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Early Mobilisation After Abdominal Surgery: a Randomised Trial
- BDCTR ID
- BDCTR-2026-000046
- Sponsor
- Bangladesh Medical University
- Information provided by
- Dr Nazmul Hoque (Responsible Party)
- Last Update Posted
- 2026-05-29
Completed
No longer looking for participants
Study Record Versions
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| Select | Version | Date submitted (YYYY-MM-DD) | Changes |
|---|---|---|---|
| 2 | 2026-05-29Current |
|
Select two versions to compare.
Viewing V2 (2026-05-29)
Study Details
Study Identification
| Unique Protocol ID | BMU-SUR-2026-002 |
|---|---|
| Brief Title | Early Mobilisation After Abdominal Surgery: a Randomised Trial |
| Official Title | A Structured Early Mobilisation Protocol Versus Usual Care After Elective Abdominal Surgery |
| Secondary IDs |
Study Status
| Record Verification | 2026-05 |
|---|---|
| Overall Status | Completed |
| Study Start | 2025-08-01 |
| Primary Completion | 2026-04-30 |
| Study Completion | 2026-05-31 |
| First Submitted | |
| First Submitted that Met QC Criteria | 2025-07-29 |
| First Posted | 2025-07-29 [Actual] |
| Last Update Submitted that Met QC Criteria | 2026-05-29 |
| Last Update Posted | 2026-05-29 [Actual] |
Sponsor/Collaborators
| Sponsor | Bangladesh Medical University |
|---|---|
| Responsible Party | Dr Nazmul Hoque |
| Collaborators |
Oversight
| U.S. FDA-regulated Drug | |
|---|---|
| U.S. FDA-regulated Device | |
| Product manufactured in and exported from the U.S. | |
| Data Monitoring | No |
Study Description
| Brief Summary | This trial compared a structured early mobilisation protocol with usual care on length of hospital stay after elective abdominal surgery. |
|---|---|
| Detailed Description | Patients undergoing elective abdominal surgery were randomised to a structured early mobilisation protocol or usual care. Length of postoperative stay was the primary endpoint. |
Conditions
| Condition | Postoperative Recovery |
|---|---|
| Keywords | surgery early mobilisation recovery |
Study Design
| Study Type | Interventional |
|---|---|
| Primary Purpose | Supportive Care |
| Study Phase | N/A |
| Interventional Study Model | Parallel Assignment |
| Number of Arms | 2 |
| Masking | Single blind |
| Allocation | Randomized |
| Enrollment | 410 [Estimated] |
Arms and Interventions
| Arms | Assigned Interventions |
|---|---|
| Experimental: Early mobilisation | Behavioral: Structured early mobilisation protocol Protocolised mobilisation starting on the first postoperative day. Procedure/Surgery: Elective abdominal surgery |
| Active Comparator: Usual care | Procedure/Surgery: Elective abdominal surgery |
Outcome Measures
| Primary Outcome Measures | Length of postoperative hospital stay Time Frame: Through hospital discharge, up to 30 days |
|---|---|
| Secondary Outcome Measures | Postoperative complication rate Time Frame: 30 days |
Eligibility
| Minimum Age | 18 Years |
|---|---|
| Maximum Age | 70 Years |
| Ages | 18 Years to 70 Years (Adult, Older Adult) |
| Sex | All |
| Gender-based Eligibility | |
| Gender Eligibility Description | |
| Accepts Healthy Volunteers | No |
| Criteria | <p>Inclusion Criteria:</p><ul><li>Adults aged 18 to 70 years undergoing elective abdominal surgery.</li></ul><p>Exclusion Criteria:</p><ul><li>Emergency surgery.</li></ul> |
Contacts/Locations
| Central Contact Person | Dr Nazmul Hoque surgery-mobilise@bmu.ac.bd |
|---|---|
| Study Officials | |
| Location | Dhaka, Dhaka, Bangladesh, 1000 Status: Completed Facility: Bangladesh Medical University, Department of Surgery |
IPD Sharing
| IPD information | Plan to Share IPD: Not provided |
|---|
References
| Citations | |
|---|---|
| Links | |
| Available IPD/Information |
Document Section
| Documents |
|---|
Study Results
Participant Flow
Recruitment Details
Adults undergoing elective abdominal surgery were enrolled at the Bangladesh Medical University Department of Surgery between August 2025 and April 2026.
Pre-assignment Details
[Not Specified]
Period Title: Overall study
| Arm/Group Title | Early mobilisation | Usual care |
|---|---|---|
| Arm/Group Description | Structured early mobilisation protocol from the first postoperative day. | Standard postoperative care. |
| Started | 206 | 204 |
| NOT COMPLETED | 8 | 14 |
| Completed | 198 | 190 |
| Not Completed | 8 | 14 |
| Reason Not Completed | ||
| Lost to Follow-up | 5 | 9 |
| Withdrawal by Subject | 3 | 5 |
Baseline Characteristics
| Arm/Group Title | Early mobilisation | Usual care | Total |
|---|---|---|---|
| Arm/Group Description | Total of all reporting groups | ||
| Overall Number of Baseline Participants | 206 | 204 | — |
Baseline Analysis Population Description
[Not Specified]
Age, ContinuousMean (Standard Deviation) | Unit of measure: years
| Arm/Group Title | Early mobilisation | Usual care | Total |
|---|---|---|---|
| Arm/Group Description | Total of all reporting groups | ||
| Number Analyzed | 206 participants | 204 participants | — |
| Age, Continuous | 46.8 (13.4) | 47.5 (13.9) | — |
Sex: Female, MaleMeasure Type: Count of Participants | Unit of measure: Participants
| Arm/Group Title | Early mobilisation | Usual care | Total |
|---|---|---|---|
| Arm/Group Description | Total of all reporting groups | ||
| Number Analyzed | 206 participants | 204 participants | — |
| Female | 112 54.4% | 108 52.9% | 220 |
| Male | 94 45.6% | 96 47.1% | 190 |
Outcome Measures
1. Length of postoperative hospital stayType: Primary | Time Frame: Through hospital discharge, up to 30 days
Description
Days from surgery to hospital discharge.
Analysis Population Description
[Not Specified]
| Arm/Group Title | Early mobilisation | Usual care |
|---|---|---|
| Overall Number of Participants Analyzed | 198 | 190 |
| Measure Type: Mean | Unit of Measure: days | ||
| Length of postoperative hospital stay | 4.2 (1.3) | 5.1 (1.6) |
2. Postoperative complication rateType: Secondary | Time Frame: 30 days
Description
[Not Specified]
Analysis Population Description
[Not Specified]
| Arm/Group Title | Early mobilisation | Usual care |
|---|---|---|
| Overall Number of Participants Analyzed | — | — |
| Measure Type: Number | Unit of Measure: percentage of participants | ||
| Postoperative complication rate | 9.1 | 14.7 |
Adverse Events
Time Frame
30 days
Adverse Event Reporting Description
[Not Specified]
All-Cause Mortality
| Arm/Group Title | Early mobilisation | Usual care |
|---|---|---|
| Affected / at Risk (%) | Affected / at Risk (%) | |
| Total | — | — |
Serious Adverse Events
| Arm/Group Title | Early mobilisation | Usual care | ||
|---|---|---|---|---|
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 7/206 (3.40%) | 11/204 (5.39%) | ||
| Infections and infestations | ||||
| Surgical site infection | 5/206 (2.43%) | 9/204 (4.41%) | ||
| Gastrointestinal disorders | ||||
| Postoperative ileus | 2/206 (0.97%) | 2/204 (0.98%) | ||
Other (Not Including Serious) Adverse Events
5% Frequency Threshold for Reporting Other Adverse Events
| Arm/Group Title | Early mobilisation | Usual care | ||
|---|---|---|---|---|
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 34/206 (16.50%) | 42/204 (20.59%) | ||
| Gastrointestinal disorders | ||||
| Postoperative nausea | 22/206 (10.68%) | 27/204 (13.24%) | ||
| General disorders | ||||
| Wound pain | 12/206 (5.83%) | 15/204 (7.35%) | ||
Limitations and Caveats
[Not Specified]