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

Postoperative Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05485857
• Other study ID #: CHCS-intestine
• Status: Completed
• Phase: N/A
• Start date: November 29, 2022
• Est. completion date: March 1, 2023

Study information

• Verified date: March 2023
• Source: Changhai Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: March 1, 2023
• Est. primary completion date: February 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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;

Related Conditions & MeSH terms

• Postoperative Complications

Intervention

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.

Locations

Country	Name	City	State
China	Changhai Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Changhai Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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