Mechanical Bowel Preparation Versus no Bowel Preparation for Esophageal Cancer Surgery

Mechanical Bowel Preparation Versus no Bowel Preparation for Esophageal Cancer Surgery: a Multi-center, Randomized, Parallel, Single-blinded Trial

The study type was designed as a prospective multicenter randomized controlled study. The patients will be divided into intervention group and control group, 281 patients were needed for each group and 562 patients would be needed totally to show this difference. Due to a possible loss of 14%, the final sample size was calculated to be 652 patients. The intervention group will not implement mechanical bowel preparation(MBP) before surgery; the control group will receive routine preoperative MBP for oral administration of compound polyethylene glycol electrolyte powder and fasting water. Perioperative complications, intestinal recovery speed and quality of life will be investigated between the two groups.

Study Overview

• Status: Completed
• Conditions: Esophageal Cancer
• Intervention / Treatment: Procedure: No MBP

Detailed Description

Patients allocated to MBP will be instructed by the study nurse to prepare their bowel mechanically by drinking 3~4L of polyethylene glycol (Polyethylene Glycol Electrolytes Powder 68.56g; Shenzhen, China) with water before 6pm in the evening the day before the surgery. Patients allocated to NBP were instructed to not prepare the bowel. The receipt of the allocated intervention will be controlled by study nurse asking the patients on the morning of the surgery whether they had acted as instructed by the allocation. This information will be also concealed from treating physicians and surgeons, data collectors, and data analysts, until the primary and secondary outcomes were analyzed. All patients will follow the ERAS protocol. Prophylactic intravenous antibiotics (cephamycin 1000mg) will be given to all patients 30 minutes before skin incision. The prophylactic intravenous antibiotics will re-administered if the surgery lasted longer than 3h from the first antibiotic dose. Surgical skin preparation will involve taking a bath well the night before operation without shaving the hair. Just before skin incision, the area will then washed three times with denatured 80% alcohol to left to dry.

• Study Type: Interventional
• Enrollment (Actual): 652
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients who were scheduled for esophageal cancer resection in participating centers were eligible for inclusion.

Exclusion Criteria:

• need for emergency surgery;
• previous chronic constipation or diarrhea;
• previous abdominal surgery; need for colonic reconstruction;
• other indications for mechanical preparation or contraindications;
• allergy to drugs used in the trial (polyethylene glycol)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NBP group; Patients allocated to NBP were instructed to not prepare the bowel.	Procedure: No MBP; No mechanical bowel preparation before operation
Other: MBP group; Patients allocated to MBP were instructed by the study nurse to prepare their bowel mechanically by drinking 3~4L of polyethylene glycol (Polyethylene Glycol Electrolytes Powder 68.56g; Shenzhen, China) with water before 6pm in the evening the day before the surgery.	Procedure: No MBP; No mechanical bowel preparation before operation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the rate of major complications	A major intraoperative and postoperative complication was defined as a surgical or medical complication with a Clavien-Dindo (CD) grade of Ⅱor higher (this five-grade system includes sub-grades in grades Ⅲ and Ⅳ, and higher grades indicate more life-threatening complications) according to Esophagectomy Complications Consensus Group (ECCG)	during surgery orwithin 30 days after surgery

Collaborators and Investigators

• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Actual): January 1, 2023
• Study Completion (Actual): April 30, 2023

Study Registration Dates

• First Submitted: August 29, 2022
• First Submitted That Met QC Criteria: August 29, 2022
• First Posted (Actual): September 1, 2022

Study Record Updates

• Last Update Posted (Actual): May 7, 2024
• Last Update Submitted That Met QC Criteria: May 4, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Esophageal Neoplasms
• Other Study ID Numbers: NCC2020C-511

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No