Surgical approaches to hysterectomy for benign gynaecological disease
Abstract
This is a protocol for a Cochrane Review (Intervention). The objectives are as follows:
The aim of this review is to assess the most appropriate surgical approach to hysterectomy, in terms of the outcome measures, when considering abdominal hysterectomy (AH), vaginal hysterectomy (VH), laparo‐vaginal hysterectomy (LVH) and laparoscopic hysterectomy (LH) for women with benign gynaecological conditions.
Background
Hysterectomy is the surgical removal of the uterus. The first reported elective hysterectomy was performed through a vaginal approach by Conrad Langenbeck in 1813. The first elective abdominal hysterectomy, a sub‐total operation (where the cervix was conserved), was performed by Charles Clay of Manchester in 1863 (Sutton 1997). These approaches remained the only two options until the latter part of the 20th century. The first laparoscopic‐assisted vaginal hysterectomy was performed by Harry Reich in 1989 (Reich 1989). He also reported the first total laparoscopic hysterectomy in 1993. These four different approaches ‐ abdominal hysterectomy (AH), vaginal hysterectomy (VH), laparo‐vaginal hysterectomy (LVH) (also widely referred to as laparoscopic assisted vaginal hysterectomy, LAVH) and laparoscopic hysterectomy (LH), remain the options of surgical approach to hysterectomy.
The abdominal approach (AH) has traditionally been the surgical approach for gynaecological malignancy, when other pelvic pathology is present such as endometriosis or adhesions, and in the context of an enlarged uterus. It remains the 'fallback option' if the uterus cannot be removed by another approach.
The vaginal approach (VH) was originally used only for prolapse, but has become more widely used for menstrual abnormalities such as dysfunctional uterine bleeding (DUB) when the uterus is fairly normal size. Compared to AH, VH was (and still is) regarded as less invasive and seemed to have the advantages of fewer blood transfusions, less febrile morbidity (fever) and less risk of injury to the ureter, but the disadvantages of more bleeding complications and greater risk of bladder injury (Harris 1996).
The laparo‐vaginal approach (LVH), an approach where part of the hysterectomy is performed by laparoscopic surgery and part vaginally, requires greater surgical expertise. The proportion of LVHs has gradually increased and, although the surgery takes longer, its proponents have argued that the main advantages are the possibility to diagnose and treat other pelvic diseases such as endometriosis, to carry out adnexal surgery including the removal of the ovaries, the ability to secure thorough intraperitoneal haemostasis (direct laparoscopic vision enables careful sealing of bleeding vessels at the end of the procedure) and a more rapid recovery time from surgery compared to AH (Garry 1998).
In the total laparoscopic approach there is no vaginal component and the uterus is removed entirely using a laparoscopic technique. This requires the highest degree of surgical skill and currently only a very small proportion of gynecologists are able to perform this type of surgery. It remains unclear whether LH offers any benefit over LVH. The laparoscopic approach lends itself to conservation of the cervix and, although it is possible to conserve the cervix in a LVH, there is a particular niche for sub‐total LH.
In common with the overall hysterectomy rate, the proportion of hysterectomies currently being performed by each of the above approaches varies markedly across countries, within the same country and even between individual surgeons working within the same unit. Women's expectations and individual surgeons' training and experience are factors underlying this. Even though VH has been widely considered to be the operation of choice for DUB, the VALUE Study showed that 74% of the hysterectomies performed in 1995 for this indication in the UK were AHs (Hall 1998). The surgical approach taken at hysterectomy continues to depend upon the experience and biases of the surgeon (Johns 1995). It was interesting to note in 1998 that there was not a single randomised controlled trial (RCT) comparing AH versus VH (Garry 1998). The introduction of the newer approaches to hysterectomy (LVH and LH) has stimulated a much greater interest in the proper scientific evaluation of all forms of hysterectomy.
Apart from the surgical approach to hysterectomy, other aspects of the surgical technique may have an effect on the outcome of surgery. Examples of this include total versus subtotal (where the cervix is not removed) hysterectomy; Doderlein VH or LVH versus standard VH or LVH; techniques to support the vaginal vault; bilateral elective oophorectomy versus ovarian conservation; other strategies, used mainly by those conducting laparoscopic surgery with the aim of reducing the likelihood of complications, include the use of vaginal delineators, rectal probes and illuminated ureteric stents. These other aspects will not be within the scope of this review (other than for assessing trial quality) which will focus simply on the different surgical approaches.
Objectives
The aim of this review is to assess the most appropriate surgical approach to hysterectomy, in terms of the outcome measures, when considering abdominal hysterectomy (AH), vaginal hysterectomy (VH), laparo‐vaginal hysterectomy (LVH) and laparoscopic hysterectomy (LH) for women with benign gynaecological conditions.
Methods
Criteria for considering studies for this review
Types of studies
Randomised controlled trials (RCTs) where one surgical approach to hysterectomy is compared with another.
Types of participants
Women undergoing hysterectomy for benign disease.
Exclusions ‐ women with gynaecological cancer. (Where trials include women with benign and women with malignant disease, authors will be requested for a breakdown in order to include only women with benign disease, but trials will be excluded if this information is not forthcoming.)
Sub‐groups of indication for hysterectomy will be considered.
Types of interventions
Surgical approach to removal of the uterus ‐ where at least one approach is compared with another from, for example, AH, VH, LVH and LH.
Sub‐total versus total hysterectomy is the scope of another Cochrane review and trials making this comparison will be excluded from this review. However, if some or all of the trial participants have a sub‐total hysterectomy, but the comparison is made between any of the 4 approaches outlined above, the trial will be included.
Types of outcome measures
Not all clinical outcome data are of equal importance when assessing the worth of a technique. It is not possible to define some of these outcomes as 'primary' without unduly imposing reviewer bias on the review, since the effect of certain approaches for many of the outcome measures is predictable. For example, LVH and LH are renowned to be associated with a longer operating time (a detrimental effect of this approach), but a shorter hospital stay (a beneficial effect).
The outcome measures will therefore be considered will be as follows:
Operating time
Immediate complications of surgery:
Surgical injury:
Bladder
Ureter
Bowel
Vascular
Short‐term outcomes:
Pain
Sequelae of bleeding:
Haemoglobin/haematocrit drop
Transfusion
Pelvic haematoma
Infection
Thrombo‐embolism
Perioperative mortality
Recovery from surgery:
Length of hospital stay
Return to normal activities
Long‐term outcomes:
Fistula
Pelvi‐abdominal pain
Urinary dysfunction
Bowel dysfunction
Pelvic floor condition (prolapse)
Sexual dysfunction
Satisfaction/quality of life
Data on the cost of treatment will be sought but will be described qualitatively and will not be included in the meta‐analysis, since 'cost' could be defined differently in different studies depending upon whether they incorporate the cost of sequelae. Different health‐care systems could produce markedly different results.
Search methods for identification of studies
All reports which describe (or might describe) RCTs of surgical approaches to hysterectomy will be obtained using the following search strategy.
1) The Menstrual Disorders & Subfertility Group's Specialised Register of controlled trials will be searched for any trials. See the Review Group for more details on the make‐up of the Specialised Register.
2) The following electronic databases will be searched using Ovid software;
Medline ‐ 1966 to date
Embase ‐ 1980 to date
Bio extracts ‐ 1980 to date
The Medline, Embase and Bioabstract databases will be searched using the following keywords:
1. Hysterectom$.tw.
2. Abdom$.tw.
3. Vaginal$.tw
4. Lap$ adj Assist$.tw
5. Lap$ adj vaginal$.tw
6. LAVH.tw
7. LVH.tw
8. Laparoscop$.tw
9. Or/2‐8
10. 1 and 9
11. Route.tw
12. Technique.tw
13. Approach.tw
14. Or/11‐13
15. 1 and 14
16. 10 and 15
17. exp clinical trials/
18. exp research design/
19. clinical trial.pt.
20. randomized controlled trial.pt.
21. (singl$ or doubl$ or trebl$ or tripl$).tw.
22. (mask$ or Blind$).tw.
23. 21 and 22
24. placebos/ or placebo.tw.
25. 17 or 18 or 19 or 20 or 23 or 24
26. 16 and 25
3) The Cochrane Controlled Trials Register (CCTR) on the current issue of the Cochrane Library will also be searched in all fields using the following words:
1. Hysterectomy
2. Abdominal
3. Vaginal
4. Laparoscopic assisted
5. Laparo‐vaginal
6. Laparoscopic
7. 1 and 2 or 3 or 4 or 5 or 6
4) The National Research Register (NRR), a register of ongoing and recently completed research projects funded by, or of interest to, the United Kingdom's National Health Service, as well as entries from the Medical Research Council's Clinical Trials Register, and details on reviews in progress collected by the NHS Centre for Reviews and Dissemination, will be searched for any trials with the following keywords:
1. Hysterectomy
2. Abdominal
3. Vaginal
4. Laparoscopic assisted
5. Laparo‐vaginal
6. Laparoscopic
7. 1 and 2 or 3 or 4 or 5 or 6
The Clinical Trials register, a registry of federally and privately funded US clinical trials will also be searched for the same keywords.
5) The citation lists of relevant publications, review articles, abstracts of scientific meetings and included studies will also be searched.
Data collection and analysis
Selection of trials
The selection of trials for inclusion in the review will be performed by two reviewers (NJ and AL) after employing the search strategy described previously. Differences of opinion will be resolved by consensus after consultation with a third reviewer (CF).
Trials will be excluded from the review if they made comparisons other than those specified above and these will be detailed in the table of excluded trials.
Quality assessment
Included studies will be assessed independently by two reviewers (NJ and AL) for the following quality criteria and methodological details. This information will be presented in a table describing the included studies and will provide a context for assessing the reliability of results. All RCTs will be included in the review, but sensitivity analyses will be performed to assess the stability of results with respect to the following.
(i) Where trials are not clearly third party randomised with adequate allocation concealment
(ii) Where the assessors of outcomes are not blinded.
(iii) Where trials compare a surgical approach performed by one surgeon with another surgical approach performed by a second surgeon (which cannot tease out the 'surgeon effect' from the effect of the surgical approach).
(A) Trial characteristics
a) Method of randomisation by Lilford's classification, in order of preference, as follows:
(i) third party randomisation, for example by pharmacy, computer or telephone
(ii) true randomisation by carer, for example by opaque numbered envelope or register
(iii) quasi (pseudo) randomisation
b) Study design:
(i) blinding
(ii) duration of follow‐up
(iii) type of follow‐up
c) Size of study:
(i) number of women recruited
(ii) number of women randomised
(iii) number of women excluded
(iv) number of women withdrawn and lost to follow‐up
(v) number of women analysed
d) Study setting
(i) Single‐centre or multicentre
(ii) Location
(iii) Timing and duration
(iv) Source of funding stated or not
e) Analyses
(i) Whether a power calculation was performed and adhered to
(ii) Whether 'intention to treat' analysis was performed by authors, possible from data but not performed by authors, not possible or uncertain
f) Criteria for hysterectomy
(i) Indications specified
(ii) Data broken down by indications for hysterectomy
(B) Characteristics of the study participants
a) Baseline characteristics
(i) Age
(ii) Parity
(iii) Indication for hysterectomy
(iv) Investigative work‐up, for example pelvic ultrasound scan, endometrial sampling
(v) Previous treatments
(vi) Exclusion criteria
b) Treatment characteristics
(i) Pre‐operative preparation, for example pre‐operative medical treatment
(ii) Level of training of surgeons
(C) Interventions
(a) Total or sub‐total hysterectomy
(b) Use of technique to support the vaginal vault
(c) Proportion undergoing bilateral elective oophorectomy versus ovarian conservation
(d) Other strategies to reduce the likelihood of complications
(e) Absence of co‐interventions in treatment and control groups
(f) If the trial compares a surgical approach performed by one surgeon with another surgical approach performed by a second surgeon.
(D) Outcomes
Operating time
Immediate complications of surgery:
Surgical injury:
Bladder
Ureter
Bowel
Vascular
Short‐term outcomes:
Pain
Sequelae of bleeding:
Haemoglobin/haematocrit drop
Transfusion
Pelvic haematoma
Infection
Thrombo‐embolism
Perioperative mortality
Recovery from surgery:
Length of hospital stay
Return to normal activities
Long‐term outcomes:
Fistula
Pelvi‐abdominal pain
Urinary function
Bowel function
Pelvic floor condition (prolapse)
Sexual function
Satisfaction/quality of life
Data Management
All data will be extracted independently by at least two reviewers and differences of opinion will be resolved by consensus after consultation with a third reviewer. Additional information on trial methodology or actual original trial data will be sought from the corresponding author of trials which appear to meet the eligibility criteria, when aspects of methodology are unclear, or where data are in a form unsuitable for meta‐analysis. Information on whether data was recorded which was not reported in the published paper will be sought routinely from the corresponding author for all included trials. Reminder correspondence will be sent if a reply is not received within four weeks.
Statistical Analysis
Statistical analysis will be performed in accordance with the guidelines for statistical analysis developed by the Menstrual Disorders and Subfertility Group. Statistical heterogeneity between the results of different studies will be examined by inspecting the scatter in the data points on the graphs and the overlap in their confidence intervals and, more formally, by checking the results of chi‐squared tests. The outcomes will be pooled statistically where no clinical heterogeneity is apparent.
Dichotomous data will be expressed as an odds ratio with 95% confidence intervals and combined for meta‐analysis with RevMan software using the Peto‐modified Mantel‐Haenszel method. An increase in the odds of a particular outcome will be displayed graphically in the meta‐analyses to the right of the centre‐line and a decrease in the odds of an outcome will be displayed graphically to the left of the centre‐line.
Continuous data will be combined for meta‐analysis with RevMan software using the weighted mean difference (WMD) with 95% confidence interval and a fixed effects model.
It is planned to perform sensitivity analyses to examine the stability of the results in relation to the following factors:
(i) exclusion of trials which are not clearly third party randomised with adequate allocation concealment;
(ii) exclusion of trials where the assessors of outcomes are not blinded
(iii) exclusion of trials comparing a surgical approach performed by one surgeon with another surgical approach performed by a second surgeon.
A search will be conducted for trials every twelve months and the review updated if new trials are found to be incorporated.
