Study protocol for comparing the efficacy of left-open single-flap technique versus double-flap technique after proximal gastrectomy: A multicenter randomized controlled trial
BackgroundProximal gastrectomy has gradually gained more attention due to its superiority in retaining the function of part of the stomach. The inevitable loss of the antireflux barrier and postoperative complications resulting from proximal gastrectomy can severely affect the quality of life. Conti...
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| Format: | Article |
| Language: | English |
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Frontiers Media S.A.
2022-11-01
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| Series: | Frontiers in Oncology |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fonc.2022.973810/full |
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| author | Qin Chuan Yang Wei Dong Wang Zhen Chang Mo Zhen Chang Mo Chao Yue Hai Kun Zhou Rui Qi Gao Juan Yu Dan Hong Dong Jin Qiang Liu Jiang Peng Wei Xi Sheng Yang Gang Ji Xiao Hua Li |
| author_facet | Qin Chuan Yang Wei Dong Wang Zhen Chang Mo Zhen Chang Mo Chao Yue Hai Kun Zhou Rui Qi Gao Juan Yu Dan Hong Dong Jin Qiang Liu Jiang Peng Wei Xi Sheng Yang Gang Ji Xiao Hua Li |
| author_sort | Qin Chuan Yang |
| collection | DOAJ |
| description | BackgroundProximal gastrectomy has gradually gained more attention due to its superiority in retaining the function of part of the stomach. The inevitable loss of the antireflux barrier and postoperative complications resulting from proximal gastrectomy can severely affect the quality of life. Continuous improvements in digestive tract reconstruction after proximal gastrectomy have yielded the development of a variety of methods with antireflux functions. Recently, our center attempted the left-open single-flap technique and initiated a multicenter, prospective, randomized controlled trial for patients undergoing proximal gastrectomy to reduce the difficulty of surgical anastomosis and the incidence of perioperative complications compared with the double-flap technique. These findings will provide more evidence-based medical research for the development of clinical guidelines.Methods/designThis study is a prospective, multicenter, randomized controlled clinical trial. We plan to recruit 250 patients who are eligible for proximal gastrectomy. After informed consent is obtained, patients will be randomly assigned to the trial group (left-open single-flap technique) and the control group (double-flap technique) in a 1:1 allocation ratio.DiscussionIncreasingly, clinical studies have focused on the improvement of reconstruction modalities after proximal gastrectomy. Among these methods, the double-flap technique is a clinically effective method. The purpose of this study is to establish a prospective randomized controlled trial to compare the efficacy of the left-open single-flap technique versus the double-flap technique after proximal gastrectomy, aiming to provide more evidence-based medical studies for digestive tract reconstruction in proximal gastrectomy.Clinical Trial RegistrationClinicalTrials.gov, identifier [NCT05418920]. |
| first_indexed | 2024-04-11T08:00:33Z |
| format | Article |
| id | doaj.art-9dc2073967f0460daa2d6383ff5b696e |
| institution | Directory Open Access Journal |
| issn | 2234-943X |
| language | English |
| last_indexed | 2024-04-11T08:00:33Z |
| publishDate | 2022-11-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Oncology |
| spelling | doaj.art-9dc2073967f0460daa2d6383ff5b696e2022-12-22T04:35:44ZengFrontiers Media S.A.Frontiers in Oncology2234-943X2022-11-011210.3389/fonc.2022.973810973810Study protocol for comparing the efficacy of left-open single-flap technique versus double-flap technique after proximal gastrectomy: A multicenter randomized controlled trialQin Chuan Yang0Wei Dong Wang1Zhen Chang Mo2Zhen Chang Mo3Chao Yue4Hai Kun Zhou5Rui Qi Gao6Juan Yu7Dan Hong Dong8Jin Qiang Liu9Jiang Peng Wei10Xi Sheng Yang11Gang Ji12Xiao Hua Li13Department of Gastrointestinal Surgery, Xijing Hospital, Air Force Military Medical University, Xi’an, Shaanxi, ChinaDepartment of Gastrointestinal Surgery, Xijing Hospital, Air Force Military Medical University, Xi’an, Shaanxi, ChinaDepartment of Gastrointestinal Surgery, Xijing Hospital, Air Force Military Medical University, Xi’an, Shaanxi, ChinaShaanxi University of Chinese Medicine, Xi’an, Shaanxi, ChinaDepartment of Gastrointestinal Surgery, Xijing Hospital, Air Force Military Medical University, Xi’an, Shaanxi, ChinaDepartment of Gastrointestinal Surgery, Xijing Hospital, Air Force Military Medical University, Xi’an, Shaanxi, ChinaDepartment of Gastrointestinal Surgery, Xijing Hospital, Air Force Military Medical University, Xi’an, Shaanxi, ChinaDepartment of Gastrointestinal Surgery, Xijing Hospital, Air Force Military Medical University, Xi’an, Shaanxi, ChinaDepartment of Gastrointestinal Surgery, Xijing Hospital, Air Force Military Medical University, Xi’an, Shaanxi, ChinaDepartment of Gastrointestinal Surgery, Xijing Hospital, Air Force Military Medical University, Xi’an, Shaanxi, ChinaDepartment of Gastrointestinal Surgery, Xijing Hospital, Air Force Military Medical University, Xi’an, Shaanxi, ChinaDepartment of Gastrointestinal Surgery, Xijing Hospital, Air Force Military Medical University, Xi’an, Shaanxi, ChinaDepartment of Gastrointestinal Surgery, Xijing Hospital, Air Force Military Medical University, Xi’an, Shaanxi, ChinaDepartment of Gastrointestinal Surgery, Xijing Hospital, Air Force Military Medical University, Xi’an, Shaanxi, ChinaBackgroundProximal gastrectomy has gradually gained more attention due to its superiority in retaining the function of part of the stomach. The inevitable loss of the antireflux barrier and postoperative complications resulting from proximal gastrectomy can severely affect the quality of life. Continuous improvements in digestive tract reconstruction after proximal gastrectomy have yielded the development of a variety of methods with antireflux functions. Recently, our center attempted the left-open single-flap technique and initiated a multicenter, prospective, randomized controlled trial for patients undergoing proximal gastrectomy to reduce the difficulty of surgical anastomosis and the incidence of perioperative complications compared with the double-flap technique. These findings will provide more evidence-based medical research for the development of clinical guidelines.Methods/designThis study is a prospective, multicenter, randomized controlled clinical trial. We plan to recruit 250 patients who are eligible for proximal gastrectomy. After informed consent is obtained, patients will be randomly assigned to the trial group (left-open single-flap technique) and the control group (double-flap technique) in a 1:1 allocation ratio.DiscussionIncreasingly, clinical studies have focused on the improvement of reconstruction modalities after proximal gastrectomy. Among these methods, the double-flap technique is a clinically effective method. The purpose of this study is to establish a prospective randomized controlled trial to compare the efficacy of the left-open single-flap technique versus the double-flap technique after proximal gastrectomy, aiming to provide more evidence-based medical studies for digestive tract reconstruction in proximal gastrectomy.Clinical Trial RegistrationClinicalTrials.gov, identifier [NCT05418920].https://www.frontiersin.org/articles/10.3389/fonc.2022.973810/fullgastric cancerdouble-flap techniqueleft-open single-flap techniqueproximal gastrectomystudy protocol |
| spellingShingle | Qin Chuan Yang Wei Dong Wang Zhen Chang Mo Zhen Chang Mo Chao Yue Hai Kun Zhou Rui Qi Gao Juan Yu Dan Hong Dong Jin Qiang Liu Jiang Peng Wei Xi Sheng Yang Gang Ji Xiao Hua Li Study protocol for comparing the efficacy of left-open single-flap technique versus double-flap technique after proximal gastrectomy: A multicenter randomized controlled trial Frontiers in Oncology gastric cancer double-flap technique left-open single-flap technique proximal gastrectomy study protocol |
| title | Study protocol for comparing the efficacy of left-open single-flap technique versus double-flap technique after proximal gastrectomy: A multicenter randomized controlled trial |
| title_full | Study protocol for comparing the efficacy of left-open single-flap technique versus double-flap technique after proximal gastrectomy: A multicenter randomized controlled trial |
| title_fullStr | Study protocol for comparing the efficacy of left-open single-flap technique versus double-flap technique after proximal gastrectomy: A multicenter randomized controlled trial |
| title_full_unstemmed | Study protocol for comparing the efficacy of left-open single-flap technique versus double-flap technique after proximal gastrectomy: A multicenter randomized controlled trial |
| title_short | Study protocol for comparing the efficacy of left-open single-flap technique versus double-flap technique after proximal gastrectomy: A multicenter randomized controlled trial |
| title_sort | study protocol for comparing the efficacy of left open single flap technique versus double flap technique after proximal gastrectomy a multicenter randomized controlled trial |
| topic | gastric cancer double-flap technique left-open single-flap technique proximal gastrectomy study protocol |
| url | https://www.frontiersin.org/articles/10.3389/fonc.2022.973810/full |
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