NCT01830738

Laparoscopic Hysterectomy Via a Single Port, Peri-umbilical Technique Versus a Conventional Laparoscopic Technique

Laparoscopic Hysterectomy Via a Single Port, Peri-umbilical Technique Versus a Conventional Laparoscopic Technique : a Prospective, Randomized, Multicenter Study Evaluating the Length of Hospital Stay

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Centre Hospitalier Universitaire de Nīmes · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main objective of the study is the comparison of the effective duration of hospitalization following laparoscopic hysterectomy via a single-port peri-umbilical technique versus an conventional multi-port technique.

Detailed description

The secondary objectives are to compare the following between the two arms of the study: 1. the difference between the real discharge date and the theoretical discharge date 2. measures related to intraoperative bleeding 3. operating time 4. postoperative pain 5. quality of life 6. abdominal wall complication rates 7. rates of further surgery and rehospitalization 8. use of material resources in the operating room 9. average costs of hospital stay 10. Costs of rehospitalization at 1 year 11. Indirect costs

Conditions

• Hysterectomy

Interventions

Type	Name	Description
PROCEDURE	Single-port, peri-umbilical hysterectomy	Patients in this arm have a hysterectomy via a single-port peri-umbilical laparoscopic surgical technique.
PROCEDURE	Multi-port hysterectomy	Patients in this arm have a hysterectomy via a conventional multi-port laparoscopic surgical technique.

Timeline

• Start date: 2014-02-01
• Primary completion: 2014-08-01
• Completion: 2015-04-01
• First posted: 2013-04-12
• Last updated: 2015-10-22

Locations

3 sites across 1 country: France