Trial reportSurgical endoscopy2013
Prospective, randomized clinical trial comparing the use of a single-port device with that of a flexible endoscope with no other device for transumbilical cholecystectomy: LLATZER-FSIS pilot study.
Trial report in Surgical endoscopy, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01558414 (Prospective Randomized Clinical Trial Comparing Single Incision Laparoscopic Surgery vs Flexible Single Incision Surgery on Cholecystectomy), which is not on this map. Cited by 11 papers, 7 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Prospective Randomized Clinical Trial Comparing Single Incision Laparoscopic Surgery vs Flexible Single Incision Surgery on Cholecystectomy
Who cites it
11 citing papers in PubMed, 7 syntheses or guidelines pooled it, 21 citations in OpenAlex.
- Comparison of single-incision and traditional laparoscopic surgery for the risk of incisional hernia: a systematic review and meta-analysis of randomized controlled trials.Updates in surgery · 2026Pooled it
- Single-incision versus conventional multiport laparoscopic cholecystectomy: a current meta-analysis of randomized controlled trials.Surgical endoscopy · 2020Pooled it
- Incidence of incisional hernias following single-incision versus traditional laparoscopic surgery: a meta-analysis.Hernia : the journal of hernias and abdominal wall surgery · 2019Pooled it
- Single-incision surgery trocar-site hernia: an updated systematic review meta-analysis with trial sequential analysis by the Minimally Invasive Surgery Synthesis of Interventions Outcomes Network (MISSION).Surgical endoscopy · 2018Pooled it
- The use of expanding ports in laparo-endoscopic single-site surgery may cause more pain: a meta-analysis of randomized clinical trials.Surgical endoscopy · 2017Pooled it
- Single-incision laparoscopic cholecystectomy with curved versus linear instruments assessed by systematic review and network meta-analysis of randomized trials.Surgical endoscopy · 2016Pooled it
- Single-incision laparoscopic surgery through the umbilicus is associated with a higher incidence of trocar-site hernia than conventional laparoscopy: a meta-analysis of randomized controlled trials.Hernia : the journal of hernias and abdominal wall surgery · 2016Pooled it
- Midline incisional hernia guidelines: the European Hernia Society.The British journal of surgery · 2023Article
- Single-incision Laparoscopic Gastrectomy for Gastric Cancer.Journal of gastric cancer · 2017Review
- Comparison of single-port and reduced-port totally laparoscopic distal gastrectomy for patients with early gastric cancer.Surgical endoscopy · 2016Article
- Single-incision laparoscopic surgery for biliary tract disease.World journal of gastroenterology · 2016Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundNatural orifice transumbilical endoscopic surgery (NOTES) is a technique still in experimental development that requires clinical trials to assess its safety and efficacy. We present a pilot prospective, randomized, three-arm clinical trial of 1-year duration that was conducted as a noninferiority trial comparing single-incision laparoscopic surgery (SILS) and flexible single-incision surgery (FSIS) with conventional laparoscopy for elective cholecystectomy (NCT01558414).
methodsSixty patients between aged 18 and 65 years who were eligible for elective cholecystectomy were randomly assigned in a 1:1:1 ratio (n = 20 per group): group A (SILS), single-incision endoscopic surgery using a transumbilical SILS™ device; group B (FSIS), single-incision transumbilical surgery using a flexible endoscope; and group C (CL), conventional laparoscopy. The main outcome variable of the study was "parietal complications" (wound infection, bleeding, and ventral hernia). The analysis was by intention to treat and attritions were not replaced.
resultsCholecystectomy was performed in 100 % of the cases; perioperative complications occurred in only 1.6 % of the cases, and umbilical surgical wound infection in 3.33 %, with no differences between groups. After a minimum follow-up of 1 year, no differences were noted in the frequency of parietal complications and no ventral hernias occurred. Postoperative pain, hospital length of stay, and downtime from work were similar in all three groups. Surgical time was longer in cases in which a single-incision transumbilical approach was used (58.95 min for SILS and 54.15 for FSIS vs. 49.21 for laparoscopy).
conclusionsSingle-incision transumbilical approaches are not inferior for safety or effectiveness compared with conventional laparoscopy. The transumbilical approach using a flexible endoscope is just as effective and safe as the other two procedures and is a promising single-incision approach.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.