Prepackaged formula low-residue diet vs. self-prepared low-residue diet before colonoscopy: A multicenter randomized controlled trial

Peng Pan; Lun Gu; Shengbing Zhao; Shuling Wang; Jiayi Ma; Hongyu Fu; Youxiang Chen; Shuixiang He; Zibin Tian; Le Xu; Zhijie Feng; Yanqing Li; Zhuo Yang; Lei Yang; Wen Wang; Qian Hou; Ting Liu; Chujun Li; Dean Tian; Xiaodi Wang; Yongmei Gao; Hanping Shi; Yu Bai; Zhaoshen Li

doi:10.3389/fmed.2023.1029493

Prepackaged formula low-residue diet vs. self-prepared low-residue diet before colonoscopy: A multicenter randomized controlled trial

Front Med (Lausanne). 2023 Mar 24:10:1029493. doi: 10.3389/fmed.2023.1029493. eCollection 2023.

Authors

Peng Pan¹, Lun Gu¹, Shengbing Zhao¹, Shuling Wang¹, Jiayi Ma¹, Hongyu Fu¹, Youxiang Chen², Shuixiang He³, Zibin Tian⁴, Le Xu⁵, Zhijie Feng⁶, Yanqing Li⁷, Zhuo Yang⁸, Lei Yang⁸, Wen Wang⁹, Qian Hou¹⁰, Ting Liu¹¹, Chujun Li¹², Dean Tian¹³, Xiaodi Wang¹⁴, Yongmei Gao¹⁵, Hanping Shi¹⁶, Yu Bai¹, Zhaoshen Li¹

Affiliations

¹ Department of Gastroenterology, Changhai Hospital, Second Military Medical University, Naval Military Medical University, Shanghai, China.
² Department of Gastroenterology, The First Affiliated Hospital, Nanchang University, Nanchang, China.
³ Department of Gastroenterology, The First Affiliated Hospital, Xi'an Jiaotong University, Xi'an, China.
⁴ Department of Gastroenterology, The Affiliated Hospital, Qingdao University, Qingdao, China.
⁵ Department of Gastroenterology, Beijing Hospital, Beijing, China.
⁶ Department of Gastroenterology, The Second Hospital, Hebei Medical University, Shijiazhuang, China.
⁷ Department of Gastroenterology, Qilu Hospital, Shandong University, Jinan, China.
⁸ Digestive Endoscopy Center, Northern Theater General Hospital, Shenyang, China.
⁹ Department of Gastroenterology, The 900th Hospital of the Chinese People's Liberation Army (PLA), Fuzhou, China.
¹⁰ Department of Nutrition, Xiangya Hospital, Central South University, Changsha, China.
¹¹ Department of Gastroenterology, Xiangya Hospital, Central South University, Changsha, China.
¹² Department of Gastrointestinal Endoscopy, The Sixth Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.
¹³ Department of Gastroenterology, Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology, Wuhan, China.
¹⁴ Department of Gastroenterology, China-Japan Friendship Hospital, Beijing, China.
¹⁵ Department of Gastroenterology, The First Affiliated Hospital, Hebei North University, Zhangjiakou, China.
¹⁶ Department of Gastrointestinal Surgery, Beijing Shijitan Hospital, Capital Medical University, Beijing, China.

Abstract

Background and aims: Compared with self-prepared LRD, a prepackaged low-residue diet (LRD) can improve patient compliance, but whether it can further improve the quality of bowel preparation is uncertain. The study aimed to compare the application of the prepackaged formula LRD with self-prepared LRD in bowel preparation for colonoscopy.

Methods: A multicenter randomized controlled trial was conducted in 15 centers. The eligible subjects were randomly assigned to one of two groups: the formula LRD group and the self-prepared LRD group. On the day before the colonoscopy, subjects in the self-prepared LRD group were instructed to consume a restricted LRD prepared by themselves, while subjects in the formula LRD group were given six bags of prepackaged formula LRD and instructed to consume them according to their individual need. The primary outcome was an adequate bowel preparation rate. Secondary outcomes mainly included Boston Bowel Preparation Scale (BBPS) scores, dietary restriction compliance rate, tolerance, satisfaction, adenoma detection rate (ADR), and adverse reactions. The trial was registered at ClinicalTrials.gov under the identifier NCT03943758.

Results: A total of 550 subjects were recruited. Compared with the self-prepared LRD group, the formula LRD group showed a higher adequate bowel preparation rate (94.5 vs. 80.4%; P < 0.01), BBPS scores (7.87 ± 1.13 vs. 6.75 ± 1.47; P < 0.01), dietary compliance rate (92.4 vs. 78.9%; P < 0.01), tolerance (P < 0.01 in degree of hunger, intensity of physical strength, and negative influence on daily activities), satisfaction (8.56 ± 1.61 vs. 7.20 ± 2.02; P < 0.01), and ADR (25.6 vs. 16.0%; P < 0.01). There was no significant difference in adverse reactions.

Conclusion: Compared with self-prepared LRD, the formula LRD showed similar safety and higher bowel preparation quality, compliance, and tolerance in bowel preparation. More formula LRDs could be designed according to different dietary habits and ethnic populations, and further researches are warranted to confirm their effect.

Clinical trial registration: https://register.clinicaltrials.gov, identifier: NCT03943758.

Keywords: adenoma detection rate; bowel preparation; colonoscopy; dietary restriction; low-residue diet.

Associated data

ClinicalTrials.gov/NCT03943758

Grants and funding

This study was supported by the National Natural Science Foundation of China (Nos. 82170567 and 81873546, China), the Shu Guang project of the Shanghai Municipal Education Commission and Shanghai Education Development Foundation (No. 19SG30, China), Pilot Talent Plan, Deep Blue Project of Naval Medical University, Program of Shanghai Academic/Technology Research Leader (No. 22XD1425000, China), and 234 Discipline Climbing Plan of Changhai Hospital, Naval Medical University (No. 2019YXK004, China).