Day-case Versus Inpatient Laparoscopic Supracervical Hysterectomy

NCT01127243 | Completed

• 1 other identifier: S-08447a
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine if women subjected to laparoscopic supracervical hysterectomy in a day-case setting would be less satisfied with the length of hospital stay when compared with women who had an overnight stay following their surgical procedure. The null hypothesis was that there was no difference in satisfaction with length of hospital stay.

Conditions

Hysterectomy

Keywords

Hysterectomy; laparoscopy; day-case surgery; quality of life; Ambulatory Surgical Procedures

Outcome Measures

Primary Outcomes (1)

• satisfaction with the length of stay in the hospital

  satisfaction was measured on a 10-point visual analogue scale

  on the 7th postoperative day

Secondary Outcomes (1)

• health-related quality of life

  measured on days 1, 2, 4 and 7 following surgery

Study Arms (2)

inpatient LSH

ACTIVE COMPARATOR

LSH means laparoscopic supracervical hysterectomy

Procedure: inpatient LSH

Day-case LSH

EXPERIMENTAL

LSH means laparoscopic supracervical hysterectomy

Procedure: day-case laparoscopic supracervical hysterectomy

Interventions

day-case laparoscopic supracervical hysterectomy PROCEDURE

patients discharged home the same day of the operation

Also known as: day surgery, day-case, outpatient surgery

Day-case LSH

inpatient LSH PROCEDURE

patients discharged home the day after the operation

Also known as: inpatient, overnight stay

inpatient LSH

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• women requiring a hysterectomy for benign conditions

You may not qualify if:

• previous history of cervical dysplasia, an abnormal smear test within the last two to three years,
• abnormal histology or cytology at endometrial sampling,
• a history of endometriosis,
• advanced endometriosis diagnosed intra-operatively,
• previous major abdominal or pelvic surgery (patients with previous caesarean section were considered as eligible),
• a mental disorder or somatic disease that would interfere with a normal recovery pattern such as substance dependence disorder,
• psychosis, or American Society of Anaesthesiologists (ASA) rating 3 and 4 patients, and
• inability to understand and execute oral and written Norwegian language.
• women were also excluded from the study if they did not have an adult carer (a relative or a friend) staying with them during the first night after discharge; or they were living or staying at a hotel more than an hour's drive from the hospital; and if they did not have access to a telephone.

Sponsors & Collaborators

• Oslo University Hospital: lead

Study Sites (1)

Oslo University Hospital, Ullevål

Oslo, Oslo County, 0407, Norway

Location

MeSH Terms

Interventions

Ambulatory Surgical Procedures; Inosine Monophosphate

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative; Inosine Nucleotides; Purine Nucleotides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides

Study Officials

• Jelena Kisic-Trope, MD, Msc

  Oslo University Hospital, Ullevål

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 19, 2010
• First Posted: May 20, 2010
• Study Start: June 1, 2008
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: May 20, 2010

Record last verified: 2009-06

Locations

NO (1)