|Laparoscopic hysterectomy in the treatment of endometrial cancer: a systematic review
|Granado de la Orden S, Reza M M, Blasco J A, Andradas E, Callejo D, Perez T
The authors concluded that laparoscopic surgery was equivalent or better than open surgery for women with endometrial cancer. Long–term results appeared similar but further research is required to confirm this. The authors’ conclusions appeared to reflect the limited evidence, but lack of reporting of review methods make it difficult to comment on the reliability of the review.
To compare the safety and efficacy of laparoscopic hysterectomy plus bilateral salpingo-oophorectomy, with or without lymphadenectomy, versus open surgery in women with endometrial cancer.
The Health Technology Assessment database, National Health Service Economic Evaluation Database (NHS-EED), DARE, the Cochrane Database of Systematic Reviews, MEDLINE, EMBASE, Pascal Biomed and CINAHL were searched to March 2007. Search terms were reported. In addition, reference lists from included studies were screened.
Randomised controlled trials (RCTs), systematic reviews of RCTs and health technology assessment reports, that compared laparoscopic surgery versus open surgery in women with endometrial cancer were eligible for inclusion. The review assessed short-term efficacy (number of glands resected; duration of surgery; length of hospital stay; and need to convert to laparotomy), short-term safety (blood loss during surgery and complications) and long-term outcomes (overall survival; disease-free survival; recurrence of disease and development of metastases; and quality of life).
All of the included trials compared laparoscopically assisted vaginal hysterectomy plus bilateral salpingo-oophorectomy, with or without lymphadenectomy, with total abdominal hysterectomy. In all but one of the included trials patients had Federation of Gynaecology and Obstetrics (FIGO) stage I endometrial cancer (limited to the body of uterus); one trial included a minority of women with stage II or III disease. Where reported, the mean age of patients ranged from 55 to 67 years and the duration of follow-up ranged from six to 44 months.
The authors did not state how papers were selected for the review, or how many reviewers performed the selection.
Assessment of study quality
Internal and external validity were assessed using randomisation, blinding, follow-up, analyses, quality of results and their applicability. In addition the quality of the evidence was graded using the SIGN (Scottish Intercollegiate Guidelines Network) criteria.
The authors did not state how many reviewers assessed validity.
For each trial, percentages of patients were reported for long-term outcomes and percentages or means with standard deviations were reported for short-term outcomes.
The authors did not state how many reviewers performed the data extraction.
Methods of synthesis
The trials were grouped by type of outcome and combined in a narrative synthesis.
Results of the review
Four randomised controlled trials (RCTs) were included (n=319 patients). Sample sizes ranged from 52 to 122. The trials were judged to be good quality. Two RCTs were considered to be at low risk of bias (adequate methods of randomisation; well defined inclusion and exclusion criteria; intention-to-treat analysis; high number of patients; and follow-up 6 and 44 months; one was single blinded; and one not blinded). However, it could be argued that sample sizes were not large. The other two RCTs had a greater risk of bias (smaller sample size; randomisation method not reported; and neither was blinded).
Short-term results: Between 6.9% and 12.5% of patients were converted to open surgery. Two RCTs reported a significantly longer duration of surgery with laparoscopic surgery and the other two reported no significant difference. The number of resected lymph glands was similar for laparoscopic surgery and open surgery. All RCTs reported significantly reduced blood loss with laparoscopic surgery.
One trial reported no significant difference in the degree of immediate post-operative pain between laparoscopic surgery and open surgery, but laparoscopic surgery patients required less analgesia at hospital discharge. All RCTs reported fewer post-operative complications in laparoscopic surgery patients; in two RCTs the reduction was statistically significant. Laparoscopic surgery was associated with fewer post-operative complications (four RCTs; in two trials the reduction was statistically significant), fewer days on intravenous fluids (one RCT) and a significantly shorter time till resumption of normal activity (one RCT).
Long-term results: Overall, disease-free and cause specific survival were similar for laparoscopic surgery and open surgery patients at 44 months (one RCT). Overall postoperative quality of life was significantly better in laparoscopic surgery compared to open surgery patients (one RCT).
Four economic studies examined total costs and reported different results. Two studies reported significantly lower costs for laparoscopic surgery. One study reported significantly lower costs for open surgery. In one study, the difference was not statistically significant. None of the studies took account of indirect costs.
Short-term results for laparoscopic surgery were equivalent or better than open surgery in women with endometrial cancer, whereas long-term results seemed equivalent for both types of surgery. More studies are required.
The review question was clearly stated and inclusion criteria appropriately specified. Several relevant sources were searched, but it was not clear if attempts were made to minimise publication and language bias. Methods used to select studies, assess validity and extract data were not described, so it is not known whether efforts were made to reduce reviewer error and bias. Only RCTs were included, study validity was assessed and results were reported. Combining the small number of trials in a narrative synthesis was appropriate. Only four generally small RCTs were identified; these provided limited data for a variety of different outcomes. The authors’ conclusions appeared to reflect the limited evidence, but lack of reporting of review methods make it difficult to comment on the reliability of the review.
Implications of the review for practice and research
Practice: The authors stated that review findings were only applicable to women with stage I Federation of Gynaecology and Obstetrics(FIGO) endometrial cancer and that women with a transverse uterine diameter greater than 8 cm, clinically advanced disease, other malignant or pre-malignant disease or other important health problems, are not candidates for laparoscopic surgery.
Research: The authors stated that more good quality studies are required, to compare long-term outcomes (such as mortality and recurrence rates) for laparoscopic versus open surgery in women with endometrial cancer, before laparoscopic surgery can be considered the treatment of choice. Economic studies that evaluate cost-effectiveness are also required. The authors also stated that two additional clinical trials in this field are underway (the Gynaecologic Oncology Group trial and the LACE trial - Janda 2006, see other Publications of Related Interest field).
Granado de la Orden S, Reza M M, Blasco J A, Andradas E, Callejo D, Perez T. Laparoscopic hysterectomy in the treatment of endometrial cancer: a systematic review. Journal of Minimally Invasive Gynecology 2008; 15(4): 395-401
Other publications of related interest
Janda M, Gebski V, Forder P, et al. Total laparoscopic versus open surgery for stage 1 endometrial cancer: the LACE randomized controlled trial. Contemp Clin Trials. 2006;27:353-63.
Subject indexing assigned by NLM
Endometrial Neoplasms /mortality /surgery; Fallopian Tubes /surgery; Female; Humans; Hysterectomy /adverse effects /methods; Laparoscopy; Length of Stay; Lymph Node Excision; Ovariectomy; Postoperative Complications /epidemiology; Quality of Life; Randomized Controlled Trials as Topic; Treatment Outcome
Date bibliographic record published
Date abstract record published
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.