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Transumbilical Versus Lateral Transabdominal Removal of Benign Adnexal Masses Via Laparoscopy

Primary Purpose

Postoperative Pain

Status
Unknown status
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Transumbilical removal of specimen via laparoscopy
Lateral transabdominal removal of specimen via laparoscopy
Sponsored by
Helsinki University Central Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring adnexal mass, laparoscopy, removal route, postoperative pain

Eligibility Criteria

20 Years - 60 Years (Adult)FemaleDoes not accept 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.

Sites / Locations

  • Kätilöopisto Maternity Hospital, Helsinki University hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Transumbilical route

Lateral abdominal route

Arm Description

Transumbilical removal of benign adnexal masses via laparoscopy.

Lateral transabdominal removal of benign adnexal masses via laparoscopy.

Outcomes

Primary Outcome Measures

The use of analgesics for postoperative pain
The total amount of analgesics used measured by use of Oxycodone (mg)

Secondary Outcome Measures

Complications
Frequency of complications. Values are given as n (%) and eventual complications are specified
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)
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)
Length of hospital stay in hours
Length of hospital stay measured from the end of the operation until discharge (hours)
Quality of life
A questionnaire six months after operation concerning wellbeing outcome after six months (% of respondents in the group)
Cosmetic outcome
A questionnaire six months after operation concerning cosmetic outcome after six months (% of respondents in the group)
Costs
Calculating the comparative direct costs of both techniques. The cost of equipment used in the surgical intervention. (euros)
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)
Length of need of postoperative pain medication
A questionnaire of pain medication needed postoperatively. (Days)
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)

Full Information

First Posted
January 18, 2016
Last Updated
March 9, 2016
Sponsor
Helsinki University Central Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02704663
Brief Title
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

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Unknown status
Study Start Date
November 2014 (undefined)
Primary Completion Date
May 2016 (Anticipated)
Study Completion Date
May 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Helsinki University Central Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
adnexal mass, laparoscopy, removal route, postoperative pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Transumbilical route
Arm Type
Experimental
Arm Description
Transumbilical removal of benign adnexal masses via laparoscopy.
Arm Title
Lateral abdominal route
Arm Type
Active Comparator
Arm Description
Lateral transabdominal removal of benign adnexal masses via laparoscopy.
Intervention Type
Procedure
Intervention Name(s)
Transumbilical removal of specimen via laparoscopy
Other Intervention Name(s)
Transumbilical
Intervention Description
Transumbilical removal of a benign adnexal mass from the abdominal cavity in laparoscopy
Intervention Type
Procedure
Intervention Name(s)
Lateral transabdominal removal of specimen via laparoscopy
Other Intervention Name(s)
Lateral transabdominal
Intervention Description
Lateral transabdominal removal of a benign adnexal mass from the abdominal cavity in laparoscopy
Primary Outcome Measure Information:
Title
The use of analgesics for postoperative pain
Description
The total amount of analgesics used measured by use of Oxycodone (mg)
Time Frame
Change in 24 hours after surgery
Secondary Outcome Measure Information:
Title
Complications
Description
Frequency of complications. Values are given as n (%) and eventual complications are specified
Time Frame
The first six months after the surgical intervention
Title
Nausea
Description
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
Title
Vomiting
Description
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
Title
Length of hospital stay in hours
Description
Length of hospital stay measured from the end of the operation until discharge (hours)
Time Frame
Up to one week
Title
Quality of life
Description
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
Title
Cosmetic outcome
Description
A questionnaire six months after operation concerning cosmetic outcome after six months (% of respondents in the group)
Time Frame
At baseline and 6 months after the surgery
Title
Costs
Description
Calculating the comparative direct costs of both techniques. The cost of equipment used in the surgical intervention. (euros)
Time Frame
During the surgery
Title
Surgeon perception of both techniques
Description
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
Title
Length of need of postoperative pain medication
Description
A questionnaire of pain medication needed postoperatively. (Days)
Time Frame
Change in one month after surgery
Title
Postoperative pain scores
Description
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Päivi I Pakarinen, MD PhD
Organizational Affiliation
Helsinki University Central Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kätilöopisto Maternity Hospital, Helsinki University hospital
City
Helsinki
ZIP/Postal Code
00029
Country
Finland

12. IPD Sharing Statement

Plan to Share IPD
No
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Transumbilical Versus Lateral Transabdominal Removal of Benign Adnexal Masses Via Laparoscopy

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