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

NCT05485857 | Completed

• 1 other identifier: CHCS-intestine
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Postoperative Complications

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Time to liquid diet

  70 hours

• Postoperative hospital stay

  30 days

• Paralytic ileus time after surgery

  30 days

• First defecate time after surgery

  70 hours

Study Arms (2)

Arrangement group

EXPERIMENTAL

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

No arrangement group

NO INTERVENTION

No arrangement group: After completing the routine operation of laparoscopic-assisted colorectal cancer surgery, the abdomen was closed directly.

Interventions

Arrangement of small intestine order before close the abdomen PROCEDURE

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.

Arrangement group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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；

Sponsors & Collaborators

• Changhai Hospital: lead

Study Sites (1)

Changhai Hospital

Shanghai, Shanghai Municipality, 200433, China

Location

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Wei Zhang

  Changhai Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of colorectal surgery

Study Record Dates

• First Submitted: July 24, 2022
• First Posted: August 3, 2022
• Study Start: November 29, 2022
• Primary Completion: February 1, 2023
• Study Completion: March 1, 2023
• Last Updated: March 29, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)