Dataset Information

Efficacy and oncologic safety of nerve-sparing radical hysterectomy for cervical cancer: a randomized controlled trial.

ABSTRACT:

Objective

A prospective, randomized controlled trial was conducted to evaluate the efficacy of nerve-sparing radical hysterectomy (NSRH) in preserving bladder function and its oncologic safety in the treatment of cervical cancer.

Methods

From March 2003 to November 2005, 92 patients with cervical cancer stage IA2 to IIA were randomly assigned for surgical treatment with conventional radical hysterectomy (CRH) or NSRH, and 86 patients finally included in the analysis. Adequacy of nerve sparing, radicality, bladder function, and oncologic safety were assessed by quantifying the nerve fibers in the paracervix, measuring the extent of paracervix and harvested lymph nodes (LNs), urodynamic study (UDS) with International Prostate Symptom Score (IPSS), and 10-year disease-free survival (DFS), respectively.

Results

There were no differences in clinicopathologic characteristics between two groups. The median number of nerve fiber was 12 (range, 6 to 21) and 30 (range, 17 to 45) in the NSRH and CRH, respectively (p<0.001). The extent of resected paracervix and number of LNs were not different between the two groups. Volume of residual urine and bladder compliance were significantly deteriorated at 12 months after CRH. On the contrary, all parameters of UDS were recovered no later than 3 months after NSRH. Evaluation of the IPSS showed that the frequency of long-term urinary symptom was higher in CRH than in the NSRH group. The median duration before the postvoid residual urine volume became less than 50 mL was 11 days (range, 7 to 26 days) in NSRH group and was 18 days (range, 10 to 85 days) in CRH group (p<0.001). No significant difference was observed in the 10-year DFS between two groups.

Conclusion

NSRH appears to be effective in preserving bladder function without sacrificing oncologic safety.

SUBMITTER: Roh JW

PROVIDER: S-EPMC4397238 | biostudies-literature | 2015 Apr

REPOSITORIES: biostudies-literature

ACCESS DATA

Similar Datasets

Project description:Backgroud and objectiveNerve-sparing radical hysterectomy (NSRH) may be associated with lower postoperative morbidity than radical hysterectomy (RH). We aimed to compare the clinical efficacy and safety of abdominal or laparoscopic NSRH and RH for treating cervical cancer through systematic review and meta-analysis.MethodsPubMed, EMBASE, The Cochrane Library and the Chinese National Knowledge Infrastructure databases were systematically searched for all relevant studies. Data were abstracted independently by two reviewers. A meta-analysis was performed to compare intra- and postoperative outcomes for the two techniques.ResultsA total of 17 clinical trials were identified. Meta-analysis showed that although operating time was significantly longer for abdominal or laparoscopic NSRH than for RH, NSRH based on laparotomy or laparoscopy proved more effective for postoperative recovery of bladder function. NSRH was also associated with lower bladder dysfunction morbidity and fewer postoperative complications. Two abdominal trials and one laparoscopic study further suggested that NSRH was associated with shorter time to recovery of anal/rectal function. In contrast, RH and NSRH based on laparotomy or laparoscopy were similar in terms of extent of resection, recurrence rate, survival rate, blood loss and frequency of intraoperative complications. The meta-analysis showed that abdominal NSRH was not significantly different from RH in length of hospital stay, while one trial suggested that length of hospital stay was shorter after laparoscopic NSRH than after the corresponding RH.ConclusionNSRH may be a reliable technique for treating early cervical cancer. Available evidence suggests that it is better than RH for postoperative recovery of pelvic organ function and postoperative morbidity, while the two techniques involve similar clinical safety and extent of resection. These results should be considered preliminary since they are based on a relatively small number of controlled trials, most of which were non-randomized. The findings should be verified in larger, well-designed studies.

Project description:BackgroundRadical hysterectomy is one of the standard treatments for stage Ia2 to IIa cervical cancer. Bladder dysfunction caused by disruption of the pelvic autonomic nerves is a common complication following standard radical hysterectomy and can affect quality of life significantly. Nerve-sparing radical hysterectomy is a modified radical hysterectomy, developed to permit resection of oncologically relevant tissues surrounding the cervical lesion, while preserving the pelvic autonomic nerves.ObjectivesTo evaluate the benefits and harms of nerve-sparing radical hysterectomy in women with stage Ia2 to IIa cervical cancer.Search methodsWe searched the Cochrane Central Register of Controlled Trials (CENTRAL; 2018, Issue 4), MEDLINE via Ovid (1946 to May week 2, 2018), and Embase via Ovid (1980 to 2018, week 21). We also checked registers of clinical trials, grey literature, reports of conferences, citation lists of included studies, and key textbooks for potentially relevant studies.Selection criteriaWe included randomised controlled trials (RCTs) evaluating the efficacy and safety of nerve-sparing radical hysterectomy compared to standard radical hysterectomy for women with early stage cervical cancer (stage Ia2 to IIa).Data collection and analysisWe applied standard Cochrane methodology for data collection and analysis. Two review authors independently selected potentially relevant RCTs, extracted data, evaluated risk of bias of the included studies, compared results and resolved disagreements by discussion or consultation with a third review author, and assessed the certainty of evidence.Main resultsWe identified 1332 records as a result of the search (excluding duplicates). Of the 26 studies that potentially met the review criteria, we included four studies involving 205 women; most of the trials had unclear risks of bias. We identified one ongoing trial.The analysis of overall survival was not feasible, as there were no deaths reported among women allocated to standard radical hysterectomy. However, there were two deaths in among women allocated to the nerve-sparing technique. None of the included studies reported rates of intermittent self-catheterisation over one month following surgery. We could not analyse the relative effect of the two surgical techniques on quality of life due to inconsistent data reported. Nerve-sparing radical hysterectomy reduced postoperative bladder dysfunctions in terms of a shorter time to postvoid residual volume of urine ≤ 50 mL (mean difference (MD) -13.21 days; 95% confidence interval (CI) -24.02 to -2.41; 111 women; 2 studies; low-certainty evidence) and lower volume of postvoid residual urine measured one month following operation (MD -9.59 days; 95% CI -16.28 to -2.90; 58 women; 2 study; low-certainty evidence). There were no clear differences in terms of perioperative complications (RR 0.55; 95% CI 0.24 to 1.26; 180 women; 3 studies; low-certainty evidence) and disease-free survival (HR 0.63; 95% CI 0.00 to 106.95; 86 women; one study; very low-certainty evidence) between the comparison groups.Authors' conclusionsNerve-sparing radical hysterectomy may lessen the risk of postoperative bladder dysfunction compared to the standard technique, but the certainty of this evidence is low. The very low-certainty evidence for disease-free survival and lack of information for overall survival indicate that the oncological safety of nerve-sparing radical hysterectomy for women with early stage cervical cancer remains unclear. Further large, high-quality RCTs are required to determine, if clinically meaningful differences of survival exist between these two surgical treatments.