Randomized trial of laparoscopic versus abdominal hysterectomy for benign indications and impact on surgical success

Study ID
STU 032012-067

Cancer Related
No

Healthy Volunteers
No

Study Sites

Contact
Kimberly Kho
214-648-6430
kimberly.kho@utsouthwestern.edu

Principal Investigator
Kimberly Kho

Summary

as hysterectomies are the most commonly performed major surgical procedures, with more than 500,000 cases per year in the united States, clear recommendations for the comparative effectiveness of the different modes of hysterectomy are important. as with many healthcare decisions, route of hysterectomy is usually dictated by the physician and is impacted by a combination of patient characteristics and pathology as well as training, technical skill, and other non-clinical concerns which can impact which methods are offered to patients. Limited data from well-conducted trials allows this practice to continue since no method is established to be superior to the other.
in the case of hysterectomies, the mode or method by which the uterus is removed x either through the vagina, through the abdomen via a vertical midline or low transverse incision, or through 5-10mm incisions on the abdomen x can impact perioperative issues like postoperative pain, narcotic use, and medical complications, but may also have further impacts on a woman's quality of life, body image, and sexual functioning (Gary).
To date, the gynecologic literature has attempted to compare the modalities with regards to peri-operative complications, length of hospital stay, and direct health care costs x and all considered, neither method of hysterectomy is categorically superior, but the research is limited when considering indirect costs such as lost wages from delays to return to work or complications associated with wound disruptions, the most common complication after a hysterectomy (Johnson). additionally, research has suggested that beyond symptom resolution, patient satisfaction is also driven by a sense of wellbeing which includes an assessment of women's sexual function, health related quality of life, and body image. These outcomes have not been fully nor adequately evaluated in the available studies. in order to fully describe surgical [Quote]success[Quote] all of these components should be considered. We propose to assess the [Quote]effectiveness[Quote] after hysterectomy and consider a comprehensive definition of surgical success. This analysis will consider 1) perioperative and postoperative medical issues/complications, 2) direct and indirect healthcare costs, and 3) patient-centered factors including self-image, sexual functioning and, quality of life in the immediate postoperative period to
up to 1 year post-hysterectomy.

Participant Eligibility

x All women undergoing hysterectomy for benign indications within 6 weeks of enrollment
x Age greater than 18 years old
x Non-emergent surgery
x Not pregnant