This generally well-conducted review concluded that robot-assisted fundoplication was safe and effective for treating gastro-oesophageal reflux disease, but it prolonged the surgery time. However, these conclusions need to be considered in the light of the poor quality and small sizes of the included trials.

To review the evidence for robot-assisted laparoscope fundoplication in the treatment of gastro-oesophageal reflux disease.

PubMed, EMBASE, Science Citation Index (SCI), Chinese Biomedical Database, China Academic Journals, Chinese Scientific Journals Database, China Online Journals and the Cochrane Library were searched up to November 2008 for studies published in English. Search terms were reported. Relevant journals in the field were searched. Investigators were contacted to locate ongoing and unpublished studies. Reference lists were scanned.

Randomised controlled trials (RCTs) or quasi-RCTs that compared robot-assisted fundoplication with conventional laparoscopic fundoplication for the treatment of gastro-oesophageal reflux disease were included. Eligible trials had to report surgical complications, operation time, total cost, duration of hospital stay and other relevant information. Eligible participants had to have operable pathological gastro-oesophageal reflux documented by stereoscopy, 24-hour pH measurements, barium swallow and oesophageal manometry. Trials without raw data or a clearly defined dissection type were excluded.

The mean age of included patients ranged from 38 to 52 years; their mean body mass index ranged from 24.8 to 29.2kg/m². The proportion of men ranged from 55 to 71%.

Searches and study selection were conducted independently by two reviewers, with disagreements resolved by referral to a third reviewer.

Two reviewers independently assessed trial quality using criteria adapted from the Cochrane Handbook. The assessment covered the method of sequence generation, allocation concealment, blinding, incomplete outcome data, selective outcome reporting and other potential threats to validity.

Results for binary outcomes (such as surgical complications) were used to calculate relative risks (RRs) with 95% confidence intervals (CIs). Results for continuous outcomes (such as duration of hospital stay) were used to calculate mean differences (MDs) with 95% confidence intervals. Authors were also interviewed by telephone to obtain additional information.

Data were extracted independently by two reviewers, with disagreements resolved by referral to a third reviewer.

In the absence of heterogeneity, individual trial results were pooled using fixed-effect meta-analysis; where there was heterogeneity, a random-effects meta-analysis was used. Heterogeneity between the trials was assessed using χ² and I².

Sensitivity and subgroup analyses were used to explore reasons for heterogeneity.

Five RCTs were included in the review (n=181 patients, range from 20 to 50). Two trials reported adequate methods of randomisation and allocation concealment. One trial was single-blind. All trials had incomplete outcome data and selective outcome reporting.

No statistically significant differences were seen between robot-assisted fundoplication and conventional laparoscopic fundoplication for any surgical complication including intraoperative complications, conversion to open surgery, dysphagia, pneumothorax and postoperative antisecretory medication. Heterogeneity was low for all these outcomes (I² ranged from zero to13%)

Robot-assisted fundoplication prolonged the duration of surgery compared with conventional laparoscopic fundoplication, with a mean difference of 3.17 minutes (95% CI 2.44 to 4; two RCTs; I²=24%).

There were no significant differences between robot-assisted fundoplication and conventional laparoscopic fundoplication for the time needed for hiatal dissection, time from incision to completion of sutures, total operation time, duration of hospital stay, and total costs. Heterogeneity for all these outcomes was high (I² ranged from 82 to 97%).

Two trials reported total cost in Euros. The pooled results showed no significant difference between robot-assisted fundoplication and conventional laparoscopic fundoplication with a mean difference of 6.39 Euros (95% CI -4.61 to 17.39; I²=96%)

Robot-assisted fundoplication was safe and effective for treating gastro-oesophageal reflux disease, but it prolonged the fundoplication time. However, robot-assisted fundoplication should be the future trend for treatment.

This review had a clearly stated research question and specified the inclusion criteria for study design, interventions, participants and outcomes. The literature search covered a number of relevant databases. Efforts were made to locate unpublished studies, but only studies published in English were included, so the review was at risk of language and publication bias. All the review methods were performed by two reviewers independently to reduce error or bias.

Trial quality was assessed using an appropriate tool for randomised trials and the results were reported in full. The methods of meta-analysis were generally appropriate, although in cases of extremely high heterogeneity the pooled results may be doubtful. The authors could have performed a more thorough investigation of possible causes of the heterogeneity.

The general conduct of this review was good, but the authors' conclusions need to be considered in the light of the poor quality and small sizes of the included trials.

Practice: The authors stated that robot-assisted fundoplication should be the future treatment for gastro-oesophageal reflux disease.

Research: The authors stated that well-designed large high-quality trials are needed that measure long-term outcomes.

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.