The review found no significant differences in five-year overall or progression-free survival rates between radical vaginal trachelectomy and radical hysterectomy for early cervical cancer. After radical vaginal trachelectomy there was less blood loss, fewer blood transfusions and shorter hospital stay. Given limitations in the review, including lack of information about study design or validity, these conclusions require cautious interpretation.

To compare radical vaginal trachelectomy and radical hysterectomy for early stage cervical cancer.

MEDLINE, Cochrane Central Register of Controlled Trials (CENTRAL), Wanfang and Chinese National Knowledge Infrastructure (CNKI) were searched up to January 2010. Search terms were reported.

Controlled trials that compared radical vaginal trachelectomy and radical hysterectomy in women with early stage cervical cancer (International Federation of Gynaecology and Obstetrics stage 1A-1B1) were eligible for inclusion.

The primary outcomes reported by the review were five-year overall survival rate and five-year progression-free survival rate. Secondary outcomes were blood loss, requirement for blood transfusion, duration of operation, duration of hospital stay, and intraoperative and postoperative complications

The included trials were set in Canada, Italy and the UK. The authors noted that few details about participant characteristics or clinical details were reported in the primary studies. Other trial characteristics were not described in the review.

Two reviewers independently selected the studies, with disagreements resolved by discussion.

The authors did not state that they assessed trial validity.

For dichotomous outcomes, relative risks (RRs) were extracted or calculated for each study, with 95% confidence intervals (CIs). For continuous outcomes, means were extracted for each comparison group in each trial.

Two reviewers independently extracted the data, with disagreements resolved by discussion.

Trials were combined to calculate pooled relative risks and 95% confidence intervals. Heterogeneity was assessed using Χ² and I². A fixed-effect model was used unless there was significant heterogeneity (defined as p<0.10 or I² over 50%), in which case a random-effects model was used. Continuous data were not pooled but were reported in narrative synthesis.

Five trials were included in the review (n=1,195 women, range 79 to 588). There were 303 women in the radical vaginal trachelectomy groups and 892 women in the hysterectomy groups.

There was no significant difference between the groups in five-year progression-free survival rate (RR 0.99, 95% CI 0.95 to 1.02; four trials; I²=0%) or five-year overall survival rate (RR 0.97, 95% CI 0.93 to 1.02; three trials; I²=27%).

Findings on the operation time were inconsistent. Two trials found that radical vaginal trachelectomy took significantly longer, while two found no significant difference between the groups.

Radical vaginal trachelectomy was associated with a shorter hospital stay (four trials), lower blood loss (three of four trials) and lower likelihood of blood transfusion (RR 0.33, 95% CI 0.12 to 0.90; five trials; I²=72%; random-effects model). There was no significant difference between the groups in the rate of intraoperative complications (five trials) or postoperative complications (four trials).

There were no significant differences in five-year overall survival rates or five-year progression-free survival rates between radical vaginal trachelectomy and radical hysterectomy for early cervical cancer. After radical vaginal trachelectomy there was less blood loss, fewer blood transfusions and shorter hospital stay.

The objectives of the review were clear. The inclusion criteria were mostly clear, but were insufficiently explicit on eligible study designs. The unequal numbers in the two groups in most studies suggested that they were not randomised; it was unclear whether they were prospective or retrospective. Some relevant sources were searched for studies, but no non-electronic sources were searched, and it was not stated whether there was any restriction by language or publication status. Steps were taken to minimise the risk of reviewer bias and error by more than one reviewer independently selecting studies and extracting the data.

Trial quality did not appear to have been assessed. Lack of information on trial characteristics (including design and validity) made it difficult to assess the applicability or reliability of trial findings. Appropriate methods were used to combine dichotomous data and assess statistical heterogeneity. When significant heterogeneity was detected, a random-effects model was used, but possible reasons for heterogeneity were not explored. It was unclear why continuous data were not pooled. No statistical data (such as p values) were reported for differences between the groups in continuous outcomes. As the authors noted, the included trials were relatively small, with limited follow-up information; they had low power to show a survival difference between the two interventions.

Given the limitations in the review, including lack of information about study design or quality, the authors' conclusions require cautious interpretation

Practice: The authors stated that radical vaginal trachelectomy should be considered as a viable treatment for women with early cervical cancer who wish to preserve their fertility.

Research: The authors stated that large high quality RCTs with adequate follow-up were needed to assess radical vaginal trachelectomy

Not stated.

This is a critical abstract of a systematic review that meets the criteria for inclusion on DARE. Each critical abstract contains a brief summary of the review methods, results and conclusions followed by a detailed critical assessment on the reliability of the review and the conclusions drawn.