Women Who Undergo a Laparoscopic Hysterectomy for Benign Disease. Clinical Trial
Official title:
Randomised Study Comparing Discharge 3 Days After Surgery to Home Within 24 Hours After Laparoscopic Hysterectomy.
| NCT number | NCT02150200 |
| Other study ID # | 5717 |
| Secondary ID | |
| Status | Not yet recruiting |
| Phase | N/A |
| First received | May 26, 2014 |
| Last updated | July 3, 2014 |
| Start date | May 2014 |
Hysterectomy is one of the most performed surgery in gynecologic surgery. Actually, 70 000
hysterectomies are performed each year in France. Laparoscopic surgery is in progression.
The percentage of hysterectomies performed laparoscopically is increasing. The advantage of
laparoscopy include fewer infections, less operative pain, faster recovery time and shorter
hospital stay. In France, the average of hospital stay after laparoscopic hysterectomy
reduced to 3-4 days.
The study hypothesis is that a shorter postoperative stay does not decrease the quality of
life of the patients.
This study will compare the evolution of quality of life (with a questionnaire concerning
measuring health related quality of life the Euroqol EQ-5D) of patients discharged after 3
days hospital stay to patients discharged the first day after a laparoscopic hysterectomy.
| Status | Not yet recruiting |
| Enrollment | 44 |
| Est. completion date | |
| Est. primary completion date | February 2015 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 35 Years to 70 Years |
| Eligibility |
Inclusion criteria: - age between 35 and 70. - affiliation to a social security system - signed informed consent form - disponibility of an responsible and valid accompanying person during 48 hours - home situation, less than one hour to go to an adapted structure of care - access to a phone Exclusion criteria: - comorbidity which will automatically increase the period of hospital stay - contraindication in laparoscopy - difficulty to understand the protocol - no social security cover |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label
| Country | Name | City | State |
|---|---|---|---|
| France | Hôptaux Universitaires de Strasbourg, Département de Gynécologie-Obstétrique | Strasbourg |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Strasbourg, France |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Quality of life assessed by the Euroqol EQ-5D | Measure of quality of life with a questionnaire concerning health related quality of life (the Euroqol EQ-5D).The patients will complete the questionnaire at up to 30th days after the laparoscopic hysterectomy. | up to 30th days after the laparoscopic hysterectomy. | No |
| Secondary | Quality of life with assessed by the short SF-36 score (the 36 items Short Form Health Survey). in pre-operative time and 30 days after the hysterectomy. | In pre-operative time and 30 days after the hysterectomy. | No | |
| Secondary | Patient satisfaction | Patient satisfaction assessed one month after intervention | No | |
| Secondary | Evaluation of pain by Visual Analog Scale for Pain and by analgesic drugs consumption | the day of intervention, 1 day, 2 days, 3 days, 4 days, 5 days, 6 days, 7 days and 30 days after intervention | Yes | |
| Secondary | Anxiety assessment by the State trait anxiety inventory forme Y-A | before intervention, the firt day, the second day, the third day after intervention, one week after intervention and one month after intervention. | Yes | |
| Secondary | Patient recovery and discharge after intervention assessed by Post-Anaesthetic Discharge Scoring System (PADSS score). | 8 hours after laparoscopic surgery | No | |
| Secondary | Comparison between a hospital stay of 3-4 days after laparoscopic hysterectomy costs and hospital stay of 1day after laparoscopic hysterectomy costs from the day of intervention until one month after intervention. | The assessment will take into account any case of rehospitalization | each day from the date of intervention untill one month after intervention. | No |
| Secondary | Perioperative morbidity | from intervention untill one month after intervention | Yes | |
| Secondary | Number of rehospitalization | one month after intervention | Yes |