{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,26]],"date-time":"2026-05-26T11:06:16Z","timestamp":1779793576211,"version":"3.53.1"},"reference-count":9,"publisher":"BMJ","issue":"5","license":[{"start":{"date-parts":[[2026,5,25]],"date-time":"2026-05-25T00:00:00Z","timestamp":1779667200000},"content-version":"unspecified","delay-in-days":24,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"Gorthon Foundation"}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2026,4,13]]},"published-print":{"date-parts":[[2026,5]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>A multicentre pragmatic RCT aiming to recruit 200\u2009women 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.<\/jats:p>\n                    <jats:p>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\u2019s experience.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT06964594\">NCT06964594<\/jats:ext-link>\n                      .\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2025-112126","type":"journal-article","created":{"date-parts":[[2026,5,26]],"date-time":"2026-05-26T09:05:18Z","timestamp":1779786318000},"page":"e112126","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":0,"title":["ADNOLA trial: a study-protocol \u2013 a randomised controlled trial study comparing adnexal surgery by vNOTES or laparoscopy"],"prefix":"10.1136","volume":"16","clinical-trial-number":[{"clinical-trial-number":"nct06964594","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0009-0009-9636-2447","authenticated-orcid":false,"given":"Kristin Stuhr","family":"Olsson","sequence":"first","affiliation":[{"name":"Institute of Clinical Sciences, Department of Obstetrics and Gynecology, Lund University, Lund, Sweden"},{"name":"Department of Obstetrics and Gynecology, Hospital in Helsingborg, Helsingborg, Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8344-8622","authenticated-orcid":false,"given":"Jan Filip","family":"Baekelandt","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynecology, Imelda Hospital, Bonheiden, Belgium"},{"name":"Department of Gynecology and Obstetrics, Development and Regeneration, Leuven University, Leuven, Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Karin","family":"K\u00e4ll\u00e9n","sequence":"additional","affiliation":[{"name":"Institute of Clinical Sciences, Department of Obstetrics and Gynecology, Lund University, Lund, Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Luka","family":"Matak","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynecology, General Hospital Zadar, University of Zadar, Department of Health Studies, Zadar, Croatia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marta","family":"Caretto","sequence":"additional","affiliation":[{"name":"Division of Obstetrics and Gynaecology, Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Martine M L H","family":"Wassen","sequence":"additional","affiliation":[{"name":"Department of Obstetrics & Gynecology, Zuyderland Medical Centre, Heerlen, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tommaso","family":"Simoncini","sequence":"additional","affiliation":[{"name":"Division of Obstetrics and Gynaecology, Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5131-6297","authenticated-orcid":false,"given":"Andrea","family":"Stuart","sequence":"additional","affiliation":[{"name":"Institute of Clinical Sciences, Department of Obstetrics and Gynecology, Lund University, Lund, Sweden"},{"name":"Department of Obstetrics and Gynecology, Hospital in Helsingborg, Helsingborg, Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2026,5,26]]},"reference":[{"key":"2026052603465342000_16.5.e112126.1","doi-asserted-by":"crossref","first-page":"31","DOI":"10.1016\/j.bpobgyn.2016.10.017","article-title":"Hereditary Ovarian Cancer and Risk Reduction","volume":"41","author":"Andrews","year":"2017","journal-title":"Best Pract Res Clin Obstet Gynaecol"},{"key":"2026052603465342000_16.5.e112126.2","doi-asserted-by":"crossref","unstructured":"Medeiros LRF , Rosa DD , Bozzetti MC , et al . 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Cochrane Database Syst Rev 2009;CD004751. doi:10.1002\/14651858.CD004751.pub3","DOI":"10.1002\/14651858.CD004751.pub3"},{"key":"2026052603465342000_16.5.e112126.3","unstructured":"Swedish gynecological surgery register annual report on adnexal surgery, Available: https:\/\/Arsrapport-Adnexkirurgi-utford-ar-2024.pdf"},{"key":"2026052603465342000_16.5.e112126.4","doi-asserted-by":"crossref","first-page":"738","DOI":"10.1097\/AOG.0000000000004577","article-title":"Trends in the Use of Minimally Invasive Adnexal Surgery in the United States","volume":"138","author":"Dioun","year":"2021","journal-title":"Obstet Gynecol"},{"key":"2026052603465342000_16.5.e112126.5","doi-asserted-by":"crossref","DOI":"10.1136\/bmjopen-2023-081979","article-title":"VaNoLaH trial: a study protocol\u2014a multinational randomised controlled trial including two identical substudies comparing vaginal versus vNOTES (vaginal natural orifice transluminal surgery) hysterectomy or laparoscopic versus vNOTES hysterectomy","volume":"14","author":"Baekelandt","year":"2024","journal-title":"BMJ Open"},{"key":"2026052603465342000_16.5.e112126.6","doi-asserted-by":"crossref","first-page":"160","DOI":"10.1016\/j.ejogrb.2022.05.021","article-title":"Standardised step by step approach to adnexectomy by Vaginal Natural Orifice Transluminal Endoscopic Surgery","volume":"274","author":"Baekelandt","year":"2022","journal-title":"Eur J Obstet Gynecol Reprod Biol"},{"key":"2026052603465342000_16.5.e112126.7","article-title":"Surgical approach to hysterectomy for benign gynaecological disease","volume":"8","author":"Pickett","year":"2023","journal-title":"Cochrane Database Syst Rev"},{"key":"2026052603465342000_16.5.e112126.8","doi-asserted-by":"crossref","first-page":"1782","DOI":"10.1111\/1471-0528.16838","article-title":"Adnexectomy by vaginal Natural Orifice Transluminal Endoscopic Surgery versus laparoscopy: results of a first randomised controlled trial (NOTABLE trial)","volume":"128","author":"Baekelandt","year":"2021","journal-title":"BJOG"},{"key":"2026052603465342000_16.5.e112126.9","doi-asserted-by":"crossref","DOI":"10.1136\/bmj.e7586","article-title":"SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials","volume":"346","author":"Chan","year":"2013","journal-title":"BMJ"}],"container-title":["BMJ Open"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1136\/bmjopen-2025-112126","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,5,26]],"date-time":"2026-05-26T10:51:47Z","timestamp":1779792707000},"score":1,"resource":{"primary":{"URL":"https:\/\/bmjopen.bmj.com\/lookup\/doi\/10.1136\/bmjopen-2025-112126"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,5]]},"references-count":9,"journal-issue":{"issue":"5","published-online":{"date-parts":[[2026,5,26]]},"published-print":{"date-parts":[[2026,5]]}},"alternative-id":["10.1136\/bmjopen-2025-112126"],"URL":"https:\/\/doi.org\/10.1136\/bmjopen-2025-112126","relation":{},"ISSN":["2044-6055","2044-6055"],"issn-type":[{"value":"2044-6055","type":"print"},{"value":"2044-6055","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,5]]}}}