- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03818633
Elastic Abdominal Binder Following Gynecologic Cancer Surgery
Effect of Elastic Abdominal Binder on Pain and Functional Recovery Following Gynecologic Cancer Surgery: a Randomized Controlled Trial
Surgery is the primary treatment for gynecologic malignancies. The surgical approach provides opportunities for removal of the affected organs and complete assessment of extent of cancer spread. However, the procedures are often associated with significant morbidity. This is especially true with open laparotomy, the most frequently employed approach in developing countries. Delayed functional recovery influenced by pain and immobilization are important contributing factors for increased morbidity. Elastic abdominal binder, a wide elastic belt that is wore around the patient's abdomen to support surgical incision after surgery, has been employed by clinicians for pain relief, wound complications prevention, improved pulmonary function, and stabilization. Benefits of the abdominal binder use in this patient population have not been properly examined.
The aim of this study is to examine the effect of postoperative elastic abdominal binder use on recovery by comparing pain scores and mobility function (through the 6-minute walk test [6MWT]) in postoperative gynecologic cancer patients who use versus do not use the elastic abdominal binder to support incisional site.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Chiang Mai, Thailand, 50200
- Kittipat Charoenkwan
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Women, diagnosed with gynecologic malignancies (carcinoma of the cervix, endometrium, and ovary), undergoing open abdominal surgery
Exclusion Criteria:
- Intraoperative accidental injury to urinary or gastrointestinal organs
- Postoperative admission to intensive care unit (ICU)
- Postoperative intraperitoneal drain placement
- Unable to understand and follow oral/written instructions
- Severe neuromuscular or circulatory disorders
Study Plan
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Elastic abdominal binder
|
Each woman in the intervention group is fitted with an elastic abdominal binder at the time of procedure completion just before leaving the operating room.
The binder is placed snuggly tight (keeping in mind patient's comfort) on top of the hospital gown with the incision positioned at the middle part of the binder.
The patients are encouraged to wear binders at all time.
However, periods of break from wearing the binder are allowed at their convenience.
|
NO_INTERVENTION: No binder
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Daily average postoperative pain scores
Time Frame: An average of pain scores at 8:00 am and 4:00 pm, up to 7 days postoperation
|
The participants are asked to rate postoperative pain according to 10-cm visual analog scales from '0' (no pain) to '10' (worst possible pain).
|
An average of pain scores at 8:00 am and 4:00 pm, up to 7 days postoperation
|
Six-minute walk test score change from baseline
Time Frame: One day before operation and postoperative day 3
|
Six-minute walk test (6MWT)
|
One day before operation and postoperative day 3
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of postoperative complications
Time Frame: In the morning, up to 7 days postoperation
|
The complications of interest include febrile morbidity, wound complication, bowel ileus
|
In the morning, up to 7 days postoperation
|
Quality of life: EuroQol Group's ED-5D-5L questionnaire
Time Frame: In the morning of postoperative day 3
|
The EuroQol Group's ED-5D-5L questionnaire is employed.
The health dimensions assessed include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
For each dimension, the participants are asked to indicate their health state related to that dimension as no problems (score '1'), slight problems (score '2'), moderate problems (score '3'), severe problems (score '4'), and extreme problems (score '5').
For this study, a score of 1-2 is considered "normal" while a scores of 3-5 is regarded as "problem".
In addition, the participants are asked to rate their overall health status according to a visual analog scale EQ VAS with '0' corresponding to "the worst health imaginable" and '100' indicating "the best health imaginable".
|
In the morning of postoperative day 3
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- OBG-2560-05147
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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