Trial reportSurgical endoscopy2012
Prospective randomized clinical trial comparing laparoscopic cholecystectomy and hybrid natural orifice transluminal endoscopic surgery (NOTES) (NCT00835250).
Trial report in Surgical endoscopy, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04048421 (A Phase II Study to Evaluate the Feasibility and Safety of Hybrid Transvaginal Natural Orifice Transluminal Endoscopic Surgery for Treatment of Patients With Colon Cancer), which is not on this map. Cited by 38 papers, 7 of them syntheses that pooled it.
What it found
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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.
A Phase II Study to Evaluate the Feasibility and Safety of Hybrid Transvaginal Natural Orifice Transluminal Endoscopic Surgery for Treatment of Patients With Colon Cancer
Who cites it
38 citing papers in PubMed, 7 syntheses or guidelines pooled it, 69 citations in OpenAlex.
- 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
- Safety Outcomes of NOTES Cholecystectomy Versus Laparoscopic Cholecystectomy: A Systematic Review and Meta-Analysis.Surgical laparoscopy, endoscopy & percutaneous techniques · 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
- Safety of transvaginal hybrid NOTES cholecystectomy: a systematic review and meta-analysis.Surgical endoscopy · 2015Pooled it
- Transvaginal cholecystectomy vs conventional laparoscopic cholecystectomy for gallbladder disease: A meta-analysis.World journal of gastroenterology · 2015Pooled it
- Fewer-than-four ports versus four ports for laparoscopic cholecystectomy.The Cochrane database of systematic reviews · 2014Pooled it
- Single incision versus conventional laparoscopic cholecystectomy outcomes: a meta-analysis of randomized controlled trials.PloS one · 2013Pooled it
- Comparison of postoperative pain at umbilical wound after conventional laparoscopic cholecystectomy between transumbilical and infraumbilical incisions: a randomized control trial.Surgical endoscopy · 2019Trial
- Systematic analysis of the safety and benefits of transvaginal hybrid-NOTES cholecystectomy.World journal of gastroenterology · 2015Trial
- Transvaginal/transumbilical hybrid--NOTES--versus 3-trocar needlescopic cholecystectomy: short-term results of a randomized clinical trial.Annals of surgery · 2015Trial
- Trial
- Potential benefits of single-port compared to multiport laparoscopic inguinal herniorraphy: a prospective randomized controlled study.Hernia : the journal of hernias and abdominal wall surgery · 2014Trial
- Transvaginal hybrid NOTES cholecystectomy--results of a randomized clinical trial after 6 months.Langenbeck's archives of surgery · 2014Trial
- Postoperative pain after transvaginal cholecystectomy: single-center, double-blind, randomized controlled trial.Surgical endoscopy · 2014Trial
- Evolution of minimally invasive cholecystectomy: a narrative review.BMC surgery · 2024Review
- Endoscopic Management of Benign Gallbladder Diseases.The Turkish journal of gastroenterology : the official journal of Turkish Society of Gastroenterology · 2024Review
- Midline incisional hernia guidelines: the European Hernia Society.The British journal of surgery · 2023Article
- Article
- An Observational Study Comparing Hybrid Transvaginal Notes and Four-Port Laparoscopic Cholecystectomy.Cureus · 2023Article
- Women's Perception of Transgastric and Transvaginal Natural Orifice Transluminal Endoscopic Surgery (NOTES) - Impact of Medical Education, Stage of Life and Cross-Cultural Aspects.International journal of women's health · 2022Article
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Authors and funding
5 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
BACKGROUND AND STUDY
aimsNatural orifice transluminal endoscopic surgery (NOTES) is a technique still in experimental development whose safety and effectiveness call for assessment through clinical trials. In this paper we present a three-arm, noninferiority, prospective randomized clinical trial of 1 year duration comparing the vaginal and transumbilical approaches for transluminal endoscopic surgery with the conventional laparoscopic approach for elective cholecystectomy. PATIENTS AND
methodsSixty female patients between the ages of 18 and 65 years who were eligible for elective cholecystectomy were randomized in a ratio of 1:1:1 to receive hybrid transvaginal NOTES (TV group), hybrid transumbilical NOTES (TU group) or conventional laparoscopy (CL group). The main study variable was parietal complications (wound infection, bleeding, and eventration). The analysis was by intention to treat, and losses were not replaced.
resultsCholecystectomy was successfully performed on 94% of the patients. One patient in the TU group was reconverted to CL owing to difficulty in maneuvering the endoscope. After a minimum follow-up period of 1 year, no differences were noted in the rate of parietal complications. Postoperative pain, length of hospital stay, and time off from work were similar in the three groups. No patient developed dyspareunia. Surgical time was longer among cases in which a flexible endoscope was used (CL, 47.04 min; TV, 64.85 min; TU, 59.80 min).
conclusionsNOTES approaches using the flexible endoscope are not inferior in safety or effectiveness to conventional laparoscopy. The transumbilical approach with flexible endoscope is as effective and safe as the transvaginal approach 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.