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Clinical Trials/NCT03820115
NCT03820115
Completed
Not Applicable

Effect of Elastic Abdominal Binder on Pain and Functional Recovery After Open Abdominal Surgery for Benign Gynecologic Conditions: a Randomized Controlled Trial

Chiang Mai University1 site in 1 country66 target enrollmentOctober 1, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Gynecologic Disease
Sponsor
Chiang Mai University
Enrollment
66
Locations
1
Primary Endpoint
Six-minute walk test score change from baseline
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
October 1, 2018
End Date
May 31, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Kittipat Charoenkwan, MD

Associate Professor

Chiang Mai University

Eligibility Criteria

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

Outcomes

Primary Outcomes

Six-minute walk test score change from baseline

Time Frame: One day before operation and postoperative day 3

Six-minute walk test (6MWT)

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).

Secondary Outcomes

  • Rate of postoperative complications(In the morning, up to 7 days postoperation)

Study Sites (1)

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