Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06374940
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-04-19
First Post:
2024-04-16
Brief Title:
Surgical Outcomes of Conventional Hysterectomy or Manipulator-assisted Abdominal Hysterectomy
Sponsor:
Dr Lutfi Kirdar Kartal Training and Research Hospital
Organization:
Dr Lutfi Kirdar Kartal Training and Research Hospital
Study Overview
Official Title:
The Comparison of Surgical Outcomes to Conventional Hysterectomy and Manipulator-assisted Abdominal Hysterectomy
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Objective The comparison of surgical outcomes conventional hysterectomy and manipulator-assisted hysterectomy
Study design Prospective randomized controlled trial Allocation to either group occurred via computer-generated random numbers Sequentially numbered opaque envelopes were prepared according to randomization The patients were unaware of whether they would undergo a conventional hysterectomy or manipulator-assisted abdominal hysterectomy for their surgical procedure The research coordinator unveiled group assignments upon individual patient recruitment by opening the corresponding envelope
Study population Inclusion criteria were patients aged 40-70 years who underwent hysterectomy for benign gynecological indications
Primary outcomes 1 Operation Time
Secondary outcomes 1 Postoperative early pain Visual Analog Score VAS at 6th and 24th hours of the surgery 2 intraoperative complications 3 postoperative complications
Study design Prospective randomized controlled trial Allocation to either group occurred via computer-generated random numbers Sequentially numbered opaque envelopes were prepared according to randomization The patients were unaware of whether they would undergo a conventional hysterectomy or manipulator-assisted abdominal hysterectomy for their surgical procedure The research coordinator unveiled group assignments upon individual patient recruitment by opening the corresponding envelope
Study population Inclusion criteria were patients aged 40-70 years who underwent hysterectomy for benign gynecological indications
Primary outcomes 1 Operation Time
Secondary outcomes 1 Postoperative early pain Visual Analog Score VAS at 6th and 24th hours of the surgery 2 intraoperative complications 3 postoperative complications
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None