Trial reportTrials2014
The transvaginal hybrid NOTES versus conventionally assisted laparoscopic sigmoid resection for diverticular disease (TRANSVERSAL) trial: study protocol for a randomized controlled trial.
Trial report in Trials, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.
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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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
7 citing papers in PubMed, 12 citations in OpenAlex.
- Worldwide research tendencies on natural orifice transluminal endoscopic surgery: a bibliometric analysis.Frontiers in surgery · 2026Article
- Natural Orifice Specimen Extraction Surgery versus Conventional Laparoscopic-Assisted Resection in the Treatment of Colorectal Cancer: A Propensity-Score Matching Study.Cancer management and research · 2021Article
- Transvaginal hybrid-NOTES vs. traditional laparoscopic sigmoid resection for diverticulitis: a short-term comparative study.Scientific reports · 2020Article
- International consensus on natural orifice specimen extraction surgery (NOSES) for colorectal cancer.Gastroenterology report · 2019Article
- Hysterectomy and salpingo-oophorectomy by transvaginal natural orifice transluminal endoscopic surgery (V-NOTES) assisted by an umbilical camera: Case report and new hybrid technique in gynecology.International journal of surgery case reports · 2018Article
- [Implementation of hybrid-NOTES sigmoidectomy for diverticular disease : In a center for minimally invasive surgery].Der Chirurg; Zeitschrift fur alle Gebiete der operativen Medizen · 2017Article
- Feasibility and Technique for Transvaginal Natural Orifice Transluminal Endoscopic Surgery Liver Resection: A Porcine Model.Surgical laparoscopy, endoscopy & percutaneous techniques · 2017Article
Corrections and comments
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Authors and funding
10 authors at 3 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundNatural orifice transluminal endoscopic surgery (NOTES) is the consequence of further development of minimally invasive surgery to reduce abdominal incisions and surgical trauma. The potential benefits are expected to be less postoperative pain, faster convalescence, and reduced risk for incisional hernias and wound infections compared to conventional methods. Recent clinical studies have demonstrated the feasibility and safety of transvaginal NOTES, and transvaginal access is currently the most frequent clinically applied route for NOTES procedures. However, despite increasing clinical application, no firm clinical evidence is available for objective assessment of the potential benefits and risks of transvaginal NOTES compared to the current surgical standard.
methodsThe TRANSVERSAL trial is designed as a randomized controlled trial to compare transvaginal hybrid NOTES and laparoscopic-assisted sigmoid resection. Female patients referred to elective sigmoid resection due to complicated or reoccurring diverticulitis of the sigmoid colon are considered eligible. The primary endpoint will be pain intensity during mobilization 24 hours postoperatively as measured by the blinded patient and blinded assessor on a visual analogue scale (VAS). Secondary outcomes include daily pain intensity and analgesic use, patient mobility, intraoperative complications, morbidity, length of stay, quality of life, and sexual function. Follow-up visits are scheduled 3, 12, and 36 months after surgery. A total sample size of 58 patients was determined for the analysis of the primary endpoint. The confirmatory analysis will be performed based on the intention-to-treat (ITT) principle. DISCUSSION: The TRANSVERSAL trial is the first study to compare transvaginal hybrid NOTES and conventionally assisted laparoscopic surgery for colonic resection in a randomized controlled setting. The results of the TRANSVERSAL trial will allow objective assessment of the potential benefits and risks of NOTES compared to the current surgical standard for sigmoid resection.
trial registrationThe trial protocol was registered in the German Clinical Trials Register ( DRKS00005995) on March 27, 2014.
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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.