Trial reportSurgical endoscopy2014
Postoperative pain after transvaginal cholecystectomy: single-center, double-blind, randomized controlled trial.
Trial report in Surgical endoscopy, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers, 2 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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
17 citing papers in PubMed, 2 syntheses or guidelines pooled it, 32 citations in OpenAlex.
- Safety Outcomes of NOTES Cholecystectomy Versus Laparoscopic Cholecystectomy: A Systematic Review and Meta-Analysis.Surgical laparoscopy, endoscopy & percutaneous techniques · 2016Pooled it
- Safety of transvaginal hybrid NOTES cholecystectomy: a systematic review and meta-analysis.Surgical endoscopy · 2015Pooled it
- Systematic analysis of the safety and benefits of transvaginal hybrid-NOTES cholecystectomy.World journal of gastroenterology · 2015Trial
- Trial
- [Transvaginal cholecystectomy: results of a randomized study].Der Chirurg; Zeitschrift fur alle Gebiete der operativen Medizen · 2014Trial
- Transvaginal hybrid NOTES cholecystectomy--results of a randomized clinical trial after 6 months.Langenbeck's archives of surgery · 2014Trial
- Endoscopic Management of Benign Gallbladder Diseases.The Turkish journal of gastroenterology : the official journal of Turkish Society of Gastroenterology · 2024Review
- Article
- Feasibility of transgastric endoscopic gallbladder-preserving surgery for benign gallbladder diseases (with video).Surgical endoscopy · 2022Article
- Does obesity influence the results in Transvaginal Hybrid-NOTES cholecystectomy?Surgical endoscopy · 2018Article
- Transrectal rigid-hybrid NOTES cholecystectomy can be performed without peritoneal contamination: a controlled porcine survival study.Surgical endoscopy · 2018Article
- Less pain after transvaginal cholecystectomy: single-center pooled analysis.Surgical endoscopy · 2017Article
- New minimally invasive approaches for cholecystectomy: Review of literature.World journal of gastrointestinal surgery · 2015Review
- Comprehensive complication index for NOTES procedures: results from a randomized controlled trial and comparison to published NOTES complication data.Surgical endoscopy · 2015Review
- Laparoscopic-Assisted Transvaginal Cholecystectomy - the US Military Experience With Long-Term Follow Up.JSLS : Journal of the Society of Laparoendoscopic SurgeonsArticle
- Which Cholecystectomy do Medical Students Prefer?JSLS : Journal of the Society of Laparoendoscopic SurgeonsArticle
- Hybrid Transvaginal NOTES and Mini-Laparoscopic Colectomy: Benefit Through Synergy.JSLS : Journal of the Society of Laparoendoscopic SurgeonsArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
11 authors at 4 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundNatural orifice transluminal endoscopic surgery (NOTES) has the potential to reduce postoperative pain. We compared postoperative pain in the hybrid NOTES procedure transvaginal video-assisted cholecystectomy (TVC) with standard conventional laparoscopic cholecystectomy (CLC).
designSingle-center, double-blind, randomized controlled trial in a level II hospital between June 2008 and June 2012.
methodsFemale patients, older than 18 years of age with symptomatic cholecystolithiasis were randomized to receive either TVC or CLC. The follow-up period was 7 days and the primary outcome of the study was postoperative pain. We hypothesized that there is no reduction of pain (Visual Rating Scale ≥1) while resting or coughing over a 48-h period after the operation. Secondary outcome included wound infections, complications, and patient reported outcomes. Sealed envelopes with computer-generated randomization information were kept for allocation in theater. All patients received opaque wound dressing, as in standard four-trocar cholecystectomy and a vaginal tamponade. Theater protocol and surgical notes were kept separate after the procedure.
resultsOverall, 97 of 426 patients assessed for participation were randomized for either TVC or CLC. A total of 41 patients had a TVC and 51 had a CLC. Five patients were excluded from the analysis. There was no difference in age, body mass index, American Society of Anesthesiologists (ASA) grade, or hospital stay, but anesthetic and surgical times were significantly longer in TVC (p < 0.001). There was no statistical difference in postoperative pain between the two groups while resting or coughing. Complications included conversion to laparotomy, bleeding, wound infections, and re-admission. No difference in the rate of complications between the two groups was seen. Overall, 86 and 93% of CLC and TVC patients, respectively, would recommend the procedure to other patients.
conclusionIn this study, no significant difference in pain on days 1 and 2 postoperatively between the two methods was found. The safety profile of TVC is comparable to CLC, and TVC patients would generally recommend this procedure to other patients.
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