Question:In women with heavy menstrual bleeding, is there randomized controlled trial evidence to support the use of endometrial resection and ablation instead of hysterectomy?

Clinical Answer:

Moderate quality evidence suggests that hysterectomy probably reduces blood loss assessed by pictorial blood loss assessment chart score (PBAC) at 12 months compared with endometrial resection and ablation. This objective result is supported by the fact that that, when women were asked, more women having hysterectomy than endometrial ablation reported reduced bleeding symptoms.

Low quality evidence suggests that endometrial resection and ablation, compared with hysterectomy, increases the number of women requiring further surgery for heavy menstrual bleeding at 12 months. A single trial of 197 participants found that more women having endometrial resection required further surgery for heavy menstrual bleeding at four years.

Available evidence across randomized trials including between 200 to 800 participants (depending on the outcome assessed) indicates that endometrial resection and ablation is associated with lower rates of intra/post-operative complications (e.g. sepsis), shorter duration of surgery and shorter time to return to normal activity and work. Rates of post-discharge adverse events (e.g. hemorrhage) and quality of life were similar in both groups.

Full outcome data is detailed below:

1.Transcervical resection of the endometrium (TCRE)/ablation versus hysterectomy

  • Population, Intervention, Comparator

    Population:

    Women (average age approximately 40 to 45 years) with heavy menstrual bleeding that was not responding to medical treatment

    Intervention:

    TCRE/ablation

    Comparator:

    Hysterectomy

  • OUTCOME 1.1: Proportion of women with improvement in bleeding symptoms at 12 months - Woman's perception

    Quality of the evidence:

    The reviewers performed a GRADE assessment of the quality of evidence for this outcome at this time point and stated that the evidence was low quality. See Summary of findings from Cochrane review

    Narrative result:

    Four RCTs with 650 participants found that fewer women having TCRE/ablation perceived that they had reduced bleeding compared with women having hysterectomy.

    Relative effect or mean difference:

    There was a statistically significant difference between groups, in favor of hysterectomy (RR 0.89, 95% CI 0.85 to 0.93).

    Forest plot from Cochrane Review

    Absolute effect:

    890 per 1000 people (95% CI 783 to 949) with TCRE/ablation compared with 978 per 1000 people with hysterectomy.

    Reference:
    Fergusson RJ, Lethaby A, Shepperd S, Farquhar C. Endometrial resection and ablation versus hysterectomy for heavy menstrual bleeding. Cochrane Database of Systematic Reviews 2013, Issue 11. Art. No.: CD000329. DOI: 10.1002/14651858.CD000329.pub2. [Review search date: October 2013]
    • OUTCOME 1.2: Pictorial blood loss assessment chart score (PBAC) score at 12 months

      Risk of bias of studies:

      The reviewers performed a GRADE assessment of the quality of evidence for this outcome at this time point and stated that the evidence was moderate quality. See Summary of findings from Cochrane review

      Narrative result:

      One RCT with 68 participants found that TCRE/ablation was less effective at reducing PBAC score compared with hysterectomy. The PBAC is visual measure of amount of blood loss; clinically significant heavy menstrual bleeding correlates with a score > 100.

      Relative effect or mean difference:

      There was a statistically significant difference between groups, in favor of hysterectomy (mean difference 24.40, 95% CI 16.01 to 32.79).

      Forest plot from Cochrane Review

      Reference:
      Fergusson RJ, Lethaby A, Shepperd S, Farquhar C. Endometrial resection and ablation versus hysterectomy for heavy menstrual bleeding. Cochrane Database of Systematic Reviews 2013, Issue 11. Art. No.: CD000329. DOI: 10.1002/14651858.CD000329.pub2. [Review search date: October 2013]
      • OUTCOME 1.3: Proportion of women requiring further surgery for heavy menstrual bleeding at 12 months

        Quality of the evidence:

        The reviewers performed a GRADE assessment of the quality of evidence for this outcome at this time point and stated that the evidence was low quality. See Summary of findings from Cochrane review

        Narrative result:

        Six RCTs with 887 participants found that TCRE/ablation increased the proportion of women requiring further surgery for heavy menstrual bleeding at 12 months compared with hysterectomy.

        Relative effect or mean difference:

        There was a statistically significant difference between groups, in favor of hysterectomy (RR 14.94, 95% CI 5.24 to 42.57).

        Forest plot from Cochrane Review

        Absolute effect:

        36 per 1000 people (95% CI 13 to 103) with TCRE/ablation compared with 2 per 1000 people with hysterectomy.

        Reference:
        Fergusson RJ, Lethaby A, Shepperd S, Farquhar C. Endometrial resection and ablation versus hysterectomy for heavy menstrual bleeding. Cochrane Database of Systematic Reviews 2013, Issue 11. Art. No.: CD000329. DOI: 10.1002/14651858.CD000329.pub2. [Review search date: October 2013]
        • OUTCOME 1.4: Proportion of women requiring further surgery for heavy menstrual bleeding at 4 years

          Risk of bias of studies:

          The reviewers did not perform a GRADE assessment of the quality of the evidence. The trial had unclear random sequence generation and was at a high risk of performance/detection bias, but had adequate allocation concealment, and was at a low risk of attrition bias.

          Narrative result:

          One RCT with 197 participants found that TCRE/ablation increased the proportion of women requiring further surgery for heavy menstrual bleeding at 4 years compared with hysterectomy.

          Relative effect or mean difference:

          There was a statistically significant difference between groups, in favor of hysterectomy (RR 36.32, 95% CI 5.09 to 259.21).

          Forest plot from Cochrane Review

          Absolute effect:

          38 per 100 people (95% CI 5 to 273) with TCRE/ablation compared with 1 per 100 people with hysterectomy.

          Reference:
          Fergusson RJ, Lethaby A, Shepperd S, Farquhar C. Endometrial resection and ablation versus hysterectomy for heavy menstrual bleeding. Cochrane Database of Systematic Reviews 2013, Issue 11. Art. No.: CD000329. DOI: 10.1002/14651858.CD000329.pub2. [Review search date: October 2013]
          • OUTCOME 1.5: Intra/post-operative adverse events

            Narrative result:

            The review presented results for a large number of intra/post-operative adverse events; the most clinically relevant are reported here. Click below for full details.

            Reference:
            Fergusson RJ, Lethaby A, Shepperd S, Farquhar C. Endometrial resection and ablation versus hysterectomy for heavy menstrual bleeding. Cochrane Database of Systematic Reviews 2013, Issue 11. Art. No.: CD000329. DOI: 10.1002/14651858.CD000329.pub2. [Review search date: October 2013]
            • Subgroup analysis 1.5.1: Sepsis
              Quality of the evidence:

              The reviewers performed a GRADE assessment of the quality of evidence for this outcome at this time point and stated that the evidence was moderate quality. See Summary of findings from Cochrane review

              Narrative result:

              Four RCTs with 621 participants found a lower incidence of sepsis with TCRE/ablation compared with hysterectomy.

              Relative effect or mean difference:

              There was a statistically significant difference between groups, in favor of TCRE/ablation (RR 0.19, 95% CI 0.12 to 0.31).

              Forest plot from Cochrane Review

              Absolute effect:

              61 per 1000 people (95% CI 38 to 99) with TCRE/ablation compared with 319 per 1000 people with hysterectomy.

              Reference:
              Fergusson RJ, Lethaby A, Shepperd S, Farquhar C. Endometrial resection and ablation versus hysterectomy for heavy menstrual bleeding. Cochrane Database of Systematic Reviews 2013, Issue 11. Art. No.: CD000329. DOI: 10.1002/14651858.CD000329.pub2. [Review search date: October 2013]
            • Subgroup analysis 1.5.2:  Blood transfusion
              Risk of bias of studies:

              The reviewers did not perform a GRADE assessment of the quality of the evidence. All four trials were at a high risk of performance/detection bias, three (75%) had either unclear random sequence generation or allocation concealment, and one (25%) had an unclear risk of attrition bias.

              Narrative result:

              Four RCTs with 751 participants found that fewer women required blood transfusion with TCRE/ablation compared with hysterectomy.

              Relative effect or mean difference:

              There was a statistically significant difference between groups, in favor of TCRE/ablation (RR 0.20, 95% CI 0.07 to 0.59).

              Forest plot from Cochrane Review

              Absolute effect:

              1 per 100 people (95% CI 0 to 3) with TCRE/ablation compared with 5 per 100 people with hysterectomy.

              Reference:
              Fergusson RJ, Lethaby A, Shepperd S, Farquhar C. Endometrial resection and ablation versus hysterectomy for heavy menstrual bleeding. Cochrane Database of Systematic Reviews 2013, Issue 11. Art. No.: CD000329. DOI: 10.1002/14651858.CD000329.pub2. [Review search date: October 2013]
            • Subgroup analysis 1.5.3: Perforation
              Risk of bias of studies:

              The reviewers did not perform a GRADE assessment of the quality of the evidence. Both trials were at a high risk of performance/detection bias, one (50%) had unclear random sequence generation, and one (50%) had an unclear risk of attrition bias.

              Narrative result:

              Two RCTs with 430 participants found no statistically significant difference between groups.

              Relative effect or mean difference:

              There was no statistically significant difference between groups (RR 5.05, 95% CI 0.61 to 42.16).

              Forest plot from Cochrane Review

              Absolute effect:

              There was no statistically significant difference between groups.

              Reference:
              Fergusson RJ, Lethaby A, Shepperd S, Farquhar C. Endometrial resection and ablation versus hysterectomy for heavy menstrual bleeding. Cochrane Database of Systematic Reviews 2013, Issue 11. Art. No.: CD000329. DOI: 10.1002/14651858.CD000329.pub2. [Review search date: October 2013]
          • OUTCOME 1.6: Post-discharge adverse events

            Narrative result:

            The review presented results for a large number of post-discharge adverse events; the most clinically relevant are reported here.

            Reference:
            Fergusson RJ, Lethaby A, Shepperd S, Farquhar C. Endometrial resection and ablation versus hysterectomy for heavy menstrual bleeding. Cochrane Database of Systematic Reviews 2013, Issue 11. Art. No.: CD000329. DOI: 10.1002/14651858.CD000329.pub2. [Review search date: October 2013]
            • Subgroup analysis 1.6.1: Return to surgery owing to postoperative complications
              Risk of bias of studies:

              The reviewers did not perform a GRADE assessment of the quality of the evidence. The trial was at a high risk of performance/detection bias and an unclear risk of attrition bias, but a low risk of selection bias.

              Narrative result:

              One RCT with 228 participants found no statistically significant difference between groups but was likely to have been underpowered to detect clinically important differences

              Relative effect or mean difference:

              There was no statistically significant difference between groups (RR 0.15, 95% CI 0.01 to 2.93).

              Forest plot from Cochrane Review

              Absolute effect:

              There was no statistically significant difference between groups.

              Reference:
              Fergusson RJ, Lethaby A, Shepperd S, Farquhar C. Endometrial resection and ablation versus hysterectomy for heavy menstrual bleeding. Cochrane Database of Systematic Reviews 2013, Issue 11. Art. No.: CD000329. DOI: 10.1002/14651858.CD000329.pub2. [Review search date: October 2013]
            • Subgroup analysis 1.6.2: Post-discharge sepsis
              Risk of bias of studies:

              The reviewers did not perform a GRADE assessment of the quality of the evidence. The trial was at a high risk of performance/detection bias and an unclear risk of attrition bias, but a low risk of selection bias.

              Narrative result:

              One RCT with 172 participants found that fewer people having TCRE/had sepsis after hospital discharge compared with hysterectomy.

              Relative effect or mean difference:

              There was a statistically significant difference between groups, in favor of TCRE/ablation (RR 0.27, 95% CI 0.13 to 0.58).

              Forest plot from Cochrane Review

              Absolute effect:

              8 per 100 people (95% CI 4 to 16) with TCRE/ablation compared with 29 per 100 people with hysterectomy.

              Reference:
              Fergusson RJ, Lethaby A, Shepperd S, Farquhar C. Endometrial resection and ablation versus hysterectomy for heavy menstrual bleeding. Cochrane Database of Systematic Reviews 2013, Issue 11. Art. No.: CD000329. DOI: 10.1002/14651858.CD000329.pub2. [Review search date: October 2013]
            • Subgroup analysis 1.6.3: Post-discharge hemorrhage
              Risk of bias of studies:

              The reviewers did not perform a GRADE assessment of the quality of the evidence. The trial had a high risk of performance/detection bias and unclear random sequence generation, but a low risk of attrition bias.

              Narrative result:

              One RCT with 196 participants found no statistically significant difference between groups.

              Relative effect or mean difference:

              There was no statistically significant difference between groups (RR 2.94, 95% CI 0.12 to 71.30).

              Forest plot from Cochrane Review

              Absolute effect:

              There was no statistically significant difference between groups.

              Reference:
              Fergusson RJ, Lethaby A, Shepperd S, Farquhar C. Endometrial resection and ablation versus hysterectomy for heavy menstrual bleeding. Cochrane Database of Systematic Reviews 2013, Issue 11. Art. No.: CD000329. DOI: 10.1002/14651858.CD000329.pub2. [Review search date: October 2013]
          • OUTCOME 1.7: Quality of life

            Narrative result:

            Quality of life was assessed using a range of measures; none of the analyses found clear evidence of a difference between groups. Click below for full details.

            Reference:
            Fergusson RJ, Lethaby A, Shepperd S, Farquhar C. Endometrial resection and ablation versus hysterectomy for heavy menstrual bleeding. Cochrane Database of Systematic Reviews 2013, Issue 11. Art. No.: CD000329. DOI: 10.1002/14651858.CD000329.pub2. [Review search date: October 2013]
            • Subgroup analysis 1.7.1: Quality of life scores - SF-36 at 12 months
              Risk of bias of studies:

              The reviewers did not perform a GRADE assessment of the quality of the evidence. The trial had a high risk of performance/detection bias and unclear allocation concealment, but a low risk of attrition bias.

              Narrative result:

              One RCT with 181 participants found TCRE/ablation was associated with lower quality of life scores in the social functioning, energy and general health perception domains, but not the physical, emotional, mental health, pain, or physical functioning domains.

              Relative effect or mean difference:

              For full details, see

              Forest plot from Cochrane Review

              Reference:
              Fergusson RJ, Lethaby A, Shepperd S, Farquhar C. Endometrial resection and ablation versus hysterectomy for heavy menstrual bleeding. Cochrane Database of Systematic Reviews 2013, Issue 11. Art. No.: CD000329. DOI: 10.1002/14651858.CD000329.pub2. [Review search date: October 2013]
            • Subgroup analysis 1.7.2: Quality of life - GR inventory scores at 12 months
              Risk of bias of studies:

              The reviewers did not perform a GRADE assessment of the quality of the evidence. The trial had a high risk of performance/detection bias and unclear random sequence generation but a low risk of attrition bias.

              Narrative result:

              One RCT with 182 participants found no statistically significant difference between groups.

              Relative effect or mean difference:

              There was no statistically significant difference between groups (mean difference 0.00, 95% CI -1.75 to 1.75).

              Forest plot from Cochrane Review

              Reference:
              Fergusson RJ, Lethaby A, Shepperd S, Farquhar C. Endometrial resection and ablation versus hysterectomy for heavy menstrual bleeding. Cochrane Database of Systematic Reviews 2013, Issue 11. Art. No.: CD000329. DOI: 10.1002/14651858.CD000329.pub2. [Review search date: October 2013]
            • Subgroup analysis 1.7.3: Quality of life - Euroqol score at 12 months
              Risk of bias of studies:

              The reviewers did not perform a GRADE assessment of the quality of the evidence. Both trials had a high risk of performance/detection bias, one had unclear random sequence generation, and one had an unclear risk of attrition bias.

              Narrative result:

              Two RCTs with 347 participants found no statistically significant difference between groups.

              Relative effect or mean difference:

              There was no statistically significant difference between groups (mean difference -3.24, 95% CI -8.35 to 1.88).

              Forest plot from Cochrane Review

              Reference:
              Fergusson RJ, Lethaby A, Shepperd S, Farquhar C. Endometrial resection and ablation versus hysterectomy for heavy menstrual bleeding. Cochrane Database of Systematic Reviews 2013, Issue 11. Art. No.: CD000329. DOI: 10.1002/14651858.CD000329.pub2. [Review search date: October 2013]
            • Subgroup analysis 1.7.4: Proportion with improvement in quality of life - General health at 12 months
              Risk of bias of studies:

              The reviewers did not perform a GRADE assessment of the quality of the evidence. The trial had a high risk of performance/detection bias and unclear allocation concealment, but a low risk of attrition bias.

              Narrative result:

              One RCT with 185 participants found that TCRE/ablation increased the proportion of people with improved quality of life compared with hysterectomy.

              Relative effect or mean difference:

              There was a statistically significant difference between groups, in favor of TCRE/ablation (RR 4.17, 95% CI 1.47 to 11.85).

              Forest plot from Cochrane Review

              Absolute effect:

              398 per 100 people (95% CI 140 to 1132) with TCRE/ablation compared with 96 per 100 people with hysterectomy.

              Reference:
              Fergusson RJ, Lethaby A, Shepperd S, Farquhar C. Endometrial resection and ablation versus hysterectomy for heavy menstrual bleeding. Cochrane Database of Systematic Reviews 2013, Issue 11. Art. No.: CD000329. DOI: 10.1002/14651858.CD000329.pub2. [Review search date: October 2013]
          • OUTCOME 1.8: Time to return to normal activity/work

            Narrative result:

            Studies assessing these outcomes could not be meta-analyzed owing to high statistical heterogeneity, which may be explained in part by clinical heterogeneity, namely differences in interventions (most notably, mode of hysterectomy). All studies reported that hysterectomy increased the time to return to normal activity and to work compared with TCRE/ablation. Click below for full details.

            Reference:
            Fergusson RJ, Lethaby A, Shepperd S, Farquhar C. Endometrial resection and ablation versus hysterectomy for heavy menstrual bleeding. Cochrane Database of Systematic Reviews 2013, Issue 11. Art. No.: CD000329. DOI: 10.1002/14651858.CD000329.pub2. [Review search date: October 2013]
            • Subgroup analysis 1.8.1: Time to return to normal activity (days)
              Risk of bias of studies:

              The reviewers did not perform a GRADE assessment of the quality of the evidence. All four trials had a high risk of performance/detection bias, two had unclear random sequence generation or allocation concealment, and one had an unclear risk of attrition bias.

              Narrative result:

              Four RCTS including a total of 632 women each reported a longer time to return to normal activity after hysterectomy compared with TCRE/ablation. A meta-analysis was not performed owing to high heterogeneity across the trials; mean difference ranged from -21 to -1.50 days.

              Relative effect or mean difference:

              The reviewers were unable to perform a meta-analysis so we report a narrative summary of the trials only.

              Reference:
              Fergusson RJ, Lethaby A, Shepperd S, Farquhar C. Endometrial resection and ablation versus hysterectomy for heavy menstrual bleeding. Cochrane Database of Systematic Reviews 2013, Issue 11. Art. No.: CD000329. DOI: 10.1002/14651858.CD000329.pub2. [Review search date: October 2013]
          • OUTCOME 1.9: Time to return to work (weeks)

            Risk of bias of studies:

            The reviewers did not perform a GRADE assessment of the quality of the evidence. All five trials had a high risk of performance/detection bias, three (60%) had unclear random sequence generation and/or allocation concealment, and one (20%) had an unclear risk of attrition bias.

            Narrative result:

            Of five RCTS with 683 women, four with 502 women reported a longer time to return to work after hysterectomy compared with TCRE/ablation. A meta-analysis was not performed owing to high heterogeneity across the trials; mean difference ranged from -2 to-9 weeks.

            Relative effect or mean difference:

            The reviewers were unable to perform a meta-analysis so we report a narrative summary of the trials only.

            Reference:
            Fergusson RJ, Lethaby A, Shepperd S, Farquhar C. Endometrial resection and ablation versus hysterectomy for heavy menstrual bleeding. Cochrane Database of Systematic Reviews 2013, Issue 11. Art. No.: CD000329. DOI: 10.1002/14651858.CD000329.pub2. [Review search date: October 2013]

            Additional Information:

            DOI

            10.1002/cca.373

            Publication Dates

            1. Published Online: 2 JUL 2014

            CCA derived from

            Fergusson RJ, Lethaby A, Shepperd S, Farquhar C. Endometrial resection and ablation versus hysterectomy for heavy menstrual bleeding. Cochrane Database of Systematic Reviews 2013, Issue 11. Art. No.: CD000329. DOI: 10.1002/14651858.CD000329.pub2. [Review search date: October 2013]

            How to Cite

            In women with heavy menstrual bleeding, is there randomized controlled trial evidence to support the use of endometrial resection and ablation instead of hysterectomy? Newton Opiyo (PhD) (on behalf of Cochrane Clinical Answers Editors). Cochrane Clinical Answers 2012. DOI: 10.1002/cca.373.

            Further Information

            • CCA Associate editor: Newton Opiyo (PhD), Clinical Epidemiologist, KEMRI-Wellcome Trust Research Programme, Nairobi, Kenya.
            • CCA Editor: Karen Pettersen. Correspondence to kpettersen@wiley.com.