Elastic Abdominal Binder Following Gynecologic Cancer Surgery

NCT03818633 | Completed

• 1 other identifier: OBG-2560-05147
• Study Type: interventional
• Target: 109
• Locations: 1 country
• Sites: 1

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.

Conditions

Gynecologic Cancer

Outcome Measures

Primary Outcomes (2)

• Daily average postoperative pain scores

  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

  Six-minute walk test (6MWT)

  One day before operation and postoperative day 3

Secondary Outcomes (2)

• Quality of life: EuroQol Group's ED-5D-5L questionnaire

  In the morning of postoperative day 3

• Rate of postoperative complications

  In the morning, up to 7 days postoperation

Study Arms (2)

Elastic abdominal binder

EXPERIMENTAL

Device: Elastic abdominal binder

No binder

NO INTERVENTION

Interventions

Elastic abdominal binder DEVICE

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.

Elastic abdominal binder

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women, diagnosed with gynecologic malignancies (carcinoma of the cervix, endometrium, and ovary), undergoing open abdominal surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• Chiang Mai University: lead

Study Sites (1)

Kittipat Charoenkwan

Chiang Mai, 50200, Thailand

Location

Study Officials

• Kittipat Charoenkwan, MD, MSc

  Chiang Mai University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 22, 2019
• First Posted: January 28, 2019
• Study Start: April 24, 2018
• Primary Completion: May 31, 2019
• Study Completion: May 31, 2019
• Last Updated: February 5, 2020

Record last verified: 2020-02

Locations

TH (1)