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Transumbilical Versus Lateral Transabdominal Removal of Benign Adnexal Masses Via Laparoscopy

Postoperative Pain Clinical Trial

Official title:
Transumbilical Versus Lateral Transabdominal Removal of Benign Adnexal Masses Via Laparoscopy, a Randomized Trial

Clinical Trial Summary

In cases of benign adnexal mass laparoscopic surgery, women were randomized to two groups: transumbilical vs. transabdominal removal. Need for pain medication, postoperative pain and patients´ satisfaction were assessed between the groups, as well as surgeons´ opinions and costs.

Clinical Trial Description

Women assigned to laparoscopic surgery for removal of a benign adnexal mass were randomly divided into two groups as regards surgery: a transumbilical (TU) group (n=21) and a transabdominal (TA) group (n=21). General anesthesia and use of local anesthetics were standardized. Visual analog scale (VAS) scores for pain and side effects (nausea/vomiting) and the amount of postoperative analgesic used were recorded for 24 hours. Investigators also investigated the expenses related to endobags and trocars. Further, peri- and postoperative complications were recorded. Investigators inquired about patient satisfaction as well as the surgeons' opinions of the alternative methods available. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02704663
Study type Interventional
Source Helsinki University Central Hospital
Contact
Status Active, not recruiting
Phase N/A
Start date November 2014
Completion date May 2016
View Details
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