Laparoscopic Hysterectomy - Outpatient Versus Inpatient Regimen
Condition: Outpatient Hysterectomy
Study type: Interventional

Summary: 
      Laparoscopic Hysterectomy (LH) is increasingly used as a standard surgical approach to
      hysterectomy. It is a safe procedure with low rates of complications and readmissions.
      Increasing evidence indicates that LH may be suitable for an outpatient setting but this may
      impair patient's satisfaction in more than 25% of cases. In addition, change from in-patient
      care to day case surgery might influence readmission rates and postoperative physical
      activity. No data are available on the current length of sick leave in Danish patients after
      hysterectomy, and the effects of outpatient surgery on this parameter are difficult to
      predict. A randomized controlled trial of LH performed as an outpatient procedure compared
      with today's inpatient standard will provide a firm platform for future planning of routine
      treatment of patients with need of hysterectomy for benign indications.
    

Detailed description: 
      Hysterectomy is the most frequent gynecological operation world wide and the indication is
      often benign. The women are healthy and young with a median age below 50 years. In Denmark,
      hysterectomy is performed as an inpatient procedure with a median hospitalization of 1 day.
      Hysterectomies in Denmark are distributed by 45% abdominal hysterectomies (AH), 35% vaginal
      hysterectomies (VH) and 20% laparoscopic hysterectomies (LH). There is no final consensus
      whether VH or LH should be recommended as first choice but LH is gaining more and more
      acceptance. Increasing evidence indicates that LH may be suitable for an outpatient setting.
      Data seem to assure that outpatient LH is feasible but patient's satisfaction in this setting
      remains an open question. A detailed analysis of data from a Norwegian study indicates that
      patients reporting dissatisfaction with the early discharge amounts to 25-38%. Such a
      decrease in patient's satisfaction would present a significant problem, and a randomized
      controlled study of sufficient size with focus on this aspect is therefore needed.

      Recommendations on postoperative sick leave vary considerably, due to lack of evidence-based
      guidelines and no firm data are available on the relation between outpatient treatment and
      sick leave in gynecology.

      This randomized controlled study attempt to examine outpatient LH and patient satisfaction
      and related subject as readmissions and complications, time to return to work, physical
      activity in the recuperation period and an overall socioeconomic calculation of the costs of
      LH in an in- and outpatient setting.
    

Intervention name(s): Total laparoscopic hysterectomy; Total laparoscopic hysterectomy
Intervention type(s): Procedure; Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Hysterectomy; Patient satisfaction; Rehabilitation; Laparoscopy; Return to work; Exercise