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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
42
Transumbilical removal of a benign adnexal mass from the abdominal cavity in laparoscopy
Lateral transabdominal removal of a benign adnexal mass from the abdominal cavity in laparoscopy
Kätilöopisto Maternity Hospital, Helsinki University hospital
Helsinki, Finland
The use of analgesics for postoperative pain
The total amount of analgesics used measured by use of Oxycodone (mg)
Time frame: Change in 24 hours after surgery
Complications
Frequency of complications. Values are given as n (%) and eventual complications are specified
Time frame: The first six months after the surgical intervention
Nausea
Nausea after the procedure: Visual Analog Score (VAS) for nausea, to measure quality of nausea. 10-point VAS score for nausea \[(0-10), 0 indicating no nausea and 10 indicating unbearable nausea. at 1, 3, 6, 12 and 24 h (hour) after surgery. (Units on a Scale; 0-10)
Time frame: Change in 24 hours after surgery
Vomiting
Vomiting after the procedure: Visual Analog Score (VAS) for vomiting to measure quality of vomiting. 10-point VAS score for vomiting \[(0-10), 0 indicating no vomiting and 10 indicating unbearable vomiting\] at 1, 3, 6, 12 and 24 h (hour) after surgery. (Units on a Scale; 0-10)
Time frame: Change in 24 hours after surgery
Length of hospital stay in hours
Length of hospital stay measured from the end of the operation until discharge (hours)
Time frame: Up to one week
Quality of life
A questionnaire six months after operation concerning wellbeing outcome after six months (% of respondents in the group)
Time frame: At baseline and 6 months after the surgery
Cosmetic outcome
A questionnaire six months after operation concerning cosmetic outcome after six months (% of respondents in the group)
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Time frame: At baseline and 6 months after the surgery
Costs
Calculating the comparative direct costs of both techniques. The cost of equipment used in the surgical intervention. (euros)
Time frame: During the surgery
Surgeon perception of both techniques
A questionnaire one month after operation of opinion of surgeons on preferred route of specimen removal (% of respondents in the group)
Time frame: After one month after the operation
Length of need of postoperative pain medication
A questionnaire of pain medication needed postoperatively. (Days)
Time frame: Change in one month after surgery
Postoperative pain scores
Visual Analog Score (VAS) for pain to measure quality of pain. 10-point VAS score for pain \[(0-10), 0 indicating no pain and 10 indicating unbearable pain\] at 1, 3, 6, 12 and 24 h (hour) after surgery (Units on a Scale; 0-10)
Time frame: Change in 24 hours after surgery