Mechanical Bowel Preparation Versus no Bowel Preparation for Esophageal Cancer Surgery

NCT05523960 | Completed

• 1 other identifier: NCC2020C-511
• Study Type: interventional
• Target: 652
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Esophageal Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

NBP group

EXPERIMENTAL

Patients allocated to NBP were instructed to not prepare the bowel.

Procedure: No MBP

MBP group

OTHER

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

Interventions

No MBP PROCEDURE

No mechanical bowel preparation before operation

MBP group; NBP group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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)

Sponsors & Collaborators

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

Study Sites (1)

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Beijing, China

Location

MeSH Terms

Conditions

Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2022
• First Posted: September 1, 2022
• Study Start: September 1, 2022
• Primary Completion: January 1, 2023
• Study Completion: April 30, 2023
• Last Updated: May 7, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)