidence that suggests that temporary elevations in blood pressure and increase postoperative narcotic use may be associated with the use of vasopressin, but the clinical relevance of these outcomes is questionable. Overall, the benefits of intracervical injections of vasopressin at the start of vaginal hysterectomy outweigh the potential harms (moderate quality evidence).



Appendix 11. Evidence Profile for Pedicle Sealer vs Traditional Suture Outcome No.


Quality Consistenc

y

Directnes

s


Summary of Findings

Evidence Quality


Post-operative Pain (patient rated)

6 521 3A(0), 2B(0), 1C(0)

-1 0 0 Moderate No differenc

e

High

Surgical Time 14 956 7A(0), 2B (0), 5C (0)

0 0 0 High Favor pedicle sealer

High


13 652 7A(-1), 2B(-2), 4C (-2)

-1 0 0 Moderate Favor pedicle sealer

High

Hemoglobin 7 498 3A(-1), 1B(-1), 3C(-1)


e

High

Post-operative Pain Analgesia Use

3 430 3A(-1), 2C(-1) -1 0 0 Moderate No differenc

e

High


Length of Hospital Stay

11 932 5A(-1), 1B (-1), 5C(-1)


e

High

Total 15 1389

Balance of benefits and harms: comparing pedicle sealer (Ligature, BiClamp, Harmonic Scalpel, stapler, aneurysm needle) to traditional clamping, cutting, and suture ligation in a population of women undergoing vaginal hysterectomy, there are no apparent net benefits for one method over the other with regard to post-operative pain, analgesic use, or length of hospital stay (moderate quality evidence). When comparing surgical time between groups, pedical sealers were much faster (high quality evidence) with less reported blood loss but no difference in post-operative hemoglobin levels (moderate quality evidence)

Quality of overall evidence: High


Appendix 12. Evidence Profile for Vaginal Packing Outcome No.

Studies Total N Methodologic

al Quality Consiste

ncy Directnes

s


Summary of Findings

Evidence Quality


Pain 3 395 1A(0), 1A(-1), 1B(0)

0 0 0 Moderate No Differenc

e

Moderate

Hematoma 3 395 2A (0), 1B (0) -1 0 0 Moderate Unclear Moderate

Hemoglobin 1 173 1A(0) NA 0 -1 Moderate No Differenc

e

Moderate


2 250 2A(0), 2A(0) 0 0 0 Moderate No Differenc

e

Moderate

Vaginal Infection

1 173 1A(0) NA 0 -1 Moderate No Differenc

e

Moderate

Total


Balance of benefits and harms: comparing vaginal packing to no packing in a population of women undergoing vaginal hysterectomy, there are no apparent net benefits to vaginal packing for postoperative pain, bleeding, satisfaction on the Visual Analog Scale, or infections(moderate to low quality evidence). In addition, there does not appear to be any long term benefit to decreased hematoma formation six weeks after surgery, but there may be a small benefit at 1 week (low quality evidence). One study showed less nurse documented pain and more ketorolac use in women without packing.



Appendix 13. Evidence Profile for Vaginal Drain Outcome No.

Studies Total N Methodologic

al Quality Consiste

ncy Directnes

s


Summary of Findings

Evidence Quality


Hemoglobin 1 272 1A(0) Unknown 0 -1 Moderate No differenc

e

High

Fever 1 272 1A(0) Unknown 0 -1 Moderate No differenc

e

High

Return to Operating Room

1 272 1A(0) Unknown 0 -1 Moderate No differenc

e

High

Transfusion 1 272 1A(0) Unknown 0 -1 Moderate No differenc

e

High

Readmission 1 272 1A(0) Unknown 0 -1 Moderate No differenc

e

High



1 272 1A(0) Unknown 0 -1 Moderate No differenc

e

High

Length of Stay 1 272 1A(0) Unknown 0 -1 Moderate No differenc

e

High

Total 1 272

Balance of benefits and harms: comparing placement of a vaginal drain to no drain in a population of women undergoing vaginal hysterectomy, there are no net benefits to using a drain (moderate quality evidence).



Appendix 14. Evidence Profile for Vaginal Hysterectomy Feasibility in Obese vs Non-obese Patients Outcome No.


Quality Consistenc

y

Directnes

s


Summary of Findings

Evidence Quality


Operative Time 2 660 1C(0), 1B(0) 0 0 0 Moderate Favors non-

obese

Moderate

Extended Hospital Stay

2 660 1C(0), 1B(0) 0 -1 0 Low No differenc

e

Moderate


"Extensive" Intraoperative blood loss (i.e., >500mL EBL)

3 1131 2C(0), 1B(-1) 0 0 0 Low Favors non-

obese

Moderate

Intra- or Postoperative transfusion

2 915 1C(0), 1B(0) -1 0 0 Low Favors non-

obese

High


Infectious & Febrile Morbidity

Postoperative Fever (>38, >1d postop)

2 687 2C(-1) -1 -1 0 Low No differenc

e

Moderate

Postoperative Cystitis

3 1131 2C(-1), 1B(-1) -1 0 0 Low No differenc

e

Moderate

Postoperative Adverse Events

Urinary retention (i.e. 7-14d postop)

2 687 2C(0) -1 0 0 Low No differenc

e

Moderate

Venous thromboembolism

2 660 1B(0), 1C(-1) 0 0 0 Low No differenc

e

High

Injury to viscus 1 444 1B(0) NA 0 -1 Low No differenc

e

High


Requiring reoperation


e

High

Total 3 1131

Balance of benefits and harms: comparing non-obese to obese subpopulations of women undergoing vaginal hysterectomy, non-obese patients have shorter operative times (moderate quality evidence) and less intraoperative blood loss and perioperative transfusions (low quality). However, obesity does not confer any difference in duration of hospital stay, reoperation for complications, injury to viscus or venous thromboembolism, or frequency of prolonged urinary retention (low quality). Febrile morbidity and postoperative cystitis are no different in non-obese compared with obese subpopulations (low quality).



Appendix 15. Evidence Profile for Vaginal Hysterectomy Feasibility in Women With Traditional Contraindications to Vaginal Hysterectomy

Outcome No. Studies

Total N Methodological Quality

Consistenc

y

Directnes

s


Summary of Findings

Evidence Quality


Operative Time 1 500 1C(0) NA 0 -1 Low No differenc

e

Moderate

Postoperative Recovery

Length of Stay 2 920 2C(0) 0 0 0 Low No differenc

e

Moderate

Time to Regular Diet

1 500 1C(0) NA 0 -1 Low No differenc

e

Moderate


Decrease in Hematocrit


e

Moderate


Transfusion Rate


e

High

Infectious & Febrile Morbidity

Postoperative Fever


e

Moderate

Postoperative Cystitis


e

Moderate

Postoperative Adverse Events

Overall complication rate


e

Variable

Injury to lower urinary tract


e

High

Total 2 920

Balance of benefits and harms: comparing subpopulations of women undergoing vaginal Quality of overall evidence: Low


hysterectomy (i.e., those with prior laparotomy/Cesarean section, nulliparity, or large uteri >180g to those without these risks), no differences were observed in length of stay, total operative time, time to resumption of regular diet, change in hematocrit, transfusion rate, febrile morbidity, postoperative cystitis, injury to lower urinary tract, or overall complication rates (low quality of evidence).

Evidence Profile for Oophorectomy Versus No Oophorectomy ...€¦ · Length of Stay 1 100 1C(0)...

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