Transumbilical Versus Lateral Transabdominal Removal of Benign Adnexal Masses Via Laparoscopy

Not Applicable

• Conditions: Postoperative Pain
• Interventions: Procedure: Lateral transabdominal removal of specimen via laparoscopy; Procedure: Transumbilical removal of specimen via laparoscopy

• Registration Number: NCT02704663
• Lead Sponsor: Helsinki University Central Hospital

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.

Study Timeline

• Study Start: 2014-11
• Study First Submitted: 2016-01-18
• Status Verified: 2016-03
• Study First Submitted QC: 2016-03-09
• Last Update Submitted: 2016-03-09
• Study First Posted: 2016-03-10
• Last Update Posted: 2016-03-10
• Primary Completion: 2016-05
• Study Completion: 2016-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 42

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lateral abdominal route	Lateral transabdominal removal of specimen via laparoscopy	Lateral transabdominal removal of benign adnexal masses via laparoscopy.
Transumbilical route	Transumbilical removal of specimen via laparoscopy	Transumbilical removal of benign adnexal masses via laparoscopy.

Primary Outcome Measures

Name	Time	Method
The use of analgesics for postoperative pain	Change in 24 hours after surgery	The total amount of analgesics used measured by use of Oxycodone (mg)

Secondary Outcome Measures

Name	Time	Method
Complications	The first six months after the surgical intervention	Frequency of complications. Values are given as n (%) and eventual complications are specified
Surgeon perception of both techniques	After one month after the operation	A questionnaire one month after operation of opinion of surgeons on preferred route of specimen removal (% of respondents in the group)
Cosmetic outcome	At baseline and 6 months after the surgery	A questionnaire six months after operation concerning cosmetic outcome after six months (% of respondents in the group)
Postoperative pain scores	Change in 24 hours after surgery	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)
Nausea	Change in 24 hours after surgery	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)
Vomiting	Change in 24 hours after surgery	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)
Length of hospital stay in hours	Up to one week	Length of hospital stay measured from the end of the operation until discharge (hours)
Quality of life	At baseline and 6 months after the surgery	A questionnaire six months after operation concerning wellbeing outcome after six months (% of respondents in the group)
Costs	During the surgery	Calculating the comparative direct costs of both techniques. The cost of equipment used in the surgical intervention. (euros)
Length of need of postoperative pain medication	Change in one month after surgery	A questionnaire of pain medication needed postoperatively. (Days)

Trial Locations

Locations (1)

Kätilöopisto Maternity Hospital, Helsinki University hospital; 🇫🇮 Helsinki, Finland