Hysterectomy (MeSH nr: E04.950.300.399) Clinical Trial
Official title:
General Anesthesia Versus Spinal Anesthesia Combined With Intrathecal Morphine in Abdominal Hysterectomy for Benign Gynecological Diseases. A Randomized Open Controlled Study.
| Verified date | January 2012 |
| Source | University Hospital, Linkoeping |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Sweden: Medical Products Agency |
| Study type | Interventional |
The purpose of this study is to determine whether spinal anesthesia combined with intrathecal morphine in abdominal hysterectomy on benign gynecological indications gives better outcome concerning duration of hospital stay and postoperative patient comfort than general anesthesia.
| Status | Completed |
| Enrollment | 180 |
| Est. completion date | December 2009 |
| Est. primary completion date | June 2009 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years to 60 Years |
| Eligibility |
Inclusion Criteria: - Female between 18 and 60 years of age. - Scheduled for abdominal hysterectomy - total or subtotal -on benign gynecological indication. - At least one ovary planned to be preserved at the hysterectomy. - Can understand and communicate in Swedish - Accept participation after written and verbal information and after signed informed consent. - Has supervision at home after discharge from hospital during the first couple of days and has access to a telephone. Exclusion Criteria: - Contra-indications against spinal or general anesthesia or the standard dosage of the study drugs - ASA classification = Class 3 - Postmenopausal women without HRT (hormone replacement therapy). - Suspected gynecological malignancy - Previously undergone bilateral oophorectomy - Substantial physically disabled so that a normal recovery with early physical mobilization can not be anticipated. - Mentally or severly psychic disabled |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
| Country | Name | City | State |
|---|---|---|---|
| Sweden | Eksjö Hospital | Eksjö | |
| Sweden | Ryhov Hospital | Jönköping | |
| Sweden | University Hospital | Linköping | |
| Sweden | Vrinnevi Hospital | Norrköping | |
| Sweden | Värnamo Hospital | Värnamo |
| Lead Sponsor | Collaborator |
|---|---|
| Preben Kjolhede |
Sweden,
Ellström MA, Aström M, Möller A, Olsson JH, Hahlin M. A randomized trial comparing changes in psychological well-being and sexuality after laparoscopic and abdominal hysterectomy. Acta Obstet Gynecol Scand. 2003 Sep;82(9):871-5. — View Citation
Kehlet H, Wilmore DW. Multimodal strategies to improve surgical outcome. Am J Surg. 2002 Jun;183(6):630-41. Review. — View Citation
Møller C, Kehlet H, Friland SG, Schouenborg LO, Lund C, Ottesen B. Fast track hysterectomy. Eur J Obstet Gynecol Reprod Biol. 2001 Sep;98(1):18-22. — View Citation
Persson P, Wijma K, Hammar M, Kjølhede P. Psychological wellbeing after laparoscopic and abdominal hysterectomy--a randomised controlled multicentre study. BJOG. 2006 Sep;113(9):1023-30. — View Citation
Vårdtid, funktionskapacitet och sjukskrivningstider efter hysterektomi. Nationella data från 6503 patienter opererade år 2000 och 2001. Återrapport från Nationella registret för kvalitetsutveckling inom gynekologisk kirurgi (Gynop-registret), SFOG, 2003.
Wilmore DW, Kehlet H. Management of patients in fast track surgery. BMJ. 2001 Feb 24;322(7284):473-6. Review. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Duration of Hospital Stay. | Duration of hospital stay defined as time from start anesthesia to leaving the hospital | Within 6 months after surgery | Yes |
| Secondary | Occurrence and Degree of Postoperative Symptoms. | Within 6 months after the surgery | Yes | |
| Secondary | Postoperative Consumption of Analgesics and Antiemetics. | Within 6 months after surgery | No | |
| Secondary | Complications and Complication Rates. | Within 6 months after the surgery | Yes | |
| Secondary | Quality of Life and QALYs (Quality Adjusted Life Years). | Within 6 months after the surgery | No | |
| Secondary | Sick Leave. | Within 6 months after the surgery | No | |
| Secondary | The Stress Coping Ability Impact on Postoperative Symptoms and Recovery. | Within 6 months after the surgery | No | |
| Secondary | Health-related Economy. | Within 6 months after the surgery | No |