Elastic Abdominal Binder After Open Abdominal Surgery for Benign Gynecologic Conditions

Gynecologic Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03820115
• Other study ID #: OBG-2561-05421
• Status: Completed
• Phase: N/A
• Start date: October 1, 2018
• Est. completion date: May 31, 2019

Study information

• Verified date: February 2020
• Source: Chiang Mai University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: May 31, 2019
• Est. primary completion date: May 31, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Genital Diseases, Female
• Gynecologic Disease

Intervention

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.

Locations

Country	Name	City	State
Thailand	Kittipat Charoenkwan	Chiang Mai

Sponsors (1)

Lead Sponsor	Collaborator
Chiang Mai University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Six-minute walk test score change from baseline	Six-minute walk test (6MWT)	One day before operation and postoperative day 3
Secondary	Rate of postoperative complications	The complications of interest include febrile morbidity, wound complication, bowel ileus	In the morning, up to 7 days postoperation