Mechanical Bowel Preparation Versus no Bowel Preparation for Esophageal Cancer Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

652 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-01

Study Completion Date

2023-04-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Esophageal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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NBP group

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

Group Type EXPERIMENTAL

No MBP

Intervention Type PROCEDURE

No mechanical bowel preparation before operation

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.

Group Type OTHER

No MBP

Intervention Type PROCEDURE

No mechanical bowel preparation before operation

Interventions

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No MBP

No mechanical bowel preparation before operation

Intervention Type PROCEDURE

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No