Transumbilical Versus Lateral Transabdominal Removal of Benign Adnexal Masses Via Laparoscopy

Helsinki University Central Hospital (HUCH)

Status: Unknown

Conditions: Postoperative Pain

Treatments: Procedure: Transumbilical removal of specimen via laparoscopy; Procedure: Lateral transabdominal removal of specimen via laparoscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT02704663

98/13/03/03/2014

Details and patient eligibility

About

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.

Full 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.

Enrollment: 42 patients

Sex: Female

Ages: 20 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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42 participants in 2 patient groups

Transumbilical route

Experimental group

Description:

Transumbilical removal of benign adnexal masses via laparoscopy.

Treatment:

Procedure: Transumbilical removal of specimen via laparoscopy

Lateral abdominal route

Active Comparator group

Description:

Lateral transabdominal removal of benign adnexal masses via laparoscopy.

Treatment:

Procedure: Lateral transabdominal removal of specimen via laparoscopy