Influence of Arrangement of Small Intestine Order on the Recovery of Bowel Function After Laparoscopic Colorectal Surgery

Influence of Arrangement of Small Intestine Order on the Recovery of Bowel Function After Laparoscopic Colorectal Surgery.

The method of arranging and restoring the position of the small intestine under laparoscopy is used to determine whether it can promote the recovery of intestinal function after colorectal surgery.

Study Overview

• Status: Completed
• Conditions: Postoperative Complications
• Intervention / Treatment: Procedure: Arrangement of small intestine order before close the abdomen

• Study Type: Interventional
• Enrollment (Actual): 160
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200433
      • Changhai Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Pathologically confirmed colorectal cancer, patients undergoing colon cancer or radical resection of high rectal cancer；
• Tumor Stage (TNM): I-III；
• Age: >18 years old; <80 years old;
• ASA: I-III;
• Agree and sign the informed consent form.

Exclusion Criteria:

• Stoma patients；
• Patients with preoperative intestinal obstruction；
• Constipation patients (More than three days before the last bowel movement)；
• Combined other organ resection patients；
• Stroke or spinal cord injury patients；
• Long-term opioid use patients；
• Patients with a history of previous abdominal surgery；
• Patients refused entry into the trial；

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: Arrangement group; Experimental group: After the completion of laparoscopic-assisted colorectal cancer surgery, the chief surgeon performed laparoscopic small bowel arrangement before closing the abdomen, straightening the small bowel from the colon-small bowel anastomosis or the ileocecal valve to the ligament of Trevor, and restoring the original position of the small bowel. Afterwards, close the abdomen.	Procedure: Arrangement of small intestine order before close the abdomen; After the completion of laparoscopic-assisted colorectal cancer surgery, the chief surgeon performed laparoscopic small bowel arrangement before closing the abdomen, straightening the small bowel from the colon-small bowel anastomosis or the ileocecal valve to the ligament of Trevor, and restoring the original position of the small bowel. Afterward, close the abdomen.
No Intervention: No arrangement group; No arrangement group: After completing the routine operation of laparoscopic-assisted colorectal cancer surgery, the abdomen was closed directly.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
First flatus time after surgery	The investigators will record the time from the end of the surgery to the patient's first flatus time by hours.	50 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to liquid diet	The investigators will record the time from the end of the surgery to the patient's first diet time by hours.	70 hours
Postoperative hospital stay	The investigators will record the time from the end of the surgery to the patient's decharge time by days.	30 days
Paralytic ileus time after surgery	The investigators will record the time after surgery if the patient's first fluid time is more than seven days after the operation.	30 days
First defecate time after surgery	The investigators will record the time from the end of the surgery to the patient's first defecate time by hours.	70 hours

Collaborators and Investigators

• Sponsor: Changhai Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 29, 2022
• Primary Completion (Actual): February 1, 2023
• Study Completion (Actual): March 1, 2023

Study Registration Dates

• First Submitted: July 24, 2022
• First Submitted That Met QC Criteria: August 1, 2022
• First Posted (Actual): August 3, 2022

Study Record Updates

• Last Update Posted (Actual): March 29, 2023
• Last Update Submitted That Met QC Criteria: March 27, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications
• Other Study ID Numbers: CHCS-intestine

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