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Background:
No randomised trials have been conducted, and only a single retrospective study exists comparing 3D and 2D laparoscopic hysterectomy. In that study, operative time for hysterectomy was significantly lower for 3D compared to 2D conventional laparoscopy. Complication rates were similar for the two groups. Thus, although one out of nine women is hysterectomized and although laparoscopy is one of the recommended routes of surgery, evidence whether to choose 2D laparoscopy, 3D laparoscopy is sparse.
Objective:
To compare pain and recurrence to usual activity level. Secondary to compare complications during the operation, postoperative complications, time to return to work, length of hospital stay and operative time.
Design:
Investigator-initiated, blinded, randomised controlled trial.
Intervention description:
Operative procedures follow the same principles and the same standard whether the surgeon's vision is 2D or 3D.
Trial size Roskilde/Herlev Hospital, Denmark:
200 patients in each arm of the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2-Dimensional laparoscopic hysterectomy | Active Comparator | traditional 2-D laparoscopy |
|
| 3-Dimensional laparoscopic hysterectomy | Experimental | experimental 3-D laparoscopy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3-D laparoscopy | Device | 3-D laparoscopy |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Score on SF 36 psychical health survey 6 weeks after surgery | 6 weeks | |
| Pain (VAS score) assessed immediately at return to the gynaecological unit (about 5 hours postoperatively) and (VAS score) in the morning days 1-3 postoperatively. | 3 days |
| Measure | Description | Time Frame |
|---|---|---|
| Major complications during the operation, postoperative complications | 6 weeks | |
| Minor complications during the operation, postoperative complications | 6 weeks | |
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Inclusion Criteria:
Exclusion Criteria:
Women not suitable for laparoscopic hysterectomy including:
Inability to give informed consent
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Elise Hoffmann, MD | Contact | +45 20252017 | elisehoffmann78@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sjaellands Univercety Hospital | Recruiting | Roskilde | Region Sjælland | 4000 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28882141 | Derived | Hoffmann E, Bennich G, Larsen CR, Lindschou J, Jakobsen JC, Lassen PD. 3-dimensional versus conventional laparoscopy for benign hysterectomy: protocol for a randomized clinical trial. BMC Womens Health. 2017 Sep 7;17(1):76. doi: 10.1186/s12905-017-0434-7. |
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| ID | Term |
|---|---|
| D005350 | Fibroma |
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D018218 | Neoplasms, Fibrous Tissue |
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
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| 2-D laparoscopy |
| Device |
2-D laparoscopy |
|
| Score on SF 36 mental health survey 6 weeks after surgery |
| 6 weeks |
| Length of hospital stay | 6 weeks |
| Operative time | 4 hours |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |