Efficacy of Short Time Intervals in Split-Dose Bowel Preparation of Oral Sulfate Solution for Colonoscopy

Summary

To evaluate whether oral sulfate solution administered in a short time interval (6-8 hours) between the first and last dose of laxative is not inferior to a long time interval (10-12 hours) in bowel preparation quality.

Conditions

• Colonoscopy: Bowel Preparation

Interventions

DRUG

Magnesium Sulfate，Sodium Sulfate and Potassium Sulfate Concentrate Oral Solution

OSS contained 17.5 g sodium sulfate, 3.13 g potassium sulfate, 1.6 g magnesium sulfate, and flavoring agents in an aqueous liquid form supplied in a 177 mL bottle. Dilute 177ml sodium, potassium, and magnesium sulfate oral solution to 500ml and intake 12-14 hours before colonoscopy, followed by two doses of 500ml water or clear aqueous liquid within 2 hours; Repeat the procedure 6 hours before the colonoscopy.

DRUG

Magnesium Sulfate，Sodium Sulfate and Potassium Sulfate Concentrate Oral Solution

OSS contained 17.5 g sodium sulfate, 3.13 g potassium sulfate, 1.6 g magnesium sulfate, and flavoring agents in an aqueous liquid form supplied in a 177 mL bottle. Dilute 177ml sodium, potassium, and magnesium sulfates oral solution to 500ml and intake 16-18 hours before the colonoscopy, followed by two doses of 500ml water or clear aqueous liquid within 2 hours; Repeat the procedure 6 hours before the colonoscopy.

Sponsors & Collaborators

• Peking University People's Hospital

  collaborator OTHER

• Tianjin Medical University General Hospital

  collaborator OTHER

• The Affiliated Suzhou Hospital of Nanjing Medical University

  collaborator UNKNOWN

• Tianjin First Central Hospital

  collaborator OTHER

• Tianjin Beichen Hospital

  collaborator UNKNOWN

• Shandong Provincial Hospital

  collaborator OTHER_GOV

• The Affiliated Hospital of Qingdao University

  collaborator OTHER

• First People's Hospital of Hangzhou

  collaborator OTHER

• The Third People's Hospital of Chengdu

  collaborator OTHER

• Ningbo Yinzhou District Second Hospital

  collaborator UNKNOWN

• Changshu Affiliated Hospital of Soochow University

  collaborator OTHER

• Linyi People's Hospital

  collaborator OTHER

• Shanghai East Hospital

  collaborator OTHER

• Heilongjiang Province Hospital Nangang Branch

  collaborator UNKNOWN

• The Affiliated Jiangyin Hospital of Nantong University

  collaborator UNKNOWN

• West China Hospital

  collaborator OTHER

• Changhai Hospital

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-03-15

Primary Completion

2024-12-01

Completion

2024-12-30

Countries

• China

Study Locations