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

NCT ID: NCT05485857

Last Updated: 2023-03-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-29
• Study Completion Date: 2023-03-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Arrangement of small intestine order before close the abdomen

Intervention Type: 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.

No arrangement group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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；

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Changhai Hospital

OTHER

Sponsor Role: lead

Responsible Party

Wei Zhang

Head of colorectal surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Wei Zhang

Role: STUDY_CHAIR

Changhai Hospital

Locations

Changhai Hospital

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

CHCS-intestine

Identifier Type: -

Identifier Source: org_study_id