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A C TA Obstetricia et Gynecologica

ACTA REVIE W

Radical trachelectomy versus radical hysterectomy for the


treatment of early cervical cancer: a systematic review
LI XU1 , FU-QING SUN2 & ZAN-HONG WANG2
1
Department of Respiratory Medicine, The First Affiliated Hospital of Chongqing Medical University, Chongqing, and
2
Department of Gynecology, The First Hospital, Shanxi Medical University, Taiyuan, PR China

Key words Abstract


Cervical cancer, radical trachelectomy, radical
hysterectomy, systematic review, controlled Objective. To assess the efficacy and safety of radical trachelectomy (RT) and radical
trail hysterectomy (RH) for patients with early cervical cancer. Design. Systematic review
with meta-analysis. Population. Women who had early cervical cancer. Methods.
Correspondence Prospective controlled clinical trials comparing RT with RH were identified using a
Zan-Hong Wang, Department of Gynecology,
predefined search strategy. Recurrence, five-year recurrence-free survival rate, five-
The First Hospital, Shanxi Medical University,
Taiyuan, 030001, PR China.
year overall survival rate, postoperative mortality, intraoperative and postoperative
E-mail: wangzanhong@126.com complications between the two operations were compared by using the methods
provided by the Cochrane Handbook for Systematic Reviews of Interventions. Re-
Conflict of interest sults. Three controlled clinical trials involving 587 participants were included. Meta-
The authors have stated explicitly that there analysis showed that there was no significant difference between the two groups in
are no conflicts of interest in connection with recurrence rate [1.38; 95% confidence interval (CI) 0.58–3.28, p=0.47], five-year
this article.
recurrence-free survival rate (1.17; 95% CI 0.54–2.53, p=0.69), five-year overall
survival rate (0.86; 95% CI 0.30–2.43, p=0.78), postoperative mortality (1.14; 95%
Received: 21 January 2011
Accepted: 21 June 2011 CI 0.42–3.11, p=0.80), intraoperative complications (1.66; 95% CI 0.11–25.28,
p=0.72), postoperative complications (0.52; 95% CI 0.11–2.48, p=0.41), blood
DOI: 10.1111/j.1600-0412.2011.01231.x transfusion (0.29; 95% CI 0.06–1.36, p=0.12) and number of harvested lymph
nodes. However, RT, compared with RH, reduced blood loss and shortened dura-
tion to normal urine residual volume and postoperative hospital stay. Moreover,
RT may achieve to normal conception rates, while RH makes patients sterile. Con-
clusions. Radical trachelectomy has similar efficacy and safety to RH as the surgical
treatment for early cervical cancer. Moreover, it reduced blood loss and shortened
the duration to normal urine residual volumes and postoperative hospital stay. Rad-
ical trachelectomy can be used to treat early stage cervical cancer as an alternative
operation for patients who wish to preserve fertility.

Abbreviations:CCT, controlled clinical trial; CI, confidence interval; CLS, capillary


lymphatic space; OR, odds ratio; RCT, randomized controlled trial; RH, radical
hysterectomy; RT, radical trachelectomy

cancer and a noticeable shift from more advanced to earlier


Introduction stage disease, together with late marriage, there will be an
Worldwide, cancer of the cervix is the second most com- increasing number of women who may wish to give birth
mon cancer in women and the leading cause of death among even if they are at risk of cervical cancer and thus possibly
gynecological cancers. Wertheim (1) first reported using ab- requiring hysterectomy. Approximately 15% of all cervical
dominal hysterectomy to treat early cervical cancer in 1900. cancers and 45% of surgically treated stage IB cancers occur
Nowadays, radical hysterectomy in combination with pelvic in women under the age of 40years (7). Small invasive cancer
lymphadenectomy has been extensively used to treat early has become a more frequently encountered clinical problem
cervical cancer (2–6). With the use of cervical carcinoma and is often diagnosed in women who wish to preserve their
screening, a decreased incidence and mortality from cervical childbearing prospects. It is a dilemma.


C 2011 The Authors

1200 Acta Obstetricia et Gynecologica Scandinavica 


C 2011 Nordic Federation of Societies of Obstetrics and Gynecology 90 (2011) 1200–1209
L. Xu et al. Efficacy and safety of radical trachelectomy

Daniel Dargent performed the first vaginal radical trach- Inclusion and exclusion criteria
electomy associated with laparoscopic pelvic lymphadenec-
The types of studies were comparative trials with recorded
tomy (LARVT or Dargent’s operation) in 1986 and described
oncological outcomes (recurrence, five-year recurrence-free
the approach in 1994 (8). This new surgical technique was
survival rate, five-year overall survival rate and postoperative
designed to effect a radical excision of the cervix (includ-
mortality), operative results (intraoperative and postopera-
ing the proximal part of parametrium and the upper vaginal
tive complications) and obstetrical outcomes were included.
cuff) while preserving the uterus corpus. In spite of initial
Noncomparative studies, case series, case reports and studies
disbelief, this new approach was picked up by centers in
using historical controls were excluded. Patients with Inter-
Europe and North America (8–11). The treatment of more
national Federation of Gynecology and Obstetrics (FIGO)
than 900 women with early stage cervical cancer who subse-
stage I–IIA cervical cancer were included from trials com-
quently gave birth to around 200 children has been reviewed
paring radical trachelectomy and radical hysterectomy. Trials
(12). Subsequently, radical trachelectomy (RT), a fertility-
in which patients had distant metastasis, synchronous malig-
preserving surgical technique, has gained ever-increasing
nancy in other organs, serious cardiovascular or respiratory
recognition as a safe oncological alternative to radical hys-
disorders, hepatic or renal failure were excluded. In the case
terectomy (RH) for early stage cervical cancer patients of
of overlap or duplicate studies, we retained only the most
childbearing age, and demand for this operation is likely to
comprehensive one. Trials were included. Trials comparing
grow in the future (13,14). However, it has not yet been fully
the results of these two operations but where the patients
evaluated as an alternative to RH. A new surgical approach
had also received preoperative or postoperative chemother-
for cancer can only be fully accepted if it matches the stan-
apy were excluded.
dard procedure, with regard to the extent of tissue removed,
All outcomes were defined prior to the literature search.
the number of harvested lymph nodes, the safety profile and
The primary outcomes were oncological results (recurrence,
the survival outcomes. We assessed the existing literature and
five-year recurrence-free survival rate, five-year overall sur-
conducted a meta-analysis to compare the clinical effective-
vival rate and postoperative mortality). The secondary out-
ness of these two operations.
comes were operative outcomes (operation time, blood loss
during operation, transfusion, intra-/postoperative compli-
cations and so on) and obstetrical outcomes.
Methods
Search strategy
Data extraction and statistical analyses
The methodology followed the Quality of Reporting of
Meta-analyses (QUORUM) statement (15). The following All data were extracted independently by two reviewers (FQS
databases were searched systematically: MEDLINE, EM- and ZHW), and differences of opinion were resolved by con-
BASE, PUBMED, SCIENCE-DIRECT, BIOSIS Previews, and sensus. Titles and abstracts were scanned first to make a list of
the China Biological Medicine Database (CBM) CNKI possibly related literature, and then full texts were obtained
(China National Knowledge Infrastructure Whole Article for those articles identified as either relevant or not clear, but
Database) from January 1994 to November 2010, as well only trials coincident with our predetermined criteria were
as the Cochrane Central Register of Controlled Trials (CEN- included.
TRAL) on the Cochrane Library issue 4, 2010. All controlled As there was no consensus about quality assessment of
trials comparing radical trachelectomy and radical hysterec- nonrandomized studies, the Cochrane Handbook for Sys-
tomy in the surgical treatment of cervical cancer were iden- tematic Reviews of Interventions, in which criteria for non-
tified. In this review, the following search terms were used: randomized studies were the same as randomized controlled
cervical cancer, cervical tumor, cervical carcinoma, uterine trials (RCTs), was used to assess the methodological qual-
cervical neoplasm, radical hysterectomy and radical trach- ity of included studies (16). The criteria included six items,
electomy. Both free text and a MeSH search for keywords as follows: (1) adequate sequence generation; (2) allocation
were used. The references for retrieved articles together with concealment; (3) blinding, defined as such if results of mea-
the proceedings of relevant conferences were hand-searched surements were masked and if regarded as of low risk with
in order to identify other potentially eligible studies for in- regard to both performance and detection bias (only wound
clusion in the analysis and missed by the initial search or degree of surgery and postoperative morbidity included, not
any unpublished data. Additional cross-searches were per- considering five-year survival rates and postoperative mor-
formed in MEDLINE and PUBMED using the names of in- tality); (4) incompletely addressed outcome data; (5) data free
vestigators who were the lead authors of at least one eligible of selective reporting; and (6) free of other bias. We consid-
study. ered missing outcome data in the categories <10% as low risk


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C 2011 Nordic Federation of Societies of Obstetrics and Gynecology 90 (2011) 1200–1209 1201
Efficacy and safety of radical trachelectomy L. Xu et al.

of bias, 10–15% as moderate risk of bias and >15% as high with reference to aspects of study design and quality, differ-
risk of bias. The results of quality assessment were classified ences in intervention and baseline characteristics of included
as follows: yes (low risk of bias); probably yes (moderate risk patients, by using methods of subgroup and sensitivity anal-
of bias); and no (high risk of bias). No rating of the studies ysis. Statistical analysis was performed using RevMan 5.0.18,
was performed; each was accepted or rejected based on the which was provided by the Cochrane Collaboration. Funnel
six items noted above. plots were drawn to assess publication bias.
Using a predefined data extraction form, two reviewers
(FQS and ZHW) extracted data about characteristics of in-
cluded studies and baseline characteristics of patients inde-
pendently, which included following items: the first author, Results
publication date, country of the investigators, number of
Selection of included studies
patients, interventions, age, recurrence, five-year recurrence-
free survival rate, five-year overall survival rate, postopera- Two trial assessors agreed on the selection of three CCTs.
tive mortality, operation time, blood loss during operation, The QUORUM flow diagram illustrates the main reasons for
transfusion, number of harvested lymph nodes, postoper- trial exclusions (Figure 1). The overall sample included 587
ative hospital stay, duration to normal urine residual vol- patients in these three CCTs (19–21) comparing RT with RH.
umes and obstetrical outcomes. If necessary, the authors of
the original articles were contacted for additional data. Final
agreement was achieved through discussion.
The individual and pooled statistics were calculated us- Description and risk of bias of included studies
ing the fixed effect model (Mantel–Haenszel method) (17), Characteristics of included studies, baseline characteristics of
but if a p-value of the heterogeneity test was less than patients and potential bias in included studies are listed in
0.1, a random-effect model was used. The results were ex- Tables 1–3, respectively. There were 248 patients in the RT
pressed with incidence odds ratio (OR) for dichotomous and 339 patients in the RH groups, and the sample size of
data and weighted mean differences for continuous data (16) studies ranged from 150 to 257 women. No randomization
(http://www.cochrane-handbook.org/), and 95% confidence and concealment of allocation were used. According to our
intervals (CI) were also calculated. Heterogeneity between in- definition of blinding, this was unclear in all three included
cluded studies was tested using I 2 statistics, which describes studies. Completeness of data was good; only Marchiole et al.
the percentage of total variation across studies that are due (21) recorded four patients lost to follow up (two in each
to heterogeneity rather than chance (18). The interpretation group). The description of selective reporting and other bias
of I 2 depends on the magnitude and direction of effects, as possibilities was not present in detail. Apart from a significant
well as the strength of evidence for heterogeneity (such as difference in age in the studies of Beiner et al. (20) and Diaz
p-value from the χ 2 test, or a confidence interval for I 2 ). If et al. (19), baseline characteristics were similar between RT
heterogeneity was present, we checked the potential reason and RH groups.

622 potentially eligible abstracts


from computer searches

606 abstracts excluded


Reasons: no valid survival data, reviews,
meta-analysis, retrospective studies

16 trials retrieved for detail

13 trials excluded
Reasons: low quality, duplicates,
retrospective design

Figure 1. Quality of Reporting of


3 prospective CCTs finally
Meta-analyses (QUORUM) flow chart for
included
studies on radical trachelectomy and radical
hysterectomy. CCT, controlled clinical trial.


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C 2011 Nordic Federation of Societies of Obstetrics and Gynecology 90 (2011) 1200–1209
L. Xu et al. Efficacy and safety of radical trachelectomy

Table 1. Characteristics of included studies on radical trachelectomy and radical hysterectomy.

Study (author, year) Country Date Design Methods Interventions

Diaz et al. (2008;19) USA November 2001 to CCT Single-center, parallel group, RT vs. RH
June 2007 prospective study without
randomization
Beiner et al. (2008;20) Canada March 1994 to July CCT Single-center, parallel group, RVT vs. RH
2007 prospective study without
randomization
Marchiole et al. (2007;21) France December 1986 to CCT Single-center, parallel group, LARVT vs. LARVH
December 2003 prospective study without
randomization

(continue) Patients Outcomes

RT: patients with stage IB1 cervical carcinoma Oncological outcomes, operative results, obstetrical
RH: all women with stage IB1 cervical carcinoma and who would have been eligible outcomes, OR, blood loss, blood transfusion, lymph
for a fertility-sparing alternative node count
RVT: all patients who sought preservation of fertility with cervical cancer, tumor size Oncological outcomes, operative results, OR, blood loss,
≤2cm, and did not meet Society of Gynecologic Oncologists’ definition of blood transfusion, hospital stay, time to normal urine
microinvasive cancer residual volume
RH: patients with stage IA and IB cervical cancer
LARVT: women affected by an early cervical cancer (stage I–IIA) Oncological outcomes, operative results, OR, blood
LARVH: patients with stage I–IIA cervical cancer transfusion, lymph node count

Abbreviations: CCT, controlled clinical trial; LARVH, laparoscopic assisted radical vaginal hysterectomy;, LARVT, laparoscopic assisted radical vaginal
trachelectomy; OR, operative time; RH radical hysterectomy; RT, radical trachelectomy; and RVT, radical vaginal trachelectomy.

Table 2. Baseline characteristics of patients in included studies.

Study (author, year)

Diaz et al. (2008; 19) Beiner et al. (2008; 20) Marchiole et al. (2007; 21)

Age (years) [mean (range)] 32(20–43) vs. 37(22–45), 31(20–44) vs. 34(19–44), –
p<0.001 p<0.01
Sample size 40 vs. 110 90 vs. 90 118 vs. 139
FIGO IB1 IA/IB I–IIA

Histology

SCC 20 vs. 57 NS 39 vs. 39 NS 90 vs. 102 NS


Adenocarcinoma/adenosquamous 20 vs. 52 50 vs. 50 25 vs. 33
Other – 1 vs. 1 3 vs. 4
CLS invasion 9 vs. 30 NS 61 vs. 61 NS 43 vs. 35 NS
Lymph node metastasis 6 vs. 6 NS 0 vs. 0 NS 5 vs. 6 NS
Follow up (months) [mean(range)] 44(3–201) 51 vs. 58 95(31–234) vs. 113(36–249)∗

Note: Results are presented as No. RT vs. No. RH.


Abbreviations: CLS, capillary lymphatic space; FIGO, International Federation of Gynecology and Obstetrics; NS, not significantly different; SCC,
squamous cell carcinoma.

There were two patients lost to follow up in each group.

Effects of interventions ity test was 0.15 (Figure 2). The recurrence rate in the radical
trachelectomy group was not higher than in the radical hys-
Two studies (437 patients) (20,21) reported postoperative
terectomy group. For postoperative mortality, the pooled OR
recurrence rates, and the pooled OR was 1.38 (95% CI
was 1.14 (95% CI 0.42–3.11, p=0.80), suggesting that there
0.58–3.28, p=0.47), suggesting that there was no significant
was no significant difference between the groups (p-value for
difference between the groups; the p-value of the heterogene-
heterogeneity test 0.32; Figure 2).


C 2011 The Authors

Acta Obstetricia et Gynecologica Scandinavica 


C 2011 Nordic Federation of Societies of Obstetrics and Gynecology 90 (2011) 1200–1209 1203
Efficacy and safety of radical trachelectomy L. Xu et al.

Table 3. Potential bias of included studies.

Adequate Incomplete
sequence Allocation outcome data Free of selective
Study (author, year) generation concealment Blinding addressed reporting Free of other bias

Diaz et al. (2008; 19) No No Probably yes Yes Probably yes Probably yes
Beiner et al. (2008; 20) No No Probably yes Yes Probably yes Probably yes
Marchiole et al. (2007; 21) No No Probably yes Yes Probably yes Probably yes

RT RH Odds Ratio Odds Ratio


Study or Subgroup Events Total Events Total Weight M-H, Fixed, 95% CI M-H, Fixed, 95% CI
1.1.1 Rate of recurrence
Beiner et al. (2008; 20) 5 90 1 90 10.8% 5.24 [0.60, 45.74]
Marchiole et al. (2007; 21) 7 118 9 139 89.2% 0.91 [0.33, 2.53]
Subtotal (95% CI) 208 229 100.0% 1.38 [0.58, 3.28]
Total events 12 10

Test for overall effect: Z = 0.73 (P = 0.47)

1.1.3 Post-operative mortality


Beiner et al. (2008; 20) 3 90 1 90 13.6% 3.07 [0.31, 30.08]
Marchiole et al. (2007; 21) 5 118 7 139 86.4% 0.83 [0.26, 2.70]
Subtotal (95% CI) 208 229 100.0% 1.14 [0.42, 3.11]
Total events 8 8

Test for overall effect: Z = 0.25 (P = 0.80)

0.01 0.1 1 10 100


Favours RT Favours RH

Figure 2. Comparisons of recurrence and postoperative mortality between radical trachelectomy (RT) and radical hysterectomy (RH).

The pooled OR for five-year recurrence-free survival in all risk of intraoperative and postoperative complications (Fig-
three studies was 1.17 (95% CI 0.54–2.53, p=0.69; p-value for ures 4 and 5).
heterogeneity 0.13; Figure 3). Five-year overall survival rate As we could not obtain the standard deviation (SD) of op-
could be estimated from two studies (437 patients) (20,21). erative time, blood loss, lymph node count, hospital stay and
The pooled OR was 0.86 (95% CI 0.30–2.43, p=0.78). There time to normal urine residual volumes from most included
was no difference between RT and RH (p-value for hetero- trials, pooled meta-analysis could not be done on these out-
geneity 0.53; Figure 3). comes, but they are listed in Table 4. In the study by Diaz
Two studies (20,21) could be used to estimate intraoper- et al. (19), the operating time of radical trachelectomy was
ative complications and postoperative overall complications significantly longer, but this was not the case in the two other
with pooled ORs of 1.66 (95% CI 0.11–25.28, p=0.72) and studies. Beiner et al. found no significant difference in oper-
0.52 (95% CI 0.11–2.48, p=0.41), respectively (p-value for ating time between RT and RH (20). In two studies (19,20),
heterogeneity 0.008 and 0.01; Figure 4 ), suggesting no differ- blood loss during the operation was compared, with a sig-
ence between the groups. Postoperative infectious and non- nificant difference between the groups (Table 4). All three
infectious complications showed pooled ORs of 0.46 (95% studies could be used to estimate the need for blood transfu-
CI 0.16–1.33, p=0.15) and 0.53 (95% CI 0.09–3.03, p=0.48), sions, with apooled OR of 0.29 (95% CI 0.06–1.36, p=0.12;
respectively (p-value for heterogeneity test 0.13 and 0.10). p-value for heterogeneity 0.02; Figure 6), suggesting no dif-
Compared with RH, RT neither increased nor decreased the ference. In two of the studies (19,21), the count of lymph


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1204 Acta Obstetricia et Gynecologica Scandinavica 


C 2011 Nordic Federation of Societies of Obstetrics and Gynecology 90 (2011) 1200–1209
L. Xu et al. Efficacy and safety of radical trachelectomy

RT RH Odds Ratio Odds Ratio


Study or Subgroup Events Total Events Total Weight M-H, Fixed, 95% CI M-H, Fixed, 95% CI
1.2.1 Five-year recurrence-free survival rate
Diaz et al. (2008; 19) 38 40 95 110 20.9% 3.00 [0.65, 13.75]
Beiner et al. (2008; 20) 86 90 90 90 36.8% 0.11 [0.01, 2.00]
Marchiole et al. (2007; 21) 113 118 132 139 42.3% 1.20 [0.37, 3.88]
Subtotal (95% CI) 248 339 100.0% 1.17 [0.54, 2.53]
Total events 237 317

Test for overall effect: Z = 0.40 (P = 0.69)

1.2.2 Five-year overall survival rate


Beiner et al. (2008; 20) 89 90 90 90 19.5% 0.33 [0.01, 8.20]
Marchiole et al. (2007; 21) 112 118 132 139 80.5% 0.99 [0.32, 3.03]
Subtotal (95% CI) 208 229 100.0% 0.86 [0.30, 2.43]
Total events 201 222

Test for overall effect: Z = 0.28 (P = 0.78)

0.01 0.1 1 10 100


Favours RH Favours RT

Figure 3. Comparisons of rates of five-year recurrence-free survival and five-year overall survival between radical trachelectomy (RT) and radical
hysterectomy (RH).

nodes removed was compared. Marchiole et al. (21), removed RH is a randomized control trial; however, such a study is not
more lymph nodes at RT than at RH (p<0.05), while in the feasible for several reasons, as follows: (1) the issues involved
other study there was no difference (19). Beiner et al. (22) re- in recruiting young patients with small tumors who are anx-
ported the hospital stay and duration to normal urine residual ious to preserve fertility is ethically difficult; (2) the sample
volumes, both of which were significantly shorter for RT. Only size required to detect a difference in the recurrence-free sur-
one study reported on pregnancy outcomes, i.e. a total of nine vival rate as small as 5% is approximately 1 000; and (3) few
pregnancies and four deliveries, one second-trimester mis- surgeons are sufficiently skilled to perform this procedure.
carriage and two terminations. Because there were too few Therefore, the next best methodology to evaluate the efficacy
included studies, we did not draw funnel plots to test for of this procedure is a case–control design. Three CCTs with
publication bias. almost 600 patients were included in our review. In the study
of John et al. (19), radical vaginal trachelectomy and radi-
Discussion cal abdominal trachelectomy were done in 40 patients with
The standard surgical management for early stage cervical stage IB1 cervical carcinoma, and included 28 radical vaginal
carcinoma is a radical abdominal hysterectomy and pelvic trachelectomies and 12 radical abdominal trachelectomies.
with or without para-aortic lymph node dissection, obvi- According to our inclusion criteria, the two processes both
ously eliminating the possibility of future conception. Radi- preserve fertility. Recurrences, five-year recurrence-free sur-
cal trachelectomy is a fertility-preserving procedure that has vival rates, five-year overall survival rates and postoperative
recently gained worldwide acceptance as a method of surgi- mortality were similar between the two operations. Com-
cally treating small invasive cancers of the cervix. We have pared with RH, blood loss, postoperative hospital stay and
compared oncological outcomes and operative results using time to normal urine residual volume were significantly re-
the method provided by the Cochrane Collaboration. The duced in RT; however, the operation time and lymph node
meta-analysis showed that RT has similar efficacy and safety count in RT were not analyzed in this review.
to RH for early cervical cancer surgical treatment. Heterogeneity was found between intra-/postoperative
Undoubtably, the most accurate method to answer the complications and blood transfusion in all three studies. Sev-
questions whether RT is more efficient and much safer than eral factors contributed to heterogeneity. Firstly, there was a


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Acta Obstetricia et Gynecologica Scandinavica 


C 2011 Nordic Federation of Societies of Obstetrics and Gynecology 90 (2011) 1200–1209 1205
Efficacy and safety of radical trachelectomy L. Xu et al.

RT RH Odds Ratio Odds Ratio


Study or Subgroup Events Total Events Total Weight M-H, Random, 95% CI M-H, Random, 95% CI
1.3.1 Rate of intra-operative complications
Beiner et al. (2008; 20) 12 90 2 90 49.1% 6.77 [1.47, 31.19]
Marchiole et al. (2007; 21) 3 118 8 139 50.9% 0.43 [0.11, 1.65]
Subtotal (95% CI) 208 229 100.0% 1.66 [0.11, 25.28]
Total events 15 10

Test for overall effect: Z = 0.37 (P = 0.72)

1.3.3 Rate of post-operative overall complications


Beiner et al. (2008; 20) 4 90 16 90 45.3% 0.22 [0.07, 0.67]
Marchiole et al. (2007; 21) 25 118 28 139 54.7% 1.07 [0.58, 1.95]
Subtotal (95% CI) 208 229 100.0% 0.52 [0.11, 2.48]
Total events 29 44

Test for overall effect: Z = 0.83 (P = 0.41)

1.3.4 Rate of post-operative noninfectious complications


Beiner et al. (2008; 20) 1 90 6 90 34.5% 0.16 [0.02, 1.33]
Marchiole et al. (2007; 21) 23 118 27 139 65.5% 1.00 [0.54, 1.87]
Subtotal (95% CI) 208 229 100.0% 0.53 [0.09, 3.03]
Total events 24 33

Test for overall effect: Z = 0.71 (P = 0.48)

0.01 0.1 1 10 100


Favours RT Favours RH

Figure 4. Comparisons of rates of intraoperative and postoperative complications between radical trachelectomy (RT) and radical hysterectomy (RH).

RT RH Odds Ratio Odds Ratio


Study or Subgroup Events Total Events Total Weight M-H, Fixed, 95% CI M-H, Fixed, 95% CI
1.4.1 Rate of post-operative infectious complications
Beiner et al. (2008; 20) 3 90 10 90 91.5% 0.28 [0.07, 1.04]
Marchiole et al. (2007; 21) 2 118 1 139 8.5% 2.38 [0.21, 26.57]
Subtotal (95% CI) 208 229 100.0% 0.46 [0.16, 1.33]
Total events 5 11

Test for overall effect: Z = 1.44 (P = 0.15)

0.01 0.1 1 10 100


Favours RT Favours RH

Figure 5. Comparison of rate of postoperative infectious complications between radical trachelectomy (RT) and radical hysterectomy (RH).

significant difference in patients’ age (19,20), though other ing curves of surgeons, performance bias might have been
baseline characteristics were similar, which suggested a poten- been introduced. Thirdly, as seen in Table 3, blinding was
tial selection risk. Secondly, surgical outcomes were related unclear in all included studies, so measurement bias might
to the experience of the surgeon (23). Considering the learn- exist. Although common in surgical clinical trials, this may


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1206 Acta Obstetricia et Gynecologica Scandinavica 


C 2011 Nordic Federation of Societies of Obstetrics and Gynecology 90 (2011) 1200–1209
L. Xu et al. Efficacy and safety of radical trachelectomy

Table 4. Comparisons of operative time, blood loss, lymph node count, postoperative hospital stay and duration to normal urine residual volume
between radical trachelectomy and radical hysterectomy.

Study (author, year)

Diaz et al. (2008; 19) Beiner et al. (2008; 20) Marchiole et al. (2007; 21)

Operative time 300(100–630) vs. 2.9(1.5–5) vs. 2.8(1.6–5)h, 179±54 vs. 187±53min, NS
[mean(range)/mean±SD] 240(134–450)min, p=0.023 p=0.75
Blood loss (ml) [mean(range)] 150(50–600) vs. 425(75–2700), 300(100–1100) vs. –
p<0.001 600(100–2300), p<0.001
Lymph node count 26(12–64) vs. 28(1–64), NS – 19±8(5–42) vs. 17±7(5–44),
[mean(range)/mean±SD] p<0.05
Postoperative hospital stay – 1(0–7) vs. 6(1–20), p<0.001 –
(days) [mean(range)]
Time to normal urine residual – 1(1–49) vs. 6(2–63), p<0.001 –
volume (days [mean(range)]

Abbreviation: NS, not significantly different.

RT RH Odds Ratio Odds Ratio


Study or Subgroup Events Total Events Total Weight M-H, Random, 95% CI M-H, Random, 95% CI
1.5.1 Rate of blood transfusion
Diaz et al. (2008; 19) 1 40 7 110 24.8% 0.38 [0.04, 3.17]
Beiner et al. (2008; 20) 2 90 21 90 32.6% 0.07 [0.02, 0.33]
Marchiole et al. (2007; 21) 15 118 24 139 42.6% 0.70 [0.35, 1.40]
Subtotal (95% CI) 248 339 100.0% 0.29 [0.06, 1.36]
Total events 18 52

Test for overall effect: Z = 1.57 (P = 0.12)

0.01 0.1 1 10 100


Favours RT Favours RH

Figure 6. Comparison of rate of blood transfusion between radical trachelectomy (RT) and radical hysterectomy (RH).

weaken the reliability of our results to some extent. Fourthly, The development of fertility-sparing surgery has provided
lost data could affect results, and there were two patients lost patients with early stage cervical carcinoma with the opportu-
to follow up in each group in one of the studies (21). Finally, nity to pursue conception after the treatment of their disease.
publication bias might exist with the small number of in- Beiner et al. (22) indicated that pregnancy rates for those
cluded studies. women who attempted conception were 41–79%. The rate of
There were some significant differences between the RT first-trimester miscarriage was 18% for the pooled data, simi-
and RH groups. Blood loss, time to normal urination and lar to that of the general population. Plante et al. (24) showed
postoperative hospital stay were significantly shorter in the that 31 of the women became pregnant (43%) and had a
RT group, similar to reports by other centers performing total of 50 pregnancies, including 10 miscarriages (eight first
RT (24), while there was no difference as regards intra- trimester and two second trimester), while Shepherd et al.
/postoperative complications, with the pooled ORs being 2.77 (26) reported that the five-year accumulated conception rate
(95% CI 0.35–22.19) and 0.55 (95% CI 0.18–1.69, p=0.30), was 52.8%. Diaz et al. (19) reported nine pregnancies, includ-
respectively. This suggests that RT is superior to RH to some ing three term cesarean sections, one late preterm delivery at
extent. Several studies (25–28) reported intraoperative com- 35weeks, one second-trimester spontaneous abortion and
plication rates in RT from 0 to 25%. In this review, there were two second-trimester terminations. However, Covens et al.
23 patients (9%) who suffered such complications, and 16 (11) noted five pregnancies among women, including three
(6%) had accidental cystotomy in the RT group. Monitoring term cesarean sections and two spontaneous first-trimester
complication rates continuously is important for any new abortions, yielding an actuarial conception rate of 37% at
surgical procedure. one year, a lower rate of conception.


C 2011 The Authors

Acta Obstetricia et Gynecologica Scandinavica 


C 2011 Nordic Federation of Societies of Obstetrics and Gynecology 90 (2011) 1200–1209 1207
Efficacy and safety of radical trachelectomy L. Xu et al.

It is important to evaluate emotional and sexual aspects as trachelectomy for early-stage cervical cancer. Am J Obstet
well as quality-of-life issues after surgery for malignant cer- Gynecol. 1998;179:1491–6.
vical tumors. Only one study has hitherto reported that these 11. Covens A, Shaw P, Murphy J, DePetrillo D, Lickrish G,
aspects did not differ significantly by type of surgery (29). We Laframboise S, et al. Is radical trachelectomy a safe
included prospective controlled clinical trials and retained alternative to radical hysterectomy for patients with
only the most comprehensive studies, which is different from stage IA-B carcinoma of the cervix? Cancer.1999;86:
a previous systematic review (30). Radical trachelectomy has 2273–9.
similar efficacy and safety to RH for early cervical cancer, but 12. Gien LT, Covens A. Fertility-sparing options for early stage
is associated with reduced blood loss, shorter time to resump- cervical cancer. Gynecol Oncol. 2010;117:350–7.
tion of urinary function and shorter postoperative hospital 13. Plante M. Vaginal radical trachelectomy: an update. Gynecol
stay. An important subset of young women with early stage Oncol. 2008;111:S105–10.
cervical cancer can benefit from a fertility-sparing surgical 14. Einstein MH, Park KJ, Sonoda Y, Carter J, Chi DS, Barakat
approach by radical trachelectomy. RR, et al. Radical vaginal versus abdominal trachelectomy for
stage IB1 cervical cancer: a comparison of surgical and
Funding pathologic outcomes. Gynecol Oncol. 2009;112:73–7.
15. Moher D, Cook DJ, Eastwood S, Olkin I, Rennie D, Stroup
The research was supported by the National Natural Science DF. Improving the quality of reports of meta-analyses of
Foundation of China (grant no. 30740016). randomised controlled trials: the QUOROM statement.
Quality of Reporting of Meta-analyses. Lancet.
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