{
  "abstract": "Introduction Adnexal surgery is one of the most common surgeries performed in women. Minimally invasive methods are on the rise globally as they have been shown to decrease surgical morbidity compared with abdominal surgery. Adnexal surgery by vaginal natural orifice transluminal endoscopic surgery (vNOTES) is the latest innovation. It combines the vaginal approach and endoscopy via the vagina. Large pragmatic randomised controlled trials (RCTs) are lacking comparing outcomes after vNOTES and conventional laparoscopy.Methods and analysis A multicentre pragmatic RCT aiming to recruit 200 women aged 18 years and above undergoing adnexal surgery for benign disease or prophylactic reasons. Patients will be randomised to vNOTES or laparoscopy. Recruitment will start Q4 2025, and the study is estimated to end 2028.The primary outcome is postoperative pain. Secondary outcomes are units of postoperative opioid and non-opioid analgesics used, perioperative complications, operation time, postoperative complications, readmission, conversion rate and the surgeon’s experience.Ethics and dissemination The national Swedish ethical board at the main centre, Helsingborg Hospital, Sweden, has given ethical agreement (dated 20 March 2025). Before including patients, all centres will require local or national ethical approval. The results of the study will be published in international peer-reviewed journals.Trial registration number NCT06964594.",
  "authors": [
    {
      "affiliations": [
        "Institute of Clinical Sciences, Department of Obstetrics and Gynecology, Lund University, Lund, Sweden",
        "Department of Obstetrics and Gynecology, Hospital in Helsingborg, Helsingborg, Sweden"
      ],
      "name": "Kristin Stuhr Olsson"
    },
    {
      "affiliations": [
        "Department of Obstetrics and Gynecology, Imelda Hospital, Bonheiden, Belgium",
        "Department of Gynecology and Obstetrics, Development and Regeneration, Leuven University, Leuven, Belgium"
      ],
      "name": "Jan Filip Baekelandt"
    },
    {
      "affiliations": [
        "Institute of Clinical Sciences, Department of Obstetrics and Gynecology, Lund University, Lund, Sweden"
      ],
      "name": "Karin Källén"
    },
    {
      "affiliations": [
        "Department of Obstetrics and Gynecology, General Hospital Zadar, University of Zadar, Department of Health Studies, Zadar, Croatia"
      ],
      "name": "Luka Matak"
    },
    {
      "affiliations": [
        "Division of Obstetrics and Gynaecology, Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy"
      ],
      "name": "Marta Caretto"
    },
    {
      "affiliations": [
        "Department of Obstetrics & Gynecology, Zuyderland Medical Centre, Heerlen, The Netherlands"
      ],
      "name": "Martine M L H Wassen"
    },
    {
      "affiliations": [
        "Division of Obstetrics and Gynaecology, Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy"
      ],
      "name": "Tommaso Simoncini"
    },
    {
      "affiliations": [
        "Institute of Clinical Sciences, Department of Obstetrics and Gynecology, Lund University, Lund, Sweden",
        "Department of Obstetrics and Gynecology, Hospital in Helsingborg, Helsingborg, Sweden"
      ],
      "name": "Andrea Stuart"
    }
  ],
  "title": "ADNOLA trial: a study-protocol – a randomised controlled trial study comparing adnexal surgery by vNOTES or laparoscopy",
  "uid": "0ea87984-9aef-5361-bd6d-4ceba4f49852"
}