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Elastic Abdominal Binder Following Gynecologic Cancer Surgery

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ClinicalTrials.gov Identifier: NCT03818633
Recruitment Status : Completed
First Posted : January 28, 2019
Last Update Posted : February 5, 2020
Sponsor:
Information provided by (Responsible Party):
Kittipat Charoenkwan, MD, Chiang Mai University

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Gynecologic Cancer Device: Elastic abdominal binder Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 109 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Effect of Elastic Abdominal Binder on Pain and Functional Recovery Following Gynecologic Cancer Surgery: a Randomized Controlled Trial
Actual Study Start Date : April 24, 2018
Actual Primary Completion Date : May 31, 2019
Actual Study Completion Date : May 31, 2019
Arms and Interventions
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Arm Intervention/treatment
Experimental: Elastic abdominal binder Device: 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


Outcome Measures
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Primary Outcome Measures :
  1. 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).

  2. Six-minute walk test score change from baseline [ Time Frame: One day before operation and postoperative day 3 ]
    Six-minute walk test (6MWT)


Secondary Outcome Measures :
  1. 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".

  2. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03818633


Locations
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Thailand
Kittipat Charoenkwan
Chiang Mai, Thailand, 50200
Sponsors and Collaborators
Chiang Mai University
Investigators
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Principal Investigator: Kittipat Charoenkwan, MD, MSc Chiang Mai University
More Information
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Responsible Party: Kittipat Charoenkwan, MD, Associate Professor, Chiang Mai University
ClinicalTrials.gov Identifier: NCT03818633    
Other Study ID Numbers: OBG-2560-05147
First Posted: January 28, 2019    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No