Transumbilical Versus Lateral Transabdominal Removal of Benign Adnexal Masses Via Laparoscopy

March 9, 2016 updated by: Päivi Päkarinen, Helsinki University Central Hospital

Transumbilical Versus Lateral Transabdominal Removal of Benign Adnexal Masses Via Laparoscopy, a Randomized Trial

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Helsinki, Finland, 00029
        • Kätilöopisto Maternity Hospital, Helsinki University hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Transumbilical route
Transumbilical removal of benign adnexal masses via laparoscopy.
Procedure: Transumbilical removal of specimen via laparoscopy
Transumbilical removal of a benign adnexal mass from the abdominal cavity in laparoscopy
Other Names:
  • Transumbilical
Active Comparator: Lateral abdominal route
Lateral transabdominal removal of benign adnexal masses via laparoscopy.
Procedure: Lateral transabdominal removal of specimen via laparoscopy
Lateral transabdominal removal of a benign adnexal mass from the abdominal cavity in laparoscopy
Other Names:
  • Lateral transabdominal

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The use of analgesics for postoperative pain
Time Frame: Change in 24 hours after surgery
The total amount of analgesics used measured by use of Oxycodone (mg)
Change in 24 hours after surgery

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Helsinki University Central Hospital

Investigators

  • Principal Investigator: Päivi I Pakarinen, MD PhD, Helsinki University Central Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Anticipated)

May 1, 2016

Study Completion (Anticipated)

May 1, 2016

Study Registration Dates

First Submitted

January 18, 2016

First Submitted That Met QC Criteria

March 9, 2016

First Posted (Estimate)

March 10, 2016

Study Record Updates

Last Update Posted (Estimate)

March 10, 2016

Last Update Submitted That Met QC Criteria

March 9, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 98/13/03/03/2014

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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