Overview

This trial is active, not recruiting.

Condition postoperative pain
Treatments transumbilical removal of specimen via laparoscopy, lateral transabdominal removal of specimen via laparoscopy
Sponsor Helsinki University Central Hospital
Start date November 2014
End date May 2016
Trial size 42 participants
Trial identifier NCT02704663, 98/13/03/03/2014

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(Experimental)
Transumbilical removal of benign adnexal masses via laparoscopy.
transumbilical removal of specimen via laparoscopy Transumbilical
Transumbilical removal of a benign adnexal mass from the abdominal cavity in laparoscopy
(Active Comparator)
Lateral transabdominal removal of benign adnexal masses via laparoscopy.
lateral transabdominal removal of specimen via laparoscopy Lateral transabdominal
Lateral transabdominal removal of a benign adnexal mass from the abdominal cavity in laparoscopy

Primary Outcomes

Measure
The use of analgesics for postoperative pain
time frame: Change in 24 hours after surgery

Secondary Outcomes

Measure
Complications
time frame: The first six months after the surgical intervention
Nausea
time frame: Change in 24 hours after surgery
Vomiting
time frame: Change in 24 hours after surgery
Length of hospital stay in hours
time frame: Up to one week
Quality of life
time frame: At baseline and 6 months after the surgery
Cosmetic outcome
time frame: At baseline and 6 months after the surgery
Costs
time frame: During the surgery
Surgeon perception of both techniques
time frame: After one month after the operation
Length of need of postoperative pain medication
time frame: Change in one month after surgery
Postoperative pain scores
time frame: Change in 24 hours after surgery

Eligibility Criteria

Female participants from 20 years up to 60 years old.

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.

Additional Information

Official title Transumbilical Versus Lateral Transabdominal Removal of Benign Adnexal Masses Via Laparoscopy, a Randomized Trial
Principal investigator Päivi I Pakarinen, MD PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Helsinki University Central Hospital.