Clinical trial NCT02704663: Transumbilical Versus Lateral Transabdominal Removal of Benign Adnexal Masses Via Laparoscopy
Official title: Transumbilical Versus Lateral Transabdominal Removal of Benign Adnexal Masses Via Laparoscopy, a Randomized Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Postoperative Pain
Keywords: adnexal mass
laparoscopy
removal route
postoperative pain
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
First posted: 2016-03-10
Enrollment: 42
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* The criteria for inclusion were scheduled laparoscopy for oophorectomy, salpingo-oophorectomy or cyst enucleation.

Exclusion Criteria:

* The exclusion criteria were contraindications to any of the forms of medication used in the study (oxycodone, ketoprofen, paracetamol),
* language difficulties (inability to understand and speak Finnish or Swedish)
* and suspicion of malignancy.

Primary outcomes:
measure: The use of analgesics for postoperative pain
timeFrame: Change in 24 hours after surgery
Secondary outcomes:
measure: Complications
timeFrame: The first six months after the surgical intervention
measure: Nausea
timeFrame: Change in 24 hours after surgery
measure: Vomiting
timeFrame: Change in 24 hours after surgery
measure: Length of hospital stay in hours
timeFrame: Up to one week
measure: Quality of life
timeFrame: At baseline and 6 months after the surgery
measure: Cosmetic outcome
timeFrame: At baseline and 6 months after the surgery
measure: Costs
timeFrame: During the surgery
measure: Surgeon perception of both techniques
timeFrame: After one month after the operation
measure: Length of need of postoperative pain medication
timeFrame: Change in one month after surgery
measure: Postoperative pain scores
timeFrame: Change in 24 hours after surgery
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Kätilöopisto Maternity Hospital, Helsinki University hospital
Study officials:
affiliation: Helsinki University Central Hospital
name: Päivi I Pakarinen, MD PhD
role: PRINCIPAL_INVESTIGATOR
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