Mechanical Bowel Preparation Versus no Bowel Preparation for Esophageal Cancer Surgery

Esophageal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05523960
• Other study ID #: NCC2020C-511
• Status: Completed
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: April 30, 2023

Study information

• Verified date: May 2024
• Source: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 652
• Est. completion date: April 30, 2023
• Est. primary completion date: January 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms

Intervention

Procedure:
• No MBP
No mechanical bowel preparation before operation

Locations

Country	Name	City	State
China	Cancer Institute and Hospital, Chinese Academy of Medical Sciences	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 ?or higher (this five-grade system includes sub-grades in grades ? and ?, and higher grades indicate more life-threatening complications) according to Esophagectomy Complications Consensus Group (ECCG)	during surgery orwithin 30 days after surgery