Ovarian Cyst Clinical Trial
Official title:
Single Port Laparoscopy Versus Conventional Laparoscopy for Benign Adnexal Disease - A Randomized Controlled Trial.
Verified date | February 2011 |
Source | Sorlandet Hospital HF |
Contact | n/a |
Is FDA regulated | No |
Health authority | Norway: Regional Ethics Commitee |
Study type | Interventional |
Keyhole surgery for adnexal disease has traditionally been performed using three or four
small incisions. The last years a new operating method has been introduced. This method
makes use of only one incision of 2 cm in the umbilicus. This method is less invasive, and
it might benefit the patient through less postoperative pain and a higher satisfaction with
the cosmetic result. So far, many studies have shown that this new method is feasible for
adnexal disease, but its superiority compared to conventional laparoscopy is to be proven.
This study aims to show this difference.
The investigators aim to compare experienced postoperative pain and use of analgesics in
patients undergoing single port laparoscopy for benign adnexal disease with conventional
laparoscopy. The investigators hypothesize that the patients will experience less
postoperative pain and use less analgesic in the single port laparoscopy group.
Further, the investigators aim to compare the satisfaction with the cosmetic results in the
two groups. In addition, blood loss, operating time, complications and conversion to
conventional laparoscopy will be registered in the two groups.
Status | Completed |
Enrollment | 40 |
Est. completion date | December 2011 |
Est. primary completion date | September 2011 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Women = 18 years. - ASA score 1 or 2. - Presumed benign ovarian disease or a hereditary cancer risk. - Ovarian cyst = 6 cm. Exclusion Criteria: - Ovarian cyst > 6 cm. - Endometrioma. - Endometriosis. - History of chronic pelvic pain. - Known severe intra abdominal adhesions. - Daily use of analgesics. - Inability to understand Norwegian or English. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Norway | SorlandetHF Hospital | Kristiansand |
Lead Sponsor | Collaborator |
---|---|
Sorlandet Hospital HF | University of Surrey |
Norway,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Postoperative pain | Experienced pain over the last six hours measured on a VAS scale. | 6 hours | No |
Secondary | Satisfaction with cosmetic result | Satisfaction with cosmetic result, self reported and based on the Manchester scar scale. | 2 months postoperatively | No |
Secondary | Operation time | Operating time in minutes. | 0 hours after the operation | No |
Secondary | Blood loss | Estimated blood loss in ml. | 0 hours after the operation | No |
Secondary | Complications | Complications during surgery and late complications. | Two months | No |
Secondary | Shoulder tip pain | Experienced shoulder tip pain over the last 24 hours measured on a VAS scale. | 24 hours | No |
Secondary | Postoperative pain | Experienced pain over the last 24 hours measured on a VAS scale. | 24 hours | No |
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