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OpenTrials
Completed

NCT Number: NCT03820115

Elastic Abdominal Binder After Open Abdominal Surgery for Benign Gynecologic Conditions

Surgery remains the backbone of modern management of benign gynecologic conditions. Some common surgical procedures include hysterectomy for uterine leiomyoma or adenomyosis, adnexectomy for ovarian and tubal pathology, and other conservative surgeries. These procedures can be accomplished by different surgical approaches comprising abdominal, vaginal, and laparoscopic routes. Although the use of vaginal and laparoscopic approach has increased in recent years, the open abdominal route is still the most commonly employed approach. This is especially the case in developing countries where resources to support the more expensive approach such as laparoscopy are quite limited. However, the procedure can be associated with significant morbidity. 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 patients who use versus do not use the elastic abdominal binder to support incisional site.

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Key information

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 benign gynecologic conditions, undergoing open abdominal surgery

Exclusion criteria

  • Surgeries performed for cancer
  • 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. 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 After Open Abdominal Surgery for Benign Gynecologic Conditions: a Randomized Controlled Trial

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jan 29, 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.

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