{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,10]],"date-time":"2026-10-10T06:56:16Z","timestamp":1791615376261,"version":"4.3.4"},"reference-count":11,"publisher":"Public Library of Science (PLoS)","issue":"12","license":[{"start":{"date-parts":[[2025,12,18]],"date-time":"2025-12-18T00:00:00Z","timestamp":1766016000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["www.plosone.org"],"crossmark-restriction":false},"short-container-title":["PLoS One"],"abstract":"\n Background<\/jats:title>\n Laparoscopic cholecystectomy is the gold standard for treating symptomatic gallstone disease. Pneumoperitoneum is essential for adequate visualization during the procedure and is typically maintained at a standard pressure of 12\u201314 mmHg. However, high insufflation pressure may contribute to increased postoperative pain. This study aims to assess whether low-pressure pneumoperitoneum (8 mmHg) reduces postoperative pain compared to standard pressure (14 mmHg), without compromising operative safety or efficacy. We hypothesize that low pressure pneumoperitoneum at 8 mmHg reduces postoperative pain, without increasing operation time or postoperative morbidity.<\/jats:p>\n <\/jats:sec>\n \n Methods<\/jats:title>\n This is a single-center, randomized, controlled, double-blind trial. Consecutive Adult patients scheduled for elective laparoscopic cholecystectomy will be randomized in a 1:1 ratio to receive either low-pressure (8 mmHg) or standard-pressure (14 mmHg) pneumoperitoneum. The primary outcome is postoperative abdominal pain assessed using the Visual Analog Scale (VAS) at 6 hours after surgery. Secondary outcomes include VAS pain scores at 12 and 24 hours, postoperative nausea and\/or vomiting, postoperative hospital stay and postoperative 30-day morbidity. The enrollment of patients will be done between November 12, 2024 to December 31, 2025.<\/jats:p>\n <\/jats:sec>\n \n Trial registration<\/jats:title>\n \n ClinicalTrials.gov\n NCT06685250<\/jats:ext-link>\n <\/jats:p>\n <\/jats:sec>\n \n Conclusion<\/jats:title>\n If proven effective, low-pressure pneumoperitoneum may represent a simple strategy to improve postoperative comfort in laparoscopic cholecystectomy without compromising surgical outcomes.<\/jats:p>\n <\/jats:sec>","DOI":"10.1371\/journal.pone.0339161","type":"journal-article","created":{"date-parts":[[2025,12,18]],"date-time":"2025-12-18T18:36:43Z","timestamp":1766083003000},"page":"e0339161","update-policy":"https:\/\/doi.org\/10.1371\/journal.pone.corrections_policy","source":"Crossref","is-referenced-by-count":1,"title":["Randomized controlled trial comparing low pressure (8 mmHg) versus high pressure (14 mmHg) CO2 insufflation on postoperative pain in patients undergoing laparoscopic cholecystectomy: Protocol"],"prefix":"10.1371","volume":"20","author":[{"given":"Amine","family":"Ben Safta","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9565-3562","authenticated-orcid":true,"given":"Salsabil","family":"Nasri","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Imen","family":"Samaali","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hajer","family":"Taher","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mohamed Mehdi","family":"Trabelsi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chadli","family":"Dziri","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wajih","family":"Dougaz","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ramzi","family":"Nouira","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"340","published-online":{"date-parts":[[2025,12,18]]},"reference":[{"issue":"4","key":"pone.0339161.ref001","article-title":"Laparoscopic versus open cholecystectomy for patients with symptomatic cholecystolithiasis","author":"F Keus","year":"2006","journal-title":"Cochrane Database Syst Rev"},{"issue":"7","key":"pone.0339161.ref002","doi-asserted-by":"crossref","first-page":"2878","DOI":"10.1007\/s00464-020-07527-2","article-title":"The impact of intra-abdominal pressure on perioperative outcomes in laparoscopic cholecystectomy: a systematic review and network meta-analysis of randomized controlled trials","volume":"34","author":"AD Raval","year":"2020","journal-title":"Surg Endosc"},{"key":"pone.0339161.ref003","first-page":"51","article-title":"Physiopathology of pneumoperitoneum","volume":"53","author":"G Giraudo","year":"1998","journal-title":"Minerva Chir"},{"issue":"4","key":"pone.0339161.ref004","doi-asserted-by":"crossref","first-page":"553","DOI":"10.1007\/s13304-018-0591-8","article-title":"The protocol of low-impact laparoscopic cholecystectomy: the combination of mini-laparoscopy and low-pressure pneumoperitoneum","volume":"70","author":"N de\u2019Angelis","year":"2018","journal-title":"Updates Surg"},{"issue":"2","key":"pone.0339161.ref005","article-title":"The Impact of Intraoperative CO 2 Pneumoperitoneum Pressure in Gastrointestinal Surgery: A Systematic Review","volume":"35","author":"R Mahapatra","year":"2025","journal-title":"Surg Laparosc Endosc Percutan Tech"},{"key":"pone.0339161.ref006","unstructured":"Consort-Spirit. Home [Internet]. [cited 2025 Jul 26]. Available from: https:\/\/www.consort-spirit.org"},{"key":"pone.0339161.ref007","unstructured":"Schwartz D, Flamant R, Lellouch J. L\u2019essai th\u00e9rapeutique chez l\u2019homme. Paris: Flammarion; 1970. 297 p."},{"issue":"9307","key":"pone.0339161.ref008","doi-asserted-by":"crossref","first-page":"696","DOI":"10.1016\/S0140-6736(02)07816-9","article-title":"Blinding in randomised trials: hiding who got what","volume":"359","author":"KF Schulz","year":"2002","journal-title":"Lancet"},{"issue":"8","key":"pone.0339161.ref009","doi-asserted-by":"crossref","first-page":"693","DOI":"10.1111\/j.1445-2197.2005.03496.x","article-title":"Randomized, prospective comparison of postoperative pain in low- versus high-pressure pneumoperitoneum","volume":"75","author":"M Koc","year":"2005","journal-title":"ANZ J Surg"},{"key":"pone.0339161.ref010","volume-title":"L\u2019essai th\u00e9rapeutique chez l\u2019homme","author":"D Schwartz","year":"1970"},{"issue":"8","key":"pone.0339161.ref011","first-page":"429","article-title":"Twenty-five years of ambulatory laparoscopic cholecystectomy","volume":"94","author":"J Bueno Lled\u00f3","year":"2016","journal-title":"Cir Esp"}],"container-title":["PLOS One"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/dx.plos.org\/10.1371\/journal.pone.0339161","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,12,18]],"date-time":"2025-12-18T18:36:46Z","timestamp":1766083006000},"score":1,"resource":{"primary":{"URL":"https:\/\/dx.plos.org\/10.1371\/journal.pone.0339161"}},"subtitle":[],"editor":[{"given":"Imtiaz","family":"Wani","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"editor"}]}],"short-title":[],"issued":{"date-parts":[[2025,12,18]]},"references-count":11,"journal-issue":{"issue":"12","published-online":{"date-parts":[[2025,12,18]]}},"URL":"https:\/\/doi.org\/10.1371\/journal.pone.0339161","relation":{},"ISSN":["1932-6203"],"issn-type":[{"value":"1932-6203","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,12,18]]}}}