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

Primary Purpose

Postoperative Complications

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Arrangement of small intestine order before close the abdomen
Sponsored by
Changhai Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Complications

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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；

Sites / Locations

  • Changhai Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Arrangement group

No arrangement group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Postoperative hospital stay
The investigators will record the time from the end of the surgery to the patient's decharge time by 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.
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.

Full Information

First Posted
July 24, 2022
Last Updated
March 27, 2023
Sponsor
Changhai Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05485857
Brief Title
Influence of Arrangement of Small Intestine Order on the Recovery of Bowel Function After Laparoscopic Colorectal Surgery
Official Title
Influence of Arrangement of Small Intestine Order on the Recovery of Bowel Function After Laparoscopic Colorectal Surgery.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
November 29, 2022 (Actual)
Primary Completion Date
February 1, 2023 (Actual)
Study Completion Date
March 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Changhai Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Complications

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
160 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arrangement group
Arm Type
Experimental
Arm Description
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.
Arm Title
No arrangement group
Arm Type
No Intervention
Arm Description
No arrangement group: After completing the routine operation of laparoscopic-assisted colorectal cancer surgery, the abdomen was closed directly.
Intervention Type
Procedure
Intervention Name(s)
Arrangement of small intestine order before close the abdomen
Intervention Description
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.
Primary Outcome Measure Information:
Title
First flatus time after surgery
Description
The investigators will record the time from the end of the surgery to the patient's first flatus time by hours.
Time Frame
50 hours
Secondary Outcome Measure Information:
Title
Time to liquid diet
Description
The investigators will record the time from the end of the surgery to the patient's first diet time by hours.
Time Frame
70 hours
Title
Postoperative hospital stay
Description
The investigators will record the time from the end of the surgery to the patient's decharge time by days.
Time Frame
30 days
Title
Paralytic ileus time after surgery
Description
The investigators will record the time after surgery if the patient's first fluid time is more than seven days after the operation.
Time Frame
30 days
Title
First defecate time after surgery
Description
The investigators will record the time from the end of the surgery to the patient's first defecate time by hours.
Time Frame
70 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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；
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wei Zhang
Organizational Affiliation
Changhai Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Changhai Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200433
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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