Postoperative ComplicationsNCT05485857
Influence of Arrangement of Small Intestine Order on the Recovery of Bowel Function After Laparoscopic Colorectal Surgery
A study testing Arrangement of small intestine order before close the abdomen in people with Postoperative Complications, run by Changhai Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Postoperative Complications
- What is being tested?
- Arrangement of small intestine order before close the abdomen
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- 29 Nov 2022to 1 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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；
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Postoperative Complications
- Being tested
- Arrangement of small intestine order before close the abdomen
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arrangement of small intestine order before close the abdomenProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 50 hours
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 70 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2022
- Study start29 Nov 2022
- Primary completion1 Feb 2023
- Study completion1 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative ComplicationsStudies of the same condition, open and under way.
- More trials run by Changhai HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wei Zhang, Changhai Hospital
- Investigators
- Wei Zhang, Study chair, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05485857
- Sponsor's protocol ID
- CHCS-intestine
- Status last verified
- Mar 2023
- First submitted
- 24 Jul 2022
- Last updated
- 29 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ma S, Zhu X, Lou Z, Zhou Z, Gong H, Hong Y, Hao L, Yu G, Zhang W. The impact of intraoperative small intestine arrangement on postoperative intestinal function recovery in patients with laparoscopic colectomy: A single-center, double-blinded, randomized controlled trial. Surg Today. 2026 Sep 2. doi: 10.1007/s00595-026-03474-y. Online ahead of print.
PubMed 42684438
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Arrangement of Small Intestine Order on the Recovery of Bowel Function After Laparoscopic Colorectal Surgery.
- ClinicalTrials.gov ID
- NCT05485857
- Acronym / sponsor ID
- CHCS-intestine
- Conditions
- Postoperative Complications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- 29 Nov 2022 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 3 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arrangement group | Experimental | Procedure: Arrangement of small intestine order before close the abdomenExperimental 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 | No intervention | –No arrangement group: After completing the routine operation of laparoscopic-assisted colorectal cancer surgery, the abdomen was closed directly. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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；
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arrangement of small intestine order before close the abdomenAfter 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. | Procedure or surgery | Arrangement group |
Primary outcome
First flatus time after surgery
Time frame: 50 hours
The investigators will record the time from the end of the surgery to the patient's first flatus time by hours.
4 secondary outcomes
Time to liquid diet
Time frame: 70 hours
Postoperative hospital stay
Time frame: 30 days
Paralytic ileus time after surgery
Time frame: 30 days
First defecate time after surgery
Time frame: 70 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2023.
- Derived from this study: PubMed 42684438Ma S, Zhu X, Lou Z, Zhou Z, Gong H, Hong Y, Hao L, Yu G, Zhang W. The impact of intraoperative small intestine arrangement on postoperative intestinal function recovery in patients with laparoscopic colectomy: A single-center, double-blinded, randomized controlled trial. Surg Today. 2026 Sep 2. doi: 10.1007/s00595-026-03474-y. Online ahead of print.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wei Zhang study chair
Changhai Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arrangement of small intestine order before close the abdomen in people with Postoperative Complications, run by Changhai Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
First flatus time after surgery (time frame: 50 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05485857, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2023.