Skip to main content
OpenTrials
Completed

NCT Number: NCT03818633

Elastic Abdominal Binder Following Gynecologic Cancer Surgery

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Gynecologic Cancer

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Kittipat Charoenkwan

Chiang Mai, 50200, Thailand

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Chiang Mai University

Other

Registry information

Official study title

Effect of Elastic Abdominal Binder on Pain and Functional Recovery Following Gynecologic Cancer Surgery: a Randomized Controlled Trial

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jan 28, 2019
Registry last updated
Feb 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.