NCT07014046

Brief Summary

The purpose of this study is to examine the effect of simple bed exercises for reducing postoperative ileus among colorectal surgical patients who have completed colorectal surgery and are experiencing postoperative ileus. The research team will recruit participants in list of elective colorectal surgeries from the Department of Surgery in the United Christian Hospital. The potential participants will first be assessed for eligibility by completing a simple screening assessment, which may take 10 minutes at facilities within the United Christian Hospital. If the patients meet the inclusion criteria, they will continue to take part in the study. The participants will be assigned randomly (1:1) to either Group 1 or Group 2 via computer randomization. Participants of Group 1 will receive education for simple bed exercises after colorectal surgery. Participants will be asked to have simple bed exercises for 15 minutes, three times a day starting from postoperative day one, until passing the first stool after surgery. All sessions will be conducted by surgical nurse in the United Christian Hospital. Surgical nurses will educate simple bed exercises with exercise video. Participants will be instructed to practise the simple bed exercises 3 times per day for 15 minutes each time at before breakfast, before lunch and before dinner, on top of the standard usual care. Participants in Group 2 will be placed under control group to receive standard usual care. All participants are required to record defecation, flatus and tolerance of oral intake starting from postoperative day one. Records will take place at 3-time points for both groups: at breakfast, at lunch and at dinner time. Each time participants must complete one set of record on the logbook provided by nurses. If necessary, clinical records including medical history and follow-up appointment time will be retrieved from electronic medical records.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
76

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2024

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 27, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 10, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

June 18, 2025

Status Verified

June 1, 2025

Enrollment Period

10 months

First QC Date

May 27, 2025

Last Update Submit

June 14, 2025

Conditions

Keywords

postoperative ileusexercise

Outcome Measures

Primary Outcomes (1)

  • Time to first defecation

    Time to first defecation is defined as the interval between the end of the operation and the first observed passage of stool from rectum/ stoma. It will be observed via the stoma bag if defecation occur or by asking the patients or by reviewing the input and output chart when changing diapers for patients. All this observation will be done by nurses. Time to first defecation is expected to be shorter in intervention group if the intervention is effective for solving postoperative ileus as bowel movement resume faster. Time to first defecation is reliable as no defecation implied postoperative ileus.

    after surgery until first defecation (up to 7 days after operation)

Secondary Outcomes (2)

  • time to first flatus

    after surgery until first flatus (up to 7 days after operation).

  • tolerance to oral diet

    after surgery until tolerance of oral diet without any nausea and vomiting (up to 15 days after operation).

Study Arms (2)

Simple bed exercises arm

EXPERIMENTAL

The participants will be asked to perform exercise by lying flat on bed in supine position with their eyes look towards to the ceiling of the ward and start focusing on deep breathing exercises with slow inhalations and exhalations. These exercises aim to achieve regular pattern of abdominal muscles and improve the coordination between breathing, abdominal muscle contractions and colonic propulsions. After one-minute deep-breathing exercises, intervention group participants will be asked to pull both knees towards chest in return and turning body from one side to another while lying on bed.

Other: Simple bed exercises

control arm

NO INTERVENTION

usual care

Interventions

The participants will be asked to perform exercise by lying flat on bed in supine position with their eyes look towards to the ceiling of the ward and start focusing on deep breathing exercises with slow inhalations and exhalations. These exercises aim to achieve regular pattern of abdominal muscles and improve the coordination between breathing, abdominal muscle contractions and colonic propulsions. After one-minute deep-breathing exercises, intervention group participants will be asked to pull both knees towards chest in return and turning body from one side to another while lying on bed.

Simple bed exercises arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female patients aged \>/=18 years,
  • patients who are diagnosed with colorectal problems that require elective colorectal surgical intervention either anastomosis or stoma, either open or laparoscopic, and the use of any type of postoperative analgesic,
  • orientate to have informed consent and who have signed informed consent.

You may not qualify if:

  • Patients who are not in the list of elective colorectal surgeries
  • Patients who require intraoperative and long postoperative intensive care \>1 day,
  • with a history of mental disorder or confusion,
  • patients with any active limitation which affects adherence to the study procedures like severe dementia and physical limitation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

United Christian Hospital

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Central Study Contacts

Sin Kwan Siu, Doctoral

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 27, 2025

First Posted

June 10, 2025

Study Start

December 1, 2024

Primary Completion

September 30, 2025

Study Completion

December 31, 2025

Last Updated

June 18, 2025

Record last verified: 2025-06

Locations